A Family-Based Weight Loss Intervention for Youth With Intellectual Disability
| Status: | Completed |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 15 - 22 |
| Updated: | 4/21/2016 |
| Start Date: | August 2012 |
| End Date: | March 2016 |
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.
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.
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).
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