An interventional study of Dietary habits plan in Bariatric Surgery, Sleeve Gastrectomy and Obesity, sponsored by Brigham and Women's Hospital. Active, not recruiting at 1 site in United States. Open to participants aged 22 Years to 62 Years. Per ClinicalTrials.gov, last updated 2025-12-05.
Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Basic science
The purpose of the study is to test how dietary habit interventions affect patients weight loss outcomes after bariatric surgery.
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 44 is below the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Brigham and Women's Hospital is the lead sponsor of 1,267 studies on the registry; 228 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 65 (56%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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.
Post-intervention change in self-rated hunger
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
Time frame: Baseline and 4 weeks (post-intervention)
Change in caloric intake
Difference in caloric intake from baseline to post-intervention
Time frame: baseline and 4 weeks (post-intervention)
Change in energy expenditure
resting and postprandial energy expenditure measured by indirect calorimetry
Time frame: baseline and 4 weeks (post-intervention)
Change in glucose tolerance
Glucose response to mixed meal test
Time frame: baseline and 4 weeks (post-intervention)
Plan to share: No
No publications or documents are linked to this record.
Started Dec 2021 (actual). Primary completion is estimated for Jun 2028, 78 months after the start.
Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 78 months is above that.
Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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