Background

Diet quality tools have been developed to assess the adequacy of dietary patterns for predicting future morbidity and mortality. This study describes the development and evaluation of a brief food-based diet quality index for use with children at the individual or population level. The Australian Child and Adolescent Recommended Food Score (ACARFS) was developed to reflect adherence to the Dietary Guidelines for Children and Adolescents in Australia and modelled on the approach of the US Recommended Food Score.

Methods

The ACARFS has eight sub-scales and is scored from zero to 73. The diet quality score was evaluated by assessing correlation (Spearman’s correlations) and agreement (weighted κ statistics) between ACARFS scores and nutrient intakes, derived from a food frequency questionnaire in 691 children (mean age 11.0, SD 1.1) in New South Wales, Australia. Nutrient intakes for ACARFS quartiles were compared with the relevant Australian nutrient reference values.

Results

ACARFS showed slight to substantial agreement (κ 0.13-0.64) with nutrient intakes, with statistically significant moderate to strong positive correlations with all vitamins, minerals and energy intake (r = 0.42-0.70). ACARFS was not related to BMI.Participants who scored less than the median ACARFS were more likely to have sub-optimal intakes of fibre, folic acid and calcium.

Conclusion

ACARFS demonstrated sufficient accuracy for use in future studies evaluating diet quality. Future research on its utility in targeting improvements in the nutritional quality of usual eating habits of children and adolescents is warranted.

Background

The development and use of Web-based programs for weight loss is increasing rapidly, yet they have rarely been evaluated using randomized controlled trials (RCTs). Interestingly, most people who attempt weight loss use commercially available programs, yet it is very uncommon for commercial programs to be evaluated independently or rigorously.

Objective

To compare the efficacy of a standard commercial Web-based weight-loss program (basic) versus an enhanced version of this Web program that provided additional personalized e-feedback and contact from the provider (enhanced) versus a wait-list control group (control) on weight outcomes in overweight and obese adults.

Methods

This purely Web-based trial using a closed online user group was an assessor-blinded RCT with participants randomly allocated to the basic or enhanced 12-week Web-based program, based on social cognitive theory, or the control, with body mass index (BMI) as the primary outcome.

Results

We enrolled 309 adults (129/309, 41.8% male, BMI mean 32.3, SD 4 kg/m2) with 84.1% (260/309) retention at 12 weeks. Intention-to-treat analysis showed that both intervention groups reduced their BMI compared with the controls (basic: –0.72, SD 1.1 kg/m2, enhanced: –1.0, SD 1.4, control: 0.15, SD 0.82; P < .001) and lost significant weight (basic: –2.1, SD 3.3 kg, enhanced: –3.0, SD 4.1, control: 0.4, SD 2.3; P < .001) with changes in waist circumference (basic: –2.0, SD 3.5 cm, enhanced: –3.2, SD 4.7, control: 0.5, SD 3.0; P < .001) and waist-to-height ratio (basic: –0.01, SD 0.02, enhanced: –0.02, SD 0.03, control: 0.0, SD 0.02; P < .001), but no differences were observed between the basic and enhanced groups. The addition of personalized e-feedback and contact provided limited additional benefits compared with the basic program.

Conclusions

A commercial Web-based weight-loss program can be efficacious across a range of weight-related outcomes and lifestyle behaviors and achieve clinically important weight loss. Although the provision of additional personalized feedback did not facilitate greater weight loss after 12 weeks, the impact of superior participant retention on longer-term outcomes requires further study. Further research is required to determine the optimal mix of program features that lead to the biggest treatment impact over time.

Trial Registration

Australian New Zealand Clinical Trials Registry (ANZCTR): 12610000197033; http://www.anzctr.org.au/trial_view.aspx?id=335159 (Archived by WebCite at http://www.webcitation.org/66Wq0Yb7U)

Background

A poor understanding of the specific lifestyle behaviors that result in weight loss has hindered the development of effective interventions. The aim of this paper was to identify potential behavioral mediators of weight loss in the Healthy Dads, Healthy Kids (HDHK) intervention for overweight fathers.

