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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of Massachusetts, Boston
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Richard Fleming, University of Massachusetts, Boston
ClinicalTrials.gov Identifier:
NCT02033642
First received: January 3, 2014
Last updated: January 10, 2014
Last verified: January 2014
  Purpose

The first purpose of this randomized controlled trial is to test the efficacy of a 24-session, 6-month family-based behavioral intervention (FBBI) - as compared to a delayed treatment group which later receives the same FBBI - that targets weight loss in adolescents/young adults with intellectual disability aged 15-22 years. The second purpose of this randomized controlled trial is 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. Outcome measures include Body Mass Index (BMI), waist circumference, physical activity/sedentary behavior (measured via accelerometry), dietary patterns (3-Day Food Records), self-efficacy and psychosocial characteristics (Adolescent Depression and Anxiety Scale). Hypotheses are that (1) participants in the FBBI condition will lose more weight (reduced BMI) than participants in the delayed treatment condition, and that (2) participants in the Maintenance condition will maintain weight lost (reductions in BMI) or experience less weight regain, as compared with participants who receive no further intervention following FBBI.


Condition Intervention
Obesity
Behavioral: Family Based Behavioral Intervention
Behavioral: Maintenance

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Family-Based Weight Loss Intervention for Youth With Intellectual Disability

Resource links provided by NLM:


Further study details as provided by University of Massachusetts, Boston:

Primary Outcome Measures:
  • Body Mass Index (BMI) [ Time Frame: Baseline (BL), change from BL to 6 months, change from BL to 12 months and change from BL to 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Waist circumference [ Time Frame: Baseline (BL), change from BL to 6 months, change from BL to 12 months and change from BL to 18 months ] [ Designated as safety issue: No ]
  • Physical activity [ Time Frame: Baseline (BL), change from BL to 6 months, change from BL to 12 months and change from BL to 18 months ] [ Designated as safety issue: No ]
    Physical activity is measured via Actigraph accelerometers worn over 7 day intervals at each measurement point - baseline, 6 months, 12 months and 18 months. Sedentary, light, moderate and vigorous physical activity will be obtained from Actigraph records.

  • Dietary patterns [ Time Frame: Baseline (BL), change from BL to 6 months, change from BL to 12 months and change from BL to 18 months ] [ Designated as safety issue: No ]
    Dietary patterns will be measured via 3-Day Food Records completed at each measurement point -baseline, 6 months, 12 months and 18 months.

  • Self-Efficacy [ Time Frame: Baseline (BL), change from BL to 6 months, change from BL to 12 months and change from BL to 18 months ] [ Designated as safety issue: No ]
    Self-efficacy will be obtained via a brief, 2-question interview with adolescent participants. Self-efficacy is a measure of confidence in one's ability to competently engage in a behavior. In this case, self efficacy will be assessed for adolescents' dietary and physical activity behaviors.

  • Psychosocial status [ Time Frame: Baseline (BL), change from BL to 6 months, change from BL to 12 months and change from BL to 18 months ] [ Designated as safety issue: No ]
    The Adolescent Depression and Anxiety Scale (ADAMS) will be administered at baseline, 6 months, 12 months and 18 months to assess changes in psychosocial (mental health) status.


Estimated Enrollment: 48
Study Start Date: August 2012
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Family Based Behavioral Intervention
Family Based Behavioral Intervention (FBBI) is a 24-session lifestyle intervention designed to train parents or family members of adolescent/young adult participants with intellectual disability to monitor diet and physical activity behavior, set goals, provide support and reinforcement, and assess and make changes to the home environment.
Behavioral: Family Based Behavioral Intervention
Family Based Behavioral Intervention (FBBI) is a 24-session lifestyle intervention designed to train parents or family members of adolescent/young adult participants with intellectual disability to monitor diet and physical activity behavior, set goals, provide support and reinforcement, and assess and make changes to the home environment.
Experimental: Maintenance
The Maintenance condition in this study is a 12-session intervention for parent/family member of adolescents with intellectual disability, designed to teach families to continue lifestyle behaviors, generalize healthful behaviors to new environments, find additional social and community supports and prevent relapse.
Behavioral: Maintenance
The Maintenance condition in this study is a 12-session intervention for parent/family member of adolescents with intellectual disability, designed to teach families to continue lifestyle behaviors, generalize healthful behaviors to new environments, find additional social and community supports and prevent relapse.

  Eligibility

Ages Eligible for Study:   15 Years to 22 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: Inclusion criteria for the adolescents with intellectual disability (ID) will be:

  1. Age 15-22 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 Edition35 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 control 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: Exclusion criteria will be:

  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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02033642

Contacts
Contact: Judith Ellen, BS 774-455-6540 judith.ellen@umassmed.edu
Contact: Richard K Fleming, PhD 617-287-5569 richard.fleming@umb.edu

Locations
United States, Massachusetts
Eunice Kennedy Shriver Center Recruiting
Charlestown, Massachusetts, United States, 02129
Contact: Judith Ellen, BS    774-455-6540    judith.ellen@umassmed.edu   
Contact: Richard K Fleming, PhD    617-287-5569    richard.fleming@umb.edu   
Principal Investigator: Richard K Fleming, PhD         
Sub-Investigator: Linda Bandini, PhD         
Sub-Investigator: Carol Curtin, MSW         
Sponsors and Collaborators
University of Massachusetts, Boston
Investigators
Study Director: Carol Curtin, MSW University of Massachusetts, Worcester
Study Director: Linda Bandini, PhD University of Massachusetts, Worcester
  More Information

Publications:
Responsible Party: Richard Fleming, Associate Professor, University of Massachusetts, Boston
ClinicalTrials.gov Identifier: NCT02033642     History of Changes
Other Study ID Numbers: HealthU R01, 5R01HD072573-03
Study First Received: January 3, 2014
Last Updated: January 10, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Additional relevant MeSH terms:
Mental Retardation
Obesity
Weight Loss
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Mental Disorders Diagnosed in Childhood
Mental Disorders
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Body Weight Changes

ClinicalTrials.gov processed this record on July 22, 2014