Study Summary
This trial will test whether a weight loss program that involves both kids and their parents is more effective than a program that just involves the kids.
Eligible Conditions
- Childhood Obesity
- Obesity in Adolescents
- Parent-Child Relationship
- Weight Loss
- Family and Household
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 11 Secondary · Reporting Duration: 6 months
6 months
Alanine Aminotransferase-Levels of ALT for all participants, measured in units per liter
Aspartate Transaminase
BMI z-score
Caloric intake expressed in kcals
Concentration of fasting Insulin for all participants, mg/dL
Concentration of fasting glucose for all participants, mg/dL
Concentration of total cholesterol (mg/dL)
Economic costs of the three intervention arms over duration of program (USD)
Hemoglobin A1c concentration for all participants, measured in percentage
Physical Activity Assessed by Accelerometry
Physical Activity Assessed by IPAQ
Physical Activity Assessed by PAQ-A
Trial Safety
Safety Progress
Trial Design
3 Treatment Groups
Adolescent Participants
1 of 3
Caregivers of Adolescent Participants
1 of 3
Co-enrollment
1 of 3
Active Control
Experimental Treatment
90 Total Participants · 3 Treatment Groups
Primary Treatment: Dyad Plus · No Placebo Group · N/A
Caregivers of Adolescent Participants
Behavioral
Experimental Group · 1 Intervention: By Design Essentials · Intervention Types: BehavioralCo-enrollment
Behavioral
Experimental Group · 1 Intervention: Dyad Plus · Intervention Types: BehavioralAdolescent Participants
Behavioral
ActiveComparator Group · 1 Intervention: Brenner FIT Standard · Intervention Types: BehavioralTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months
Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,127 Previous Clinical Trials
1,137,337 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,444 Previous Clinical Trials
24,578,353 Total Patients Enrolled
Justin MoorePrincipal InvestigatorWake Forest University Health Sciences
Eligibility Criteria
Age 13 - 65 · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are eligible for enrollment in Brenner FIT and/or By Design Essentials.
You have a caregiver who is overweight or obese.
References
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- Moore, Justin B., John C. Hanes, Paule Barbeau, Bernard Gutin, Roberto P. Treviño, and Zenong Yin. 2007. “Validation of the Physical Activity Questionnaire for Older Children in Children of Different Races”. Pediatric Exercise Science. Human Kinetics. doi:10.1123/pes.19.1.6.
- Thompson, Frances E., Sujata Dixit-Joshi, Nancy Potischman, Kevin W. Dodd, Sharon I. Kirkpatrick, Lawrence H. Kushi, Gwen L. Alexander, et al.. 2015. “Comparison of Interviewer-administered and Automated Self-administered 24-hour Dietary Recalls in 3 Diverse Integrated Health Systems”. American Journal of Epidemiology. Oxford University Press (OUP). doi:10.1093/aje/kwu467.
- Compas, Bruce E., Glen E. Davis, Carolyn J. Forsythe, and Barry M. Wagner. 1987. “Assessment of Major and Daily Stressful Events During Adolescence: The Adolescent Perceived Events Scale.”. Journal of Consulting and Clinical Psychology. American Psychological Association (APA). doi:10.1037/0022-006x.55.4.534.
- Motl, Robert W., Rod K. Dishman, Marsha Dowda, and Russell R. Pate. 2004. “Factorial Validity and Invariance of a Self-report Measure of Physical Activity Among Adolescent Girls”. Research Quarterly for Exercise and Sport. Informa UK Limited. doi:10.1080/02701367.2004.10609159.
- Kelly, T, W Yang, C-S Chen, K Reynolds, and J He. 2008. “Global Burden of Obesity in 2005 and Projections to 2030”. International Journal of Obesity. Springer Science and Business Media LLC. doi:10.1038/ijo.2008.102.
- Ogden, Cynthia L., Margaret D. Carroll, Brian K. Kit, and Katherine M. Flegal. 2014. “Prevalence of Childhood and Adult Obesity in the United States, 2011-2012”. Jama. American Medical Association (AMA). doi:10.1001/jama.2014.732.
- Anderson-Bill, Eileen Smith, Richard A Winett, and Janet R Wojcik. 2011. “Social Cognitive Determinants of Nutrition and Physical Activity Among Web-health Users Enrolling in an Online Intervention: The Influence of Social Support, Self-efficacy, Outcome Expectations, and Self-regulation”. Journal of Medical Internet Research. JMIR Publications Inc.. doi:10.2196/jmir.1551.
