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Role of Dietary Habits in Efficacy of Bariatric Surgery - Study A

Sponsor
Brigham and Women's Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT03470558
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
400
Enrollment
1
Location
64.8
Anticipated Duration (Months)
6.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to evaluate how dietary habits in the post-surgical year impact outcomes of bariatric surgery.

Condition or Disease Intervention/Treatment Phase
  • Other: Dietary habits

Detailed Description

The obesity epidemic is a major public health concern with a significant economic burden in the USA. Bariatric surgery is the most effective and durable weight loss treatment, with long-term cardiometabolic health benefits. Among different types of bariatric procedures, sleeve gastrectomy (SG) has become the most commonly performed in USA. While SG is expected to result in a 50-60% excess weight loss, inter-individual differences in weight loss are large and approximately 25% of patients can be considered poor weight-loss responders who either do not lose a substantial amount of weight or regain the lost weight afterwards. The mechanisms underlying this clinical variation remain unknown and interventions to improve on these outcomes critically lacking. Of interest, altered daily dietary habits are experienced by a substantial proportion of bariatric surgery candidates, raising the question whether such alterations may contribute to inter-individual differences in weight loss success. Therefore, the purpose of this study is to evaluate how dietary habits in the post-surgical year impact outcomes of bariatric surgery.

Study Design

Study Type:
Observational
Anticipated Enrollment :
400 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Role of Dietary Habits in Efficacy of Bariatric Surgery - Study A
Actual Study Start Date :
Dec 6, 2018
Anticipated Primary Completion Date :
May 1, 2024
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Sleeve gastrectomy patients

Patients electing to undergo sleeve gastrectomy will monitor their dietary habits.

Other: Dietary habits
Sleeve gastrectomy patients will be asked to monitor dietary habits before surgery and at 2, 6, and 12 months after surgery.

Outcome Measures

Primary Outcome Measures

  1. Change in BMI at 1-year post-surgical [Baseline and one year]

    Body mass index at one year after surgery compared to baseline

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Bariatric surgery (sleeve gastrectomy) patients
Exclusion Criteria:
  • Prior bariatric surgical procedures

Contacts and Locations

Locations

Site City State Country Postal Code
1 Brigham and Women's Hospital Boston Massachusetts United States 02115

Sponsors and Collaborators

  • Brigham and Women's Hospital
  • National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Frank Scheer, PhD, Brigham and Women's Hospital
  • Principal Investigator: Ali Tavakkoli, MD, Brigham and Women's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Frank AJL Scheer, PhD, Professor of Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT03470558
Other Study ID Numbers:
  • 2017P002526A
  • R01HL140574
First Posted:
Mar 20, 2018
Last Update Posted:
Aug 2, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Frank AJL Scheer, PhD, Professor of Medicine, Brigham and Women's Hospital
Diet
Dietary Habits
Weight changes

Study Results

No Results Posted as of Aug 2, 2022