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

NCT ID: NCT02033642

Last Updated: 2019-12-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-22
• Study Completion Date: 2018-01-19

Brief 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

Keywords

weight loss, nutrition, physical activity, lifestyle, intellectual disability, adolescence, families

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Family Based Behavioral Intervention

Intervention Type: BEHAVIORAL

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.

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 at home.

Group Type: EXPERIMENTAL

Maintenance

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Age 14-22 years

2. Clinically overweight or obese, as indicated by BMI guidelines set by the Centers for Disease Control and Prevention

3. Scores of ≤ 75 on the Kaufman Brief Intelligence Test (KBIT) and Vineland Adaptive Behavior Scales, 2nd Edition to establish criteria for the presence of an intellectual disability

4. Living at home in a single- or two-parent family with no plans to leave home in the next year

5. Verbal ability and necessary behavioral/social skills to participate in a group classroom-based educational program (determined by clinical observation and judgment accomplished through a structured interview during enrollment)

6. Signed approval to participate by the adolescent's primary care provider (and by other specialists such as cardiologists or neurologists if the participant has a heart condition or neurological disorder).

Exclusion Criteria

1. Cardiac problems that preclude participation in moderate-to-vigorous-physical-activity (MVPA)

2. Insulin-dependent diabetes

3. An active seizure disorder not stabilized on medication

4. Non-ambulatory, i.e. uses a wheelchair, or orthopedic injuries/deformities that prohibit moderate walking and other exercise

5. Colitis, Crohn's Disease, and Inflammatory Bowel Disease

6. Prader Willi syndrome

7. Unwillingness to wear the accelerometer at screening or enrollment

8. Recent history of disruptive, inappropriate or dangerous behaviors (e.g., self-injury, aggression/injury to others, property destruction, and extreme and ongoing use of inappropriate language).

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

NIH

Sponsor Role: collaborator

University of Massachusetts, Boston

OTHER

Sponsor Role: lead

Responsible Party

Richard Fleming

Professor (retired)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard K Fleming, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Massachusetts Boston - retired

Locations

University of Massachusetts Boston

Boston, Massachusetts, United States

Countries

United States

References

Curtin C, Bandini LG, Must A, Gleason J, Lividini K, Phillips S, Eliasziw M, Maslin M, Fleming RK. Parent support improves weight loss in adolescents and young adults with Down syndrome. J Pediatr. 2013 Nov;163(5):1402-8.e1. doi: 10.1016/j.jpeds.2013.06.081. Epub 2013 Aug 20.

Reference Type: BACKGROUND

PMID: 23968742 (View on PubMed)

Other Identifiers

5R01HD072573-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HealthU R01

Identifier Type: -

Identifier Source: org_study_id