ObeseNCT01399177
Influence of Changes in Food Group Variety on Food Cravings, Energy Intake, and Weight Loss After Bariatric Surgery
An observational study of Obese, run by The University of Tennessee, Knoxville at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obese
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Bariatric Surgery Patients associated with the University of Tennessee Medical Center
Who may be able to join
- Age between 18 and 65 years
- Bariatric surgery occurring within 3-6 months
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Healthy Eating and Activity Laboratory
Knoxville, Tennessee, 37996
About this study
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.
Read the 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])
- changes in dietary variety from pre- to post-bariatric surgery at 3, 6, and 12-months
- changes in variety of high-energy-dense foods and changes in cravings of high-energy-dense foods at 3, 6, and 12 months and
- 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.
- Conditions
- Obese
- Medical subject headings
- Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
Diet
Measured: 0, 3, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2011 (estimated)
- Study startJun 2011
- Primary completion31 Dec 2018
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObeseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Tennessee, Knoxville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hollie Raynor, The University of Tennessee, Knoxville
- Investigators
- Hollie A Raynor, PhD, RD, PDN, Principal investigator, University of Tennessee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01399177
- Sponsor's protocol ID
- 3177
- Status last verified
- Jun 2026
- First submitted
- 19 Jul 2011
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Changes in Food Group Variety on Food Cravings, Energy Intake, and Weight Loss After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT01399177
- Acronym / sponsor ID
- 3177
- Conditions
- Obese
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- The University of Tennessee, KnoxvilleUniversity, hospital or other
- Study start
- Jun 2011 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 21 Jul 2011 (estimated)
- 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 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.
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])
- changes in dietary variety from pre- to post-bariatric surgery at 3, 6, and 12-months
- changes in variety of high-energy-dense foods and changes in cravings of high-energy-dense foods at 3, 6, and 12 months and
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Bariatric Surgery Patients associated with the University of Tennessee Medical Center
Key inclusion criteria (2 listed)
- Age between 18 and 65 years
- Bariatric surgery occurring within 3-6 months
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diet
Time frame: 0, 3, 6, and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- This is the website for the Healthy Eating and Activity Laboratory (HEAL), where this program is being conducted.)Link provided by the sponsor.
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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.
Hollie A Raynor, PhD, RD, PDN principal investigator
University of Tennessee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obese, run by The University of Tennessee, Knoxville 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 9 Jun 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Diet (time frame: 0, 3, 6, and 12 months). 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 9 Jun 2026.