University of Massachusetts Boston
Boston, Massachusetts, 02125-3393, United States
NCT Number: NCT02033642
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.
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Notify Me14 year–22 year
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02125-3393, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Inclusion criteria for the adolescents with intellectual disability (ID) will be:
Exclusion criteria
Exclusion criteria will be:
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.
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.
Time frame: Baseline (BL), change from BL to 6 months, change from BL to 12 months and change from BL to 18 months
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
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
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
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
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.
University of Massachusetts, Boston
Other
Acronym: HealthU
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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