Findings

The three-month intervention was evaluated in a randomized controlled trial and conducted in Newcastle, New South Wales, Australia. Baseline, three month (immediate post-intervention) and six month assessments were conducted. Recruitment and follow-up occurred between October 2008 and May 2009. The study sample included 53 overweight/obese men [mean ( SD) age=40.6( 97.1) years; body mass index (BMI)=33.2 (3.9) kgm-2] and their primary school-aged children [n=71, 54% boys; age=8.2 (2.0) years] who were randomized to HDHK program or a wait-list control group. Physical activity (PA) was assessed using pedometers and dietary behaviors were measured using a validated food frequency questionnaire. The intervention resulted in significant weight loss (5.131.27kg, P<0.0001) and increased PA among fathers (2769750 steps/day, P<0.001) and their children (1486521 steps/day, P<0.01). Fathers PA mediated weight loss in the intervention (AB=2.31, 95% CI=4.63 to 0.67) and was responsible for 47% of the intervention effect. Changes in dietary behaviors were not statistically significant.

Conclusions

PA was an important mediator of weight loss in the HDHK intervention. Encouraging overweight fathers to be more active with their children appears to be a promising strategy for obesity treatment in men.

Background

Preconception and pregnancy dietary intakes can influence the health of future generations. In this study we compared the food intakes of reproductive-aged women by pregnancy status, to current Australian recommendations.

Methods

Data are from the Australian Longitudinal Study on Women's Health, younger cohort aged 25-30 years in 2003, with self-reported status as pregnant (n = 606), trying to conceive (n = 454), given birth in the last 12 months (n = 829) or other (n = 5597). Diet was assessed using a validated 74-item food frequency questionnaire. Food group servings and nutrient intakes were compared to the Australian Guide to Healthy Eating (AGHE) and Australian Nutrient Reference Values (NRVs).

Results

No women met all AGHE food group recommendations. Highest adherence rates [mean (95% CI) servings/day] were for meat [85%, 1.9(1.8-1.9)], fruit [44%, 2.1(2.1-2.2)] and dairy [35%, 1.8(1.8-1.9)], with < 14% meeting remaining recommendations. Women who achieved NRVs (folate, iron, calcium, zinc, fibre) for pregnancy, breastfeeding and adult life stages were 1.5%, 3.3% and 13.7%, respectively. Compared to AGHE, women consumed more servings of fruit (4.9 vs 4.0;P = 0.034) and dairy (3.4 vs 2.0;P = 0.006) to achieve pregnancy NRVs; more dairy (2.9 vs 2.0;P = 0.001), less fruit (3.9 vs 5.0;P < .001) and vegetables (3.4 vs 7.0;P < .001) to achieve breastfeeding NRVs; more fruit (3.6 vs 3.0;P < .001), dairy (2.5 vs 2.0;P < .001), meat (1.8 vs 1.5;P = 0.015), less vegetables (3.6 vs 5.0;P < .001) to achieve adult NRVs.

Conclusions

The AGHE does not align with contemporary diets of Australian women or enable them to meet all NRVs. Current tools to guide food consumption by women during pregnancy require revision.

Optimal dietary quality, indicated by higher diet quality index scores, reflects greater adherence to National dietary recommendations and is also associated with lower morbidity and mortality from chronic disease. Whether this is reflected in lower health care cost over time has rarely been examined. The aim of this study was to examine whether higher diet quality, as measured by the Australian Recommended Food Score (ARFS), was associated with lower health care costs within the mid-aged cohort of the Australian Longitudinal Study on Women’s Health. We found that there was a statistically significant association between five year cumulative costs and ARFS, but in the opposite direction to that predicted, with those in the highest quintiles of ARFS having higher health care costs. However the number of Medicare claims over the six year period (2002–2007) was lower for those in the highest compared with the lowest quintile, p = 0.002. There is a need to monitor both costs and claims over time to examine health care usage in the longer term in order to determine whether savings are eventually obtained for those with the dietary patterns that adhere more closely to National recommendations.

Background

An understanding of the factors that predict retention and website use are critical to the development of effective Web-based weight loss interventions. However, poor retention (dropout attrition) and website utilization (nonusage attrition) are major inhibitors to the effectiveness of Web-based programs.

