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

November 28, 2025 updated by: Frank AJL Scheer, PhD, Brigham and Women's Hospital
The purpose of the study is to test how dietary habit interventions affect patients weight loss outcomes after bariatric surgery.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 the study is to test how dietary habit interventions affect patients weight loss outcomes after bariatric surgery. Since this is a single blind study, the details of the dietary interventions cannot be released during recruitment stage, but will be made public once enrollment closes.

Study Type

Interventional

Enrollment (Estimated)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 62 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Bariatric surgery (sleeve gastrectomy) patients

Exclusion Criteria:

  • Insulin-dependent diabetes
  • Anemia
  • Smoking
  • Shift work within the past 1 year
  • Drug or alcohol dependency
  • Bipolar disorder
  • Post traumatic stress disorder (PTSD)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Subject will be advised to follow dietary habits plan A. Since this is a single blind study, the details of the dietary interventions cannot be released during recruitment stage, but will be made public once enrollment closes.
Behavioral: Dietary habits plan
Patients will be given a personalized plan regarding their diet.
Experimental: Group B
Subject will be advised to follow dietary habits plan B. Since this is a single blind study, the details of the dietary interventions cannot be released during recruitment stage, but will be made public once enrollment closes.
Behavioral: Dietary habits plan
Patients will be given a personalized plan regarding their diet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-intervention change in self-rated hunger
Time Frame: Baseline and 4 weeks (post-intervention)
Differences in self-rated hunger as measured from the visual analogue scale (VAS; 0-100 score with 0 as ''not at all'' and 100 as ''very much''/''extremely'') questionnaire at baseline and after the intervention
Baseline and 4 weeks (post-intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in caloric intake
Time Frame: baseline and 4 weeks (post-intervention)
Difference in caloric intake from baseline to post-intervention
baseline and 4 weeks (post-intervention)
Change in energy expenditure
Time Frame: baseline and 4 weeks (post-intervention)
resting and postprandial energy expenditure measured by indirect calorimetry
baseline and 4 weeks (post-intervention)
Change in glucose tolerance
Time Frame: baseline and 4 weeks (post-intervention)
Glucose response to mixed meal test
baseline and 4 weeks (post-intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 7, 2021

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2028

Study Registration Dates

First Submitted

March 12, 2018

First Submitted That Met QC Criteria

March 28, 2018

First Posted (Actual)

March 29, 2018

Study Record Updates

Last Update Posted (Estimated)

December 5, 2025

Last Update Submitted That Met QC Criteria

November 28, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017P002526C
  • R01HL140574 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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