- Irby, Megan B., Stacy Kolbash, Dara Garner-Edwards, and Joseph A. Skelton. 2012. “Pediatric Obesity Treatment in Children with Neurodevelopmental Disabilities”. ICAN: Infant, Child, & Adolescent Nutrition. SAGE Publications. doi:10.1177/1941406412448527.
- Brown, Callie L., and Joseph A. Skelton. 2017. “Opportunities and Cautions in the Use of Commercially Delivered Weight-management Programs for Children and Adolescents”. The Journal of Pediatrics. Elsevier BV. doi:10.1016/j.jpeds.2017.02.068.
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- Næss, Marit, Turid Lingaas Holmen, Mette Langaas, Johan Håkon Bjørngaard, and Kirsti Kvaløy. 2016. “Intergenerational Transmission of Overweight and Obesity from Parents to Their Adolescent Offspring – the HUNT Study”. Edited by David Meyre. Plos One. Public Library of Science (PLoS). doi:10.1371/journal.pone.0166585.
- Kirkpatrick, Sharon I, Amy F Subar, Deirdre Douglass, Thea P Zimmerman, Frances E Thompson, Lisa L Kahle, Stephanie M George, Kevin W Dodd, and Nancy Potischman. 2014. “Performance of the Automated Self-administered 24-hour Recall Relative to a Measure of True Intakes and to an Interviewer-administered 24-h Recall”. The American Journal of Clinical Nutrition. Oxford University Press (OUP). doi:10.3945/ajcn.114.083238.
- Saint-Maurice, Pedro F, Gregory J Welk, Nicholas K Beyler, Roderick T Bartee, and Kate A Heelan. 2014. “Calibration of Self-report Tools for Physical Activity Research: The Physical Activity Questionnaire (PAQ)”. BMC Public Health. Springer Science and Business Media LLC. doi:10.1186/1471-2458-14-461.
- Moore, Justin B., Lori Schneider, Suzanne Lazorick, Kindal A. Shores, Aaron Beighle, Stephanie B. Jilcott, and Jimmy Newkirk. 2010. “Rationale and Development of the Move More North Carolina”. Journal of Public Health Management and Practice. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/phh.0b013e3181ca2634.
- Kamath, Celia C., Kristin S. Vickers, Angela Ehrlich, Lauren McGovern, Jonathan Johnson, Vibha Singhal, Remberto Paulo, Allison Hettinger, Patricia J. Erwin, and Victor M. Montori. 2008. “Behavioral Interventions to Prevent Childhood Obesity: A Systematic Review and Metaanalyses of Randomized Trials”. The Journal of Clinical Endocrinology & Metabolism. The Endocrine Society. doi:10.1210/jc.2006-2411.
- Loveman E, Al-Khudairy L, Johnson RE, Robertson W, Colquitt JL, Mead EL, Ells LJ, Metzendorf MI, Rees K. Parent-only interventions for childhood overweight or obesity in children aged 5 to 11 years. Cochrane Database Syst Rev. 2015 Dec 21;(12):CD012008. doi: 10.1002/14651858.CD012008. Review.
- Skelton, J. A., and B. M. Beech. 2011. “Attrition in Paediatric Weight Management: A Review of the Literature and New Directions”. Obesity Reviews. Wiley. doi:10.1111/j.1467-789x.2010.00803.x.
- Devakumar, Delan, Carlos Grijalva‐Eternod, Mario Cortina‐Borja, Jane Williams, Mary Fewtrell, and Jonathan Wells. 2016. “Disentangling the Associations Between Parental BMI and Offspring Body Composition Using the Four‐component Model”. American Journal of Human Biology. Wiley. doi:10.1002/ajhb.22825.
- Boutelle, Kerri N., Guy Cafri, and Scott J. Crow. 2012. “Parent Predictors of Child Weight Change in Family Based Behavioral Obesity Treatment”. Obesity. Wiley. doi:10.1038/oby.2012.48.
- Spear, Bonnie A., Sarah E. Barlow, Chris Ervin, David S. Ludwig, Brian E. Saelens, Karen E. Schetzina, and Elsie M. Taveras. 2007. “Recommendations for Treatment of Child and Adolescent Overweight and Obesity”. Pediatrics. American Academy of Pediatrics (AAP). doi:10.1542/peds.2007-2329f.
- Golan, M.. 2013. “Fifteen Years of the Family Eating and Activity Habits Questionnaire (FEAHQ): An Update and Review”. Pediatric Obesity. Wiley. doi:10.1111/j.2047-6310.2013.00144.x.
