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

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Family Based Behavioral Intervention
Maintenance
Sponsored by
University of Massachusetts, Boston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring weight loss, nutrition, physical activity, lifestyle, intellectual disability, adolescence, families

Eligibility Criteria

14 Years - 22 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

  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: 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).

Sites / Locations

  • University of Massachusetts Boston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Family Based Behavioral Intervention

Maintenance

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Physical activity
Physical activity refers to participants' physical movement, performed at light, moderate, and vigorous levels of exertion. Physical activity was measured via Actigraph accelerometers worn over 7 day intervals at each measurement point - baseline, 6 months, 12 months and 18 months. In addition to light, moderate and vigorous physical activity, sedentary behavior was also estimated from the Actigraph records.
Dietary patterns
Dietary patterns refers to consistencies in each participants' food intake, determined via analysis of 3-Day Food Records completed at each measurement point: baseline, 6 months, 12 months, and 18 months.
Self-Efficacy
Self-efficacy is a measure of a participant's perceived confidence in their ability to competently engage in a behavior. In this study, self-efficacy is assessed for adolescent participants' dietary and physical activity behaviors. Self-efficacy was obtained via a brief, 2-question interview with the adolescent participants.

Full Information

First Posted
January 3, 2014
Last Updated
December 14, 2019
Sponsor
University of Massachusetts, Boston
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT02033642
Brief Title
A Family-Based Weight Loss Intervention for Youth With Intellectual Disability
Acronym
HealthU
Official Title
A Family-Based Weight Loss Intervention for Youth With Intellectual Disability
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
August 22, 2012 (Actual)
Primary Completion Date
January 19, 2018 (Actual)
Study Completion Date
January 19, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Boston
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
weight loss, nutrition, physical activity, lifestyle, intellectual disability, adolescence, families

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Family Based Behavioral Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Maintenance
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Family Based Behavioral Intervention
Intervention Description
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
Intervention Name(s)
Maintenance
Intervention Description
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.
Primary Outcome Measure Information:
Title
Weight
Description
Adolescent/young adult participants' body weight was measured in kg using a Seca digital scale.
Time Frame
Baseline (BL), change from BL to 6 months, change from BL to 12 months and change from BL to 18 months
Title
Body Mass Index (BMI)
Description
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.
Time Frame
Baseline (BL), change from BL to 6 months, change from BL to 12 months and change from BL to 18 months
Secondary Outcome Measure Information:
Title
Physical activity
Description
Physical activity refers to participants' physical movement, performed at light, moderate, and vigorous levels of exertion. Physical activity was measured via Actigraph accelerometers worn over 7 day intervals at each measurement point - baseline, 6 months, 12 months and 18 months. In addition to light, moderate and vigorous physical activity, sedentary behavior was also estimated from the Actigraph records.
Time Frame
Baseline (BL), change from BL to 6 months, change from BL to 12 months and change from BL to 18 months
Title
Dietary patterns
Description
Dietary patterns refers to consistencies in each participants' food intake, determined via analysis of 3-Day Food Records completed at each measurement point: baseline, 6 months, 12 months, and 18 months.
Time Frame
Baseline (BL), change from BL to 6 months, change from BL to 12 months and change from BL to 18 months
Title
Self-Efficacy
Description
Self-efficacy is a measure of a participant's perceived confidence in their ability to competently engage in a behavior. In this study, self-efficacy is assessed for adolescent participants' dietary and physical activity behaviors. Self-efficacy was obtained via a brief, 2-question interview with the adolescent participants.
Time Frame
Baseline (BL), change from BL to 6 months, change from BL to 12 months and change from BL to 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Inclusion criteria for the adolescents with intellectual disability (ID) will be: 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). Exclusion Criteria: Exclusion criteria will be: 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard K Fleming, PhD
Organizational Affiliation
University of Massachusetts Boston - retired
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Massachusetts Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02125-3393
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23968742
Citation
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.
Results Reference
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A Family-Based Weight Loss Intervention for Youth With Intellectual Disability

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