Exploring the Familial Reach of Adolescent Obesity Treatment

Study Overview
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Brief Summary
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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
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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.

Official Title
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Exploring the Familial Reach of Adolescent Obesity Treatment

Conditions
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Pediatric Obesity

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non-targeted individuals<br>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<br>* 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).<br>|

What is the study measuring?
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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)] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatric Obesity, Lifestyle Intervention, Family-Level Change, Family-based Intervention