Clinical trial NCT05780970: Exploring the Familial Reach of Adolescent Obesity Treatment
Official title: Exploring the Familial Reach of Adolescent Obesity Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric Obesity
Keywords: Pediatric Obesity
Lifestyle Intervention
Family-Level Change
Family-based Intervention
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: University of Connecticut
name: University of North Carolina
name: University of Tennessee
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2023-03-23
Enrollment: 55
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Family-level changes to the shared home environment.
timeFrame: 4 months (baseline to 4 months)
measure: Weight changes.
timeFrame: 4 months (baseline to 4 months)
measure: Household changes and target adolescent weight.
timeFrame: 8 months [weight loss (baseline to 4 months) and maintenance (4-8)]
Secondary outcomes:
Other outcomes:
Locations:
city: Henrico
country: United States
facility: Children's Hospital of Richmond at VCU Healthy Lifestyles Center
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Melanie K Bean, PhD
role: PRINCIPAL_INVESTIGATOR
References: