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

NCT02033642 | Completed DMC

• 2 other identifiers: HealthU R015R01HD072573-03
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Weight

  Adolescent/young adult participants' body weight was measured in kg using a Seca digital scale.

  Baseline (BL), change from BL to 6 months, change from BL to 12 months and change from BL to 18 months

• Body Mass Index (BMI)

  Adolescent/young adult participants' BMI was determined by taking their height and weight on a Seca digital scale and stadiometer, respectively, and calculating their BMI.

  Baseline (BL), change from BL to 6 months, change from BL to 12 months and change from BL to 18 months

Secondary Outcomes (3)

• Physical activity

  Baseline (BL), change from BL to 6 months, change from BL to 12 months and change from BL to 18 months

• Dietary patterns

  Baseline (BL), change from BL to 6 months, change from BL to 12 months and change from BL to 18 months

• Self-Efficacy

  Baseline (BL), change from BL to 6 months, change from BL to 12 months and change from BL to 18 months

Study Arms (2)

Family Based Behavioral Intervention

EXPERIMENTAL

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.

Behavioral: Family Based Behavioral Intervention

Maintenance

EXPERIMENTAL

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.

Behavioral: Maintenance

Interventions

Family Based Behavioral Intervention 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.

Family Based Behavioral Intervention

Maintenance 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.

Maintenance

Eligibility Criteria

• Age: 14 Years - 22 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 14-22 years
• Clinically overweight or obese, as indicated by BMI guidelines set by the Centers for Disease Control and Prevention
• 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
• Living at home in a single- or two-parent family with no plans to leave home in the next year
• 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)
• 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).

You may not qualify if:

• Cardiac problems that preclude participation in moderate-to-vigorous-physical-activity (MVPA)
• Insulin-dependent diabetes
• An active seizure disorder not stabilized on medication
• Non-ambulatory, i.e. uses a wheelchair, or orthopedic injuries/deformities that prohibit moderate walking and other exercise
• Colitis, Crohn's Disease, and Inflammatory Bowel Disease
• Prader Willi syndrome
• Unwillingness to wear the accelerometer at screening or enrollment
• 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).

Sponsors & Collaborators

• University of Massachusetts, Boston: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Massachusetts Boston

Boston, Massachusetts, 02125-3393, United States

Location

Related Publications (1)

• 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.

  PMID: 23968742 BACKGROUND

MeSH Terms

Conditions

Obesity; Weight Loss; Motor Activity; Intellectual Disability

Interventions

Maintenance

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Behavior; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Health Care Facilities Workforce and Services

Study Officials

• Richard K Fleming, PhD

  University of Massachusetts Boston - retired

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor (retired)

Study Record Dates

• First Submitted: January 3, 2014
• First Posted: January 13, 2014
• Study Start: August 22, 2012
• Primary Completion: January 19, 2018
• Study Completion: January 19, 2018
• Last Updated: December 18, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)