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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 : May 8, 2020
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Frank AJL Scheer, PhD, Brigham and Women's Hospital

Tracking Information
First Submitted Date  ICMJE March 12, 2018
First Posted Date  ICMJE March 29, 2018
Last Update Posted Date May 8, 2020
Actual Study Start Date  ICMJE January 1, 2019
Estimated Primary Completion Date May 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2018)
  • change in caloric intake [ Time Frame: baseline and 12 weeks post-intervention ]
    Difference in caloric intake from baseline to post-intervention
  • change in energy expenditure [ Time Frame: baseline and 12 weeks post-intervention ]
    resting and postprandial energy expenditure measured by indirect calorimetry
  • change in glucose tolerance [ Time Frame: baseline and 12 weeks post-intervention ]
    glucose response to mixed meal test
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Role of Dietary Habits in Efficacy of Bariatric Surgery - Study C
Official Title  ICMJE Role of Dietary Habits in Efficacy of Bariatric Surgery - Study C
Brief Summary The purpose of the study is to test how dietary habit interventions affect patients with poor 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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Condition  ICMJE
  • Bariatric Surgery
  • Sleeve Gastrectomy
  • Obesity
Intervention  ICMJE Behavioral: Dietary habits plan
Patients will be given a personalized plan regarding their diet.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Dietary habits plan
  • 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.
    Intervention: Behavioral: Dietary habits plan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 28, 2018)
44
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2022
Estimated Primary Completion Date May 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Diabetes
  • Anemia
  • Smoking
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years to 61 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Courtney O'Keefe 617-525-7032 cokeefe1@bwh.harvard.edu
Contact: Ivy Mason, PhD 617-732-6256 imason@bwh.harvard.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03482986
Other Study ID Numbers  ICMJE 2017P002526C
R01HL140574 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Frank AJL Scheer, PhD, Brigham and Women's Hospital
Study Sponsor  ICMJE Brigham and Women's Hospital
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Frank Scheer, PhD Brigham and Women's Hospital
Principal Investigator: Ali Tavakkoli, MD Brigham and Women's Hospital
PRS Account Brigham and Women's Hospital
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP