CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 129 enrolled
Drug / intervention
enhanced Stop Light Diet +2 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04046471
NCT04046471N/ACompleted

Weight Management for Adults With Mobility Related Disabilities

University of Kansas Medical Center·interventional·Posted Aug 6, 2019·Updated Aug 5, 2025

In Brief

A clinical study evaluating enhanced Stop Light Diet, Group Remote, and 1 other intervention for Physical Disability. Completed, enrolled 129 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedAug 6, 2019
Enrollment StartFeb 1, 2020
Primary CompletionJun 22, 2023
Study CompletionJun 20, 2024
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 6.9 years ago

Interventions

enhanced Stop Light Dietdietary

Stop light diet enhanced with portion-controlled meals

Group Remotebehavioral

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

Individual In-Personbehavioral

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