Steps in the design, development and formative evaluation of obesity prevention-related behavior change trials

Tom Baranowski, Ester Cerin, Janice Baranowski, Tom Baranowski, Ester Cerin, Janice Baranowski

Abstract

Obesity prevention interventions through dietary and physical activity change have generally not been effective. Limitations on possible program effectiveness are herein identified at every step in the mediating variable model, a generic conceptual framework for understanding how interventions may promote behavior change. To minimize these problems, and thereby enhance likely intervention effectiveness, four sequential types of formative studies are proposed: targeted behavior validation, targeted mediator validation, intervention procedure validation, and pilot feasibility intervention. Implementing these studies would establish the relationships at each step in the mediating variable model, thereby maximizing the likelihood that an intervention would work and its effects would be detected. Building consensus among researchers, funding agencies, and journal editors on distinct intervention development studies should avoid identified limitations and move the field forward.

Figures

Figure 1
Figure 1
Model of Mediation and Moderation of Intervention Outcomes

References

    1. Ogden C, Carroll M, Curtin L, McDowell M, Tabak C, Flegal K. Prevalence of overweight in the United States, 1999–2004. JAMA. 2006:1549–1555. doi: 10.1001/jama.295.13.1549.
    1. Popkin BM. Will China's nutrition transition overwhelm its health care system and slow economic growth? Health Aff (Millwood) 2008;27:1064–1076. doi: 10.1377/hlthaff.27.4.1064.
    1. Mozaffarian D, Wilson PW, Kannel WB. Beyond established and novel risk factors: lifestyle risk factors for cardiovascular disease. Circulation. 2008;117:3031–3038. doi: 10.1161/CIRCULATIONAHA.107.738732.
    1. Summerbell C, Waters E, Edmunds L, Kelly S, Brown T, Campbell K. Interventions for preventing obesity in children. Cochrane Database Syst Rev. 2005:CD001871.
    1. Ammerman AS, Lindquist CH, Lohr KN, Hersey J. The efficacy of behavioral interventions to modify dietary fat and fruit and vegetable intake: A review of the evidence. Prev Med. 2002;35:25–41. doi: 10.1006/pmed.2002.1028.
    1. Lemmens VE, Oenema A, Klepp KI, Henriksen HB, Brug J. A systematic review of the evidence regarding efficacy of obesity prevention interventions among adults. Obes Rev. 2008
    1. Contento I, Balch GI, Bronner YL, Lytle L, Maloney SK, Olson CM, Swadener SS. The effectiveness of nutrition education and implications for nutrition education policy, programs, and research: A review of research. J Nutr Educ. 1995;27:277–418.
    1. Laven GT. Insufficient evidence for committee recommendations on obesity. Pediatrics. 2008;121:1077–1078. doi: 10.1542/peds.2008-0003. author reply 1078–1079.
    1. Kumanyika SK, Obarzanek E, Stettler N, Bell R, Field AE, Fortmann SP, Franklin BA, Gillman MW, Lewis CE, Poston WC, 2nd, Stevens J, Hong Y. Population-based prevention of obesity. The need for comprehensive promotion of healthful eating, physical activity, and energy balance. A scientific statement from American Heart Association Council on Epidemiology and Prevention, Interdisciplinary Committee for Prevention (Formerly the Expert Panel on Population and Prevention Science) Circulation. 2008
    1. Kok G. Quality of planning as a decisive determinant of health education effectiveness. Hygie. 1992;11:5–9.
    1. Hardeman W, Sutton S, Griffin S, Johnston M, White A, Wareham NJ, Kinmonth AL. A causal modelling approach to the development of theory-based behaviour change programmes for trial evaluation. Health Educ Res. 2005;20:676–687. doi: 10.1093/her/cyh022.
    1. Campbell NC, Murray E, Darbyshire J, Emery J, Farmer A, Griffiths F, Guthrie B, Lester H, Wilson P, Kinmonth AL. Designing and evaluating complex interventions to improve health care. BMJ. 2007;334:455–459. doi: 10.1136/.
    1. Caballero B, Clay T, Davis SM, Ethelbah B, Rock BH, Lohman T, Norman J, Story M, Stone EJ, Stephenson L, Stevens J. Pathways: a school-based, randomized controlled trial for the prevention of obesity in American Indian schoolchildren. Am J Clin Nutr. 2003;78:1030–1038.
    1. Wardle J, Rapoport L, Miles A, Afuape T, Duman M. Mass education for obesity prevention: the penetration of the BBC's 'Fighting Fat, Fighting Fit' campaign. Health Educ Res. 2001;16:343–355. doi: 10.1093/her/16.3.343.
    1. Baranowski T, Lin LS, Wetter DW, Resnicow K, Hearn MD. Theory as mediating variables: why aren't community interventions working as desired? Ann Epidemiol. 1997;7:S89–S95. doi: 10.1016/S1047-2797(97)80011-7.
    1. Bachman CM, Baranowski T, Nicklas TA. Is there an association between sweetened beverages and adiposity? Nutr Rev. 2006;64:153–174. doi: 10.1111/j.1753-4887.2006.tb00199.x.
    1. Bar-Or O, Baranowski T. Physical activity, obesity and adiposity among adolescents. Pediatric Exercise Science. 1994. pp. 348–360.
    1. Foster E, Matthews JN, Lloyd J, Marshall L, Mathers JC, Nelson M, Barton KL, Wrieden WL, Cornelissen P, Harris J, Adamson AJ. Children's estimates of food portion size: the development and evaluation of three portion size assessment tools for use with children. Br J Nutr. 2008;99:175–184.
    1. Haerens L, Cerin E, Deforche B, Maes L, De Bourdeaudhuij I. Explaining the effects of a 1-year intervention promoting a low fat diet in adolescent girls: a mediation analysis. Int J Behav Nutr Phys Act. 2007;4:55. doi: 10.1186/1479-5868-4-55.
    1. Watson K, Baranowski T, Thompson D. Item response modeling: an evaluation of the children's fruit and vegetable self-efficacy questionnaire. Health Educ Res. 2006;21:i47–57. doi: 10.1093/her/cyl136.
    1. Baranowski T, Anderson C, Carmack C. Mediating variable framework in physical activity interventions. How are we doing? How might we do better? Am J Prev Med. 1998;15:266–297. doi: 10.1016/S0749-3797(98)00080-4.
    1. Resnicow K, Davis M, Smith M, Lazarus-Yaroch A, Baranowski T, Baranowski J, Doyle C, Wang DT. How best to measure implementation of health curricula: A comparison of three measures. Health Educ Res. 1998;13:239–250. doi: 10.1093/her/13.2.239.
    1. Glanz K. Dietary Change. Cancer Cause Control. 1997;8:S13–16.
    1. Gucciardini E, Cameron J, Liao C, Palmer A, Steward D. Program design features that can imporve participation in health education interventions. BMC Health Res Methodol. 2007;7:47. doi: 10.1186/1471-2288-7-47.
    1. Garnett SP, Baur LA, Cowell CT. Waist-to-height ratio: a simple option for determining excess central adiposity in young people. Int J Obes (Lond) 2008;32:1028–1030. doi: 10.1038/ijo.2008.51.
    1. Stevens J, Taber DR, Murray DM, Ward DS. Advances and controversies in the design of obesity prevention trials. Obesity (Silver Spring) 2007;15:2163–2170. doi: 10.1038/oby.2007.257.
    1. Prentice AM, Jebb SA. Beyond body mass index. Obes Rev. 2001;2:141–147. doi: 10.1046/j.1467-789x.2001.00031.x.
    1. Romero-Corral A, Somers VK, Sierra-Johnson J, Thomas RJ, Collazo-Clavell ML, Korinek J, Allison TG, Batsis JA, Sert-Kuniyoshi FH, Lopez-Jimenez F. Accuracy of body mass index in diagnosing obesity in the adult general population. Int J Obes (Lond) 2008;32:959–966. doi: 10.1038/ijo.2008.11.
