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NCT02777177 · ClinicalTrials.gov registry record
Ecological Momentary Assessment of Behavioral and Psychosocial Predictors of Weight Loss Following Bariatric Surgery
A clinical trial, sponsored by The Miriam Hospital.
- Completed
- Registry status
- 92
- Enrollment target
NCT02777177: Completed study, sponsored by The Miriam Hospital.
NCT02777177 is a clinical trial that has completed, run by The Miriam Hospital. The registered enrollment target is 92 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02777177 has completed, sponsored by The Miriam Hospital.
- COMPLETED
- Registry status
- 92 participants
- Enrollment target
Study Summary
Bariatric surgery is a powerful tool for producing significant and durable weight loss. Yet, not all patients achieve initial weight loss success and many patients have weight regain as early as 1-2 years post-surgery. Suboptimal weight loss patterns not fully explained by surgical, demographic, and medical factors has led to greater emphasis on patient behaviors evidenced by clinical guidelines that focus on appropriate eating and physical activity. However, research to inform such guidelines typically has relied on imprecise measures or not been specific to bariatric surgery. There is also little understanding of mechanisms by which psychosocial factors influence outcomes. Thus, there is a need to: (a) measure behaviors and psychosocial factors thought to be related to surgical outcomes (particularly those emphasized in guidelines) using innovative strategies to maximize data quality, (b) determine which behaviors and psychosocial factors are related to outcomes, and (c) explore how psychosocial factors influence weight both directly and via influences on behavior. Our research team was the first to employ innovative mobile health (mHealth) technology within an Ecological Momentary Assessment (EMA) framework to measure adherence to recommended behaviors at 6 months post-surgery. The investigators propose to build on this work by using EMA to measure behavioral, psychosocial, and environmental factors over a longer period to understand how they predict success and risk after surgery. An NIH-funded multi-sensor PiLR HEALTH platform will integrate objective sensor data measuring behaviors and the environments in which they are performed with self-report information collected via smartphone in real-time and in patients' natural environment. Participants (N=100) recruited from 2 ASMBS-designated centers of excellence will complete a 10-day EMA protocol pre-surgery and at 3, 6, and 12 months post-surgery to assess recommended behaviors \[e.g., meal frequency, PA\], psyc
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2016-05-04 |
| Est. Completion | 2019-03-21 |
What the finished NCT02777177 record still lists
NCT02777177 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 92 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT02777177 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02777177 about?
NCT02777177 is a clinical study titled "Ecological Momentary Assessment of Behavioral and Psychosocial Predictors of Weight Loss Following Bariatric Surgery". Bariatric surgery is a powerful tool for producing significant and durable weight loss. Yet, not all patients achieve initial weight loss success and many patients have weight regain as early as 1-2 years post-surgery. Suboptimal weight loss patterns not fully explained by surgical, demographic, and...
What is the current status of trial NCT02777177?
This trial is currently completed. The enrollment target is 92 participants. The study started on 2016-05-04. Estimated completion is 2019-03-21.
Who is sponsoring clinical trial NCT02777177?
This trial is sponsored by The Miriam Hospital, which has 136 total clinical trials registered on ClinicalTrials.gov.
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