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

Summary

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.

Conditions

• Obesity

Interventions

BEHAVIORAL

Family Based Behavioral Intervention

Family Based Behavioral Intervention (FBBI) is a 24-session lifestyle intervention designed to: (1) educate adolescent/young adult participants and their parents in principles of good nutrition and physical activity, and (2) train parents to implement lifestyle changes at home to facilitate weight loss in their child by monitoring diet and physical activity behaviors, setting goals, providing support and reinforcement, and assessing and making changes to the home environment.

BEHAVIORAL

Maintenance

The Maintenance condition in this study is a 12-session intervention designed to extend FBBI and continue to teach adolescent/young adult participants and their parents to continue practicing lifestyle behaviors, generalize healthful behaviors to new environments, find additional social and community supports, and prevent and manage relapse.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• University of Massachusetts, Boston

  lead OTHER

Principal Investigators

• Richard K Fleming, PhD · University of Massachusetts Boston - retired

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

14 Years

Max Age

22 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2012-08-22

Primary Completion

2018-01-19

Completion

2018-01-19

Countries

• United States

Study Locations