Objective

The study aimed to (1) describe the prevalence of dropout and nonusage attrition and (2) examine pretreatment predictors of nonusage attrition in a cohort of commercial Web-based weight loss program participants.

Methods

Participants enrolled in the online program, The Biggest Loser Club, Australia, from August 15, 2007, to May 31, 2008. Only those who subscribed for 12 or 52 weeks were included in this study. All data were collected by the program proprietors, SP Health Co Pty Ltd (Sydney, Australia), and provided in “deidentified” form. Data collected included responses to a pretreatment survey (sociodemographic and behavioral characteristics), subscription history (date of enrollment and subscription end), and website use (log-ins, food and exercise diary entries, weigh-ins, and forum posts). Participants were classified as a member of the program at 12 or 52 weeks if they held an active subscription plan at that point in time. Participants were classified as nonusers at 12 or 52 weeks if they had stopped using all of the website features and had not returned. Predictors of nonusage attrition were explored using Cox proportional hazards regression analysis.

Results

Of the 9599 eligible participants, 6943 (72%) subscribed to the program for 12 weeks, and 2656 (28%) subscribed for 52 weeks. Of all participants, 31% (2975/9599) were classified as overweight, 61% (5866/9599) were classified as obese, 86% (8279/9599) were female, and participants’ mean (SD) age was 35.7 (9.5) years. The 12 week and 52 week subscribers’ retention rates were 97% and 77% respectively. Of 12 week subscribers, 35% were classified as program “users” after 12 weeks, and 30% of 52 week subscribers were classified as “users” after 52 weeks. Significant predictors of nonusage attrition among 12 week subscribers included age (hazard ratio for 45 to 55 years of age = 0.83, 95% confidence interval [CI] 0.73 - 0.93, P = .001; hazard ratio for 55 to 65 years of age = 0.80, 95% CI 0.66 - 0.99, P = .04), exercise level (hazard ratio = 0.76, 95% CI 0.72 - 0.81, P < .001), emotional eating (hazard ratio = 1.11, 95% CI 1.04 - 1.18, P = .001), eating breakfast (hazard ratio = 0.88, 95% CI 0.82 - 0.95, P = .001), and skipping meals (hazard ratio = 1.12, 95% CI 1.04 -1.19, P = .001). For 52 week subscribers, eating breakfast (hazard ratio = 0.88, 95% CI 0.79 - 0.99, P = .04) and not drinking tea or coffee with sugar (hazard ratio = 1.23, 95% CI 1.11 - 1.37, P < .001) were the pretreatment characteristics that significantly decreased risk of nonusage attrition.

Conclusions

The findings demonstrate a high prevalence of nonusage attrition among a cohort of commercial Web-based weight loss program participants. Several sociodemographic and behavioral factors were shown to independently predict nonusage attrition.

Background

Obesity is a major cause of preventable death in Australia with prevalence increasing at an alarming rate. Of particular concern is that approximately 68% of men are overweight/obese, yet are notoriously difficult to engage in weight loss programs, despite being more susceptible than women to adverse weight-related outcomes. There is a need to develop and evaluate obesity treatment programs that target and appeal to men. The primary aim of this study is to evaluate the efficacy of two relatively low intensity weight loss programs developed specifically for men.

Methods and Design

The study design is an assessor blinded, parallel-group randomised controlled trial that recruited 159 overweight and obese men in Newcastle, Australia. Inclusion criteria included: BMI 25-40 (kg/m2); no participation in other weight loss programs during the study; pass a health-screening questionnaire and pre-exercise risk assessment; available for assessment sessions; access to a computer with e-mail and Internet facilities; and own a mobile phone. Men were recruited to the SHED-IT (Self-Help, Exercise and Diet using Internet Technology) study via the media and emails sent to male dominated workplaces. Men were stratified by BMI category (overweight, obese class I, obese class II) and randomised to one of three groups: (1) SHED-IT Resources - provision of materials (DVD, handbooks, pedometer, tape measure) with embedded behaviour change strategies to support weight loss; (2) SHED-IT Online - same materials as SHED-IT Resources plus access to and instruction on how to use the study website; (3) Wait-list Control. The intervention programs are three months long with outcome measures taken by assessors blinded to group allocation at baseline, and 3- and 6-months post baseline. Outcome measures include: weight (primary outcome), % body fat, waist circumference, blood pressure, resting heart rate, objectively measured physical activity, self-reported dietary intake, sedentary behaviour, physical activity and dietary cognitions, sleepiness, quality of life, and perceived sexual health. Generalised linear mixed models will be used to assess all outcomes for the impact of group (Resources, Online, and Control), time (treated as categorical with levels baseline, 3-months and 6-months) and the group-by-time interaction. These three terms will form the base model. 'Intention-to-treat' analysis will include all randomised participants.

