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

Obesity Clinical Trial

— HealthU  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02033642
• Other study ID #: HealthU R01
• Secondary ID: 5R01HD072573-03
• Status: Completed
• Phase: N/A
• Start date: August 22, 2012
• Est. completion date: January 19, 2018

Study information

• Verified date: December 2019
• Source: University of Massachusetts, Boston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: January 19, 2018
• Est. primary completion date: January 19, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 22 Years

Eligibility

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).

Related Conditions & MeSH terms

• Intellectual Disability
• Obesity
• Weight Loss

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Massachusetts Boston	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
University of Massachusetts, Boston	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	Baseline (BL), change from BL to 6 months, change from BL to 12 months and change from BL to 18 months
Secondary	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.	Baseline (BL), change from BL to 6 months, change from BL to 12 months and change from BL to 18 months
Secondary	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.	Baseline (BL), change from BL to 6 months, change from BL to 12 months and change from BL to 18 months