Bariatric SurgeryNCT03482986
Role of Dietary Habits in Efficacy of Bariatric Surgery - Study C
A study testing Dietary habits plan in people with Bariatric Surgery and Sleeve Gastrectomy, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The purpose of the study is to test how dietary habit interventions affect patients weight loss outcomes after bariatric surgery. Read more about this study
- Who is it for?
- Ages 22 to 62 years
- Conditions the study is for
- Bariatric Surgery, Sleeve Gastrectomy, Obesity
- What is being tested?
- Dietary habits plan
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2021to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 62 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Bariatric surgery (sleeve gastrectomy) patients
Who cannot join
- Insulin-dependent diabetes
- Anemia
- Smoking
- Shift work within the past 1 year
- Drug or alcohol dependency
- Bipolar disorder
- Post traumatic stress disorder (PTSD)
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
The purpose of the study is to test how dietary habit interventions affect patients weight loss outcomes after bariatric surgery.
Read the detailed 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.
- Conditions
- Bariatric Surgery, Sleeve Gastrectomy, Obesity
- Being tested
- Dietary habits plan
- Keywords
- Diet, Dietary Habits, Weight changes
- Medical subject headings
- Obesity, Feeding Behavior, Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary habits planBehavioural
Patients will be given a personalized plan regarding their diet.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | 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. Receives: Behavioral: Dietary habits plan |
| Group B | Experimental | 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. Receives: Behavioral: Dietary habits plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and 4 weeks (post-intervention)
Secondary outcomes (3)
Change in caloric intake
Difference in caloric intake from baseline to post-intervention
Measured: baseline and 4 weeks (post-intervention)
Change in energy expenditure
resting and postprandial energy expenditure measured by indirect calorimetry
Measured: baseline and 4 weeks (post-intervention)
Change in glucose tolerance
Glucose response to mixed meal test
Measured: baseline and 4 weeks (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start7 Dec 2021
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric SurgeryStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Frank AJL Scheer, PhD, Brigham and Women's Hospital
- Investigators
- Frank Scheer, PhD, Principal investigator, Brigham and Women's HospitalAli Tavakkoli, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03482986
- Sponsor's protocol ID
- 2017P002526C
- Other IDs
- R01HL140574
- Status last verified
- Nov 2025
- First submitted
- 12 Mar 2018
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Dietary Habits in Efficacy of Bariatric Surgery - Study C
- ClinicalTrials.gov ID
- NCT03482986
- Acronym / sponsor ID
- 2017P002526C
- Conditions
- Bariatric Surgery, Sleeve Gastrectomy, Obesity
- Keywords
- Diet, Dietary Habits, Weight changes
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 7 Dec 2021 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 29 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to test how dietary habit interventions affect patients weight loss outcomes after bariatric surgery.
Detailed 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Behavioral: Dietary habits planSubject 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. |
| Group B | Experimental | Behavioral: Dietary habits planSubject 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. |
Who may qualify
- Ages
- 22 to 62 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Bariatric surgery (sleeve gastrectomy) patients
Key exclusion criteria (7 listed)
- Insulin-dependent diabetes
- Anemia
- Smoking
- Shift work within the past 1 year
- Drug or alcohol dependency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary habits planPatients will be given a personalized plan regarding their diet. | Behavioural | Group A, Group B |
Primary outcome
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
3 secondary outcomes
Change in caloric intake
Time frame: baseline and 4 weeks (post-intervention)
Change in energy expenditure
Time frame: baseline and 4 weeks (post-intervention)
Change in glucose tolerance
Time frame: baseline and 4 weeks (post-intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Scheer, PhD principal investigator
Brigham and Women's Hospital
Ali Tavakkoli, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary habits plan in people with Bariatric Surgery and Sleeve Gastrectomy, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-intervention change in self-rated hunger (time frame: Baseline and 4 weeks (post-intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.