Primary Care Pediatrics Learning Activity and Nutrition With Families

NCT02873715 | Completed Results DMC

• 2 other identifiers: 1131521-174563U01HL131552
• Study Type: interventional
• Target: 1,010
• Locations: 1 country
• Sites: 4

Brief Summary

This study is designed to translate an evidence-based family-based weight loss treatment for childhood obesity (FBT) into primary care settings using co-located interventionists to serve as a model for care delivered within a patient-centered medical home. FBT will be compared to usual care (UC), and the families will be followed for a 2 year period to assess between group differences in the targeted child and parent outcomes, weight changes in non-targeted siblings who are overweight/obese, parent and child changes in delay of gratification, and how these changes relate to weight loss, and the assessment of how provider attitudes predict their intention to use FBT in the future. The results of this study will inform future dissemination and implementation of FBT into primary care settings.

Conditions

Pediatric Obesity

Keywords

Childhood weight control

Outcome Measures

Primary Outcomes (1)

• Body Composition Measures of Targeted Child. Percent Change Over the Median BMI

  Height and weight will be taken to calculate changes in over weight status for children in FBT versus UC. Change in percent over median BMI from baseline to 24-month. Percent over the age- and sex-specific 50th BMI percentile for kids, percent over the sex-specific 50th BMI percentile for 20-year-olds for parents. Parents are not included in this measurement. This measurement is to describe child body composition and not used for parents. Results are pooled across 10 multiple imputations and reported as mean (standard error)

  0 - 24 months

Secondary Outcomes (3)

• Body Composition Measures of Participating Parent. BMI (kg/m^2) Change From Baseline to 24 Month

  0-24 months

• Body Composition Measures, Siblings

  0-24 months

• Delay Discounting

  0, and 24 months

Study Arms (2)

Usual Care (UC)

ACTIVE COMPARATOR

Usual Care will consist of the care typically delivered by the family's primary care provider for children with overweight or obesity. The implementations of UC may vary between providers but typically includes and assessment of the child's weight, help remove barriers to weight loss and introductions of goals for better weight management.

Behavioral: Usual Care

Family-based treatment (FBT)

EXPERIMENTAL

Family- Based treatment utilizes behavior change techniques to target family-wide changes in diet and physical activity habits with the goal of promoting weight loss and subsequently healthy weight maintenance in all participants. Participants will have visits between 30 to 60 minutes as frequent as weekly and no longer than monthly over the two year study

Behavioral: Family-based treatment; Behavioral: Usual Care

Interventions

Family-based treatment BEHAVIORAL

Family based treatment as the invention to randomized participants. Family Based treatment utilizes behavior change techniques to target family-wide changes in diet and physical activity habits with the goal of promoting weight loss and subsequently healthy weight maintenance in all participants. Participants will have visits between 30 to 60 minutes as frequent as weekly and no longer than monthly over the two year study

Also known as: FBT

Family-based treatment (FBT)

Usual Care BEHAVIORAL

Usual care is a treatment that is normally provided to patients in pediatric offices by a pediatrician, physician assistant, or other primary care staff.

Also known as: UC

Family-based treatment (FBT); Usual Care (UC)

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The participating child will be between the ages of 6 and 12 and have a BMI above the 85th percentile for age and sex. The participating child will have at least one parent who has overweight or obesity (BMI\>25) and who must agree to attend all parent/child treatment meetings as the participating parent. For families in which one parent has overweight/obesity, this parent will be required to be the participating parent in order for the family to be eligible for the study; if two parents have overweight/obesity, the family will choose one parent to enroll in the study. Similarly, if two children in the family have overweight/obesity, it will be encouraged that the older sibling be the primary participant, as it is more likely the younger sibling will model the older sibling. Though only the child who has overweight/obesity and the participating parent will be required to attend treatment sessions, all family members living in the household, including other adults and siblings, will be encouraged to participate indirectly by supporting changes in the family's lifestyle. Because a secondary aim of the study involves the tracking of treatment effects through the household to non-targeted siblings, heights and weights of at least one sibling with overweight/obesity (BMI\>85th percentile for age and sex)in the family will be collected, if applicable. Only siblings ages 2- 18 would qualify. All participants must be able to speak and comprehend English at a first-grade level.

You may not qualify if:

• The participating parent or child will not have had a concussion in the past three months; will not have any significant developmental delays or intellectual disabilities; will not be receiving treatment for a Diagnostic and Statistical Manual Diploma in Social Medicine (DSM-5) disorder that interferes with treatment delivered as part of the intervention; will not have a physical disability or diagnosis that prevents performance of physical activity at a level equivalent to a brisk walk or that places severe restriction on diet; will not be on a medication regimen that affects weight; will not have a medical condition that alters nutritional status, intestinal absorption, or affects weight; will not have undergone weight loss surgery; and will not be participating in an alternate weight control program. Families in which either the participating child or parent is actively involved in other weight-loss treatment, is using weight-affecting medications, or has an impairing psychiatric or medical condition that would hinder participation in the study will be excluded as identified by the screening assessments. Families that are planning to move or in which the participating parent is pregnant or is planning on becoming pregnant during the 2 year study period will also be excluded.