- Turner-McGrievy, Gabrielle M., Julie A. Wright, Jeffrey P. Migneault, Lisa Quintiliani, and Robert H. Friedman. 2014. “The Interaction Between Dietary and Life Goals: Using Goal Systems Theory to Explore Healthy Diet and Life Goals”. Health Psychology and Behavioral Medicine. Informa UK Limited. doi:10.1080/21642850.2014.927737.
- BAILEY, ROBERT C., JODI OLSON, SARA L. PEPPER, JANOS PORSZASZ, THOMAS J. BARSTOW, and DAN M. COOPER. 1995. “The Level and Tempo of Children???s Physical Activities: An Observational Study”. Medicine & Science in Sports & Exercise. Ovid Technologies (Wolters Kluwer Health). doi:10.1249/00005768-199507000-00012.
- Anderson, Eileen S., Richard A. Winett, and Janet R. Wojcik. 2007. “Self-regulation, Self-efficacy, Outcome Expectations, and Social Support: Social Cognitive Theory and Nutrition Behavior”. Annals of Behavioral Medicine. Oxford University Press (OUP). doi:10.1007/bf02874555.
- Moore, Justin B., Zenong Yin, John Hanes, Joan Duda, Bernard Gutin, and Paule Barbeau. 2009. “Measuring Enjoyment of Physical Activity in Children: Validation of the Physical Activity Enjoyment Scale”. Journal of Applied Sport Psychology. Informa UK Limited. doi:10.1080/10413200802593612.
- Eys, Mark, Todd Loughead, Steven R. Bray, and Albert V. Carron. 2009. “Development of a Cohesion Questionnaire for Youth: The Youth Sport Environment Questionnaire”. Journal of Sport and Exercise Psychology. Human Kinetics. doi:10.1123/jsep.31.3.390.
- Little, R. J., M. L. Cohen, K. Dickersin, S. S. Emerson, J. T. Farrar, J. D. Neaton, W. Shih, J. P. Siegel, and H. Stern. 2012. “The Design and Conduct of Clinical Trials to Limit Missing Data”. Statistics in Medicine. Wiley. doi:10.1002/sim.5519.
- Nelson, Joni D., Justin B. Moore, Christine Blake, Sara F. Morris, and Mary Bea Kolbe. 2013. “Characteristics of Successful Community Partnerships to Promote Physical Activity Among Young People, North Carolina, 2010–2012”. Preventing Chronic Disease. Centers for Disease Control and Prevention (CDC). doi:10.5888/pcd10.130110.
- Anderson-Bill, Eileen Smith, Richard A Winett, and Janet R Wojcik. 2011. “Social Cognitive Determinants of Nutrition and Physical Activity Among Web-health Users Enrolling in an Online Intervention: The Influence of Social Support, Self-efficacy, Outcome Expectations, and Self-regulation”. Journal of Medical Internet Research. JMIR Publications Inc.. doi:10.2196/jmir.1551.
- Djafarian K, Speakman JR, Stewart J, Jackson DM. Comparison of activity levels measured by a wrist worn accelerometer and direct observation in young children. Open Journal of Pediatrics. 2013;03(04):422-427.
- Chandler JL, Beets MW, Drenowatz C, et al. Analysis of Accelerometer Counts during Sedentary Activities on Dominant and Non-Dominant Wrists in 5-11 year old Children. Under review.
- Eys M, Loughead T, Bray SR, Carron AV. Development of a cohesion questionnaire for youth: the Youth Sport Environment Questionnaire. J Sport Exerc Psychol. 2009 Jun;31(3):390-408. doi: 10.1123/jsep.31.3.390.
- Barlow SE; Expert Committee. Expert committee recommendations regarding the prevention, assessment, and treatment of child and adolescent overweight and obesity: summary report. Pediatrics. 2007 Dec;120 Suppl 4:S164-92. doi: 10.1542/peds.2007-2329C.
- Spear BA, Barlow SE, Ervin C, Ludwig DS, Saelens BE, Schetzina KE, Taveras EM. Recommendations for treatment of child and adolescent overweight and obesity. Pediatrics. 2007 Dec;120 Suppl 4:S254-88. doi: 10.1542/peds.2007-2329F.
- Yang L, Colditz GA. Prevalence of Overweight and Obesity in the United States, 2007-2012. JAMA Intern Med. 2015 Aug;175(8):1412-3. doi: 10.1001/jamainternmed.2015.2405. No abstract available.
