Skip to main content
Clinical Trials/NCT05780970
NCT05780970
Completed
Not Applicable

Exploring the Familial Reach of Adolescent Obesity Treatment

Virginia Commonwealth University1 site in 1 country55 target enrollmentJanuary 18, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pediatric Obesity
Sponsor
Virginia Commonwealth University
Enrollment
55
Locations
1
Primary Endpoint
Family-level changes to the shared home environment.
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 18, 2022
End Date
June 29, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Family-level changes to the shared home environment.

Time Frame: 4 months (baseline to 4 months)

Changes in the home food available and the home exercise and electronic media environment.

Weight changes.

Time Frame: 4 months (baseline to 4 months)

Weight changes observed among untreated individuals (child zBMI and caregiver % weight loss)

Household changes and target adolescent weight.

Time Frame: 8 months [weight loss (baseline to 4 months) and maintenance (4-8)]

Associations between household changes and target adolescent weight loss and maintenance.

Study Sites (1)

Loading locations...

Similar Trials