Weight Loss Physical Disabilities

Physical Disability Clinical Trial

Official title:

Weight Management for Adults With Mobility Related Disabilities

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04046471
• Other study ID #: 142753
• Secondary ID: 1R01DK116669-01A
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: June 20, 2024

Study information

• Verified date: April 2024
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 129
• Est. completion date: June 20, 2024
• Est. primary completion date: June 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Physical Disability
• Weight Loss

Intervention

Dietary Supplement:
• enhanced Stop Light Diet
Stop light diet enhanced with portion-controlled meals

Behavioral:
• Group Remote
Participants will receive remotely delivered weight loss in a group setting.
• Individual In-Person
Participants will receive a weight loss intervention during individual, at-home visits.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Compliance with the Diet Recommendations	Will be assessed using photo-assisted food records over 4 consecutive days (3 wk. days and 1 wk. end day) starting the weekend prior to scheduled outcome assessments.	Baseline, 6, 12, and 18 months
Other	Compliance with Physical Activity Recommendations	Assessed using the Physical Activity and Disability Survey (PADS). The PADS is a semi-structured interview that includes subscales for exercise, leisure time PA, household activity, and inactivity (sleeping, TV, computer use).	Baseline, 6, 12, and 18 months
Other	Behavioral Session Attendance	Expressed as the percentage of possible sessions attended	Across 18 months
Other	Self-monitoring of Diet/PA	The percentage of prescribed monitoring days completed across 18 mos.	Across 18 months
Other	Self-efficacy for Dietary Change	Assessed using the Weight Efficacy Lifestyle Scale. This scale has participants rate a question from 1 to 10 with 1 being "Not at all confident" and 10 being "Very confident."	Baseline, 6, 12, and 18 months
Other	Barriers to Exercise	Assessed using the Barriers to Exercise for Disabled Person. Individuals are asked a question relating to a specific exercise barrier and if it has limited their participation in the past three months. If they answer yes, they are asked to rate the limitation of that barrier on a scale of 1 to 5 with 1 being the least and 5 being the most limiting. Scores are calculated using weighted sums of the items.	Baseline, 6, 12, and 18 months
Other	Diet Self-regulation	Assessed using the Three-Factor Eating Inventory, a widely-used measure of eating behavior (restraint, disinhibition, hunger). Participant is asked a question and to rate how they feel on a 1-4 scale with 1 being "definitely false" and 4 being "definitely true."	Baseline, 6, 12, and 18 months
Other	Social Support	Social support for both exercise and dietary habits will be assessed using the Social Support and Exercise/Diet Survey. This survey utilizes questions focusing on support by peers and family members that participants answer using a 1-5 rating with 1 being "no support" and 5 being "very supportive."	Baseline, 6, 12, and 18 months
Other	Sleep	Sleep Quality will be assessed using The Pittsburgh Sleep Quality Index. Participants answer open-ended questions as well as questions on a 0-3 scale. Seven component scores are tallied using provided measures, and a global sum of "5"or greater on all seven components indicates a "poor" sleeper.	Baseline, 6, 12, and 18 months
Other	Medication Information	Medication name/frequency/amount will be collected by participant self-report	Baseline, 6, 12, and 18 months
Other	Energy expenditure	Energy expenditure of the remote sessions will be assessed in a volunteer sample using a previously validated portable, open-circuit indirect calorimeter (Cosmed, Italy) which measures breath-by-breath ventilation, expired oxygen, and carbon dioxide.	3-12 months
Primary	Change from baseline weight at 6 months	Weight will be measured in duplicate with a portable, calibrated digital scale. (Model #PS6600, Befour, Saukville, WI.). For those in a wheelchair, weight will be measured in duplicate using a portable calibrated, digital wheelchair scale (Model MX420, Befour, Saukville, WI.). Participant weight will be calculated as participant + chair weight minus chair weight.	Baseline and 6 months
Secondary	Weight	Weight will be measured in duplicate with a portable, calibrated digital scale. (Model #PS6600, Befour, Saukville, WI.). For those in a wheelchair, weight will be measured in duplicate using a portable calibrated, digital wheelchair scale (Model MX420, Befour, Saukville, WI.). Participant weight will be calculated as participant + chair weight minus chair weight.	Baseline, 6, 12, and 18 months
Secondary	Waist Circumference	Measured in cm around narrowest part of the waist.	Baseline, 6, 12, and 18 months
Secondary	Blood Pressure	Obtained with an automated sphygmomanometer (DinaMap ProCare 100, General Electric) using the NHANES blood pressure protocol.	Baseline, 6, 12, and 18 months
Secondary	Change in Quality of Life	Assessed with the SF-36E. The SF-36E measures quality of life on a 0-100 scale with 0 being low quality and 100 being high quality.	Baseline, 6, 12, and 18 months
Secondary	Cost of intervention	The cost of both the IH and GR interventions will be calculated along with the cost per additional kg of weight loss.	Across 18 months