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1.  The long-term effectiveness of a lifestyle intervention in severely obese individuals 
The American journal of medicine  2013;126(3):236-242.e2.
Objective
Severe obesity (BMI≥40kg/m2) is a serious public health concern. Although bariatric surgery is an efficacious treatment approach, it is limited in reach; thus non-surgical treatment alternatives are needed. We examined the 4-year effects of an intensive lifestyle intervention on body weight and cardiovascular disease risk factors among severely obese, compared to overweight (25≤BMI<30), class I (30≤BMI<35), and class II obese (35≤BMI<40) participants.
Methods
5,145 individuals with type 2 diabetes (45–76 years, BMI≥25kg/m2) were randomized to an intensive lifestyle intervention or diabetes support and education. The lifestyle intervention received a behavioral weight loss program which included group and individuals meetings, a ≥10% weight loss goal, calorie restriction, and increased physical activity. Diabetes support and education received a less intense educational intervention. 4-year changes in body weight and cardiovascular disease risk factors were assessed.
Results
Across BMI categories, 4-year changes in body weight were significantly greater in lifestyle participants compared to diabetes support and education (p’s<0.05). At year 4, severely obese lifestyle participants lost 4.9±8.5% which was similar to class I (4.8±7.2%) and class II obese (4.4±7.6%) and significantly greater than overweight (3.4±7.0%; p<0.05). 4-year changes in LDL-cholesterol, triglycerides, diastolic blood pressure, HbA1c, and blood glucose were similar across BMI categories in lifestyle participants; however the severely obese had less favorable improvements in HDL-cholesterol (3.1±0.4mg/dL) and systolic blood pressure (−1.4±0.7mmHg) compared to the less obese (p’s<0.05).
Conclusion
Lifestyle interventions can result in important long-term weight losses and improvements in cardiovascular disease risk factors among a significant proportion of severely obese individuals.
doi:10.1016/j.amjmed.2012.10.010
PMCID: PMC3574274  PMID: 23410564
Severe obesity; weight loss; lifestyle intervention; diabetes; cardiovascular disease
2.  Binge eating and weight loss outcomes in overweight and obese individuals with type 2 diabetes: Results from the Look AHEAD trial 
Archives of general psychiatry  2008;65(12):1447-1455.
Context
Binge eating (BE) is common in overweight and obese individuals with type 2 diabetes yet little is known about how BE affects weight loss in this population.
Objective
To determine whether BE was related to 1-year weight losses in overweight and obese individuals with type 2 diabetes participating in an ongoing clinical trial.
Design and Setting
Look AHEAD is a randomized controlled trial examining the long-term effect of intentional weight loss on CVD in overweight and obese adults with type 2 diabetes.
Participants
Overweight and obese individuals, 45–76 years old, with type 2 diabetes (n=5145).
Interventions
Participants were randomly assigned to an intensive lifestyle intervention (ILI) or to enhanced usual care (DSE).
Main outcome measures
At baseline and 1-year, participants had their weight measured and completed a fitness test and self-report measures of BE and dietary intake. Four groups were created based on BE status at baseline and 1-year (Yes/Yes, No/No, Yes/No, No/Yes). Analyses controlled for baseline differences between binge eaters and non-binge eaters.
Results
Most individuals (85.4%) did not report BE at baseline or 1-year, 7.5% reported BE only at baseline, 3.7% reported BE at both times, and 3.4% reported BE only at 1-year, with no differences between ILI and DSE conditions (p=.14). Across ILI and DSE, greater weight losses were observed in participants who stopped BE at 1-year (5.3±.4 kg) and in those who reported no BE at either time point (4.8±.1 kg) than in those who continued to BE (3.1±.6 kg) and those who began BE at 1-year (3.0±.6 kg) (p=.0003). Post hoc analyses suggested these differences were due to changes in caloric intake.
Conclusions
Overweight and obese individuals with type 2 diabetes who stop binge eating appear just as successful at weight loss as non-binge eaters after one year of treatment.
doi:10.1001/archpsyc.65.12.1447
PMCID: PMC2791958  PMID: 19047532
3.  Cardiovascular Effects of Intensive Lifestyle Intervention in Type 2 Diabetes 
The New England journal of medicine  2013;369(2):145-154.
BACKGROUND
Weight loss is recommended for overweight and obese individuals with type 2 diabetes based on short-term studies, but long-term effects on cardiovascular disease remain unknown. We examined whether intensive lifestyle intervention for weight loss decreased cardiovascular morbidity and mortality in overweight or obese adults with type 2 diabetes.
METHODS
We randomly assigned 5,145 overweight or obese individuals with type 2 diabetes recruited at 16 US centers to intensive lifestyle intervention (the intervention group), which promoted weight loss through decreased calorie intake and increased physical activity, or diabetes support and education (the control group). The primary outcome was the first post-randomization occurrence of a composite cardiovascular outcome (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or hospitalized angina) over a planned maximum follow-up of 13.5 years.
RESULTS
The trial was stopped early based on a futility analysis when median follow-up was 9.6 years. Weight loss was greater in the intervention group than the control group throughout (8.6% vs. 0.7% at 1 year; 6.0% vs. 3.5% at study end). Intensive lifestyle intervention also produced greater reductions in hemoglobin A1c and greater initial improvements in fitness and all cardiovascular risk factors, except LDL cholesterol. The primary outcome occurred in 403 patients in the intervention group and in 418 in the control group (1.83/100 person-years and 1.92/100 person-years, respectively; hazard ratio 0.95; 95% CI 0.83 to 1.09, p=0.505).
CONCLUSION
In our study, intensive lifestyle intervention focused on weight loss did not reduce cardiovascular events in overweight or obese adults with type 2 diabetes. (Funded by the Department of Health and Human Services and others; ClinicalTrials.gov number, NCT00017953.)
doi:10.1056/NEJMoa1212914
PMCID: PMC3791615  PMID: 23796131
4.  One-Year Changes in Symptoms of Depression and Weight in Overweight/Obese Individuals with Type 2 Diabetes in the Look AHEAD study 
Obesity (Silver Spring, Md.)  2011;20(4):783-793.
Depressed individuals are frequently excluded from weight loss trials because of fears that weight reduction may precipitate mood disorders, as well as concerns that depressed participants will not lose weight satisfactorily. The present study examined participants in the Look AHEAD study to determine whether moderate weight loss would be associated with incident symptoms of depression and suicidal ideation, and whether symptoms of depression at baseline would limit weight loss at 1 year. Overweight/obese adults with type 2 diabetes (n=5145) were randomly assigned to an Intensive Lifestyle Intervention (ILI) or a usual care group, Diabetes Support and Education (DSE). Of these, 5129 participants completed the Beck Depression Inventory (BDI) and had their weight measured at baseline and 1 year. Potentially significant symptoms of depression were defined by a BDI score ≥10. Participants in ILI lost 8.6±6.9% of initial weight at 1 year, compared to 0.7±4.8% for DSE (P<0.001, effectsize=−1.33), and had a reduction of 1.4±4.7 points on the BDI, compared to 0.4±4.5 for DSE (P<0.001, effectsize=0.23). At 1 year, the incidence of potentially significant symptoms of depression was significantly (RR=0.66, 95%CI=0.5,0.8; P<0.001) lower in the ILI than DSE group (6.3% vs. 9.6%). In the ILI group, participants with and without symptoms of depression lost 7.8±6.7% and 8.7±6.9%, respectively, a difference not considered clinically meaningful. Intentional weight loss was not associated with the precipitation of symptoms of depression, but instead appeared to protect against this occurrence. Mild (or greater) symptoms of depression at baseline did not prevent overweight/obese individuals with type 2 diabetes from achieving significant weight loss.
doi:10.1038/oby.2011.315
PMCID: PMC3298842  PMID: 22016099
5.  Baseline Predictors of Missed Visits in the Look AHEAD Study 
Obesity (Silver Spring, Md.)  2014;22(1):131-140.
Objective
To identify baseline attributes associated with consecutively missed data collection visits during the first 48 months of Look AHEAD—a randomized, controlled trial in 5145 overweight/obese adults with type 2 diabetes designed to determine the long-term health benefits of weight loss achieved by lifestyle change.
Design and Methods
The analyzed sample consisted of 5016 participants who were alive at month 48 and enrolled at Look AHEAD sites. Demographic, baseline behavior, psychosocial factors, and treatment randomization were included as predictors of missed consecutive visits in proportional hazard models.
Results
In multivariate Cox proportional hazard models, baseline attributes of participants who missed consecutive visits (n=222) included: younger age ( Hazard Ratio [HR] 1.18 per 5 years younger; 95% Confidence Interval 1.05, 1.30), higher depression score (HR 1.04; 1.01, 1.06), non-married status (HR 1.37; 1.04, 1.82), never self-weighing prior to enrollment (HR 2.01; 1.25, 3.23), and randomization to minimal vs. intensive lifestyle intervention (HR 1.46; 1.11, 1.91).
Conclusions
Younger age, symptoms of depression, non-married status, never self-weighing, and randomization to minimal intervention were associated with a higher likelihood of missing consecutive data collection visits, even in a high-retention trial like Look AHEAD. Whether modifications to screening or retention efforts targeted to these attributes might enhance long-term retention in behavioral trials requires further investigation.
doi:10.1002/oby.20613
PMCID: PMC3943994  PMID: 23996977
randomized clinical trials; behavioral trial; retention; obesity
6.  Long Term Effects of a Lifestyle Intervention on Weight and Cardiovascular Risk Factors in Individuals with Type 2 Diabetes: Four Year Results of the Look AHEAD Trial 
Archives of internal medicine  2010;170(17):1566-1575.
Objective
Lifestyle interventions produce short-term improvements in glycemia and cardiovascular disease (CVD) risk factors in individuals with type 2 diabetes, but no long-term data are available. We examined the effects of a lifestyle intervention on changes in weight, fitness and cardiovascular (CVD) risk factors over 4 years.
Research Design and Methods
Look AHEAD is a multi-center randomized clinical trial comparing the effects of intensive lifestyle intervention (ILI) and diabetes support and education (DSE, control group) on the incidence of major CVD events in 5145 individuals with type diabetes, aged 45 to 76 years, who were overweight or obese (BMI > 25 kg/m2). Participants have ongoing intervention and annual assessments.
Results
Averaged across four years of follow-up, participants in ILI had greater percent weight losses than those in DSE (−6.15% vs −0.88%, p<.0001) and greater improvements in fitness (12.74% vs. 1.96%, p < .0001), HbA1c (A1c, −0.36% vs. 0.09%, p<.0001), systolic blood pressure (SBP, −5.33 vs. −2.97 mmHg, p<.0001), diastolic blood pressure (DBP, −2.92 vs. −2.48 mmHg, p<.012), HDL-cholesterol (HDL-C, 3.67 vs. 1.97 mg/dl, p<.0001), and triglycerides (−25.56 vs. −19.75 mg/dl, p<.0006). Reductions in LDL-C were greater in DSE than ILI (−11.27 vs. −12.84 mg/dl, p=.009), but adjusted for medication use, changes in LDL-C did not differ between the two groups. Although the greatest benefits were often seen at 1 year, ILI participants still had greater improvements than DSE in weight, fitness, HbA1c, SBP, and HDL-C at 4 years.
Conclusions
Intensive lifestyle intervention can produce and maintain significant weight losses and improvements in fitness in individuals with type 2 diabetes. Across four years of follow-up, those in ILI had better overall levels of glycemic control, blood pressure, HDL-C and triglycerides, and thus spent considerable time with lower CVD risk. Whether this translates to reduction in CVD events will ultimately be addressed by the Look AHEAD study.
doi:10.1001/archinternmed.2010.334
PMCID: PMC3084497  PMID: 20876408
7.  Eight-Year Weight Losses with an Intensive Lifestyle Intervention: The Look AHEAD Study 
Obesity (Silver Spring, Md.)  2014;22(1):5-13.
Objective
To evaluate 8-year weight losses achieved with intensive lifestyle intervention (ILI) in the Look AHEAD (Action for Health in Diabetes) study.
Design and Methods
Look AHEAD assessed the effects of intentional weight loss on cardiovascular morbidity and mortality in 5,145 overweight/obese adults with type 2 diabetes, randomly assigned to ILI or usual care (i.e., diabetes support and education [DSE]). The ILI provided comprehensive behavioral weight loss counseling over 8 years; DSE participants received periodic group education only.
Results
All participants had the opportunity to complete 8 years of intervention before Look AHEAD was halted in September 2012; ≥88% of both groups completed the 8-year outcomes assessment. ILI and DSE participants lost (mean±SE) 4.7±0.2% and 2.1±0.2% of initial weight, respectively (p<0.001) at year 8; 50.3% and 35.7%, respectively, lost ≥5% (p<0.001), and 26.9% and 17.2%, respectively, lost ≥10% (p<0.001). Across the 8 years ILI participants, compared with DSE, reported greater practice of several key weight-control behaviors. These behaviors also distinguished ILI participants who lost ≥10% and kept it off from those who lost but regained.
Conclusions
Look AHEAD’s ILI produced clinically meaningful weight loss (≥5%) at year 8 in 50% of patients with type 2 diabetes and can be used to manage other obesity-related co-morbid conditions.
Trial Registration
clinicaltrials.gov Identifier: NCT00017953
doi:10.1002/oby.20662
PMCID: PMC3904491  PMID: 24307184
8.  Baseline characteristics of the randomized cohort from the Look AHEAD (Action for Health in Diabetes) Research Study 
OBJECTIVE
Look AHEAD (Action for Health in Diabetes) Study is a 16-center randomized clinical trial in overweight and obese individuals with type 2 diabetes designed to evaluate the long-term effects (up to 11.5 years) of an intensive weight loss intervention on the time to incidence for major cardiovascular events.
RESEARCH DESIGN AND METHODS
Eligibility requirements are diagnosis of type 2 diabetes (determined by self-report and verification) in individuals age 45–74 years, BMI >25 kg/m2 (>27 kg/m2 if currently taking insulin). The intensive lifestyle intervention is designed to achieve and maintain weight loss through decreased caloric intake and increased physical activity. The study is designed to provide 90% probability of detecting an 18% difference in major cardiovascular disease event rates in patients randomized to the intensive lifestyle intervention compared to the control group receiving standard diabetes support and education.
RESULTS
The 5145 participants who were randomized between 2001 and 2004 were 63.3 % white, 15.6% African-American, 13.2% Hispanic, 5.1% American Indian, and 1.0% Asian-American, which closely paralleled the ethnic distribution of diabetes in the NHANES 1999–2000 survey. Their average age at entry was 59 ± 6.8 years (mean ± SD), and 60% were women. There were 31.5% between 45-54 years of age, 51.5% were 55–64, and 17.0% ≥65 years of age. There were 14.6% of participants who were taking insulin at the time of randomization and 14.1 % had a history of cardiovascular disease. More men (21.2%) than women (9.3%) had a history of cardiovascular disease. Few participants (4.4%) were current cigarette smokers compared to 16.2% in the NHANES 1999–2000 survey. Furthermore, 65% of participants had a first-degree relative with diabetes. Overall, BMI averaged 36 ± 5.9 kg/m2 at baseline with 83.6% of the men and 86.0% of women having a BMI >30 kg/m2 and 17.9% of men and 25.4% of women having a BMI > 40 kg/m2.
CONCLUSIONS
The Look AHEAD study has successfully randomized a large cohort of participants who have type 2 diabetes with a wide distribution of age, obesity, ethnicity and racial background.
doi:10.3132/dvdr.2006.031
PMCID: PMC2660200  PMID: 17160917
9.  Effect of a 12-Month Intensive Lifestyle Intervention on Hepatic Steatosis in Adults With Type 2 Diabetes 
Diabetes Care  2010;33(10):2156-2163.
OBJECTIVE
Weight loss through lifestyle changes is recommended for nonalcoholic fatty liver disease (NAFLD). However, its efficacy in patients with type 2 diabetes is unproven.
RESEARCH DESIGN AND METHODS
Look AHEAD (Action for Health in Diabetes) is a 16-center clinical trial with 5,145 overweight or obese adults with type 2 diabetes, who were randomly assigned to an intensive lifestyle intervention (ILI) to induce a minimum weight loss of 7% or a control group who received diabetes support and education (DSE). In the Fatty Liver Ancillary Study, 96 participants completed proton magnetic resonance spectroscopy to quantify hepatic steatosis and tests to exclude other causes of liver disease at baseline and 12 months. We defined steatosis >5.5% as NAFLD.
RESULTS
Participants were 49% women and 68% white. The mean age was 61 years, mean BMI was 35 kg/m2, mean steatosis was 8.0%, and mean aspartate aminotransferase (AST) and alanine aminotransferase (ALT) were 20.5 and 24.2 units/l, respectively. After 12 months, participants assigned to ILI (n = 46) lost more weight (−8.5 vs. −0.05%; P < 0.01) than those assigned to DSE and had a greater decline in steatosis (−50.8 vs. −22.8%; P = 0.04) and in A1C (−0.7 vs. −0.2%; P = 0.04). There were no significant 12-month changes in AST or ALT levels. At 12 months, 26% of DSE participants and 3% (1 of 31) of ILI participants without NAFLD at baseline developed NAFLD (P < 0.05).
