Advances and Controversies in the Design of Obesity Prevention Trials

Because randomized controlled trial designs are used more frequently to evaluate obesity prevention programs, nuances in the methodology used for this application become apparent. Areas of attention are the selection of outcome measures with high validity, attention to the description of the intervention, the use of analyses that match the sampling design, and dealing with loss to follow‐up. We recommend increased use of preliminary or evidentiary research designed to develop and test intervention components and hypothesized mediators before fully powered, randomized, obesity prevention trials are attempted. Both randomized and observational designs can be used for the purpose. Attention to design issues will ultimately lead to more successful, cost‐effective randomized trials, and more rapid movement toward efficacious and effective obesity prevention programs.

[1]  D. Murray,et al.  Imputation strategies for missing data in a school-based multi-centre study: the Pathways study. , 2001, Statistics in medicine.

[2]  J. Himes,et al.  Impact of the Pathways intervention on dietary intakes of American Indian schoolchildren. , 2003, Preventive medicine.

[3]  Jessica B. Janega,et al.  Design and analysis of group-randomized trials: a review of recent practices. , 2004, American journal of public health.

[4]  C. Summerbell,et al.  Interventions for preventing obesity in children (Review) , 2016 .

[5]  Elaine Stone,et al.  The effects of the Pathways Obesity Prevention Program on physical activity in American Indian children. , 2003, Preventive medicine.

[6]  M. Story School-based approaches for preventing and treating obesity , 1999, International Journal of Obesity.

[7]  Yang Gao,et al.  Interventions for preventing obesity in children. , 2005, The Cochrane database of systematic reviews.

[8]  Diane J Catellier,et al.  Design of the Trial of Activity in Adolescent Girls (TAAG). , 2005, Contemporary clinical trials.

[9]  J. Jobe,et al.  Intervention-related bias in reporting of food intake by fifth-grade children participating in an obesity prevention study. , 2004, American journal of epidemiology.

[10]  J Cornfield,et al.  Randomization by group: a formal analysis. , 1978, American journal of epidemiology.

[11]  D. Zucker Design and Analysis of Cluster Randomization Trials , 2003 .

[12]  J. Jobe,et al.  Physical activity as a predictor of body composition in American Indian children. , 2004, Obesity research.

[13]  J. Sallis,et al.  Physical activity assessment in American Indian schoolchildren in the Pathways study. , 1999, The American journal of clinical nutrition.

[14]  T. Wadden,et al.  Behavioral assessment of the obese patient. , 2002 .

[15]  David M. Murray,et al.  Design and Analysis of Group- Randomized Trials , 1998 .

[16]  C. Meinert Clinical Trials Dictionary: Terminology and Usage Recommendations , 1996 .

[17]  R. Uauy,et al.  Obesity in children and young people: a crisis in public health. , 2004, Obesity reviews : an official journal of the International Association for the Study of Obesity.

[18]  Kosuke Imai,et al.  Survey Sampling , 1998, Nov/Dec 2017.

[19]  T. Lohman,et al.  Estimation of body fat from anthropometry and bioelectrical impedance in Native American children , 2000, International Journal of Obesity.

[20]  Jonathan L. Blitstein,et al.  Design and analysis of group-randomized trials: a review of recent methodological developments. , 2004, American journal of public health.

[21]  Allan Donner,et al.  Design and Analysis of Cluster Randomization Trials in Health Research , 2001 .

[22]  June Stevens,et al.  Pathways: a school-based, randomized controlled trial for the prevention of obesity in American Indian schoolchildren. , 2003, The American journal of clinical nutrition.

[23]  D. Paulhus Measurement and control of response bias. , 1991 .

[24]  H. Thomas Obesity prevention programs for children and youth: why are their results so modest? , 2006, Health education research.

[25]  Diane J Catellier,et al.  School-level intraclass correlation for physical activity in adolescent girls. , 2004, Medicine and science in sports and exercise.

[26]  Jerome Cornfield,et al.  SYMPOSIUM ON CHD PREVENTION TRIALS: DESIGN ISSUES IN TESTING LIFE STYLE INTERVENTIONRANDOMIZATION BY GROUP: A FORMAL ANALYSIS , 1978 .

[27]  T. Lohman,et al.  Body composition assessment in American Indian children. , 1999, The American journal of clinical nutrition.

[28]  S Kumanyika,et al.  Obesity prevention: a proposed framework for translating evidence into action , 2005, Obesity reviews : an official journal of the International Association for the Study of Obesity.

[29]  David M. Murray,et al.  Methods To Reduce The Impact Of Intraclass Correlation In Group-Randomized Trials , 2003, Evaluation review.