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NCT04046471 · ClinicalTrials.gov registry record · NA
Weight Loss Physical Disabilities
A NA study, sponsored by University of Kansas Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 129
- Enrollment target
NCT04046471: Completed NA study, sponsored by University of Kansas Medical Center.
NCT04046471 is a NA study that has completed, run by University of Kansas Medical Center. The registered enrollment target is 129 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04046471, a NA study, has completed, sponsored by University of Kansas Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 129 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DIETARY_SUPPLEMENT enhanced Stop Light Diet
- BEHAVIORAL Group Remote
- BEHAVIORAL Individual In-Person
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 129 participants |
| Start Date | 2020-02-01 |
| Est. Completion | 2024-06-20 |
| Phase | NA |
What the finished NCT04046471 record still lists
NCT04046471 is an interventional study that assigns participants to a tested intervention. The registered 129 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 3 interventions - of which enhanced Stop Light Diet is the first listed.
NCT04046471 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04046471 about?
NCT04046471 is a clinical study titled "Weight Loss Physical Disabilities". 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)...
What is the current status of trial NCT04046471?
This trial is currently completed. It is a NA study. The enrollment target is 129 participants. The study started on 2020-02-01. Estimated completion is 2024-06-20.
What interventions are being tested in trial NCT04046471?
The interventions under investigation include: enhanced Stop Light Diet (DIETARY_SUPPLEMENT), Group Remote (BEHAVIORAL), Individual In-Person (BEHAVIORAL).
Who is sponsoring clinical trial NCT04046471?
This trial is sponsored by University of Kansas Medical Center, which has 408 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04046471's enrollment target sits among peer trials
129 744th of 2000 higher than 1,257 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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