We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

Influence of Changes in Food Group Variety on Food Cravings, Energy Intake, and Weight Loss After Bariatric Surgery

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01399177
Recruitment Status : Active, not recruiting
First Posted : July 21, 2011
Last Update Posted : July 17, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to find out if there is any change in diet on food cravings and weight loss in the 12 months following bariatric surgery.

Condition or disease

Detailed Description:

Research suggests that satiation processes in obese patients may be impaired, possibly resulting in excessive energy intake and poorer weight loss outcomes. One factor that may contribute to disruption of satiation processes and related overconsumption is dietary variety. Additionally, food cravings for restricted foods are believed to contribute to poor compliance to diets, and in controlled feeding studies, food cravings are the most frequently provided reason for poor dietary adherence. Interestingly, several investigations have found that cravings decrease when individuals follow a very-low-calorie or monotonous diet (9-11). Thus, reductions in the variety of the diet may also reduce food cravings, and assist in dietary adherence. It is also possible that the type of surgical procedure performed may influence changes in dietary variety, and consequently food cravings. To date, few studies have analyzed bariatric surgery patients' selection of foods within specific food groups and no study has examined the variety of foods consumed within food groups. Changes in food group variety which facilitate improvements in regulation of energy intake and body weight among obese individuals after behavioral weight loss may have a similar impact in patients who undergo bariatric surgery. Additionally, no studies have examined the relationship between changes in dietary variety and food cravings, and how these factors may be related to weight loss outcomes in any population.

Primary Objectives:

To examine by surgery type(Roux-En-Y gastric bypass [RYGB], laparoscopic adjustable gastric banding [LAGB], vertical sleeve gastrectomy [VSG])

  1. changes in dietary variety from pre- to post-bariatric surgery at 3, 6, and 12-months
  2. changes in variety of high-energy-dense foods and changes in cravings of high-energy-dense foods at 3, 6, and 12 months and
  3. changes in variety of high-energy-dense and low-energy-dense foods and changes in energy intake and weight loss at 3, 6, and 12 months.

Study Design

Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Influence of Changes in Food Group Variety on Food Cravings, Energy Intake, and Weight Loss After Bariatric Surgery
Actual Study Start Date : June 2011
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. Diet [ Time Frame: 0, 3, 6, and 12 months ]

Eligibility Criteria

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.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Bariatric Surgery Patients associated with the University of Tennessee Medical Center

Inclusion Criteria:

  • Age between 18 and 65 years
  • Bariatric surgery occurring within 3-6 months

Exclusion Criteria:

  • Intend to move outside of the metropolitan area within the time frame of the investigation.
  • Are pregnant, lactating, less than 6 months post-partum, or plan to become pregnant during the time frame of the investigation.
Contacts and Locations

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): NCT01399177

United States, Tennessee
Healthy Eating and Activity Laboratory
Knoxville, Tennessee, United States, 37996
Sponsors and Collaborators
University of Tennessee
Principal Investigator: Hollie A Raynor, PhD, RD, PDN University of Tennessee
More Information

Additional Information:
Responsible Party: Hollie Raynor, Professor, University of Tennessee
ClinicalTrials.gov Identifier: NCT01399177     History of Changes
Other Study ID Numbers: 3177
First Posted: July 21, 2011    Key Record Dates
Last Update Posted: July 17, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms