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1.  Comparison of a Mindful Eating Intervention to a Diabetes Self-Management Intervention Among Adults With Type 2 Diabetes: A Randomized Controlled Trial 
Mindful eating may be an effective intervention for increasing awareness of hunger and satiety cues, improving eating regulation and dietary patterns, reducing symptoms of depression and anxiety, and promoting weight loss. Diabetes self-management education (DSME), which addresses knowledge, self-efficacy, and outcome expectations for improving food choices, also may be an effective intervention for diabetes self-care. Yet few studies have compared the impact of mindful eating to a DSME-based treatment approach on patient outcomes. Adults 35 to 65 years old with type 2 diabetes for ≥1 year not requiring insulin therapy were recruited from the community and randomly assigned to treatment group. The impact of a group-based 3-month mindful eating intervention (MB-EAT-D; n = 27) to a group-based 3-month DSME “Smart Choices” (SC) intervention (n = 25) postintervention and at 3-month follow-up was evaluated. Repeated-measures ANOVA with contrast analysis compared change in outcomes across time. There was no significant difference between groups in weight change. Significant improvement in depressive symptoms, outcome expectations, nutrition and eating-related self-efficacy, and cognitive control and disinhibition of control regarding eating behaviors occurred for both groups (all p < .0125) at 3-month follow-up. The SC group had greater increase in nutrition knowledge and self-efficacy than the MB-EAT-D group (all p < .05) at 3-month follow-up. MB-EAT-D had significant increase in mindfulness, whereas the SC group had significant increase in fruit and vegetable consumption at study end (all p < .0125). Both SC and MB-EAT-D were effective treatments for diabetes self-management. The availability of mindful eating and DSME-based approaches offers patients greater choices in meeting their self-care needs.
PMCID: PMC4217158  PMID: 23855018
meditation; patient education; randomized controlled trial; type 2 diabetes mellitus
2.  Race/Ethnicity, Education, and Treatment Parameters as Moderators and Predictors of Outcome in Binge Eating Disorder 
Binge eating disorder (BED) is prevalent among individuals from minority racial/ethnic groups and among individuals with lower levels of education, yet the efficacy of psychosocial treatments for these groups has not been examined in adequately powered analyses. This study investigated the relative variance in treatment retention and post-treatment symptom levels accounted for by demographic, clinical, and treatment variables as moderators and predictors of outcome.
Data were aggregated from eleven randomized, controlled trials of psychosocial treatments for BED conducted at treatment sites across the United States. Participants were N = 1,073 individuals meeting criteria for BED including n = 946 Caucasian, n = 79 African American, and n = 48 Hispanic/Latino participants. Approximately 86% had some higher education; 85% were female. Multi-level regression analyses examined moderators and predictors of treatment retention, Eating Disorder Examination (EDE) global score, frequency of objective bulimic episodes (OBEs), and OBE remission.
Moderator analyses of race/ethnicity and education were non-significant. Predictor analyses revealed African Americans were more likely to drop out of treatment than Caucasians, and lower level of education predicted greater post-treatment OBEs. African Americans showed a small but significantly greater reduction in EDE global score relative to Caucasians. Self-help treatment administered in a group showed negative outcomes relative to other treatment types, and longer treatment was associated with better outcome.
Observed lower treatment retention among African Americans and lesser treatment effects for individuals with lower levels of educational attainment are serious issues requiring attention. Reduced benefit was observed for shorter treatment length and self-help administered in groups.
PMCID: PMC4175452  PMID: 23647283
binge eating disorder; race; ethnicity; socioeconomic status; treatment outcome
3.  Comparative Effectiveness of a Mindful Eating Intervention to a Diabetes Self-Management Intervention among Adults with Type 2 Diabetes: A Pilot Study 
Mindful eating offers promise as an effective approach for weight management and glycemic control in people with diabetes. Diabetes self-management education (DSME) is an essential component of effective self-care. Yet, little research has compared the effect of mindful eating to DSME-based treatment. This study compared the impact of these two interventions in adults with type 2 diabetes mellitus (T2DM). A prospective randomized controlled trial with two parallel interventions was employed. Participants included adults aged 35–65 with T2DM for ≥ 1 year, body mass index (BMI) ≥ 27.0, and A1c ≥ 7.0% who were randomly assigned to a 3-month mindful eating (MB-EAT-D; n=27) or Smart Choices (SC) DSME-based (n=25) intervention. Follow-up occurred 3-months following intervention completion. Dietary intake, physical activity, weight, glycemia, and fasting insulin were assessed using repeated measures ANOVA with contrast analysis. There was no significant difference between groups in the change in weight or glycemia at study end. Significant difference occurred between groups in the change in dietary intake/1000 kcal of trans fats, total fiber, and sugars (all P<0.05). Mean (±SE) reduction in weight (−2.92 ± 0.54 kg for SC vs. −1.53 ± 0.54 kg for MB-EAT-D) and A1c (−0.67 ± 0.24% for SC and −0.83 ± 0.24% for MB-EAT-D) were significant (P<0.01). Significant reduction in energy intake and glycemic load occurred (all P<0.0001) for both groups. Training in mindful eating and diabetes self-management facilitate improvement in dietary intake, modest weight loss, and glycemic control. The availability of effective treatments allows diabetes patients choices in meeting their self-care needs.
PMCID: PMC3485681  PMID: 23102183
type 2 diabetes mellitus; meditation; patient education; randomized controlled trial
4.  Racial/Ethnic Differences in Adults in Randomized Clinical Trials of Binge Eating Disorder 
Recent studies suggest that binge eating disorder (BED) is as prevalent among African American and Hispanic Americans as among Caucasian Americans; however, data regarding the characteristics of treatment-seeking individuals from racial and ethnic minority groups are scarce. The purpose of this study was to investigate racial/ethnic differences in demographic characteristics and eating disorder symptoms in participants enrolled in treatment trials for BED.
Data from 11 completed randomized, controlled trials were aggregated in a single database, the Clinical Trials of Binge Eating Disorder (CT-BED) database, which included 1,204 Caucasian, 120 African American, and 64 Hispanic participants assessed at baseline. Age, gender, race/ethnicity, education, body mass index (BMI), binge eating frequency, and Eating Disorder Examination (EDE) Restraint, Shape, Weight, and Eating Concern subscale scores were examined.
Mixed model analyses indicated that African American participants in BED treatment trials had higher mean BMI than Caucasian participants, and Hispanic participants had significantly greater EDE shape, weight, and eating concerns than Caucasian participants. No racial or ethnic group differences were found on the frequency of binge eating episodes. Observed racial/ethnic differences in BED symptoms were not substantially reduced after adjusting for BMI and education. Comparisons between the CT-BED database and epidemiological data suggest limitations to the generalizability of data from treatment-seeking samples to the BED community population, particularly regarding the population with lower levels of education.
Further research is needed to assess alternative demographic, psychological, and culturally specific variables to better understand the diversity of treatment-seeking individuals with BED.
PMCID: PMC3668439  PMID: 22201327
binge eating; eating disorders; treatment; health disparities; ethnicity
5.  Changes in stress, eating, and metabolic factors are related to changes in telomerase activity in a randomized mindfulness intervention pilot study 
Psychoneuroendocrinology  2011;37(7):917-928.
Psychological distress and metabolic dysregulation are associated with markers of accelerated cellular aging, including reduced telomerase activity and shortened telomere length. We examined whether participation in a mindfulness-based intervention, and, secondarily, improvements in psychological distress, eating behavior, and metabolic factors are associated with increases in telomerase activity in peripheral blood mononuclear cells (PBMCs).
We enrolled 47 overweight/obese women in a randomized waitlist-controlled pilot trial (n = 47) of a mindfulness-based intervention for stress eating and examined changes in telomerase activity from pre- to post-intervention. In secondary analyses, changes in telomerase activity across the sample were examined in relation to pre- to post-intervention changes in psychological distress, eating behavior, and metabolic factors (weight, serum cortisol, fasting glucose and insulin, and insulin resistance).
Both groups increased in mean telomerase activity over 4 months in intent-to-treat and treatment efficacy analyses (p < 0.001). Nonsignificant trends showed that greater attendance was associated with increases in telomerase, and telomerase increases were 18% higher among ‘as treated’ participants compared to controls. Across groups, changes in chronic stress, anxiety, dietary restraint, dietary fat intake, cortisol, and glucose were negatively correlated with changes in telomerase activity. In exploratory analyses, decreases in dietary fat intake partially mediated the association between dietary restraint and telomerase activity with marginal significance.
While there was no clear effect of the intervention on telomerase activity, there was a striking pattern of correlations between improvements in psychological distress, eating behavior, and metabolic health and increases in telomerase activity. These findings suggest that telomerase activity may be in part regulated by levels of both psychological and metabolic stress.
PMCID: PMC3384690  PMID: 22169588
Stress; Anxiety; Mindfulness; Dietary restraint; Telomerase; Cell aging; Cortisol
6.  Mindfulness Intervention for Stress Eating to Reduce Cortisol and Abdominal Fat among Overweight and Obese Women: An Exploratory Randomized Controlled Study 
Journal of Obesity  2011;2011:651936.
Psychological distress and elevated cortisol secretion promote abdominal fat, a feature of the Metabolic Syndrome. Effects of stress reduction interventions on abdominal fat are unknown. Forty-seven overweight/obese women (mean BMI = 31.2) were randomly assigned to a 4-month intervention or waitlist group to explore effects of a mindfulness program for stress eating. We assessed mindfulness, psychological distress, eating behavior, weight, cortisol awakening response (CAR), and abdominal fat (by dual-energy X-ray absorptiometry) pre- and posttreatment. Treatment participants improved in mindfulness, anxiety, and external-based eating compared to control participants. Groups did not differ on average CAR, weight, or abdominal fat over time. However, obese treatment participants showed significant reductions in CAR and maintained body weight, while obese control participants had stable CAR and gained weight. Improvements in mindfulness, chronic stress, and CAR were associated with reductions in abdominal fat. This proof of concept study suggests that mindfulness training shows promise for improving eating patterns and the CAR, which may reduce abdominal fat over time.
PMCID: PMC3184496  PMID: 21977314
7.  Multicenter Trial of Fluoxetine as an Adjunct to Behavioral Smoking Cessation Treatment 
The authors evaluated the efficacy of fluoxetine hydrochloride (Prozac; Eli Lilly and Company, Indianapolis, IN) as an adjunct to behavioral treatment for smoking cessation. Sixteen sites randomized 989 smokers to 3 dose conditions: 10 weeks of placebo, 30 mg, or 60 mg fluoxetine per day. Smokers received 9 sessions of individualized cognitive–behavioral therapy, and biologically verified 7-day self-reported abstinence follow-ups were conducted at 1, 3, and 6 months posttreatment. Analyses assuming missing data counted as smoking observed no treatment difference in outcomes. Pattern-mixture analysis that estimates treatment effects in the presence of missing data observed enhanced quit rates associated with both the 60-mg and 30-mg doses. Results support a modest, short-term effect of fluoxetine on smoking cessation and consideration of alternative models for handling missing data.
PMCID: PMC1852538  PMID: 12182272
8.  Influence of fluoxetine on positive and negative affect in a clinic-based smoking cessation trial 
Psychopharmacology  2004;173(1-2):153-159.
Fluoxetine improves affect in clinical syndromes such as depression and premenstrual dysphoric disorder. Little is known about fluoxetine’s influence on mood changes after quitting smoking, which often resemble sub-clinical depression.
The present study, a re-analysis of previously published data (Niaura et al. 2002), examined fluoxetine’s effect on changes in negative and positive affect following quitting smoking.
Adult smokers (n=175) without clinically significant depression were randomized on a double-blind basis to receive fluoxetine hydrochloride (30 or 60 mg daily) or placebo for 10 weeks in combination with cognitive-behavioral therapy (CBT) for smoking cessation. We postulated that fluoxetine would beneficially influence post-cessation changes in positive and negative affect.
Mood change across treatment was analyzed using mixed linear modeling controlling for initial level of nicotine dependence, plasma fluoxetine metabolites, and change in cotinine (a nicotine metabolite) at each visit. Relative to placebo, those on 60 mg fluoxetine experienced an elevation in positive affect that increased across time [t(526)=2.50, P=0.01], and a reduction in negative affect that returned to baseline across time [t(524)=2.26, P=0.02]. There were no differences between 30 mg and placebo on changes in positive or negative affect.
Results indicate that 60 mg of fluoxetine improves both positive and negative mood states after quitting smoking and that diminished positive affect may be an overlooked affective response to smoking cessation.
PMCID: PMC1847574  PMID: 14727000
Fluoxetine; Smoking cessation; Positive affect; Negative affect

Results 1-8 (8)