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NCT03704064 · ClinicalTrials.gov registry record · NA
Behavioral Weight Loss and Stigma Reduction
A NA study of Obesity, sponsored by University of Pennsylvania.
- Completed
- Registry status
- NA
- Development phase
- 105
- Enrollment target
- 1
- Study location
NCT03704064: Completed NA study of Obesity, sponsored by University of Pennsylvania.
NCT03704064 is a NA study of Obesity that has completed, run by University of Pennsylvania. The registered enrollment target is 105 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03704064, a NA study of Obesity, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- NA
- Development phase
- 105 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a randomized controlled trial to test the effects on long-term weight loss of a novel stigma-reduction intervention combined with standard BWL treatment, as compared to BWL alone. Participants will be a total of 104 men and women seeking weight loss, ages 18 years and older, with a body mass index (BMI) of 30 kg/m2 or above (or 27 kg/m2 or above with an obesity-related comorbidity), a history of experiencing weight bias, and elevated levels of WBI. Participants will attend a screening visit in which they will complete a behavioral evaluation with a psychologist and a medical history that will be reviewed by a nurse practitioner or physician. Questionnaires assessing experiences and internalization of weight bias, with confirmation by interviewer assessment during the behavioral evaluation, will be used to determine whether participants meet criteria for having high levels of WBI. Eligible consenting participants will be randomly assigned to the standard BWL intervention (n = 52) or the stigma + BWL intervention (n = 52). All participants will attend weekly, 90-minute group meetings for 20 weeks (20 visits). In the stigma + BWL treatment group, 60 minutes will be devoted to BWL and 30 minutes to weight stigma. In the standard BWL treatment group, the additional 30 minutes will be devoted to sharing recipes and food preparation tips. Following 20 weeks of weight loss treatment, participants will attend group meetings focused on weight loss maintenance, monthly from weeks 21-46 (6 visits), and every-other-month from weeks 47-72 (3 visits). Maintenance sessions in the stigma + BWL group will continue to incorporate discussion of WBI and stigma-related barriers to physical activity. Assessments - which include questionnaires, blood draws, and measurements of body weight and physical activity - will occur at baseline and weeks 20, 46 (no blood draw this week), and 72. Weight will be measured at every group meeting for clinical purposes.
Primary Outcome
Estimated mean percent change in weight from baseline to week 72
Conditions Studied
Interventions
- BEHAVIORAL Stigma-Reduction Intervention
- BEHAVIORAL Behavioral Weight Loss (BWL)
Study Locations (1)
Pennsylvania
- The University of Pennsylvania Center for Weight and Eating Disorders - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2018-10-16 |
| Est. Completion | 2021-08-02 |
| Phase | NA |
What the finished NCT03704064 record still lists
NCT03704064 is an interventional study that assigns participants to a tested intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (87% lower).
The record links to 1 condition, with Obesity appearing as the primary indexed condition, and to 2 interventions - of which Stigma-Reduction Intervention is the first listed.
NCT03704064 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03704064 about?
NCT03704064 is a clinical study titled "Behavioral Weight Loss and Stigma Reduction". This is a randomized controlled trial to test the effects on long-term weight loss of a novel stigma-reduction intervention combined with standard BWL treatment, as compared to BWL alone. Participants will be a total of 104 men and women seeking weight loss, ages 18 years and older, with a body mass...
What is the current status of trial NCT03704064?
This trial is currently completed. It is a NA study. The enrollment target is 105 participants. The study started on 2018-10-16. Estimated completion is 2021-08-02.
What conditions does trial NCT03704064 study?
This clinical trial studies the following conditions: Obesity.
What interventions are being tested in trial NCT03704064?
The interventions under investigation include: Stigma-Reduction Intervention (BEHAVIORAL), Behavioral Weight Loss (BWL) (BEHAVIORAL).
Who is sponsoring clinical trial NCT03704064?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03704064 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03704064's enrollment target sits among peer trials
105 465th of 1053 higher than 587 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity 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.
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