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Dietary Habits for Post-Bariatric Surgery Weight Loss
N/A
Waitlist Available
Led By Frank Scheer, PhD
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Bariatric surgery (sleeve gastrectomy) patients
Be between 18 and 65 years old
Must not have
Insulin-dependent diabetes
Anemia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 4 weeks (post-intervention)
Awards & highlights
No Placebo-Only Group
Summary
This trial will test how different diets affect weight loss in patients who have had bariatric surgery.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial focuses on dietary habits rather than medication or invasive procedures, side effects may include gastrointestinal discomfort due to diet change but are generally expected to be minimal.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had a sleeve gastrectomy.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I use insulin to manage my diabetes.
Select...
I have anemia.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 4 weeks (post-intervention)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 4 weeks (post-intervention)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Post-intervention change in self-rated hunger
Secondary study objectives
Change in caloric intake
Change in energy expenditure
Change in glucose tolerance
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Group BExperimental Treatment1 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 AExperimental Treatment1 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.
Find a Location
Who is running the clinical trial?
Brigham and Women's HospitalLead Sponsor
1,670 Previous Clinical Trials
11,878,222 Total Patients Enrolled
47 Trials studying Obesity
278,080 Patients Enrolled for Obesity
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,944 Previous Clinical Trials
47,799,788 Total Patients Enrolled
255 Trials studying Obesity
211,632 Patients Enrolled for Obesity
Frank Scheer, PhDPrincipal InvestigatorBrigham and Women's Hospital
4 Previous Clinical Trials
516 Total Patients Enrolled
2 Trials studying Obesity
444 Patients Enrolled for Obesity
Ali Tavakkoli, MDPrincipal InvestigatorBrigham and Women's Hospital
3 Previous Clinical Trials
464 Total Patients Enrolled
2 Trials studying Obesity
444 Patients Enrolled for Obesity
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I use insulin to manage my diabetes.I have been diagnosed with PTSD.I have had a sleeve gastrectomy.I have anemia.
Research Study Groups:
This trial has the following groups:- Group 1: Group A
- Group 2: Group B
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.