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Exploring the Familial Reach of Adolescent Obesity Treatment

Virginia Commonwealth University (VCU) logo

Virginia Commonwealth University (VCU)

Status

Completed

Conditions

Pediatric Obesity

Treatments

Other: No intervention

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT05780970
R21HD105906 (U.S. NIH Grant/Contract)
HM20014304 Phase 3

Details and patient eligibility

About

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.

Full 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.

Enrollment

55 patients

Sex

All

Ages

8+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

55 participants in 1 patient group

Non-targeted individuals
Description:
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.
Treatment:
Other: No intervention

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Melanie K Bean, PhD; Sarah M Farthing, MS

Data sourced from clinicaltrials.gov

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