Status:
COMPLETED
Weight Loss Physical Disabilities
Lead Sponsor:
University of Kansas Medical Center
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Physical Disability
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objective of this study is to compare weight loss (6 mos.) and maintenance (18 mos.) between an individual home visit intervention (IH) and an intervention delivered remotely via video conferencin...
Detailed Description
The investigators propose a 2-arm randomized trial (group remote (GR) vs. individual home visit (IH)) using intent-to-treat principles, to compare body weight following weight loss (6 mos.) and mainte...
Eligibility Criteria
Inclusion
- A permanent MRD (\>= 1 yr. duration) requiring the use of a wheelchair or resulting in the inability to walk 0.25 miles without stopping, with or without assistive devices, as documented by 7 items from the NHANES Physical Funding Survey (113), and confirmed by the Primary Care Physician (PCP). Individuals with MRDs, associated with, but not limited to spinal cord injury (SCI), spina bifida, multiple sclerosis, cerebral palsy, stroke, muscular dystrophy, and lower limb amputation will be included.
- Age 18 yrs and above. Weight management for younger individuals requires different behavioral strategies.
- Body mass index (BMI) above 25 kg/m squared. Individuals with BMI, with a BMI \<25kg/m squared are not overweight. We are aware of the difficulty in the assessment of BMI, and issues related to the use of BMI for classifying overweight/obesity in individuals with SCI or amputations. Thus, in questionable cases we will defer to the PCP regarding eligibility based on weight status.
- Wireless internet access in the home.
Exclusion
- Unable to participate in light-to-moderate intensity PA, e.g., seated aerobics, resistance exercise, or physically unable to use the iPad.
- Participation in a structured weight loss or exercise program in the previous 6 mos. These proximal exercises may influence this trial.
- Not weight stable (plus/minus 4.6 kg) for 3 mos. prior to intake.
- Unwilling to be randomized.
- Pregnancy during the previous 6 mos. currently lactating, or planned pregnancy in the following 18 mos.
- Serious medical risk, e.g., cancer, recent heart attack, stroke as determined by the PCP.
- Current use of antipsychotics, untreated depression, or other psychiatric illness that would preclude participation in weight management, as determined by the PCP. Psychiatric co-morbidity may limit the benefits from health education. Addressing psychiatric issues is beyond the scope of this study.
- Cognitive, visual, or hearing impairments that may interfere with compliance to the study protocol as determined by the PCP.
- Adherence to specialized diets, e.g., food allergies, vegetarian, macrobiotic.
- Binge (Binge Eating Scale) or other eating disorders (EATs-26).
Key Trial Info
Start Date :
February 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 20 2024
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT04046471
Start Date
February 1 2020
End Date
June 20 2024
Last Update
August 5 2025
Active Locations (1)
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1
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160