Dietary Habits for Post-Bariatric Surgery Weight Loss

Overseen By Raphael Knaier, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Disqualifiers: Insulin-dependent diabetes, Anemia, Smoking, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 4 weeks

44 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Research Team

Frank Scheer, PhD

Principal Investigator

Brigham and Women's Hospital

Ali Tavakkoli, MD

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

This trial is for individuals who have undergone bariatric surgery, specifically sleeve gastrectomy, and are not currently smokers or dependent on drugs or alcohol. It's also important that they don't have bipolar disorder, anemia, PTSD, insulin-dependent diabetes or haven't done shift work in the past year.

Inclusion Criteria

I have had a sleeve gastrectomy.

Exclusion Criteria

I use insulin to manage my diabetes.

Shift work within the past 1 year

Drug or alcohol dependency

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo bariatric surgery followed by dietary habit interventions

4 weeks

1 visit (in-person) for surgery, weekly follow-ups (virtual)

Follow-up

Participants are monitored for changes in self-rated hunger, caloric intake, energy expenditure, and glucose tolerance

4 weeks

Treatment Details

Interventions

• Dietary habits plan

Trial Overview The study is examining how following a specific dietary habits plan can influence weight loss results after patients have had bariatric surgery. The goal is to see if these dietary changes improve the effectiveness of the surgery.

Participant Groups

Group I: Group B Experimental Treatment 1 Intervention

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.

Group II: Group A Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+