Implementing Prevention Plus for Childhood Overweight and Obesity in Food Secure and Insecure Families
NCT ID: NCT02684214
Last Updated: 2022-03-16
Study Results
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Basic Information
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COMPLETED
NA
73 participants
INTERVENTIONAL
2016-04-30
2021-11-30
Brief Summary
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Detailed Description
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PP+
Following baseline assessment, children will continue to receive standard care at CHS and the monthly newsletter. Additionally, each family will be provided with a scale; wall growth chart to measure height; a BMI wheel to calculate BMI; a BMI-for-age growth chart; a binder for intervention materials; a self-monitoring diary to record child's monthly height, weight, BMI and BMI percentile; and picture-based diaries to monitor daily energy balance behaviors. Family materials provided at each session will outline a process to measure growth and include information about how children grow, as well as cover behavioral parenting strategies to assist with changing child behavior for energy balance behaviors.
Families will meet in person with a BHC at the CHS clinic in which they receive care for 30 minutes during months 1, 3, and 5. In these sessions, child height and weight will be taken, and BMI will be plotted on the BMI-for-age growth chart. Families will receive feedback about growth and the weight status of their child. Additionally, the session materials will be reviewed and behavioral parenting strategies will be encouraged to aid with changing two dietary and two leisure-time activity (energy balance) behaviors of the child. As is traditional in a family-based approach, the caretaker will also change the same energy balance behaviors as the child, as adult caretakers can then model healthy behaviors for the child, assisting the child in learning the new weight-related behaviors.13 Thus, both the caretaker and child will be encouraged to change and self-monitor energy balance behaviors with the use of the picture-based diaries.
During months 2, 4, and 6, BHCs will complete a 20-minute phone call with the caretaker. Caretakers will be asked to measure the height and weight of their child, calculate BMI and plot it on the BMI-for-age growth chart prior to the call. During the call, the BHC will provide feedback on the changes in child growth since the previous contact. Additionally, the BHC will discuss the family's progress on achieving child and caretaker energy balance behavior goals and implementation of behavioral parenting strategies.
The child's energy balance behavioral goals will be to consume \< 3 sugar-sweetened beverage (e.g., regular carbonated soft drinks, sports drinks, lemonades, ice teas, flavored milk, juice drinks \< 100% juice, and punches) servings /wk, ≥1 ½ cups/day of whole vegetables and ≥ 1 cup/day of whole fruit, engage in ≥ 60 minutes/day of moderate- to vigorous-intensity physical activity, and reduce TV viewing to \< 2 hours/day. The caretaker's energy balance behavioral goals will be to consume \< 3 sugar-sweetened beverage servings/wk, ≥ 2 ½ cups/day of whole vegetables and ≥ 1 ½ cups/day of whole fruit, engage in ≥ 150 minutes of moderate- to vigorous-intensity physical activity per week, and reduce TV viewing to \< 10 hours/wk. To increase self-efficacy, the goals will be incrementally increased, with families implementing the full program goals at month four. Additionally, children and caretakers will be asked to achieve at least three of the five goals each day (child) or week (adult caretaker).
PP-
This condition will be identical to PP+ except that caretakers will not receive any energy balance behavior goals. Additionally, the caretaker will not self-monitor energy balance behaviors. The focus will be on all other behavioral parenting strategies to assist the child with making changes in the targeted behaviors (i.e., stimulus control, positive reinforcement, and assisting child in self-monitoring energy-balance behaviors).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Food secure families
high and marginal household food security
Prevention Plus +
Families will receive 6 monthly newsletters and meet with a BHC at the clinic for 30 minutes during months 1, 3, and 5. Child height and weight will be taken. Families will receive feedback about growth and the weight status of their child. The session materials will be reviewed and behavioral parenting strategies will be encouraged to aid with changing two dietary and two leisure-time activity (energy balance) behaviors of the child. The caretaker will also change the same energy balance behaviors as the child, as adult caretakers can then model healthy behaviors. The caretaker and child will be encouraged to change and self-monitor energy balance behaviors with the use of the picture-based diaries. During months 2, 4, and 6, BHCs will complete a 20-minute phone call with the caretaker. Caretakers will be asked to measure the height and weight of their child, calculate BMI and plot it on the BMI-for-age growth chart prior to the call. The BHC will provide feedback.
