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NCT02603601 · ClinicalTrials.gov registry record · NA
A Trial of Lifestyle Interventions to Control Weight After Bariatric Surgery
A NA study of Obesity and Weight Gain, sponsored by Beth Israel Deaconess Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT02603601 is a NA study of Obesity and Weight Gain that has completed, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 18 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02603601, a NA study of Obesity and Weight Gain, has completed, sponsored by Beth Israel Deaconess Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
This randomized controlled trial is designed to test the feasibility and efficacy of a novel 10-week mindfulness-based intervention (MBI) on weight maintenance as well as behavioral and psychosocial outcomes in patients who have undergone bariatric surgery. Primary hypothesis: Bariatric patients who have stopped losing weight (\< 5 lbs weight loss in past month) 1-5 years post-surgery will be willing to participate in this 10-week intervention. The investigators expect a high adherence rate (\>70%) and no issues with meeting recruitment goals. Secondary hypotheses: Patients assigned to the MBI will show greater improvement in a) weight control (defined by differences in body weight between baseline and follow-up); b) eating behaviors (binge eating, emotional eating); and c) psychosocial measures (quality of life, depression, perceived stress, eating self-efficacy, coping ability) than a standard lifestyle intervention (1 hr lifestyle counseling). Patients assigned to the MBI intervention will show greater improvement in biomarkers of stress and inflammation \[salivary cortisol, high sensitivity C-reactive protein (hs-CRP), interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-alpha)\] as compared with a standard lifestyle intervention. Food-related attentional bias as measured by the food-related Stroop task will be differentially affected among patients assigned to the MBI as compared with the intensive lifestyle intervention and standard lifestyle intervention.
Conditions Studied
Interventions
- BEHAVIORAL Mind-body lifestyle intervention
- BEHAVIORAL Standard lifestyle intervention
Study Locations (1)
Massachusetts
- Beth Israel Deaconness Medical Center - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2014-03 |
| Est. Completion | 2014-10 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02603601
The ClinicalTrials.gov registry entry for NCT02603601 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (98% lower). The listed sponsor is Beth Israel Deaconess Medical Center, which has 488 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Obesity appearing as the primary indexed condition, and to 2 interventions - of which Mind-body lifestyle intervention is the first listed.
NCT02603601 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT02603601 about?
NCT02603601 is a clinical study titled "A Trial of Lifestyle Interventions to Control Weight After Bariatric Surgery". This randomized controlled trial is designed to test the feasibility and efficacy of a novel 10-week mindfulness-based intervention (MBI) on weight maintenance as well as behavioral and psychosocial outcomes in patients who have undergone bariatric surgery. Primary hypothesis: Bariatric patients w...
What is the current status of trial NCT02603601?
This trial is currently completed. It is a NA study. The enrollment target is 18 participants. The study started on 2014-03. Estimated completion is 2014-10.
What conditions does trial NCT02603601 study?
This clinical trial studies the following conditions: Obesity, Weight Gain.
What interventions are being tested in trial NCT02603601?
The interventions under investigation include: Mind-body lifestyle intervention (BEHAVIORAL), Standard lifestyle intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT02603601?
This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02603601 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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