Sponsors & Collaborators

• State University of New York at Buffalo: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (4)

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

University at Buffalo

Buffalo, New York, 14214, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Nationwide Childrens Hospital

Columbus, Ohio, 43205, United States

Location

Related Publications (8)

• Kolko RP, Kass AE, Hayes JF, Levine MD, Garbutt JM, Proctor EK, Wilfley DE. Provider Training to Screen and Initiate Evidence-Based Pediatric Obesity Treatment in Routine Practice Settings: A Randomized Pilot Trial. J Pediatr Health Care. 2017 Jan-Feb;31(1):16-28. doi: 10.1016/j.pedhc.2016.01.001. Epub 2016 Feb 9.

  PMID: 26873293 BACKGROUND

• Maddison R, Marsh S, Foley L, Epstein LH, Olds T, Dewes O, Heke I, Carter K, Jiang Y, Mhurchu CN. Screen-Time Weight-loss Intervention Targeting Children at Home (SWITCH): a randomized controlled trial. Int J Behav Nutr Phys Act. 2014 Sep 10;11:111. doi: 10.1186/s12966-014-0111-2.

  PMID: 25204320 BACKGROUND

• Epstein LH, Paluch RA, Wrotniak BH, Daniel TO, Kilanowski C, Wilfley D, Finkelstein E. Cost-effectiveness of family-based group treatment for child and parental obesity. Child Obes. 2014 Apr;10(2):114-21. doi: 10.1089/chi.2013.0123. Epub 2014 Mar 21.

  PMID: 24655212 BACKGROUND

• Quattrin T, Roemmich JN, Paluch R, Yu J, Epstein LH, Ecker MA. Efficacy of family-based weight control program for preschool children in primary care. Pediatrics. 2012 Oct;130(4):660-6. doi: 10.1542/peds.2012-0701. Epub 2012 Sep 17.

  PMID: 22987879 BACKGROUND

• Theim KR, Sinton MM, Stein RI, Saelens BE, Thekkedam SC, Welch RR, Epstein LH, Wilfley DE. Preadolescents' and parents' dietary coping efficacy during behavioral family-based weight control treatment. J Youth Adolesc. 2012 Jan;41(1):86-97. doi: 10.1007/s10964-011-9728-5. Epub 2011 Nov 12.

  PMID: 22081241 BACKGROUND

• Button AM, Paluch RA, Schechtman KB, Wilfley DE, Geller N, Quattrin T, Cook SR, Eneli IU, Epstein LH. Parents, but not their children, demonstrate greater delay discounting with resource scarcity. BMC Public Health. 2023 Oct 12;23(1):1983. doi: 10.1186/s12889-023-16832-z.

  PMID: 37828503 DERIVED

• Epstein LH, Rizwan A, Paluch RA, Temple JL. Delay Discounting and the Income-Food Insecurity-Obesity Paradox in Mothers. J Obes. 2023 Sep 19;2023:8898498. doi: 10.1155/2023/8898498. eCollection 2023.

  PMID: 37766882 DERIVED

• Epstein LH, Wilfley DE, Kilanowski C, Quattrin T, Cook SR, Eneli IU, Geller N, Lew D, Wallendorf M, Dore P, Paluch RA, Schechtman KB. Family-Based Behavioral Treatment for Childhood Obesity Implemented in Pediatric Primary Care: A Randomized Clinical Trial. JAMA. 2023 Jun 13;329(22):1947-1956. doi: 10.1001/jama.2023.8061.

  PMID: 37314275 DERIVED

Related Links

• Ten-year outcomes of behavioral family-based treatment for childhood obesity. Epstein, Leonard H.; Valoski, Alice; Wing, Rena R.; McCurley, James Health Psychology, Vol 13(5), Sep 1994, 373-383. http://dx.doi.org/10.1037/0278-

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Leonard H. Epstein, PhD, SUNY Distinguished Professor
• Organization: University at Buffalo

lhenet@buffalo.edu

716-829-3400

Study Officials

• Leonard H Epstein, PhD

  State University of New York at Buffalo

  PRINCIPAL INVESTIGATOR

• Denise Wilfley, PhD

  Washington University in Saint Louis

  PRINCIPAL INVESTIGATOR

• Ken Schechtman, PhD

  Washington University in Saint Louis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Assessor will be blinded to the families group assignment. Coaches will be back up assessor. Coach 1 will be an assessor for families assigned to Coach 2, Coach 2 will collect measures for families assigned to Coach 3, and Coach 3 will collect measures for families assigned to Coach 1. Thus, coaches will not collect height and weight measures for families from their caseload. Although not possible to guarantee that coaches are blind to condition for families that are not in their caseload due to the families not being blinded, use of a standard protocol (see Appendix C) ensures objective and reliable measurement of the primary outcome. Assessors will be blind to prior heights/weights, further protecting against assessment bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 17, 2016
• First Posted: August 19, 2016
• Study Start: November 20, 2017
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: July 26, 2024
• Results First Posted: August 14, 2023

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)