Exploring the Familial Reach of Adolescent Obesity Treatment

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pediatric Obesity
• Intervention / Treatment: Other: No intervention

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 Type: Observational
• Enrollment (Actual): 55

Contacts and Locations

• Study Contact: Name: Melanie K Bean, PhD; Phone Number: 804-527-4765; Email: melanie.bean@vcuhealth.org

Study Locations

• United States
  • Virginia
    • Henrico, Virginia, United States, 23239
      • Children's Hospital of Richmond at VCU Healthy Lifestyles Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Individuals residing in the home with the parent/child dyad who are participating in the TEENS+ (R01HD095910) RCT. Participating dyads must have overweight or obesity.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non-targeted individuals; 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.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
Weight changes.	Weight changes observed among untreated individuals (child zBMI and caregiver % weight loss)	4 months (baseline to 4 months)
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)]

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); University of Tennessee; University of Connecticut; University of North Carolina
• Investigators: Principal Investigator: Melanie K Bean, PhD, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Estimated): June 29, 2024
• Study Completion (Estimated): June 29, 2024

Study Registration Dates

• First Submitted: March 10, 2023
• First Submitted That Met QC Criteria: March 10, 2023
• First Posted (Actual): March 23, 2023

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Lifestyle Intervention; Pediatric Obesity; Family-based Intervention; Family-Level Change
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: HM20014304 Phase 3; R21HD105906 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No