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

Mass General Brigham

Status: Active, not recruiting

Conditions: Sleeve Gastrectomy; Bariatric Surgery; Obesity

Treatments: Behavioral: Dietary habits plan

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03482986

2017P002526C

R01HL140574 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 44 estimated patients

Sex: All

Ages: 22 to 62 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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44 participants in 2 patient groups

Group A

Experimental group

Description:

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.

Treatment:

Behavioral: Dietary habits plan

Group B

Experimental group

Description:

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.

Treatment:

Behavioral: Dietary habits plan