Discussion

Our study will compare evidence-based and theoretically driven, low cost and easily disseminated strategies specifically targeting weight loss in men. The SHED-IT community trial will provide evidence to inform development and dissemination of sustainable strategies to reduce obesity in men.

Trial Registration

Australian New Zealand Clinical Trials Registry (ACTRN12610000699066)

Background

Obesity rates in adults continue to rise and effective treatment programs with a broad reach are urgently required. This paper describes the study protocol for a web-based randomized controlled trial (RCT) of a commercially available program for overweight and obese adult males and females. The aim of this RCT was to determine and compare the efficacy of two web-based interventions for weight loss and maintenance of lost weight.

Methods/Design

Overweight and obese adult males and females were stratified by gender and BMI and randomly assigned to one of three groups for 12-weeks: waitlist control, or basic or enhanced online weight-loss. Control participants were re-randomized to the two weight loss groups at the end of the 12-week period. The basic and enhanced group participants had an option to continue or repeat the 12-week program. If the weight loss goal was achieved at the end of 12, otherwise on completion of 24 weeks of weight loss, participants were re-randomized to one of two online maintenance programs (maintenance basic or maintenance enhanced), until 18 months from commencing the weight loss program. Assessments took place at baseline, three, six, and 18 months after commencing the initial weight loss intervention with control participants repeating the initial assessment after three month of waiting. The primary outcome is body mass index (BMI). Other outcomes include weight, waist circumference, blood pressure, plasma markers of cardiovascular disease risk, dietary intake, eating behaviours, physical activity and quality of life.

Both the weight loss and maintenance of lost weight programs were based on social cognitive theory with participants advised to set goals, self-monitor weight, dietary intake and physical activity levels. The enhanced weight loss and maintenance programs provided additional personalized, system-generated feedback on progress and use of the program. Details of the methodological aspects of recruitment, inclusion criteria, randomization, intervention programs, assessments and statistical analyses are described.

Discussion

Importantly, this paper describes how an RCT of a currently available commercial online program in Australia addresses some of the short falls in the current literature pertaining to the efficacy of web-based weight loss programs.

Australian New Zealand Clinical Trials Registry (ANZCTR) number: ACTRN12610000197033

Background

Child and adolescent obesity predisposes individuals to an increased risk of morbidity and mortality from a range of lifestyle diseases. Although there is some evidence to suggest that rates of pediatric obesity have leveled off in recent years, this has not been the case among youth from low socioeconomic backgrounds. The purpose of this paper is to report the rationale, study design and baseline findings of a school-based obesity prevention program for low-active adolescent girls from disadvantaged secondary schools.

Methods/Design

The Nutrition and Enjoyable Activity for Teen Girls (NEAT Girls) intervention will be evaluated using a group randomized controlled trial. NEAT Girls is a 12-month multi-component school-based intervention developed in reference to Social Cognitive Theory and includes enhanced school sport sessions, interactive seminars, nutrition workshops, lunch-time physical activity (PA) sessions, PA and nutrition handbooks, parent newsletters, pedometers for self-monitoring and text messaging for social support. The following variables were assessed at baseline and will be completed again at 12- and 24-months: adiposity, objectively measured PA, muscular fitness, time spent in sedentary behaviors, dietary intake, PA and nutrition social-cognitive mediators, physical self-perception and global self-esteem. Statistical analyses will follow intention-to-treat principles and hypothesized mediators of PA and nutrition behavior change will be explored.

