Clinical trial NCT04046471: Weight Loss Physical Disabilities
Official title: Weight Management for Adults With Mobility Related Disabilities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Disability
Keywords: Weight Loss
Physical Activity
Diet
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2019-08-06
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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 maintenance (18 mos.) in overweight/obese adults with Mobility Related Disabilities (MRDs). Adults with MRDs (n=128) will be randomized (1:1) to one of the 2 intervention arms for an 18-mo. trial (6 mos. weight loss, 12 mos. maintenance). Cohorts of \~30-45 individuals will be recruited. Following baseline testing, participants will be stratified by their primary mode of locomotion outside the home, i.e., ambulatory or assistive device (wheelchair, scooter, etc.), and randomized with equal allocation to GR or IH arms. Both interventions will be delivered in a format that eliminates the transportation barrier, prescribed an enhanced stop light diet, and will self-monitor body weight using electronic scales. The GR arm will include group behavioral counseling and group PA delivered remotely via video conferencing (Zoom trademark software) on a tablet computer (iPad mini) to participants in their homes, and use commercially available web-based applications for self-monitoring/participant feedback for diet (Lose It! software) and PA (Fitbit activity tracker). The IH arm will include behavioral counseling delivered during individual home visits, a prescription for self-directed PA, and self-monitoring of diet and PA using conventional paper and pencil self-reports. All outcomes will be collected by trained research assistants who are blinded to the study condition. The primary aim will be to compare weight loss (0-6 mos.) between the GR and IH interventions. Secondarily, the research team will compare 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, the influence of behavioral session attendance, compliance with the recommendations for diet (energy intake, number of entrees/shakes, servings of fruits/vegetables), 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 between the IH and GR arms will be explored, with 80% power and a type 1 error rate of 0.05, assuming a common standard deviation of 6 kg, will require 64 participants/group. A 2-sample independent t-test will be used to compare 6 mo. weight loss (primary aim) between the 2 intervention arms in both an intent-to-treat and completer only analysis. For the secondary aim 1, comparison of 18 mo. weight loss, will mirror the analysis for the primary aim. A 2-sample t-test will be used to compare weight change (0-18 mos.) between the 2 intervention arms. For secondary aim 2, a between arm comparison of the proportion of participants achieving \>=5% weight loss (0-18 mos.) will be evaluated using a chi-square test. Secondary aims 3 and 4, between arm comparison of change in risk factors and quality of life (0-6 and 0-18 mos.), will be evaluated using a 2-sample ttest. Exploratory aims will examine the influence of the following on weight loss at 6 mos.: behavioral session attendance; compliance with the recommendations for diet (energy intake, number of entrees/shakes, servings of fruits/vegetables), PA (min of moderate-vigorous PA, min sedentary time), self-monitoring of diet and PA, sleep, and medications assessed over the time period of interest i.e. (0-6 and 0-18 mos.); and the changes in self-efficacy for PA and dietary change, dietary self-regulation, social support for diet/PA, and barriers to PA from 0-6 mos. The influence of these factors as covariates will be examined, in addition to treatment, on weight loss at 6 mos. This will allow the ability to identify which variables most highly influence the outcome along with treatment and/or the mechanism(s) of action that are impacting weight loss.

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).

Primary outcomes:
measure: Weight Change in kg From Baseline to 6-months
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Weight
timeFrame: Baseline, 6, 12, and 18 months
measure: Waist Circumference
timeFrame: Baseline, 6, 12, and 18 months
measure: Blood Pressure
timeFrame: Baseline, 6, 12, and 18 months
measure: Change in Quality of Life
timeFrame: Baseline, 6, 12, and 18 months
measure: Cost of Intervention
timeFrame: Across 18 months
Other outcomes:
measure: Compliance With the Diet Recommendations
timeFrame: Baseline, 6, 12, and 18 months
measure: Compliance With Physical Activity Recommendations
timeFrame: Baseline, 6, 12, and 18 months
measure: Behavioral Session Attendance
timeFrame: Across 18 months
measure: Self-monitoring of Diet/PA
timeFrame: Across 18 months
measure: Self-efficacy for Dietary Change
timeFrame: Baseline, 6, 12, and 18 months
measure: Barriers to Exercise
timeFrame: Baseline, 6, 12, and 18 months
measure: Diet Self-regulation
timeFrame: Baseline, 6, 12, and 18 months
measure: Social Support
timeFrame: Baseline, 6, 12, and 18 months
measure: Sleep
timeFrame: Baseline, 6, 12, and 18 months
measure: Medication Information
timeFrame: Baseline, 6, 12, and 18 months
measure: Energy Expenditure
timeFrame: 3-12 months
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Joseph Donnelly, EdD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Washburn RA, Ptomey LT, Gorczyca AM, Smith PR, Mayo MS, Lee R, Donnelly JE. Weight management for adults with mobility related disabilities: Rationale and design for an 18-month randomized trial. Contemp Clin Trials. 2020 Sep;96:106098. doi: 10.1016/j.cct.2020.106098. Epub 2020 Aug 6.