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OpenTrials
Completed

NCT Number: NCT05780970

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.

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Key information

Age range

8 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital of Richmond at VCU Healthy Lifestyles Center

Henrico, Virginia, 23239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

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).

Primary outcomes

  1. 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.

  2. Weight changes.

    Time frame: 4 months (baseline to 4 months)

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

  3. 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.

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • University of Connecticut
  • University of North Carolina
  • University of Tennessee

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 23, 2023
Registry last updated
Oct 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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