Discussion

NEAT Girls is an innovative intervention targeting low-active girls using evidence-based behavior change strategies and nutrition and PA messages and has the potential to prevent unhealthy weight gain and reduce the decline in physical activity and poor dietary habits associated with low socio-economic status. Few studies have reported the long-term effects of school-based obesity prevention programs and the current study has the potential to make an important contribution to the field.

Trial registration

Australian New Zealand Clinical Trials Registry No: ACTRN12610000330044

Background

Statistical mediation analysis can be used to improve the design of obesity prevention and treatment programs by identifying the possible mechanisms through which an intervention achieved its effects. The aim of this study was to identify mediators of weight loss in an Internet-based weight-loss program specifically designed for overweight men.

Methods

The Self-Help, Exercise and Diet using Information Technology (SHED-IT) program was a 3-month randomized controlled trial (Internet-based intervention group vs information only control group) that was implemented in 2007 with baseline and 6-month follow-up assessment of weight, physical activity and dietary behaviors. Intention-to-treat and per-protocol mediation analyses were conducted using a product-of-coefficients test.

Results

Participants (N = 65) were overweight and obese male academic (n = 10) and non-academic (n = 27) staff and students (n = 28) from the University of Newcastle, Australia. Mean (SD) age = 35.9 (11.1) years and mean (SD) BMI = 30.6 (2.8). In the intention-to-treat analysis, both groups lost weight, but relative to the control group, the intervention did not have a statistically significant 'total effect' on weight, τ = -.507, p = .716 (95% CI = -3.277 to 2.263). In the per-protocol analysis, the intervention had a statistically significant 'total effect' on weight, τ = -4.487, p < .05 (95% CI = -8.208 to -.765). The intervention did not have a statistically significant effect on any of the hypothesized mediators and none of the behavioral variables mediated weight loss in the SHED-IT program. Although participants in the intervention group reduced their fat intake over the study period, the changes did not satisfy the criteria for mediation.

Conclusion

Few studies have examined the mediators of weight loss in obesity treatment interventions. While none of the hypothesized mediators satisfied the criteria for mediation in the current study, there was some evidence to suggest that overweight men in the SHED-IT intervention reduced their fat intake over the study period. Future obesity treatment and prevention programs should explore behavioral mediators of weight loss using appropriate statistical methods.

Trial Registration

Australian New Zealand Clinical Trials Registry No: ANZCTRN12607000481471.

Background

Dietary intake during childhood and adolescence is of increasing interest due to its influence on adult health, particularly obesity, cardiovascular disease and diabetes. There is a need to develop and validate dietary assessment methods suitable for large epidemiologic studies of children and adolescents. Limited large scale dietary studies of youth have been undertaken in Australia, due partly to the lack of a suitable dietary intake tool. A self-administered, semi-quantitative food-frequency questionnaire (FFQ), the 'Australian Child and Adolescent Eating Survey' (ACAES), was developed for youth aged 9-16 years. This study evaluated reproducibility and comparative validity of the ACAES FFQ using assisted food records (FRs) as the reference method.

Methods

The ACAES FFQ was completed twice (FFQ1 and FFQ2) at an interval of 5 months, along with four one-day assisted FRs. Validity was evaluated by comparing the average of the FRs with FFQ2 (n = 113) as well as with the average of FFQ1 and FFQ2 (n = 101). Reproducibility was evaluated by comparing FFQ1 and FFQ2 (n = 101). The two methods were compared using correlations, Kappa statistics and Bland-Altman plots.

Results

Correlation coefficients for comparative validity ranged from 0.03 for retinol to 0.56 for magnesium for transformed, energy-adjusted, deattenuated nutrient data, with correlation coefficients greater than 0.40 for total fat, saturated fat, monounsaturated fat, carbohydrate, sugars, riboflavin, vitamin C, folate, beta-carotene, magnesium, calcium and iron. Correlation coefficients for reproducibility ranged from 0.18 for vitamin A to 0.50 for calcium for transformed, energy-adjusted, deattenuated nutrient data. The ACAES FFQ ranked individuals reasonably accurately, with the comparative validity analysis showing that over 50% of participants were classified within one quintile for all nutrients, with only a small percentage grossly misclassified (0-7%).