CONCLUSIONS
A 12-month intensive lifestyle intervention in patients with type 2 diabetes reduces steatosis and incident NAFLD.
doi:10.2337/dc10-0856
PMCID: PMC2945152  PMID: 20664019
10.  Effect of the Look AHEAD Study Intervention on Medication Use and Related Cost to Treat Cardiovascular Disease Risk Factors in Individuals With Type 2 Diabetes 
Diabetes Care  2010;33(6):1153-1158.
OBJECTIVE
To examine the effect of a lifestyle intervention to produce weight loss and increased physical fitness on use and cost of medications to treat cardiovascular disease (CVD) risk factors in people with type 2 diabetes.
RESEARCH DESIGN AND METHODS
Look AHEAD is a multicenter randomized controlled trial of 5,145 overweight or obese individuals with type 2 diabetes, aged 45–76 years. An intensive lifestyle intervention (ILI) involving group and individual meetings to achieve and maintain weight loss through decreased caloric intake and increased physical activity was compared with a diabetes support and education (DSE) condition. Medications prescribed to treat diabetes, hypertension, and hyperlipidemia were compared at baseline and 1 year. Medication costs were conservatively estimated using prices from a national online pharmacy.
RESULTS
Participants randomized to an ILI had significantly greater improvements in CVD risk parameters and reduced medication use and cost compared with those assigned to DSE. At 1 year, average number of medications prescribed to treat CVD risk factors was 3.1 ± 1.8 for the ILI group and 3.6 ± 1.8 for the DSE group (P < 0.0001), with estimated total monthly medication costs of $143 and $173, respectively (P < 0.0001). DSE participants meeting optimal care goals at 1 year were taking an average of 3.8 ± 1.6 medications at an estimated cost of $194/month. ILI participants at optimal care required fewer medications (3.2 ± 1.7) at lower cost ($154/month) (P < 0.001).
CONCLUSIONS
At 1 year, ILI significantly improved CVD risk factors, while at the same time reduced medication use and cost. Continued intervention and follow-up will determine whether these changes are maintained and reduce cardiovascular risk.
doi:10.2337/dc09-2090
PMCID: PMC2875414  PMID: 20332353
11.  Impact of a Weight Management Program on Health-related Quality of Life In Overweight Adults with Type 2 Diabetes 
Archives of internal medicine  2009;169(2):163-171.
Context
Inconsistent findings have been reported regarding improved health-related quality of life (HRQOL) following weight loss.
Objective
To test the efficacy of a weight management program for improving HRQOL in overweight/obese adults diagnosed with type 2 diabetes.
Design
Randomized multi-site clinical trial with two treatment arms and blinded measurements at baseline and end of Year 1.
Setting
Study was conducted at 16 outpatient research centers.
Participants
Total of 5,145 participants (mean age = 58.7±6.9 yr; mean BMI = 36.0±5.9; % women = 59.5%; % white = 63.3%) were randomized to two treatment arms.
Intervention
The two treatment arms were: Intensive Lifestyle Intervention 1 and Diabetes Support and Education (DSE).
Main Outcome Measures
SF-36, physical (PCS) and mental health (MCS) summary scores, and Beck Depression Inventory-II (BDI-II) scores. Baseline means were: PCS = 47.9±7.9; MCS = 54.0±8.1; and BDI-II = 5.7±5.0.
Results
HRQOL, as measured by PCS and BDI-II scores, improved (p<0.001) in the ILI arm compared to the DSE arm. The largest effect was observed for PCS (difference = −2.91, 99% CI: −3.44 ~ −2.37). HRQOL improved greatest in participants with the lowest baseline levels of quality of life. Changes in weight (ILI = −8.77±8.2 kg; DSE = −0.86±5.0 kg), improved fitness, and improved physical complaints mediated treatment effects associated with BDI-II and PCS.
Conclusions
HRQOL was significantly improved in overweight adults diagnosed with type 2 diabetes by enrollment in a weight management program that yielded significant weight loss, improved physical fitness, and reduced physical complaints. Trial Registration: NCT00017953
doi:10.1001/archinternmed.2008.544
PMCID: PMC2705948  PMID: 19171813
12.  Four-Year Weight Losses in the Look AHEAD Study: Factors Associated with Long-Term Success 
Obesity (Silver Spring, Md.)  2011;19(10):1987-1998.
This report provides a further analysis of the year 4 weight losses in the Look AHEAD (Action for Health in Diabetes) study and identifies factors associated with long-term success. A total of 5145 overweight/obese men and women with type 2 diabetes were randomly assigned to an intensive lifestyle intervention (ILI) or a usual care group, referred to as Diabetes Support and Education (DSE). ILI participants were provided approximately weekly group or individual treatment in year 1; continued but less frequent contact was provided in years 2–4. DSE participants received three group educational sessions in all years. As reported previously, at year 4, ILI participants lost an average of 4.7% of initial weight, compared with 1.1% for DSE (p<0.0001). More ILI than DSE participants lost ≥5% (46% vs 25%, p<0.0001) and ≥10% (23% vs 10%, p<0.0001) of initial weight. Within the ILI, acheivement of both the 5% and 10% categorical weight losses at year 4 was strongly related to meeting these goals at year 1. A total of 887 participants in ILI lost ≥10% at year 1, of whom 374 (42.2%) achieved this loss at year 4. Participants who maintained the loss, compared with those who did not, attended more treatment sessions and reported more favorable physical activity and food intake at year 4. These results provide critical evidence that a comprehensive lifestyle intervention can induce clinically significant weight loss (i.e., ≥5%) in overweight/obese participants with type 2 diabetes and maintain this loss in more than 45% of patients at 4 years.
doi:10.1038/oby.2011.230
PMCID: PMC3183129  PMID: 21779086
weight loss; weight maintenance; lifestyle modification; prediction
13.  The Look AHEAD Study: A Description of the Lifestyle Intervention and the Evidence Supporting It 
Obesity (Silver Spring, Md.)  2006;14(5):737-752.
