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

NCT02777177 | Completed

• 1 other identifier: R01DK108579
• Study Type: observational
• Target: 92
• Locations: 1 country
• Sites: 2

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Weight Loss

  12-months post bariatric surgery

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals diagnosed with obesity who plan to have bariatric surgery within 8 weeks.

You may qualify if:

• Body mass index of at least 35 kg/m-squared

You may not qualify if:

• 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

Sponsors & Collaborators

• The Miriam Hospital: lead

Study Sites (2)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Miriam Hospital Weight Control and Diabetes Resarch Center

Providence, Rhode Island, 02903, United States

Location

Related Publications (2)

• Bond DS, Smith KE, Schumacher LM, Vithiananthan S, Jones DB, Papasavas P, Webster J, Thomas JG. Associations of daily weight management-focused social support with weight loss, activity behaviors, and eating regulation in the context of metabolic and bariatric surgery. Obes Sci Pract. 2023 Nov 10;10(1):e717. doi: 10.1002/osp4.717. eCollection 2024 Feb.

  PMID: 38263993 DERIVED

• Goldstein SP, Thomas JG, Vithiananthan S, Blackburn GA, Jones DB, Webster J, Jones R, Evans EW, Dushay J, Moon J, Bond DS. Multi-sensor ecological momentary assessment of behavioral and psychosocial predictors of weight loss following bariatric surgery: study protocol for a multicenter prospective longitudinal evaluation. BMC Obes. 2018 Nov 5;5:27. doi: 10.1186/s40608-018-0204-6. eCollection 2018.

  PMID: 30410772 DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor (Research)

Study Record Dates

• First Submitted: May 17, 2016
• First Posted: May 19, 2016
• Study Start: May 4, 2016
• Primary Completion: March 21, 2019
• Study Completion: March 21, 2019
• Last Updated: June 13, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)