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NCT02033642: HealthU

A Family-Based Weight Loss Intervention for Youth With Intellectual Disability

Completed NA Last updated 18 December 2019
What this trial tests

NA trial testing Family Based Behavioral Intervention in Obesity in 31 participants. Completed in 19 January 2018.

Timeline
22 August 2012
Primary endpoint
19 January 2018
19 January 2018

Quick facts

Lead sponsorUniversity of Massachusetts, Boston
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment31
Start date22 August 2012
Primary completion19 January 2018
Estimated completion19 January 2018
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Massachusetts, Boston

Who can join

Adults 14 to 22, any sex, with Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this randomized controlled trial is twofold. First, to examine the efficacy of a 24-session, 6-month family-based behavioral intervention (FBBI) - as compared to a waitlist FBBI group, which later receives the same FBBI - that targets weight loss in adolescents/young adults with intellectual disability aged 14-22 years. Second, to examine the efficacy of a 12-session, 6-month Maintenance intervention that targets maintenance of weight loss in the same population of adolescents/young adults with intellectual disability. The Maintenance condition follows the completion of each FBBI group and involves a re-randomization to either the Maintenance intervention or no further intervention. Primary outcome measures include body weight and Body Mass Index (BMI). Secondary outcome measures include physical activity/sedentary behavior (measured via accelerometry), dietary patterns (3-Day Food Records), and self-efficacy (brief questionnaire). Hypotheses are that: (1) participants in the FBBI condition will lose more weight (and reduced BMI) than participants in the waitlist treatment condition, and that (2) participants in the Maintenance condition will maintain weight lost (and reductions in BMI) or experience less weight regain, as compared with participants who receive no further intervention following FBBI.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. A family-based weight loss randomized controlled trial for youth with intellectual disabilities.
    Bandini LG, Eliasziw M, Dittrich GA, Curtin C, et al · · 2021 · cited 8× · PMID 34076370 · DOI 10.1111/ijpo.12816

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Other recruiting trials for Obesity

Currently open trials in the same condition.

Other University of Massachusetts, Boston trials

Trials by the same sponsor.

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Data sources for this page

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