OverweightLEAPNCT00944099
Lifestyle, Eating, and Activity Patterns
A study testing Behavioral weight loss intervention in people with Overweight and Obesity, run by The University of Tennessee, Knoxville at 1 site in United States.
Trial summary
The purpose of this research is to test the effect of manipulating eating frequency on hunger and the reinforcing value of food in 50 overweight/obese adults participating in a 6-month behavioral weight loss intervention. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Behavioral weight loss intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Dec 2011
- Phase
- Interventional
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- body mass index (BMI) between 27 and 45 kg/m2
Who cannot join
- report a heart condition, chest pain during periods of activity or rest, or loss of consciousness
- report being unable to walk 1/4 mile without stopping
- report major psychological disease or organic brain syndromes
- report a diagnosis of type I or type II diabetes
- are currently participating in a weight loss program, are taking weight loss medication, have had surgery for weight loss, or have lost > 5% of their body weight in the past 6 months
- are currently participating in a program that manipulates their eating habits
Show all 9Show fewer
- intent to move outside of the East Tennessee area within the time frame of the intervention
- are pregnant, lactating, less than 6 months post-partum, or plan to become pregnant during the time frame of the intervention
- are unwilling to attend group intervention meetings, assessments, or complete a food diary for the duration of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Healthy Eating and Acitivty Laboratory, University of Tennessee
Knoxville, Tennessee, 37996-1920
About this study
Official title: Eating Frequency Prescription for a Behavioral Weigh Loss Intervention
The purpose of this research is to test the effect of manipulating eating frequency on hunger and the reinforcing value of food in 50 overweight/obese adults participating in a 6-month behavioral weight loss intervention.
Read the detailed description
Previous observational and experimental research suggests that increased eating frequency is related to lower weight, body mass index (BMI)and body fatness. It is proposed that eating frequently during the day reduces overall energy consumed by preventing the development of excessive hunger. As elevated hunger increases the reinforcing value of food, and greater intake occurs when the reinforcing value of food increases, eating frequently during the day may be a dietary strategy that can aid with reducing energy intake and improving weight loss during a behavioral weight control program. Therefore, the purpose of this proposed research is to test the effect of manipulating eating frequency on hunger and the reinforcing value of food in 50 overweight/obese adults participating in a 6-month behavioral weight loss intervention. Participants will be randomized to 1 of 2 conditions: 1) a condition in which participants will be given an eating frequency prescription to eat every 2 to 3 hours (Grazing); or 2) a condition in which participants will be given an eating frequency prescription of eating 3 meals per day (Three Meals). Both conditions will receive an identical dietary prescription, a low-calorie (1200 to 1500 kcals/d), low-fat (≤ 30% kcals from fat) diet and an identical physical activity goal of 200 minutes of moderate-intense physical activity per week. Additionally, both conditions will receive an identical state-of-the-art, 6-month, behavioral weight loss program.
- Conditions
- Overweight, Obesity
- Being tested
- Behavioral weight loss intervention
- Keywords
- intervention studies, feeding behavior, eating frequency, weight loss, dietary intake
- Medical subject headings
- Overweight, Obesity, Feeding Behavior, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral weight loss interventionBehavioural
both conditions will receive an identical dietary prescription, low-calorie and less than 30% calories from fat and an identical physical activity goal of 200 minutes of moderate-intense physical activity per week during a 6 month behavioral weight loss program
| Study group | Role | What they receive |
|---|---|---|
| Grazing | Experimental | participants will be given an eating frequency prescription to eat every 2 to 3 hours Receives: Behavioral: Behavioral weight loss intervention |
| Three Meals | Experimental | participants will be given an eating frequency prescription of eating 3 meals per day Receives: Behavioral: Behavioral weight loss intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
eating occasions per day
Measured: 0, 3, and 6 months
hunger and reinforcing value of food
Measured: 0, 3, and 6 months
Secondary outcomes (2)
energy and percent calories from fat intake
Measured: 0, 3, and 6 months
body weight, percent body fat, percent fat free mass
Measured: 0, 3, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2009 (estimated)
- Study startJan 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Tennessee, Knoxville
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Hollie Raynor, The University of Tennessee, Knoxville
- Investigators
- Jessica L Bachman, MS, MPH, RD, Principal investigator, University of TennesseeHollie A Raynor, PhD, RD, Study chair, University of Tennessee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00944099
- Sponsor's protocol ID
- AHA 09PRE2020150
- Acronym
- LEAP
- Status last verified
- Apr 2018
- First submitted
- 21 Jul 2009
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eating Frequency Prescription for a Behavioral Weigh Loss Intervention
- ClinicalTrials.gov ID
- NCT00944099
- Acronym / sponsor ID
- LEAP / AHA 09PRE2020150
- Conditions
- Overweight, Obesity
- Keywords
- intervention studies, feeding behavior, eating frequency, weight loss, dietary intake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- The University of Tennessee, KnoxvilleUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- Jan 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 23 Jul 2009 (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 research is to test the effect of manipulating eating frequency on hunger and the reinforcing value of food in 50 overweight/obese adults participating in a 6-month behavioral weight loss intervention.
