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Completed No phase listed Observational

Ecological Momentary Assessment of Behavioral and Psychosocial Predictors of Weight Loss Following Bariatric Surgery

ClinicalTrials.gov ID: NCT02777177

Public ClinicalTrials.gov record NCT02777177. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 2:13 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 \[e.g., meal frequency, PA\], psychosocial indicators with the most prior evidence of an association with surgical outcomes (e.g., mood/depression), and key environmental factors (e.g., type/quality of the food environment). Participants will also be weighed at the above time points. Along with describing patterns in behaviors and their relation to weight loss, the investigators will test causal models to understand how complex systems of behavioral, psychosocial, and environmental factors affect weight loss, and to identify optimal targets for intervention. This project has the potential to build a much more sophisticated and valid understanding of who is and is not successful after bariatric surgery and why. This new understanding will directly contribute to improved (i.e., specific, consistent, and validated) guidelines for recommended pre and postoperative behaviors, which could lead to improved surgical outcomes. The enhanced understanding will also inform behavioral, psychosocial, and environmental targets for intervention that are mostly likely to improve surgical outcomes.

Study identification

NCT ID
NCT02777177
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Lead sponsor
The Miriam Hospital
Other
Enrollment
92 participants

Conditions and interventions

Conditions

Interventions

Not listed

Eligibility (public fields only)

Age range
21 Years to 70 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 3, 2016
Primary completion
Mar 20, 2019
Completion
Mar 20, 2019
Last update posted
Jun 12, 2022

2016 – 2019

United States locations

U.S. sites
2
U.S. states
2
U.S. cities
2
Facility City State ZIP Site status
Beth Israel Deaconess Medical Center Boston Massachusetts 02215
Miriam Hospital Weight Control and Diabetes Resarch Center Providence Rhode Island 02903

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02777177, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 12, 2022 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02777177 live on ClinicalTrials.gov.

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