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ObesityHealthUNCT02033642

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

A study testing Family Based Behavioral Intervention and Maintenance in people with Obesity, run by University of Massachusetts, Boston at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 14 to 22 yearsHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
Family Based Behavioral Intervention and Maintenance
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteUnited States
Study dates
22 Aug 2012to 19 Jan 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 22 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

None listed.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Massachusetts Boston

    Boston, Massachusetts, 02125-3393

Other trials in United States

About this study

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.

Conditions
Obesity
Being tested
Family Based Behavioral Intervention, Maintenance
Keywords
weight loss, nutrition, physical activity, lifestyle, intellectual disability, adolescence, families
Medical subject headings
Obesity, Weight Loss, Motor Activity, Intellectual Disability

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Family Based Behavioral InterventionBehavioural

    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.

  • MaintenanceBehavioural

    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.

Study groups in NCT02033642
Study groupRoleWhat they receive
Family Based Behavioral InterventionExperimentalFamily 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.
Receives: Behavioral: Family Based Behavioral Intervention
MaintenanceExperimentalThe 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.
Receives: Behavioral: Maintenance

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weight

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

    Measured: Baseline (BL), change from BL to 6 months, change from BL to 12 months and change from BL to 18 months

  2. 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.

    Measured: Baseline (BL), change from BL to 6 months, change from BL to 12 months and change from BL to 18 months

Secondary outcomes (3)

  1. 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.

    Measured: Baseline (BL), change from BL to 6 months, change from BL to 12 months and change from BL to 18 months

  2. 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.

    Measured: Baseline (BL), change from BL to 6 months, change from BL to 12 months and change from BL to 18 months

  3. 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.

    Measured: Baseline (BL), change from BL to 6 months, change from BL to 12 months and change from BL to 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2014 (estimated)
  2. Study start22 Aug 2012
  3. Primary completion19 Jan 2018
  4. Study completion19 Jan 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02033642
Sponsor's protocol ID
HealthU R01
Other IDs
5R01HD072573-03
Acronym
HealthU
Status last verified
Dec 2019
First submitted
3 Jan 2014
Last updated
18 Dec 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 23968742

Questions about this trial

What is this clinical trial studying?

A study testing Family Based Behavioral Intervention and Maintenance in people with Obesity, run by University of Massachusetts, Boston at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight (time frame: Baseline (BL), change from BL to 6 months, change from BL to 12 months and change from BL to 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02033642, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2019.

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