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NCT Number: NCT03482986

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

The purpose of the study is to test how dietary habit interventions affect patients weight loss outcomes after bariatric surgery.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Bariatric Surgery Behavior Behavior, Animal Body Weight Body Weight Changes Feeding Behavior Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleeve Gastrectomy

Age range

22 year–62 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Dietary habits plan

Behavioral

Patients will be given a personalized plan regarding their diet.

Primary outcomes

  1. 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

Secondary outcomes

  1. Change in caloric intake

    Time frame: baseline and 4 weeks (post-intervention)

    Difference in caloric intake from baseline to post-intervention

  2. Change in energy expenditure

    Time frame: baseline and 4 weeks (post-intervention)

    resting and postprandial energy expenditure measured by indirect calorimetry

  3. Change in glucose tolerance

    Time frame: baseline and 4 weeks (post-intervention)

    Glucose response to mixed meal test

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2021
Primary completion
2028
Study completion
2028
First posted
Mar 29, 2018
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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