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CompletedNCT01256112Updated Oct 18, 2017

Parent Supported Weight Reduction in Down Syndrome

An interventional study of Parent Supported Behavioral Intervention and Nutrition/Activity Education (NAE) in Down Syndrome, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Completed at 1 site in United States. Open to participants aged 13 Years to 26 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-18.

Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
21
Allocation
Randomized
Ages
13 Years to 26 Years
Sex
All
01

Study summary

The purpose of this study is to determine whether a nutrition and physical activity education program for families of overweight or obese adolescents with Down syndrome is more effective when behavioral lifestyle change strategies are added.

Read the detailed description

Children with intellectual disabilities, including Down syndrome (DS), are as likely to be overweight than their typically developing peers. The consequences of childhood obesity include increased risk for Type-2 diabetes, orthopedic problems, sleep apnea, elevated cardiovascular risk and menstrual irregularities. Research indicating a high prevalence of overweight, obesity, low fitness levels and other health problems among adults with DS suggest the need for more attention to health promotion among adolescents with DS, which has been limited to date. Educational interventions in nutrition and physical activity have not been tested through randomized clinical trial with families of adolescents with DS; nor have behavioral "lifestyle change" interventions based on Social Cognitive Theory. Among typical populations, the addition of training in behavior and lifestyle change to education-alone interventions increasingly is being seen as critical in helping to promote long-term weight loss and weight maintenance. The hypothesis of this study is that a parent supported weight reduction (PSWR) intervention that combines behavioral strategies with nutrition and activity education (NAE) will be more effective in reducing overweight in adolescents with DS than a program that provides NAE alone or a Wait-List (WL) control.

02

Conditions studied

  • Down Syndrome

Keywords

  • obesity
  • behavioral intervention
  • family based
  • weight loss
03

In context

Down Syndrome

432 studies on the registry are indexed under Down Syndrome; 100 are open to participants now.

This study's enrollment of 21 is below the median of 36 across 283 interventional studies indexed under Down Syndrome.

Browse Down Syndrome studies →

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is the lead sponsor of 529 studies on the registry; 54 are open to participants now.

Of its 79 completed or terminated interventional studies of FDA-regulated products, 50 (63%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years to 26 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Age 13-26 with Down syndrome
  • Living at home in single- or two-parent family, w/no plans to leave home in next year
  • Achieves IQ score 45 or above on the Kaufman Brief Intelligence Test (K-BIT)
  • Academic ability and necessary behavioral/social control to participate in a group classroom-based educational program
  • Clinically overweight, as indicated by a BMI at or above 85th percentile for age and gender
  • Signed approval to participate, which includes a completed recent thyroid screen, provided by participant's Primary Physician (and participant's cardiologist is he/she has a history of a heart condition), and participant's neurologist if he/she has a history of seizures)

Exclusion criteria

Exclusion Criteria:

  • Untreated thyroid disorder
  • Type I or II Diabetes
  • Cardiac problem, treated or untreated, for whom the participant's treating cardiologist indicates restrictions in physical activity
  • Epilepsy/seizure disorder in which participant is not stable on medications
  • Orthopedic injuries or deformities
  • Chronic GI illness (except constipation) including inflammatory bowel diseases and celiac disease
  • Prader Willi syndrome
  • Unwillingness to wear accelerometer at screening or enrollment
  • Non-ambulatory, i.e., uses wheelchair or other assistive devices for moving about and walking
  • Chronic/severe foot infection (as screened by physical therapist, but in coordination with physician)
  • Severe balance problems (as screened by physical therapist)
  • Resting heart rate less than 50 beats per minute (bpm), or greater to or equal to 100 bpm (observed in physical therapy screening)
  • History of major medical illness (i.e., cancer, leukemia)
  • History of profound behavioral problems, i.e., self injury, injury to others, property destruction, etc.
  • Other diagnosed disorders, including autism spectrum disorders, bipolar disorder (within the last year), eating disorder (within the last year), major depression (within the last year), psychosis \& schizophrenia
  • Other exclusion conditions left to the discretion of the study team
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
21 participants (actual)

Study arms

  • Experimental
    NAE + Behavioral Intervention

    Parents of participants receive training in behavioral support at home, in addition to a standard nutrition and physical activity education (NAE) program.

    Behavioral: Parent Supported Behavioral Intervention · Behavioral: Nutrition/Activity Education (NAE)

  • Active comparator
    Nutrition/Activity Education

    Parents and participants receive a standard nutrition and physical activity education (NAE) program.

    Behavioral: Nutrition/Activity Education (NAE)

Interventions

  • BehavioralParent Supported Behavioral Intervention

    Parents of participants receive training in behavioral support at home in order to facilitate lifestyle change associated with dietary choices and physical activity designed to produce gradual weight loss.

    Also known as: lifestyle modification, behavior modification, behavior therapy

  • BehavioralNutrition/Activity Education (NAE)
06

Study locations

1 site
  • Eunice Kennedy Shriver Center at UMASS Medical School
    Waltham, Massachusetts 02452, United States
07

References and documents

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 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 18, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01256112
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators
University of Massachusetts, Worcester
Responsible party
Sponsor
First posted
Dec 8, 2010
Start date
Sep 2006
Primary completion
Mar 2010
Completion
Mar 2010
Last update
Oct 18, 2017

Study contacts

Richard K Fleming, PhD
principal investigator · University of Massachusetts Medical School, Eunice Kennedy Shriver Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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