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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of Tennessee
Sponsor:
Information provided by (Responsible Party):
University of Tennessee
ClinicalTrials.gov Identifier:
NCT01399177
First received: July 19, 2011
Last updated: July 24, 2014
Last verified: July 2014
  Purpose

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
Obese

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Tennessee:

Primary Outcome Measures:
  • Diet [ Time Frame: 0, 3, 6, and 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: June 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Bariatric Surgery Patients associated with the University of Tennessee Medical Center

Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01399177

Contacts
Contact: Hollie A Raynor, PhD, RD, LDN 865-974-6259 hraynor@utk.edu

Locations
United States, Tennessee
Healthy Eating and Activity Laboratory Recruiting
Knoxville, Tennessee, United States
Contact: Hollie A Raynor, PhD, RD, LDN    865-974-6259    hraynor@utk.edu   
Sponsors and Collaborators
University of Tennessee
Investigators
Principal Investigator: Hollie A Raynor, PhD, RD, PDN University of Tennessee
  More Information

Additional Information:
No publications provided

Responsible Party: University of Tennessee
ClinicalTrials.gov Identifier: NCT01399177     History of Changes
Other Study ID Numbers: 3177
Study First Received: July 19, 2011
Last Updated: July 24, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 26, 2014