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NCT04892030 · ClinicalTrials.gov registry record · NA
Evaluating a Remotely Delivered Plant-Based Behavioral Weight Loss Treatment
A NA study, sponsored by Drexel University.
- Completed
- Registry status
- NA
- Development phase
- 22
- Enrollment target
NCT04892030: Completed NA study, sponsored by Drexel University.
NCT04892030 is a NA study that has completed, run by Drexel University. The registered enrollment target is 22 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04892030, a NA study, has completed, sponsored by Drexel University.
- COMPLETED
- Registry status
- NA
- Development phase
- 22 participants
- Enrollment target
Study Summary
Many individuals do not achieve clinically significant weight loss following traditional lifestyle modification interventions, potentially because weight loss is dependent upon calorie tracking compliance (to achieve calorie prescriptions), which decreases over time for most. By contrast, non-energy-restricted whole food plant-based diets (WFPBD) have been demonstrated to promote clinically significant weight loss even without calorie prescriptions. The present pilot trial represents the first, to the knowledge of our study team, to empirically test a remotely delivered WFPBD behavioral weight loss intervention for adults with overweight or obesity. Over 12-weeks, participants (N = 21) will follow a non-energy-restricted WFPBD and received nutritional counseling and behavioral weight loss intervention. Participation will occur in two phases (Phase 1: n = 7; Phase 2: n = 14), between which iterative changes to the intervention will be made. Assessments will occur at baseline, mid-treatment, post-treatment, and 3-month follow-up. Data will be analyzed using an intent-to-treat approach. The primary aims of the study will be to assess retention feasibility and acceptability. The secondary aims will be to evaluate the preliminary effectiveness of the intervention on: (1) percent weight loss; (2) dietary intake (i.e., increased intake of low-fat plant-based whole foods and decreased in intake of processed foods and animal products); and (3) waist circumference. The exploratory aims will be to evaluate the preliminary effectiveness of the intervention on physical- and mental health-related quality of life, and to examine potential moderators of treatment success (plant-based diet history, internal disinhibition, social support vs. social sabotage, self-compassion, and psychological flexibility).
Primary Outcome
The number of participants who are retained in the study, as defined by completing the post-treatment assessment and at least 10 out of 12 of the weekly intervention modules. Successful retention will be defined as at least 80% of participants being retained in the study.
Interventions
- BEHAVIORAL Whole Food Plant-Based Behavioral Weight Loss Treatment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2020-11-25 |
| Est. Completion | 2021-05-18 |
| Phase | NA |
What the finished NCT04892030 record still lists
NCT04892030 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Whole Food Plant-Based Behavioral Weight Loss Treatment is the first listed.
NCT04892030 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04892030 about?
NCT04892030 is a clinical study titled "Evaluating a Remotely Delivered Plant-Based Behavioral Weight Loss Treatment". Many individuals do not achieve clinically significant weight loss following traditional lifestyle modification interventions, potentially because weight loss is dependent upon calorie tracking compliance (to achieve calorie prescriptions), which decreases over time for most. By contrast, non-energy...
What is the current status of trial NCT04892030?
This trial is currently completed. It is a NA study. The enrollment target is 22 participants. The study started on 2020-11-25. Estimated completion is 2021-05-18.
What interventions are being tested in trial NCT04892030?
The interventions under investigation include: Whole Food Plant-Based Behavioral Weight Loss Treatment (BEHAVIORAL).
Who is sponsoring clinical trial NCT04892030?
This trial is sponsored by Drexel University, which has 92 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04892030's enrollment target sits among peer trials
22 1756th of 2000 higher than 239 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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