The Look AHEAD (Action for Health in Diabetes) study is a multi-center, randomized controlled trial, designed to determine whether intentional weight loss reduces cardiovascular morbidity and mortality in overweight individuals with type 2 diabetes. The study began in 2001 and is scheduled to conclude in 2012. A total of 5,145 participants, with a mean age of 60 years and body mass index of 36.0 kg/m2, have been randomly assigned to a lifestyle intervention or to enhanced usual care condition (i.e., Diabetes Support and Education). This article describes the lifestyle intervention and the empirical evidence to support it. The two principal intervention goals are to induce a mean loss ≥ 7% of initial weight and to increase participants’ moderately-intense physical activity to ≥ 175 minutes a week. For the first 6 months, participants attend one individual and three group sessions per month and are encouraged to replace two meals and one snack a day with liquid shakes and meal bars. From months 7−12, they attend one individual and two group meetings per month and continue to replace one meal per day (which is recommended for the duration of the program). Starting at month 7, more intensive behavioral interventions, as well as weight loss medication, are available from a toolbox, designed to help participants with limited weight loss. In years 2−4, treatment is provided mainly on an individual basis and includes at least one on-site visit per month and a second contact by telephone, mail, or e-mail. Short-term (6−8 weeks) refresher groups and motivational campaigns also are offered three times yearly to help participants reverse small weight gains. After year 4, participants are offered monthly individual visits, as well as one refresher group and one campaign a year. The intervention is delivered by a multi-disciplinary team that includes medical staff who monitor participants at risk of hypoglycemic episodes. The study's evidence-based protocol should be of use to researchers, as well as to practitioners who care for overweight individuals with type 2 diabetes.
doi:10.1038/oby.2006.84
PMCID: PMC2613279  PMID: 16855180
weight loss; diet; physical activity; lifestyle modification; weight maintenance
14.  Effect of a Lifestyle Intervention on Change in Cardiorespiratory Fitness in Adults with Type 2 Diabetes: Results from the Look AHEAD Study 
Objective
To examine the effect of an intensive lifestyle weight loss intervention (ILI) compared to diabetes support and education (DSE) on changes in fitness and physical activity in the Look AHEAD trial.
Design
Randomized clinical trial to compare a lifestyle intervention for weight loss with a diabetes support and education condition in individuals with type 2 diabetes.
Subjects
Data from 4,376 overweight or obese adults with type 2 diabetes (age = 58.7±6.8 years, BMI = 35.8±5.8 kg/m2) who completed one-year of the Look AHEAD trial and had available fitness data were analyzed.
Intervention
Subjects were randomly assigned to DSE or ILI. DSE received standard-care plus 3 education sessions over the one-year period. ILI included individual and group contact throughout the year, restriction in energy intake, and 175 min/wk of prescribed physical activity.
Measurements
Fitness was assessed using a submaximal graded exercise test. Physical activity was assessed via questionnaire in a subset of 2,221 subjects.
Results
Change in fitness was statistically greater in ILI vs. DSE after adjustment for baseline fitness (20.9% vs. 5.7%) (p<0.0001). Multivariate analysis showed that change in fitness was greater in overweight vs. obese Class II and III (p<0.05). Physical activity increased by 892±1694 kcal/wk in ILI vs. 108±1254 kcal/wk in DSE (p<0.01). Changes in fitness (r=0.41) and physical activity (r=0.42) were significantly correlated with weight loss (p<0.0001).
Conclusions
The ILI was effective in increasing physical activity and improving cardiorespiratory fitness in overweight and obese individuals with type 2 diabetes. This effect may add to weight loss in improving metabolic control in patients in lifestyle intervention programs.
doi:10.1038/ijo.2008.280
PMCID: PMC2656590  PMID: 19153582
fitness; diabetes; obesity; physical activity; exercise
15.  Constructing Common Cohorts From Trials with Overlapping Eligibility Criteria: Implications for Comparing Effect Sizes Between Trials 
Background
Comparing findings from separate trials is necessary to choose among treatment options, however differences among study cohorts may impede these comparisons.
Purpose
As a case study, to examine the overlap of study cohorts in two large randomized controlled clinical trials that assess interventions to reduce risk of major cardiovascular disease events in adults with type 2 diabetes in order to explore the feasibility of cross-trial comparisons
Methods
The Action for Health in Diabetes (Look AHEAD) and The Action to Control Cardiovascular Risk in Diabetes (ACCORD) trials enrolled 5,145 and 10,251 adults with type 2 diabetes, respectively. Look AHEAD assesses the efficacy of an intensive lifestyle intervention designed to produce weight loss; ACCORD tests pharmacological therapies for control of glycemia, hyperlipidemia, and hypertension. Incidence of major cardiovascular disease events is the primary outcome for both trials. A sample was constructed to include participants from each trial who appeared to meet eligibility criteria and be appropriate candidates for the other trial’s interventions. Demographic characteristics, health status, and outcomes of members and non-members of this constructed sample were compared.
Results
Nearly 80% of Look AHEAD participants were projected to be ineligible for ACCORD; ineligibility was primarily due to better glycemic control or no early history of cardiovascular disease. Approximately 30% of ACCORD participants were projected to be ineligible for Look AHEAD, often for reasons linked to poorer health. The characteristics of participants projected to be jointly eligible for both trials continued to reflect differences between trials according to factors likely linked to retention, adherence, and study outcomes.
Limitations
Accurate ascertainment of cross-trial eligibility was hampered by differences between protocols.
Conclusions
Despite several similarities, the Look AHEAD and ACCORD cohorts represent distinct populations. Even within the subsets of participants who appear to be eligible and appropriate candidates for trials of both modes of intervention, differences remained. Direct comparisons of results from separate trials of lifestyle and pharmacologic interventions are compromised by marked differences in enrolled cohorts.
doi:10.1177/1740774509344440
PMCID: PMC3254056  PMID: 19737845
Randomized clinical trials; Cross-trial comparisons; Type 2 diabetes
16.  Translating the Diabetes Prevention Program Lifestyle Intervention for Weight Loss into Primary Care: A Randomized Trial 
JAMA internal medicine  2013;173(2):10.1001/2013.jamainternmed.987.
