Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03482986
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : February 6, 2020
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Frank AJL Scheer, PhD, Brigham and Women's Hospital

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

Condition or disease Intervention/treatment Phase
Bariatric Surgery Sleeve Gastrectomy Obesity Behavioral: Dietary habits plan Not Applicable

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 with poor 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Role of Dietary Habits in Efficacy of Bariatric Surgery - Study C
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group A
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
Patients will be given a personalized plan regarding their diet.

Experimental: Group B
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.




Primary Outcome Measures :
  1. Post-intervention change in self-rated hunger [ Time Frame: baseline and 12 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


Secondary Outcome Measures :
  1. change in caloric intake [ Time Frame: baseline and 12 weeks post-intervention ]
    Difference in caloric intake from baseline to post-intervention

  2. change in energy expenditure [ Time Frame: baseline and 12 weeks post-intervention ]
    resting and postprandial energy expenditure measured by indirect calorimetry

  3. change in glucose tolerance [ Time Frame: baseline and 12 weeks post-intervention ]
    glucose response to mixed meal test



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   22 Years to 56 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Bariatric surgery (sleeve gastrectomy) patients
  • Pre-surgery BMI of 35-55 kg/m^2

Exclusion Criteria:

  • Diabetes
  • Anemia
  • Smoking
  • Use of more than 1 anti-hypertensive drug or beta-blockers
  • Shift work within the past 1 year
  • History of psychiatric illnesses or psychiatric disorders
  • Obstructive sleep apnea or prescribed continuous positive air pressure
  • Drug or alcohol dependency

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03482986


Contacts
Layout table for location contacts
Contact: Courtney O'Keefe 617-525-7032 cokeefe1@bwh.harvard.edu
Contact: Ivy Mason, PhD 617-732-6256 imason@bwh.harvard.edu

Locations
Layout table for location information
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Courtney O'Keefe    617-525-7032    cokeefe1@bwh.harvard.edu   
Contact: Ivy Mason, PhD    617-732-6256    imason@bwh.harvard.edu   
Principal Investigator: Frank Scheer, PhD         
Principal Investigator: Ali Tavakkoli, MD         
Sponsors and Collaborators
Brigham and Women's Hospital
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Layout table for investigator information
Principal Investigator: Frank Scheer, PhD Brigham and Women's Hospital
Principal Investigator: Ali Tavakkoli, MD Brigham and Women's Hospital

Layout table for additonal information
Responsible Party: Frank AJL Scheer, PhD, Associate Professor of Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT03482986    
Other Study ID Numbers: 2017P002526C
R01HL140574 ( U.S. NIH Grant/Contract )
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: February 6, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Frank AJL Scheer, PhD, Brigham and Women's Hospital:
Diet
Dietary Habits
Weight changes