Back to results

Parent Supported Weight Reduction in Down Syndrome

Primary Purpose

Down Syndrome

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Parent Supported Behavioral Intervention

Nutrition/Activity Education (NAE)

About this trial

This is an interventional treatment trial for Down Syndrome focused on measuring obesity, behavioral intervention, family based, weight loss

Eligibility Criteria

13 Years - 26 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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:

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

Sites / Locations

Eunice Kennedy Shriver Center at UMASS Medical School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NAE + Behavioral Intervention

Nutrition/Activity Education

Arm Description

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

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

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT01256112

First Posted

December 6, 2010

Last Updated

October 16, 2017

Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborators

University of Massachusetts, Worcester

1. Study Identification

Unique Protocol Identification Number

NCT01256112

Brief Title

Parent Supported Weight Reduction in Down Syndrome

Official Title

Parent Supported Weight Reduction in Down Syndrome

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Completed

Study Start Date

September 2006 (undefined)

Primary Completion Date

March 2010 (Actual)

Study Completion Date

March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborators

University of Massachusetts, Worcester

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Down Syndrome

Keywords

obesity, behavioral intervention, family based, weight loss

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NAE + Behavioral Intervention

Arm Type

Experimental

Arm Description

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

Arm Title

Nutrition/Activity Education

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Parent Supported Behavioral Intervention

Other Intervention Name(s)

lifestyle modification, behavior modification, behavior therapy

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Nutrition/Activity Education (NAE)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

13 Years

Maximum Age & Unit of Time

26 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Richard K Fleming, PhD

Organizational Affiliation

University of Massachusetts Medical School, Eunice Kennedy Shriver Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Eunice Kennedy Shriver Center at UMASS Medical School

City

Waltham

State/Province

Massachusetts

ZIP/Postal Code

02452

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

23968742

Citation

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.

Results Reference

result

Links:

URL

http://www.umassmed.edu/shriver/index.aspx

Description

Web site for organization in which research was conducted

Learn more about this trial

Parent Supported Weight Reduction in Down Syndrome

We'll reach out to this number within 24 hrs