    1. Burkhauser RV, Cawley J, Beyond BMI. the value of more accurate measures of fatness and obesity in social science research. J Health Econ. 2008;27:519–529. doi: 10.1016/j.jhealeco.2007.05.005.
    1. Cole TJ, Faith MS, Pietrobelli A, Heo M. What is the best measure of adiposity change in growing children: BMI, BMI %, BMI z-score or BMI centile? Eur J Clin Nutr. 2005;59:419–425. doi: 10.1038/sj.ejcn.1602090.
    1. Lohman TG, Caballero B, Himes JH, Davis CE, Stewart D, Houtkooper L, Going SB, Hunsberger S, Weber JL, Reid R, Stephenson L. Estimation of body fat from anthropometry and bioelectrical impedance in Native American children. Int J Obes Relat Metab Disord. 2000;24:982–988. doi: 10.1038/sj.ijo.0801318.
    1. Schatzkin A, Kipnis V. Could exposure assessment problems give us wrong answers to nutrition and cancer questions? J Natl Cancer Inst. 2004;96:1564–1565.
    1. Golay A, Bobbioni E. The role of dietary fat in obesity. Int J Obes. 1997;21:S2–S11.
    1. Bessesen DH, Bull S, Cornier MA. Trafficking of dietary fat and resistance to obesity. Physiol Behav. 2008;94:681–688. doi: 10.1016/j.physbeh.2008.04.019.
    1. Jago R, Baranowski T, Baranowski JC, Thompson D, Greaves KA. BMI from 3–6 y of age is predicted by TV viewing and physical activity, not diet. Int J Obes (Lond) 2005;29:557–564. doi: 10.1038/sj.ijo.0802969.
    1. Ruottinen S, Niinikoski H, Lagstrom H, Ronnemaa T, Hakanen M, Viikari J, Jokinen E, Simell O. High sucrose intake is associated with poor quality of diet and growth between 13 months and 9 years of age: the special Turku Coronary Risk Factor Intervention Project. Pediatrics. 2008;121:e1676–1685. doi: 10.1542/peds.2007-1642.
    1. Newby PK, Muller D, Hallfrisch J, Andres R, Tucker KL. Food patterns measured by factor analysis and anthropometric changes in adults. Am J Clin Nutr. 2004;80:504–513.
    1. Newby PK, Weismayer C, Akesson A, Tucker KL, Wolk A. Longitudinal changes in food patterns predict changes in weight and body mass index and the effects are greatest in obese women. J Nutr. 2006;136:2580–2587.
    1. Murtaugh MA, Sweeney C, Giuliano AR, Herrick JS, Hines L, Byers T, Baumgartner KB, Slattery ML. Diet patterns and breast cancer risk in Hispanic and non-Hispanic white women: the Four-Corners Breast Cancer Study. Am J Clin Nutr. 2008;87:978–984.
    1. Shi Z, Hu X, Yuan B, Hu G, Pan X, Dai Y, Byles JE, Holmboe-Ottesen G. Vegetable-rich food pattern is related to obesity in China. Int J Obes (Lond) 2008;32:975–984. doi: 10.1038/ijo.2008.21.
    1. Ayala GX, Rogers M, Arredondo EM, Campbell NR, Baquero B, Duerksen SC, Elder JP. Away-from-home food intake and risk for obesity: examining the influence of context. Obesity (Silver Spring) 2008;16:1002–1008. doi: 10.1038/oby.2008.34.
    1. Strong WB, Malina RM, Blimkie CJ, Daniels SR, Dishman RK, Gutin B, Hergenroeder AC, Must A, Nixon PA, Pivarnik JM, Rowland T, Trost S, Trudeau F. Evidence based physical activity for school-age youth. J Pediatr. 2005;146:732–737. doi: 10.1016/j.jpeds.2005.01.055.