Detailed description
Previous observational and experimental research suggests that increased eating frequency is related to lower weight, body mass index (BMI)and body fatness. It is proposed that eating frequently during the day reduces overall energy consumed by preventing the development of excessive hunger. As elevated hunger increases the reinforcing value of food, and greater intake occurs when the reinforcing value of food increases, eating frequently during the day may be a dietary strategy that can aid with reducing energy intake and improving weight loss during a behavioral weight control program. Therefore, the purpose of this proposed research is to test the effect of manipulating eating frequency on hunger and the reinforcing value of food in 50 overweight/obese adults participating in a 6-month behavioral weight loss intervention. Participants will be randomized to 1 of 2 conditions: 1) a condition in which participants will be given an eating frequency prescription to eat every 2 to 3 hours (Grazing); or 2) a condition in which participants will be given an eating frequency prescription of eating 3 meals per day (Three Meals). Both conditions will receive an identical dietary prescription, a low-calorie (1200 to 1500 kcals/d), low-fat (≤ 30% kcals from fat) diet and an identical physical activity goal of 200 minutes of moderate-intense physical activity per week. Additionally, both conditions will receive an identical state-of-the-art, 6-month, behavioral weight loss program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Grazing | Experimental | Behavioral: Behavioral weight loss interventionparticipants will be given an eating frequency prescription to eat every 2 to 3 hours |
| Three Meals | Experimental | Behavioral: Behavioral weight loss interventionparticipants will be given an eating frequency prescription of eating 3 meals per day |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- body mass index (BMI) between 27 and 45 kg/m2
Key exclusion criteria (9 listed)
- report a heart condition, chest pain during periods of activity or rest, or loss of consciousness
- report being unable to walk 1/4 mile without stopping
- report major psychological disease or organic brain syndromes
- report a diagnosis of type I or type II diabetes
- are currently participating in a weight loss program, are taking weight loss medication, have had surgery for weight loss, or have lost > 5% of their body weight in the past 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral weight loss interventionboth conditions will receive an identical dietary prescription, low-calorie and less than 30% calories from fat and an identical physical activity goal of 200 minutes of moderate-intense physical activity per week during a 6 month behavioral weight loss program | Behavioural | Grazing, Three Meals |
Primary outcome
eating occasions per day
Time frame: 0, 3, and 6 months
hunger and reinforcing value of food
Time frame: 0, 3, and 6 months
2 secondary outcomes
energy and percent calories from fat intake
Time frame: 0, 3, and 6 months
body weight, percent body fat, percent fat free mass
Time frame: 0, 3, and 6 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 5 Apr 2018.
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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.
Jessica L Bachman, MS, MPH, RD principal investigator
University of Tennessee
Hollie A Raynor, PhD, RD study chair
University of Tennessee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral weight loss intervention in people with Overweight and Obesity, 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 1 inclusion and 9 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 5 Apr 2018. 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?
eating occasions per day (time frame: 0, 3, and 6 months). 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?
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 5 Apr 2018.