Exploring the Familial Reach of Adolescent Obesity Treatment

Completed

• Conditions: Pediatric Obesity
• Interventions: Other: No intervention

• Registration Number: NCT05780970
• Lead Sponsor: Virginia Commonwealth University

Brief Summary

An observational study ancillary to the randomized clinical trial (RCT) TEENS+ (R01HD095910), a family-based lifestyle intervention, for adolescents with obesity, to determine: 1) if family-wide changes to the shared home environment are implemented, 2) if ripple effects to untreated family members are observed, and 3) whether these changes are predictive of adolescents' weight management success.

Funding support from NIH via R21HD105906.

Detailed Description

Investigators will recruit non-targeted children (8-17yrs) and caregivers living in the same household as the target TEENS+ parent/adolescent dyad. At 0, 2, 4 and 8m, the target adolescent/parent dyad (n=60), and non-targeted children and caregivers will complete anthropometric assessments, and measures of the shared home feeding and weight-related environment will be conducted.

Study Timeline

• Study Start: 2022-01-18
• Study First Submitted: 2023-03-10
• Study First Submitted QC: 2023-03-10
• Study First Posted: 2023-03-23
• Primary Completion: 2024-06-29
• Study Completion: 2024-06-29
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-30
• Last Update Posted: 2024-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

• Untreated children: must be between 8-17 years of age and primarily living in the same household as the TEENS+ participants.
• Untreated caregiver: must be 18 years of age or older and primarily living in the same household as the TEENS+ participants.
• Treated caregivers: must have another individual in the household that meets the eligbility for an untreated child or untreated caregiver.

Exclusion Criteria

• temporarily (<1yr) living in the home
• children with a BMI<5th%ile or caregivers with a BMI<18.5 kg/m2
• non-English speaking
• medical condition(s) that may be associated with unintentional weight change or significant disruption to eating behaviors (e.g., hypothalamic injury, Prader-Willi, G-tube placement, or malignancy
• clinically significant eating disorder (e.g., anorexia nervosa or bulimia nervosa)
• following a medically-supervised/prescribed diet
• psychiatric, cognitive, physical or developmental conditions that would impair the individual's ability to complete assessments.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-targeted individuals	No intervention	Non-targeted children and caregivers living in the same household as the target parent/adolescent dyad. Non-targeted meaning they did not receive the TEENS+ intervention.

Primary Outcome Measures

Name	Time	Method
Family-level changes to the shared home environment.	4 months (baseline to 4 months)	Changes in the home food available and the home exercise and electronic media environment.
Weight changes.	4 months (baseline to 4 months)	Weight changes observed among untreated individuals (child zBMI and caregiver % weight loss)
Household changes and target adolescent weight.	8 months [weight loss (baseline to 4 months) and maintenance (4-8)]	Associations between household changes and target adolescent weight loss and maintenance.

Trial Locations

Locations (1)

Children's Hospital of Richmond at VCU Healthy Lifestyles Center; 🇺🇸 Henrico, Virginia, United States