Parent Supported Weight Reduction in Down Syndrome



Status:Completed
Conditions:Other Indications
Therapuetic Areas:Other
Healthy:No
Age Range:13 - 26
Updated:10/20/2017
Start Date:September 2006
End Date:March 2010

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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.

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.

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
We found this trial at
1
site
200 Trapelo Road
Waltham, Massachusetts 02452
636
mi
from 43215
Waltham, MA
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