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

Sponsor
The Miriam Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02777177
Collaborator
(none)
92
Enrollment
2
Locations
34.5
Actual Duration (Months)
46
Patients Per Site
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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], 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    92 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Ecological Momentary Assessment of Behavioral and Psychosocial Predictors of Weight Loss Following Bariatric Surgery
    Actual Study Start Date :
    May 4, 2016
    Actual Primary Completion Date :
    Mar 21, 2019
    Actual Study Completion Date :
    Mar 21, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Weight Loss [12-months post bariatric surgery]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Body mass index of at least 35 kg/m-squared
    Exclusion Criteria:

    • Currently involved in a weight loss or related behavioral form of treatment outside the context of standard surgical care

    • Any condition that in the opinion of the investigators would preclude adherence to the measurement protocol, including plans to relocate, substance abuse or other significant psychiatric problems, or terminal illness

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215
    2 Miriam Hospital Weight Control and Diabetes Resarch Center Providence Rhode Island United States 02903

    Sponsors and Collaborators

    • The Miriam Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    John Graham Thomas, Associate Professor (Research), The Miriam Hospital
    ClinicalTrials.gov Identifier:
    NCT02777177
    Other Study ID Numbers:
    • R01DK108579
    First Posted:
    May 19, 2016
    Last Update Posted:
    Jun 13, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Weight Loss

    Study Results

    No Results Posted as of Jun 13, 2022