Exploring the Familial Reach of Adolescent Obesity Treatment

Pediatric Obesity Clinical Trial

Official title:

Exploring the Familial Reach of Adolescent Obesity Treatment

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05780970
• Other study ID #: HM20014304 Phase 3
• Secondary ID: R21HD105906
• Status: Active, not recruiting
• Start date: January 1, 2022
• Est. completion date: June 29, 2024

Study information

• Verified date: March 2024
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 55
• Est. completion date: June 29, 2024
• Est. primary completion date: June 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Pediatric Obesity

Intervention

Other:
• No intervention
Non-treated children and caregivers complete assessments only. The primary (treated) parent / adolescent dyad participate in family based weight management treatment through the main trial. In the main trial, families are randomized to either TEENS+Parents as Coaches (parent skills training) or TEENS+Parent Weight Loss (parent behavioral weight loss).

Locations

Country	Name	City	State
United States	Children's Hospital of Richmond at VCU Healthy Lifestyles Center	Henrico	Virginia

Sponsors (5)

Lead Sponsor	Collaborator
Virginia Commonwealth University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Connecticut, University of North Carolina, University of Tennessee

Country where clinical trial is conducted

United States, 

Outcome

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