- Skelton JA, Beech BM. Attrition in paediatric weight management: a review of the literature and new directions. Obes Rev. 2011 May;12(5):e273-81. doi: 10.1111/j.1467-789X.2010.00803.x. Epub 2010 Sep 29.
- Naess M, Holmen TL, Langaas M, Bjorngaard JH, Kvaloy K. Intergenerational Transmission of Overweight and Obesity from Parents to Their Adolescent Offspring - The HUNT Study. PLoS One. 2016 Nov 16;11(11):e0166585. doi: 10.1371/journal.pone.0166585. eCollection 2016.
- Irby MB, Kolbash S, Garner-Edwards D, Skelton JA. Pediatric Obesity Treatment in Children With Neurodevelopmental Disabilities: A Case Series and Review of the Literature. Infant Child Adolesc Nutr. 2012 Aug 1;4(4):215-221. doi: 10.1177/1941406412448527.
- Turner-McGrievy GM, Wright JA, Migneault JP, Quintiliani L, Friedman RH. The interaction between dietary and life goals: using goal systems theory to explore healthy diet and life goals. Health Psychol Behav Med. 2014 Jan 1;2(1):759-769. doi: 10.1080/21642850.2014.927737. Epub 2014 Jul 15.
- Moore JB, Hanes JC Jr, Barbeau P, Gutin B, Trevino RP, Yin Z. Validation of the Physical Activity Questionnaire for Older Children in children of different races. Pediatr Exerc Sci. 2007 Feb;19(1):6-19. doi: 10.1123/pes.19.1.6.
- Kelly T, Yang W, Chen CS, Reynolds K, He J. Global burden of obesity in 2005 and projections to 2030. Int J Obes (Lond). 2008 Sep;32(9):1431-7. doi: 10.1038/ijo.2008.102. Epub 2008 Jul 8.
- Compas BE, Davis GE, Forsythe CJ, Wagner BM. Assessment of major and daily stressful events during adolescence: the Adolescent Perceived Events Scale. J Consult Clin Psychol. 1987 Aug;55(4):534-541. doi: 10.1037/0022-006X.55.4.534. No abstract available.
- Kamath CC, Vickers KS, Ehrlich A, McGovern L, Johnson J, Singhal V, Paulo R, Hettinger A, Erwin PJ, Montori VM. Clinical review: behavioral interventions to prevent childhood obesity: a systematic review and metaanalyses of randomized trials. J Clin Endocrinol Metab. 2008 Dec;93(12):4606-15. doi: 10.1210/jc.2006-2411. Epub 2008 Sep 9.
- Loveman E, Al-Khudairy L, Johnson RE, Robertson W, Colquitt JL, Mead EL, Ells LJ, Metzendorf MI, Rees K. Parent-only interventions for childhood overweight or obesity in children aged 5 to 11 years. Cochrane Database Syst Rev. 2015 Dec 21;2015(12):CD012008. doi: 10.1002/14651858.CD012008.
- Anderson ES, Winett RA, Wojcik JR. Self-regulation, self-efficacy, outcome expectations, and social support: social cognitive theory and nutrition behavior. Ann Behav Med. 2007 Nov-Dec;34(3):304-12. doi: 10.1007/BF02874555.
- Measuring Enjoyment of Physical Activity in Children: Validation of the Physical Activity Enjoyment Scale. J Appl Sport Psychol. 2009 Jan 1;21(S1):S116-S129. doi: 10.1080/10413200802593612.
- Brown CL, Skelton JA. Opportunities and Cautions in the Use of Commercially Delivered Weight-Management Programs for Children and Adolescents. J Pediatr. 2017 Jun;185:12-14. doi: 10.1016/j.jpeds.2017.02.068. Epub 2017 Mar 15. No abstract available.
- Golan M. Fifteen years of the Family Eating and Activity Habits Questionnaire (FEAHQ): an update and review. Pediatr Obes. 2014 Apr;9(2):92-101. doi: 10.1111/j.2047-6310.2013.00144.x. Epub 2013 Feb 28.
- Bailey RC, Olson J, Pepper SL, Porszasz J, Barstow TJ, Cooper DM. The level and tempo of children's physical activities: an observational study. Med Sci Sports Exerc. 1995 Jul;27(7):1033-41. doi: 10.1249/00005768-199507000-00012.
- Motl RW, Dishman RK, Dowda M, Pate RR. Factorial validity and invariance of a self-report measure of physical activity among adolescent girls. Res Q Exerc Sport. 2004 Sep;75(3):259-71. doi: 10.1080/02701367.2004.10609159.
- 2021. "Dyad Plus Effectiveness". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04036331.
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