N/A
N=129
Weight Loss Physical Disabilities
Physical Disability
Bottom Line
View on ClinicalTrials.gov: NCT04046471 ↗Enrolled (actual)
129
Serious AEs
4.7%
Results posted
Jul 2024
Primary outcome: Primary: Weight Change in kg From Baseline to 6-months — -6.23; -8.16 kg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- enhanced Stop Light Diet (Dietary_supplement); Group Remote (Behavioral); Individual In-Person (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Kansas Medical Center
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Weight Change in kg From Baseline to 6-months |
-6.23; -8.16 | — |
| SECONDARY Weight |
— | — |
| SECONDARY Waist Circumference |
— | — |
| SECONDARY Blood Pressure |
— | — |
| SECONDARY Change in Quality of Life |
— | — |
| SECONDARY Cost of Intervention |
— | — |
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 conferencing to groups of overweight/obese adults with Mobility Related Disabilities (MRDs) in their homes (GR). The primary aim will be to compare weight loss (0-6 mos.) between the two interventions (IH vs. GR). Secondarily, the study team will compare the mean weight loss from 0-18 mos., the proportion of participants achieving >=5% weight loss from baseline, changes in cardiovascular risk factors and quality of life, and conduct a cost analysis. In addition, factors that will be explored include the influence of behavioral session attendance, compliance with the recommendations for diet (energy intake, number of entrees/shakes, servings of fruits/vegetables), Physical Activity (PA, min of moderate vigorous PA, min sedentary time), and self-monitoring of diet and PA, self-efficacy for dietary change and PA, dietary self-regulation, social support for diet/PA, barriers to PA, sleep and medications on weight loss at 6 and 18 mos.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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).
Data sourced from ClinicalTrials.gov (NCT04046471). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.