Weight Loss Physical Disabilities

NCT04046471 | Completed Results

• 2 other identifiers: 1427531R01DK116669-01A1
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

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.

Conditions

Physical Disability

Keywords

Weight Loss; Physical Activity; Diet

Outcome Measures

Primary Outcomes (1)

• Weight Change in kg From Baseline to 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 Outcomes (5)

• Weight

  Baseline, 6, 12, and 18 months

• Waist Circumference

  Baseline, 6, 12, and 18 months

• Blood Pressure

  Baseline, 6, 12, and 18 months

• Change in Quality of Life

  Baseline, 6, 12, and 18 months

• Cost of Intervention

  Across 18 months

Other Outcomes (11)

• Compliance With the Diet Recommendations

  Baseline, 6, 12, and 18 months

• Compliance With Physical Activity Recommendations

  Baseline, 6, 12, and 18 months

• Behavioral Session Attendance

  Across 18 months

Study Arms (2)

Individual In-Person

OTHER

Dietary Supplement: enhanced Stop Light Diet; Behavioral: Individual In-Person

Group Remote

OTHER

Dietary Supplement: enhanced Stop Light Diet; Behavioral: Group Remote

Interventions

enhanced Stop Light Diet DIETARY_SUPPLEMENT

Stop light diet enhanced with portion-controlled meals

Group Remote; Individual In-Person

Group Remote BEHAVIORAL

Participants will receive remotely delivered weight loss in a group setting.

Group Remote

Individual In-Person BEHAVIORAL

Participants will receive a weight loss intervention during individual, at-home visits.

Individual In-Person

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Related Publications (1)

• 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.

  PMID: 32768682 DERIVED

MeSH Terms

Conditions

Weight Loss; Motor Activity

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Results Point of Contact

• Title: Dr. Joseph Donnelly
• Organization: University of Kansas Medical Center

jdonnelly2@kumc.edu

785-864-1687

Study Officials

• Joseph Donnelly, EdD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2019
• First Posted: August 6, 2019
• Study Start: February 1, 2020
• Primary Completion: June 22, 2023
• Study Completion: June 20, 2024
• Last Updated: August 5, 2025
• Results First Posted: July 22, 2024

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)