Prevention Plus -
This condition will be identical to PP+ except that caretakers will not receive any energy balance behavior goals. Additionally, the caretaker will not self-monitor energy balance behaviors. The focus will be on all other behavioral parenting strategies to assist the child with making changes in the targeted behaviors.
Food insecure families
low and very low household food security
Prevention Plus +
Families will receive 6 monthly newsletters and meet with a BHC at the clinic for 30 minutes during months 1, 3, and 5. Child height and weight will be taken. Families will receive feedback about growth and the weight status of their child. The session materials will be reviewed and behavioral parenting strategies will be encouraged to aid with changing two dietary and two leisure-time activity (energy balance) behaviors of the child. The caretaker will also change the same energy balance behaviors as the child, as adult caretakers can then model healthy behaviors. The caretaker and child will be encouraged to change and self-monitor energy balance behaviors with the use of the picture-based diaries. During months 2, 4, and 6, BHCs will complete a 20-minute phone call with the caretaker. Caretakers will be asked to measure the height and weight of their child, calculate BMI and plot it on the BMI-for-age growth chart prior to the call. The BHC will provide feedback.
Prevention Plus -
This condition will be identical to PP+ except that caretakers will not receive any energy balance behavior goals. Additionally, the caretaker will not self-monitor energy balance behaviors. The focus will be on all other behavioral parenting strategies to assist the child with making changes in the targeted behaviors.
Interventions
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Prevention Plus +
Families will receive 6 monthly newsletters and meet with a BHC at the clinic for 30 minutes during months 1, 3, and 5. Child height and weight will be taken. Families will receive feedback about growth and the weight status of their child. The session materials will be reviewed and behavioral parenting strategies will be encouraged to aid with changing two dietary and two leisure-time activity (energy balance) behaviors of the child. The caretaker will also change the same energy balance behaviors as the child, as adult caretakers can then model healthy behaviors. The caretaker and child will be encouraged to change and self-monitor energy balance behaviors with the use of the picture-based diaries. During months 2, 4, and 6, BHCs will complete a 20-minute phone call with the caretaker. Caretakers will be asked to measure the height and weight of their child, calculate BMI and plot it on the BMI-for-age growth chart prior to the call. The BHC will provide feedback.
Prevention Plus -
This condition will be identical to PP+ except that caretakers will not receive any energy balance behavior goals. Additionally, the caretaker will not self-monitor energy balance behaviors. The focus will be on all other behavioral parenting strategies to assist the child with making changes in the targeted behaviors.
Eligibility Criteria
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Inclusion Criteria
* BMI \> 85th percentile
* have an adult (\> 18 years) female caretaker living in the household willing to participate in the program.
4 Years
10 Years
ALL
Yes
Sponsors
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Cherokee Health Systems
UNKNOWN
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
The University of Tennessee, Knoxville
OTHER
Responsible Party
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Hollie Raynor
Professor
Locations
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Healthy Eating and Activity Laboratory, University of Tennessee
Knoxville, Tennessee, United States
Countries
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References
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Kranz S, Mitchell DC, Smiciklas-Wright H, Huang SH, Kumanyika SK, Stettler N. Consumption of recommended food groups among children from medically underserved communities. J Am Diet Assoc. 2009 Apr;109(4):702-7. doi: 10.1016/j.jada.2008.12.018.
Nackers LM, Appelhans BM. Food insecurity is linked to a food environment promoting obesity in households with children. J Nutr Educ Behav. 2013 Nov-Dec;45(6):780-4. doi: 10.1016/j.jneb.2013.08.001. Epub 2013 Sep 8.
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.
Raynor HA, Osterholt KM, Hart CN, Jelalian E, Vivier P, Wing RR. Efficacy of U.S. paediatric obesity primary care guidelines: two randomized trials. Pediatr Obes. 2012 Feb;7(1):28-38. doi: 10.1111/j.2047-6310.2011.00005.x. Epub 2011 Dec 13.
