ObesityNCT00837694
Snack Food Reinforcement in Obese and Non-obese Women
An observational study of Obesity, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
Food reinforcement, motivation to obtain food, is associated with energy intake and obesity. Finding ways to decrease the reinforcing value of unhealthy foods may help with adherence to diets and weight loss. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Jun 2008
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women ages 18 - 50 years who were obese (body mass index >/= 30) or non-obese (BMI < 30)
Who may be able to join
- women
- non-smoker
- not on a diet
- no restrained eating
- had to like potential snack foods
- willing to visit the laboratory 3 times
Show all 9Show fewer
- willing to eat snacks provided
- no medications or medical conditions that affect appetite
- no food allergies
Who cannot join
- see above
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Differential Effects of Daily Snack Food Intake on Reinforcing Value of Food in Obese and Non-obese Women.
Food reinforcement, motivation to obtain food, is associated with energy intake and obesity. Finding ways to decrease the reinforcing value of unhealthy foods may help with adherence to diets and weight loss. Our previous study in non-obese adults showed that daily consumption of the same snack food (food typically consumed outside of meals) for 14 days significantly decreased its reinforcing value. The purpose of this study was to replicate and extend these findings to obese individuals as well as to examine effects of different portion sizes of snack foods on food reinforcement. Thirty-one obese (body mass index > 30 kg/m2) and 27 non-obese (BMI < 30 kg/m2) women had food reinforcement and liking tested at baseline and after two weeks of daily consumption of either 0 kcal, 100 kcals, or 300 kcals daily of the same snack food.
- Conditions
- Obesity
- Keywords
- BMI, obesity, sensitization, food reinforcement, snack food, Portion size of daily snacks, Weight status
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Non-obese/0 kcal | |
| 2 | Non-obese/100 kcal | |
| 3 | Non-obese/300 kcal | |
| 4 | Obese/0 kcal | |
| 5 | Obese/100 kcal | |
| 6 | Obese/300 kcal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Responses Made by Clicking a Mouse Button for Food
Participants were asked to click a button on a computer mouse and after a certaion number of responses, participants would receive a point. After 5 points, the participants received a portion of snack food.
Measured: During 2nd and 3rd visits
Energy Intake
energy contained in eaten foods and beverages
Measured: visits 1, 2, and 3 plus on the phone throughout the study.
Secondary outcomes (2)
Body Weight
body weight
Measured: visit 1 and visit 3
Height
height
Measured: visits 1 and 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2009 (estimated)
- Study startMay 2007
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Temple, State University of New York at Buffalo
- Investigators
- Jennifer L Temple, Ph.D., Principal investigator, University at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00837694
- Sponsor's protocol ID
- Temple1
- Status last verified
- Jun 2019
- First submitted
- 3 Feb 2009
- Last updated
- 1 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Temple JL, Bulkley AM, Badawy RL, Krause N, McCann S, Epstein LH. Differential effects of daily snack food intake on the reinforcing value of food in obese and nonobese women. Am J Clin Nutr. 2009 Aug;90(2):304-13. doi: 10.3945/ajcn.2008.27283. Epub 2009 May 20.
PubMed 19458018
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differential Effects of Daily Snack Food Intake on Reinforcing Value of Food in Obese and Non-obese Women.
- ClinicalTrials.gov ID
- NCT00837694
- Acronym / sponsor ID
- Temple1
- Conditions
- Obesity
- Keywords
- BMI, obesity, sensitization, food reinforcement, snack food, Portion size of daily snacks, Weight status
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 5 Feb 2009 (estimated)
- Results
- Posted 1 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Food reinforcement, motivation to obtain food, is associated with energy intake and obesity. Finding ways to decrease the reinforcing value of unhealthy foods may help with adherence to diets and weight loss. Our previous study in non-obese adults showed that daily consumption of the same snack food (food typically consumed outside of meals) for 14 days significantly decreased its reinforcing value. The purpose of this study was to replicate and extend these findings to obese individuals as well as to examine effects of different portion sizes of snack foods on food reinforcement. Thirty-one obese (body mass index > 30 kg/m2) and 27 non-obese (BMI < 30 kg/m2) women had food reinforcement and liking tested at baseline and after two weeks of daily consumption of either 0 kcal, 100 kcals, or 300 kcals daily of the same snack food.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Non-obese/0 kcal |
| 2 | – | –Non-obese/100 kcal |
| 3 | – | –Non-obese/300 kcal |
| 4 | – | –Obese/0 kcal |
| 5 | – | –Obese/100 kcal |
| 6 | – | –Obese/300 kcal |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women ages 18 - 50 years who were obese (body mass index >/= 30) or non-obese (BMI < 30)
Key inclusion criteria (9 listed)
- women
- non-smoker
- not on a diet
- no restrained eating
- had to like potential snack foods
Key exclusion criteria (1 listed)
- see above
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
Number of Responses Made by Clicking a Mouse Button for Food
Time frame: During 2nd and 3rd visits
Participants were asked to click a button on a computer mouse and after a certaion number of responses, participants would receive a point. After 5 points, the participants received a portion of snack food.
Energy Intake
Time frame: visits 1, 2, and 3 plus on the phone throughout the study.
energy contained in eaten foods and beverages
2 secondary outcomes
Body Weight
Time frame: visit 1 and visit 3
Height
Time frame: visits 1 and 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 19458018Temple JL, Bulkley AM, Badawy RL, Krause N, McCann S, Epstein LH. Differential effects of daily snack food intake on the reinforcing value of food in obese and nonobese women. Am J Clin Nutr. 2009 Aug;90(2):304-13. doi: 10.3945/ajcn.2008.27283. Epub 2009 May 20.
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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.
Jennifer L Temple, Ph.D. principal investigator
University at Buffalo
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 Obesity, run by State University of New York at Buffalo 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 9 inclusion and 1 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 1 Aug 2019. 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?
Yes. Results are posted in the registry (first posted 1 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Responses Made by Clicking a Mouse Button for Food (time frame: During 2nd and 3rd visits). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00837694, which also lists 1 linked publication.
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 1 Aug 2019.