    1. Metcalf BS, Voss LD, Hosking J, Jeffery AN, Wilkin TJ. Physical activity at the government-recommended level and obesity-related health outcomes: a longitudinal study (EarlyBird 37) Arch Dis Child. 2008
    1. Ekelund U. Cardiorespiratory fitness, exercise capacity and physical activity in children: are we measuring the right thing? Arch Dis Child. 2008;93:455–456. doi: 10.1136/adc.2007.135202.
    1. Borradaile KE, Foster GD, May H, Karpyn A, Sherman S, Grundy K, Nachmani J, Vander Veur S, Boruch RF. Associations between the Youth/Adolescent Questionnaire, the Youth/Adolescent Activity Questionnaire, and body mass index z score in low-income inner-city fourth through sixth grade children. Am J Clin Nutr. 2008;87:1650–1655.
    1. Nicklas TA, Yang SJ, Baranowski T, Zakeri I, Berenson G. Eating patterns and obesity in children. The Bogalusa Heart Study. Am J Prev Med. 2003;25:9–16. doi: 10.1016/S0749-3797(03)00098-9.
    1. Keith SW, Redden DT, Katzmarzyk PT, Boggiano MM, Hanlon EC, Benca RM, Ruden D, Pietrobelli A, Barger JL, Fontaine KR, Wang C, Aronne LJ, Wright SM, Baskin M, Dhurandhar NV, et al. Putative contributors to the secular increase in obesity: exploring the roads less traveled. Int J Obes (Lond) 2006;30:1585–1594. doi: 10.1038/sj.ijo.0803326.
    1. Carnell S, Wardle J. Measuring behavioural susceptibility to obesity: validation of the child eating behaviour questionnaire. Appetite. 2007;48:104–113. doi: 10.1016/j.appet.2006.07.075.
    1. Ebbeling CB, Sinclair KB, Pereira MA, Garcia-Lago E, Feldman HA, Ludwig DS. Compensation for energy intake from fast food among overweight and lean adolescents. J Am Med Assoc. 2004;291:2828–2833. doi: 10.1001/jama.291.23.2828.
    1. Melzer K, Kayser B, Saris WH, Pichard C. Effects of physical activity on food intake. Clin Nutr. 2005;24:885–895. doi: 10.1016/j.clnu.2005.06.003.
    1. Rockett H. Commentary on lack of association between television viewing, soft drinks, physical activity and body mass index in children. Acta Paediatr. 2008;97:699–700. doi: 10.1111/j.1651-2227.2008.00817.x.
    1. Baranowski T. Advances in basic behavioral research will make the most important contributions to effective dietary change programs at this time. J Am Diet Assoc. 2006;106:808–811. doi: 10.1016/j.jada.2006.03.032.
    1. Bouchard C. The magnitude of the energy imbalance in obesity is generally underestimated. Int J Obes (Lond) 2008;32:879–880. doi: 10.1038/sj.ijo.0803796.
    1. Gutin B, Yin Z, Johnson M, Barbeau P. Preliminary findings of the effect of a 3-year after-school physical activity intervention on fitness and body fat: the Medical College of Georgia Fitkid Project. Int J Pediatr Obes. 2008;3:3–9. doi: 10.1080/17477160801896457.
    1. de Moor C, Baranowski T, Cullen KW, Nicklas T. Misclassification associated with measurement error in the assessment of dietary intake. Pub Health Nutr. 2003;6:393–399. doi: 10.1079/PHN2002446.
    1. Cerin E, Baranowski T. Impact of unreliability of behavior and adiposity measures on outcomes of obesity prevention and treatment programs. Intern J Obes.
    1. Murray D, Catellier D, Hannan P, Treuth M, Steven J, Schmitz K, Rice J, Conway T. School-level intraclass correlations for physical activity in adolescent girls. Med Sci Sports Exerc. 2004;36:876–882. doi: 10.1249/01.MSS.0000126806.72453.1C.