Background
The Diabetes Prevention Program (DPP) lifestyle intervention reduced the incidence of type 2 diabetes among high risk adults by 58%, with weight loss as the dominant predictor. However, it has not been adequately translated into primary care.
Methods
We evaluated two adapted DPP lifestyle interventions among overweight/obese adults who were recruited from one primary care clinic and had prediabetes and/or metabolic syndrome. Participants were randomized to (1) a coach-led group intervention (n=79), (2) a self-directed DVD intervention (n=81), or (3) usual care (n=81). During a 3-month intensive intervention phase, the DPP-based behavioral weight loss curriculum was delivered by lifestyle coach-led small groups or home-based DVD. During the maintenance phase, participants in both interventions received lifestyle change coaching and support remotely–through secure email within an electronic health record system and the American Heart Association Heart360 Web site for weight and physical activity goal setting and self-monitoring. The primary outcome was change in body mass index (BMI) from baseline to 15 months.
Results
At baseline, participants had a mean (±SD) age of 52.9±10.6 years and mean BMI 32.0±5.4 kg/m2 with 47% female, 78% Non-Hispanic white, and 17% Asian/Pacific Islander. At month 15, the mean (±SE) change in BMI from baseline was −2.2±0.3 kg/m2 in the coach-led group (vs. −0.9±0.3 kg/m2 in the usual care group, P<0.001) and −1.6±0.3 kg/m2 in the self-directed group (P=0.02 vs. usual care). The percentages of participants who achieved the 7% DPP-based weight loss goal were 37.0% (P=0.003) and 35.9% (P=0.004) in the coach-led and self-directed groups, respectively, versus 14.4% in the usual care group. Both interventions also achieved greater net improvements in waist circumference and fasting plasma glucose.
Conclusions
Proven effective in a primary care setting, the two DPP-based lifestyle interventions are readily scalable and exportable with potential for substantial clinical and public health impact.
Trial Registration
Clinicaltrials.gov identifier: NCT00842426
doi:10.1001/2013.jamainternmed.987
PMCID: PMC3856315  PMID: 23229846
17.  Reduction in Weight and Cardiovascular Disease Risk Factors in Individuals With Type 2 Diabetes: One-Year Results of the Look AHEAD Trial 
Diabetes care  2007;30(6):1374-1383.
Objective
The effectiveness of intentional weight loss in reducing cardiovascular disease (CVD) events in type 2 diabetes is unknown. This report describes one-year changes in CVD risk factors in a trial designed to examine the long-term effects of an intensive lifestyle intervention on the incidence of major CVD events.
Research Design and Methods
A multi-centered randomized controlled trial of 5,145 individuals with type 2 diabetes, aged 45–74 years, with body mass index ≥25 kg/m2 (≥27 kg/m2 if taking insulin). An Intensive Lifestyle Intervention (ILI) involving group and individual meetings to achieve and maintain weight loss through decreased caloric intake and increased physical activity was compared to a Diabetes Support and Education (DSE) condition.
Results
Participants assigned to ILI lost an average 8.6% of their initial weight versus 0.7% in DSE group (p<0.001). Mean fitness increased in ILI by 20.9% versus 5.8% in DSE (p<0.001). A greater proportion of ILI participants had reductions in diabetes, hypertension, and lipid-lowering medicines. Mean HbA1c dropped from 7.3% to 6.6% in ILI (p<0.001) versus from 7.3% to 7.2% in DSE. Systolic and diastolic pressure, triglycerides, HDL-cholesterol, and urine albumin/creatinine improved significantly more in ILI than DSE participants (all p<0.01).
Conclusions
At 1 year, ILI resulted in clinically significant weight loss in persons with type 2 diabetes. This was associated with improved diabetes control and CVD risk factors and reduced medicine use in ILI versus DSE. Continued intervention and follow-up will determine whether these changes are maintained and will reduce CVD risk.
Trial Registration
clinicaltrials.gov Identifier: NCT00017953
doi:10.2337/dc07-0048
PMCID: PMC2665929  PMID: 17363746
18.  A 1-Year Lifestyle Intervention for Weight Loss in Individuals With Type 2 Diabetes Reduces High C-Reactive Protein Levels and Identifies Metabolic Predictors of Change 
Diabetes Care  2010;33(11):2297-2303.
OBJECTIVE
We examined whether a 1-year intensive lifestyle intervention (ILI) for weight loss reduced elevated high-sensitivity C-reactive protein (hs-CRP) levels in obese individuals with diabetes and identified metabolic and fitness predictors of hs-CRP change.
RESEARCH DESIGN AND METHODS
Look AHEAD (Action for Health in Diabetes) is an ongoing multicenter clinical trial examining the effects of weight loss achieved through ILI on cardiovascular events and overall mortality in obese/overweight adults with type 2 diabetes. We report on 1,759 Look AHEAD participants who had hs-CRP and fitness data at baseline and 1 year. Subjects were randomly assigned to ILI or to usual care (diabetes support and education [DSE]). ILI involved frequent counseling to increase moderate-intensity exercise to 175 min/week, reduce caloric and saturated fat intake, and change macronutrient composition to improve glycemic control.
RESULTS
ILI reduced median hs-CRP by 43.6% from baseline to 1 year, compared with a 16.7% reduction with DSE (P < 0.001). ILI decreased weight (8.8%), A1C (0.7%), and triglycerides (17%) and increased fitness (19%) and HDL cholesterol (7.5%) (P < 0.0001 vs. changes with DSE). Changes in adiposity and glucose control with ILI remained independent predictors of hs-CRP change at 1 year (P < 0.0001 for each) after adjustment for demographics, smoking, cardiovascular history, statin and thiazolidinedione use, and changes in fitness and lipid control. Neither statin nor insulin therapy modified the association between ILI and hs-CRP.