Conclusion

The ACAES FFQ is the first child and adolescent specific FFQ available for ranking the dietary intakes of Australian children and adolescents for a range of nutrients in epidemiologic research and public health interventions.

OBJECTIVE—The purpose of this study was to quantify the effects of glycemic index on postprandial glucose excursion (PPGE) in children with type 1 diabetes receiving multiple daily injections and to determine optimal insulin therapy for a low–glycemic index meal.

RESEARCH DESIGN AND METHODS—Twenty subjects consumed test breakfasts with equal macronutrient contents on 4 consecutive days; high–and low–glycemic index meals (glycemic index 84 vs. 48) were consumed with preprandial ultra-short-acting insulin, and the low–glycemic index meal was also consumed with preprandial regular insulin and postprandial ultra-short-acting insulin. Each child's insulin dose was standardized. Continuous glucose monitoring was used.

RESULTS—The PPGE was significantly lower for the low–glycemic index meal compared with the high–glycemic index meal at 30–180 min (P < 0.02) when preprandial ultra-short-acting insulin was administered. The maximum difference occurred at 60 min (4.2 mmol/l, P < 0.0001). Regular insulin produced a 1.1 mmol/l higher PPGE at 30 min compared with ultra-short-acting insulin (P = 0.015) when the low–glycemic index meal was consumed. Postprandial ultra-short-acting insulin produced a higher PPGE at 30 and 60 min compared with preprandial administration when the low–glycemic index meal was consumed. The maximum difference was 2.5 mmol/l at 60 min (P < 0.0001).

CONCLUSIONS—Low–glycemic index meals produce a lower PPGE than high–glycemic index meals. Preprandial ultra-short-acting insulin is the optimal therapy for a low–glycemic index meal.

Background

This paper describes an attempt that was made to recruit child-bearing women into a nutrition-based research study and the knowledge that was gained when this approach was unsuccessful. The Assessment Before Children Develop Obesity Study was a cross-sectional survey which planned to follow-up women and children who had previously been, or were currently enrolled in the Mathematical Model of Pregnancy Study.

Methods

Ethics approval was sought and obtained over an eight month period. After just six weeks it was obvious that our research objectives were not achievable because of an inadequate response rate (10%). This led to a review of the recruiting methodology as well as all written materials provided to potential participants. Advice was sought from those with expertise in the design of large public health campaigns and literature was consulted to refine our recruitment strategy.

Results

In subsequent redevelopment, the Assessment Before Children Develop Obesity Study was merged with the Mathematical Model of Pregnancy Study to become what is now known as the Women and Their Children's Health Study. Consent rates improved from 10% and 35% in the Assessment Before Children Develop Obesity and Mathematical Model of Pregnancy studies respectively, to 61% in the Women and Their Children's Health Study (chi square test, p < 0.001). Successful recruitment for this research continues. The significant improvement in the participation rate is attributed to numerous factors including changes to the study name, recruiting method and information materials.

Conclusion

By sharing our experience we aim to assist other researcher in avoiding the same pitfalls and offer effective strategies for improving response rates.

Background

Childhood obesity is one of the most pressing health issues of our time. Key health organizations have recommended research be conducted on the effectiveness of well-designed interventions to combat childhood obesity that can be translated into a variety of settings. This paper describes the design and methods used in the Hunter Illawarra Kids Challenge Using Parent Support (HIKCUPS) trial, an ongoing multi-site randomized controlled trial, in overweight/obese children comparing the efficacy of three interventions: 1) a parent-centered dietary modification program; 2) a child-centered physical activity skill-development program; and 3) a program combining both 1 and 2 above.

Methods/Design

Each intervention consists of three components: i) 10-weekly face-to-face group sessions; ii) a weekly homework component, completed between each face-to-face session and iii) three telephone calls at monthly intervals following completion of the 10-week program. Details of the programs' methodological aspects of recruitment, randomization and statistical analyses are described here a priori.

Discussion

Importantly this paper describes how HIKCUPS addresses some of the short falls in the current literature pertaining to the efficacy of child obesity interventions.