    1. Kumanyika SK. Environmental influences on childhood obesity: ethnic and cultural influences in context. Physiol Behav. 2008;94:61–70. doi: 10.1016/j.physbeh.2007.11.019.
    1. Share M, Strain M. Making schools and young people responsible: a critical analysis of Ireland's obesity strategy. Health Soc Care Community. 2008;16:234–243.
    1. Fernandez JR, Casazza K, Divers J, Lopez-Alarcon M. Disruptions in energy balance: does nature overcome nurture? Physiol Behav. 2008;94:105–112. doi: 10.1016/j.physbeh.2007.11.021.
    1. Adair LS. Child and adolescent obesity: epidemiology and developmental perspectives. Physiol Behav. 2008;94:8–16. doi: 10.1016/j.physbeh.2007.11.016.
    1. King AC, Marcus B, Ahn D, Dunn AL, Rejeski WJ, Sallis JF, Coday M. Identifying subgroups that succeed or fail with three levels of physical activity intervention: the Activity Counseling Trial. Health Psychol. 2006;25:336–347. doi: 10.1037/0278-6133.25.3.336.
    1. Chen H. Theory-Driven Evaluations. Newbury Park, CA: Sage; 1990.
    1. MacKinnon D. Introduction to Statistical Mediation Analysis. New York, NY: Lawrence Erlbaum; 2008.
    1. Michie S, Johnston M, Abraham C, Lawton R, Parker D, Walker A. Making psychological theory useful for implementing evidence based practice: a consensus approach. Qual Saf Health Care. 2005;14:26–33. doi: 10.1136/qshc.2004.011155.
    1. Szklo M, Nieto F. Epidemiology: Beyond the Basics. Gaithersbury, MD: Aspen Publications; 2000.
    1. Baranowski T, Allen DD, Masse LC, Wilson M. Does participation in an intervention affect responses on self-report questionnaires? Health Educ Res. 2006;21:i98–109. doi: 10.1093/her/cyl087.
    1. Carbone ET, Campbell MK, Honess-Morreale L. Use of cognitive interview techniques in the development of nutrition surveys and interactive nutrition messages for low-income populations. J Am Diet Assoc. 2002;102:690–696. doi: 10.1016/S0002-8223(02)90156-2.
    1. Miles A, Rapoport L, Wardle J, Afuape T, Duman M. Using the mass-media to target obesity: an analysis of the characteristics and reported behaviour change of participants in the BBC's 'Fighting Fat, Fighting Fit' campaign. Health Educ Res. 2001;16:357–372. doi: 10.1093/her/16.3.357.
    1. Hyde J, Hankins M, Deale A, Marteau TM. Interventions to increase self-efficacy in the context of addiction behaviours: A systematic literature review. J Health Psychol. 2008;13:607–623. doi: 10.1177/1359105308090933.
    1. Michie S, Abraham C. Interventions to change health behaviors: Evidence-based or evidence-inspired? Psychol Health. 2004;19:29–49. doi: 10.1080/0887044031000141199.
    1. Michie S. Designing and implementing behavior change interventions to imporve population health. J Health Serv Res Policy. 2008:1–6.
    1. Michie S, Johnston M. Changing clinical behaviour by making guidelines specific. Bmj. 2004;328:343–345. doi: 10.1136/bmj.328.7435.343.
    1. van Assema P, Martens M, Ruiter RA, Brug J. Framing of nutrition education messages in persuading consumers of the advantages of a healthy diet. J Hum Nutr Diet. 2001;14:435–442. doi: 10.1046/j.1365-277X.2001.00315.x.
    1. Cullen K, Baranowski T, Smith S. Using goal setting as a strategy for dietary behavior change. J Am Diet Assoc. 2001;101:562–566. doi: 10.1016/S0002-8223(01)00140-7.
    1. Michie S, Hardeman W, Fanshawe T, Prevost AT, Taylor L, Kinmonth AL. Investigating theoretical explanations for behavior change: The case study ProActive. Psychol Health. 2008;23:25–39. doi: 10.1080/08870440701670588.
