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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 is a NA study that has completed, run by Drexel University. The registered enrollment target is 22 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04892030
The ClinicalTrials.gov registry entry for NCT04892030 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Drexel University, which has 92 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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