CONCLUSIONS
A 1-year lifestyle intervention for weight loss in obese individuals with diabetes was associated with substantial reductions in hs-CRP. Improved glycemic control and reduced adiposity had comparable effects on hs-CRP change.
doi:10.2337/dc10-0728
PMCID: PMC2963483  PMID: 20682679
19.  Challenges in the Management of Type 2 Diabetes Mellitus and Cardiovascular Risk Factors in Obese Subjects: What Is the Evidence and What Are the Myths? 
The increasing worldwide prevalence of diabetes mellitus and obesity has projected concerns for increasing burden of cardiovascular morbidity and mortality. The dangers of obesity in adults and children have received more attention than ever in the recent years as more research data becomes available regarding the long-term health outcomes. Weight loss in obese and overweight subjects can be induced via intensive lifestyle modifications, medications, and/or bariatric surgery. These methods have been shown to confer overall health benefits; however, their effect on remission of preexisting diabetes mellitus and reduction in cardiovascular risk has been variable. Recent research data has offered a much better understanding of the pathophysiology and outcomes of these management strategies in obese patients. In this paper, the authors have summarized the results of major studies on remission of type 2 diabetes mellitus and reduction of cardiovascular events by weight loss induced by different methods. Furthermore, the paper aims to clarify various prevailing myths and practice patterns about obesity management among clinicians.
doi:10.1155/2013/856793
PMCID: PMC3691899  PMID: 23840207
20.  Effect of One Year of an Intentional Weight Loss Intervention on Bone Mineral Density in Type 2 Diabetes: Results from the Look AHEAD Randomized Trial 
Intentional weight loss is an important component of treatment for overweight patients with type 2 diabetes, but the effects on bone density are not known. We used data from the Look AHEAD trial to determine the impact of an intensive lifestyle weight loss intervention (ILI) compared to diabetes support and education (DSE) on changes in bone mineral density (BMD) over 12 months. Overweight and obese adults with type 2 diabetes were randomly assigned to ILI or DSE. In a sub-study of BMD conducted at 5 of 16 clinical centers, hip, spine and whole body dual x-ray absorptiometry scans were obtained at baseline and one year later on 642 of 739 ILI and 632 of 740 DSE participants. At baseline, mean age was 58.4 years, and average body mass index was 35.2 kg/m2. Total hip BMD T-score was <−2.5 in 1% and <−1.0 in 8%. At one year, weight loss was greater in ILI than DSE (−8.6% versus −0.7%), and glycemic control and fitness were also improved. Bone loss over one year was greater in ILI at the total hip (−1.4% versus −0.4%; p<0.001) and femoral neck (−1.5% versus −0.8%; p=0.009), but change in BMD for the lumbar spine and whole body did not differ between groups. In ILI, bone loss at the total hip was independently associated with weight loss in men and women and with poorer glycemic control in men, but was not associated with changes in fitness. One year of an intensive lifestyle intervention in adults with type 2 diabetes, resulting in weight loss, was associated with a modest increase in hip bone loss despite improved fitness and glycemic control.
doi:10.1002/jbmr.1483
PMCID: PMC3410035  PMID: 22354851
bone mineral density; weight loss; type 2 diabetes; obesity; glycemic control; physical fitness
21.  Effects of Diet and Physical Activity Interventions on Weight Loss and Cardiometabolic Risk Factors in Severely Obese Adults 
Context
The prevalence of severe obesity is increasing markedly, as is prevalence of comorbid conditions such as hypertension and type 2 diabetes mellitus; however, apart from bariatric surgery and pharmacotherapy, few clinical trials have evaluated the treatment of severe obesity.
Objective
To determine the efficacy of a weight loss and physical activity intervention on the adverse health risks of severe obesity.
Design, Setting, and Participants
Single-blind randomized trial conducted from February 2007 through April 2010 at the University of Pittsburgh. Participants were 130 (37% African American) severely obese (class II or III) adult participants without diabetes recruited from the community.
Interventions
One-year intensive lifestyle intervention consisting of diet and physical activity. One group (initial physical activity) was randomized to diet and physical activity for the entire 12 months; the other group (delayed physical activity) had the identical dietary intervention but with physical activity delayed for 6 months.
Main Outcome Measures
Changes in weight. Secondary outcomes were additional components comprising cardiometabolic risk, including waist circumference, abdominal adipose tissue, and hepatic fat content.
Results
Of 130 participants randomized, 101 (78%) completed the 12-month follow-up assessments. Although both intervention groups lost a significant amount of weight at 6 months, the initial-activity group lost significantly more weight in the first 6 months compared with the delayed-activity group (10.9 kg [95% confidence interval {CI}, 9.1–12.7] vs 8.2 kg [95% CI, 6.4–9.9], P=.02 for group×time interaction). Weight loss at 12 months, however, was similar in the 2 groups (12.1 kg [95% CI, 10.0–14.2] vs 9.9 kg [95% CI, 8.0–11.7], P=.25 for group×time interaction). Waist circumference, visceral abdominal fat, hepatic fat content, blood pressure, and insulin resistance were all reduced in both groups. The addition of physical activity promoted greater reductions in waist circumference and hepatic fat content.
Conclusion
Among patients with severe obesity, a lifestyle intervention involving diet combined with initial or delayed initiation of physical activity resulted in clinically significant weight loss and favorable changes in cardiometabolic risk factors.
doi:10.1001/jama.2010.1505
PMCID: PMC3082279  PMID: 20935337
22.  Behavioral and pharmacologic therapies for obesity 
Nature reviews. Endocrinology  2010;6(10):578-588.