    1. Riley BL, Macdonald J, Mansi O, Kothari A, Kurtz D, Vontettenborn LI, Edwards NC. Is reporting on interventions a weak link in understanding how and why they work? A preliminary exploration using community heart health exemplars. Implement Sci. 2008;3:27. doi: 10.1186/1748-5908-3-27.
    1. Collins LM, Murphy SA, Nair VN, Strecher VJ. A strategy for optimizing and evaluating behavioral interventions. Ann Behav Med. 2005;30:65–73. doi: 10.1207/s15324796abm3001_8.
    1. Campbell MK, et al. The North Carolina Black Churches United for Better Health Project: Intervention and process evaluation. Health Educ Behav. 2000 (this issue).
    1. Kropski JA, Keckley PH, Jensen GL. School-based obesity prevention programs: an evidence-based review. Obesity (Silver Spring) 2008;16:1009–1018. doi: 10.1038/oby.2008.29.
    1. Michie S. What works and how? Designing more effective interventions needs answers to both questions. Addiction. 2008;103:886–887. doi: 10.1111/j.1360-0443.2007.02112.x.
    1. Baranowski T, Jago R. Understanding mechanisms of change in children's physical activity programs. Exercise Sport Sci R. 2005;33:163–168. doi: 10.1097/00003677-200510000-00003.
    1. West SG, Aiken LS. The Science of Prevention, Methodological Advances from Alcohol and Substance Abuse Research. Washington, DC: American Psychological Association; 1997. Toward understanding individual effects in multicomponent prevention programs: Design and analysis strategies. In: Bryant KJ, Windle M, West SG, eds.
    1. Baranowski T, Allen D, Masse L, Wilson M. Does participation in an intervention affect responses on self report questionnaires? Health Educ Res. 2006
    1. Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. Lancet. 2001;357:1191–1194. doi: 10.1016/S0140-6736(00)04337-3.
    1. Dixon JR., Jr The International Conference on Harmonization Good Clinical Practice guideline. Qual Assur. 1998;6:65–74.
    1. Des Jarlais DC, Lyles C, Crepaz N. Improving the reporting quality of nonrandomized evaluations of behavioral and public health interventions: the TREND statement. Am J Public Health. 2004;94:361–366. doi: 10.2105/AJPH.94.3.361.
    1. Glasgow RE, Magid DJ, Beck A, Ritzwoller D, Estabrooks PA. Practical clinical trials for translating research to practice: design and measurement recommendations. Med Care. 2005;43:551–557. doi: 10.1097/01.mlr.0000163645.41407.09.
    1. Klesges LM, Estabrooks PA, Dzewaltowski DA, Bull SS, Glasgow RE. Beginning with the application in mind: Designing and planning health behavior change interventions to enhance dissemination. Ann Behav Med. 2005;29:66–75. doi: 10.1207/s15324796abm2902s_10.
    1. Dzewaltowski DA, Noble JM, Shaw JM. Physical activity participation: Social cognitive theory versus the theories of reasoned action and planned behavior. J Sport Exercise Psychol. 1990;12:288–405.
    1. Godley SH, Godley MD, Wright KL, Funk RR, Petry NM. Contingent reinforcement of personal goal activities for adolescents with substance use disorders during post-residential continuing care. Am J Addict. 2008;17:278–286. doi: 10.1080/10550490802138798.
    1. Boyatzis RE. Using tipping points of emotional intelligence and cognitive competencies to predict financial performance of leaders. Psicothema. 2006;18:124–131.
    1. Herry C, Ciocchi S, Senn V, Demmou L, Muller C, Luthi A. Switching on and off fear by distinct neuronal circuits. Nature. 2008
    1. Anderson D, Raine KD, Plotnikoff RC, Cook K, Barrett L, Smith C. aBaseline assessment of organizational capacity for health promotion within regional health authorities in Alberta, Canada. Promot Educ. 2008;15:6–14. doi: 10.1177/1025382308090339.

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