The HIKCUPS trial is funded by the National Medical Research Council, Australia.

Background

The 'Healthy Dads, Healthy Kids' program was designed to help overweight fathers lose weight and positively influence the health behaviors of their children. The aim of the current study was to evaluate the previously established program in a community setting, in a large effectiveness trial.

Methods/Design

The Healthy Dads, Healthy Kids community trial consists of three stages: (i) Stage 1 - program refinement and resource development (ii) Stage 2 - community randomized controlled trial (iii) Stage 3 - community effectiveness trial. The program will be evaluated in five Local Government Areas in the Hunter Valley Region of NSW, Australia. For the community randomized controlled trial, 50 overweight/obese men (aged 18-65 years) from one Local Government Area with a child aged between 5-12 years of age will be recruited. Families will be randomized to either the program or a 6-month wait-list control group. Fathers and their children will be assessed at baseline, post-intervention (3-months) and 6-months. Inclusion criteria are: body mass index 25-40 kg/m2; no participation in other weight loss programs during the study; pass a health-screening questionnaire; and access to a computer with Internet facilities. In the community trial, the program will be evaluated using a non-randomized, prospective design in five Local Government Areas. The exclusion criteria is body mass index < 25 kg/m2 or lack of doctor's approval. Measures will be collected at baseline, 3-, 6- and 12-months. The program involves fathers attending seven face-to-face group sessions (three with children) over 3-months. Measures: The primary outcome is fathers' weight. Secondary outcomes for both fathers and children include: waist circumference, blood pressure, resting heart rate, physical activity, sedentary behaviors and dietary intake. Father-only measures include portion size, alcohol consumption, parenting for physical activity and nutrition and parental engagement. Process evaluation will determine the fidelity, dose (delivered and received), reach, recruitment and context of the program.

Discussion

As a unique approach to reducing obesity prevalence in men and improving lifestyle behaviours in children, our findings will provide important evidence relating to the translation of Healthy Dads, Healthy Kids, which will enable it to be delivered on a larger scale.

Trial registration

Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12610000608066

Background

There is a paucity of information in the scientific literature on the effectiveness of commercial weight loss programs, including Web-based programs. The potential of Web-based weight loss programs has been acknowledged, but their ability to achieve significant weight loss has not been proven.

Objective

The objectives were to evaluate the weight change achieved within a large cohort of individuals enrolled in a commercial Web-based weight loss program for 12 or 52 weeks and to describe participants’ program use in relation to weight change.

Method

Participants enrolled in an Australian commercial Web-based weight loss program from August 15, 2007, through May 31, 2008. Self-reported weekly weight records were used to determine weight change after 12- and 52-week subscriptions. The primary analysis estimated weight change using generalized linear mixed models (GLMMs) for all participants who subscribed for 12 weeks and also for those who subscribed for 52 weeks. A sensitivity analysis was conducted using the last observation carried forward (LOCF) method. Website use (ie, the number of days participants logged on, made food or exercise entries to the Web-based diary, or posted to the discussion forum) was described from program enrollment to 12 and 52 weeks, and differences in website use by percentage weight change category were tested using Kruskal-Wallis test for equality of populations.

Results

Participants (n = 9599) had a mean (standard deviation [SD]) age of 35.7 (9.5) years and were predominantly female (86% or 8279/9599) and obese (61% or 5866/9599). Results from the primary GLMM analysis including all enrollees found the mean percentage weight change was −6.2% among 12-week subscribers (n = 6943) and −6.9% among 52-week subscribers (n = 2656). Sensitivity analysis using LOCF revealed an average weight change of −3.0% and −3.5% after 12 and 52 weeks respectively. The use of all website features increased significantly (P < .01) as percentage weight change improved.

Conclusions

The weight loss achieved by 12- and 52-week subscribers of a commercial Web-based weight loss program is likely to be in the range of the primary and sensitivity analysis results. While this suggests that, on average, clinically important weight loss may be achieved, further research is required to evaluate the efficacy of this commercial Web-based weight loss program prospectively using objective measures. The potential association between greater website use and increased weight loss also requires further evaluation, as strategies to improve participants’ use of Web-based program features may be required.