Looney SM, Raynor HA. Examining the effect of three low-intensity pediatric obesity interventions: a pilot randomized controlled trial. Clin Pediatr (Phila). 2014 Dec;53(14):1367-74. doi: 10.1177/0009922814541803. Epub 2014 Jul 7.
Kitzman-Ulrich H, Wilson DK, St George SM, Lawman H, Segal M, Fairchild A. The integration of a family systems approach for understanding youth obesity, physical activity, and dietary programs. Clin Child Fam Psychol Rev. 2010 Sep;13(3):231-53. doi: 10.1007/s10567-010-0073-0.
Janicke DM, Sallinen BJ, Perri MG, Lutes LD, Huerta M, Silverstein JH, Brumback B. Comparison of parent-only vs family-based interventions for overweight children in underserved rural settings: outcomes from project STORY. Arch Pediatr Adolesc Med. 2008 Dec;162(12):1119-25. doi: 10.1001/archpedi.162.12.1119.
Wright JA, Phillips BD, Watson BL, Newby PK, Norman GJ, Adams WG. Randomized trial of a family-based, automated, conversational obesity treatment program for underserved populations. Obesity (Silver Spring). 2013 Sep;21(9):E369-78. doi: 10.1002/oby.20388. Epub 2013 Jun 11.
Dinour LM, Bergen D, Yeh MC. The food insecurity-obesity paradox: a review of the literature and the role food stamps may play. J Am Diet Assoc. 2007 Nov;107(11):1952-61. doi: 10.1016/j.jada.2007.08.006.
Metallinos-Katsaras E, Must A, Gorman K. A longitudinal study of food insecurity on obesity in preschool children. J Acad Nutr Diet. 2012 Dec;112(12):1949-58. doi: 10.1016/j.jand.2012.08.031.
Martin MA, Lippert AM. Feeding her children, but risking her health: the intersection of gender, household food insecurity and obesity. Soc Sci Med. 2012 Jun;74(11):1754-64. doi: 10.1016/j.socscimed.2011.11.013. Epub 2011 Dec 20.
Skelton JA, Buehler C, Irby MB, Grzywacz JG. Where are family theories in family-based obesity treatment?: conceptualizing the study of families in pediatric weight management. Int J Obes (Lond). 2012 Jul;36(7):891-900. doi: 10.1038/ijo.2012.56. Epub 2012 Apr 24.
Akers JD, Estabrooks PA, Davy BM. Translational research: bridging the gap between long-term weight loss maintenance research and practice. J Am Diet Assoc. 2010 Oct;110(10):1511-22, 1522.e1-3. doi: 10.1016/j.jada.2010.07.005.
Glasgow RE, Klesges LM, Dzewaltowski DA, Bull SS, Estabrooks P. The future of health behavior change research: what is needed to improve translation of research into health promotion practice? Ann Behav Med. 2004 Feb;27(1):3-12. doi: 10.1207/s15324796abm2701_2.
Livingstone MB, Robson PJ, Wallace JM. Issues in dietary intake assessment of children and adolescents. Br J Nutr. 2004 Oct;92 Suppl 2:S213-22. doi: 10.1079/bjn20041169.
Livingstone MB, Robson PJ. Measurement of dietary intake in children. Proc Nutr Soc. 2000 May;59(2):279-93. doi: 10.1017/s0029665100000318.
Guenther PM, Casavale KO, Reedy J, Kirkpatrick SI, Hiza HA, Kuczynski KJ, Kahle LL, Krebs-Smith SM. Update of the Healthy Eating Index: HEI-2010. J Acad Nutr Diet. 2013 Apr;113(4):569-80. doi: 10.1016/j.jand.2012.12.016. Epub 2013 Feb 13.
Weston AT, Petosa R, Pate RR. Validation of an instrument for measurement of physical activity in youth. Med Sci Sports Exerc. 1997 Jan;29(1):138-43. doi: 10.1097/00005768-199701000-00020.
Ridley K, Ainsworth BE, Olds TS. Development of a compendium of energy expenditures for youth. Int J Behav Nutr Phys Act. 2008 Sep 10;5:45. doi: 10.1186/1479-5868-5-45.
Other Identifiers
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UTK IRB-15-02680-FB
Identifier Type: -
Identifier Source: org_study_id
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