This article reviews novel developments in the behavioral and pharmacologic treatment of obesity and explores the potential contribution of genomics research to weight control. A comprehensive program of lifestyle modification, comprised of diet, physical activity and behavior therapy, induces a mean loss of 7–10% of initial weight in individuals with obesity. Two trials demonstrated that weight loss of this magnitude, combined with increased physical activity, substantially reduced the risk of developing type 2 diabetes mellitus in individuals with impaired glucose tolerance. A third trial is now investigating whether a lifestyle intervention will reduce cardiovascular morbidity and mortality in overweight individuals who already have diabetes mellitus. Pharmacotherapy is recommended, in some patients, as an adjunct to lifestyle modification. Two medications—orlistat and sibutramine—are currently approved in the US for long-term weight loss. Both are efficacious when combined with lifestyle modification, although health concerns have been raised about the use of sibutramine. Several novel combination therapies, which target multiple hypothalamic pathways that regulate appetite and body weight, are currently under investigation. Genomic studies provide further evidence for the role of these pathways in the regulation of body weight. Identification of new genes controlling satiety and energy expenditure may yield valuable clues for the development of novel pharmacologic treatments.
doi:10.1038/nrendo.2010.121
PMCID: PMC3031864  PMID: 20680034
23.  Design of a family-based lifestyle intervention for youth with type 2 diabetes: the TODAY study 
Type 2 diabetes is associated with obesity and is increasing at an alarming rate in youth. Although weight loss through lifestyle change is one of the primary treatment recommendations for adults with type 2 diabetes, the efficacy of this approach has not been tested with youth. This paper provides a summary of the reviews and meta-analyses of pediatric weight-loss interventions that informed the design and implementation of an intensive, family-based lifestyle weight management program for adolescents with type 2 diabetes and their families developed for the Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY) study. A total of 1092 youth have been screened, and 704 families have been randomized for inclusion in this 15-center clinical trial sponsored by the National Institutes of Health. The TODAY study is designed to test three approaches (metformin, metformin plus rosiglitazone and metformin plus an intensive lifestyle intervention) to the treatment of a diverse cohort of youth, 10–17 years of age, within 2 years of their diagnosis. The principal goal of the TODAY Lifestyle Program (TLP) is to decrease baseline weight of youth by 7–10% (or the equivalent for children who are growing in height) through changes in eating and physical activity habits, and to sustain these changes through ongoing treatment contact. The TLP is implemented by interventionists called Personal Activity and Nutrition Leaders (PALs) and delivered to youth with type 2 diabetes, and at least one family support person. The TLP provides a model for taking a comprehensive, continuous care approach to the treatment of severe overweight in youth with comorbid medical conditions such as type 2 diabetes.
doi:10.1038/ijo.2009.195
PMCID: PMC2822093  PMID: 19823189
pediatric; chronic illness; childhood obesity; adolescents
24.  Four-Year Change in Cardiorespiratory Fitness and Influence on Glycemic Control in Adults With Type 2 Diabetes in a Randomized Trial 
Diabetes Care  2013;36(5):1297-1303.
OBJECTIVE
To examine an intensive lifestyle intervention (ILI) compared with diabetes support and education (DSE) on 4-year change in fitness and physical activity (PA), and to examine the effect of change in fitness and PA, adjusting for potential confounders, on glycemic control in the Look AHEAD Trial.
RESEARCH DESIGN AND METHODS
Subjects were overweight/obese adults with type 2 diabetes mellitus (T2DM) with available fitness data at 4 years (n = 3,942).This clinical trial randomized subjects to DSE or ILI. DSE subjects received standard care plus information related to diet, PA, and social support three times per year. ILI subjects received weekly intervention contact for 6 months, which was reduced over the 4-year period, and were prescribed diet and PA. Measures included weight, fitness, PA, and HbA1c.
RESULTS
The difference in percent fitness change between ILI and DSE at 4 years was significant after adjustment for baseline fitness and change in weight (3.70 vs. 0.94%; P < 0.01). At 4 years, PA increased by 348 (1,562) kcal/week in ILI vs. 105 (1,309) kcal/week in DSE (P < 0.01). Fitness change at 4 years was inversely related to change in HbA1c after adjustment for clinical site, treatment, baseline HbA1c, prescribed diabetes medication, baseline fitness, and weight change (P < 0.01). Change in PA was not related to change in HbA1c.
CONCLUSIONS
A 4-year ILI increased fitness and PA in overweight/obese individuals with T2DM. Change in fitness was associated with improvements in glycemic control, which provides support for interventions to improve fitness in adults with T2DM.
doi:10.2337/dc12-0712
PMCID: PMC3631819  PMID: 23223405
25.  Marine ω-3 Fatty Acid Intake 
Diabetes Care  2009;33(1):197-199.
OBJECTIVE
To examine usual marine ω-3 fatty acid (mO-3FA) intake in individuals with diabetes; its association with adiposity, lipid, and glucose control; and its changes with behavioral lifestyle intervention for weight loss.
RESEARCH DESIGN AND METHODS
Cross-sectional and 1-year longitudinal analyses were performed on 2,397 Look AHEAD (Action for Health in Diabetes) participants. Look AHEAD is a cardiovascular outcome trial evaluating the effects of intensive lifestyle intervention for weight loss in overweight/obese subjects with type 2 diabetes.
RESULTS
Baseline mO-3FA intake was 162 ± 138 mg/day. It was inversely associated with triglycerides (β = −0.41, P < 0.001) and weakly with HDL (β = 4.14, P = 0.050), after multiple covariate adjustment. One-year mO-3FA and fried/sandwich fish intake decreased with intensive lifestyle intervention (P < 0.001).
CONCLUSIONS
mO-3FA intake in Look AHEAD participants was low but associated favorably with lipids. These results encourage investigation on the potential benefits of increasing mO-3FA intake in lifestyle interventions for weight loss in individuals with diabetes.
doi:10.2337/dc09-1235
PMCID: PMC2797972  PMID: 19841042

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