ObesityNCT00200239
Provision of Breakfast Food in Behavioral Weight Loss
A study testing Eating breakfast with portion and unportioned foods in people with Obesity, run by The Miriam Hospital at 1 site in United States.
Trial summary
A contributing factor to the rising prevalence of obesity may be increased portion sizes. However, the effect of portion size has not been studied independent of the effect of quantity of food in the context of a behavioral weight loss program. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Eating breakfast with portion and unportioned foods
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Jul 2006
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 21 and 65 years. Older adults may have more medical co-morbidities and may require greater medical supervision.
- Body mass index (BMI) between 25 and 40 kg/m2. Based upon the Evidence Report (National Heart, Lung, and Blood Institute [NHLBI], 1998), weight loss is recommended for individuals with a BMI > 25. However, individuals with a BMI of > 40 have more medical co-morbidities and require greater medical supervision.
- Average current consumption of breakfast on four days or fewer.
Who cannot join
- Report allergies to any of the foods provided in the treatment or report lactose intolerance due to the high lactose content of some of the foods provided.
- Report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q) (Thomas, Reading, \& Shephard, 1992). Individuals endorsing joint problems, prescription medication usage, or other medical conditions that could limit exercise will be required to obtain written physician consent to participate.
- Report major psychiatric diseases or organic brain syndromes.
- Are currently participating in a weight loss program and/or taking weight loss medication or lost > 5% of body weight during the past 6 months.
- Intend to move to another city within the time frame of the investigation or will be out of town and unavailable for meetings for more than one week during the treatment program.
- 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
The Weight Control and Diabetes Research Center
Providence, Rhode Island, 02903
About this study
A contributing factor to the rising prevalence of obesity may be increased portion sizes. However, the effect of portion size has not been studied independent of the effect of quantity of food in the context of a behavioral weight loss program. Providing pre-portioned single servings of food may make it easier to reduce caloric and dietary fat intake improving weight loss. In addition, breakfast skipping is associated with obesity and breakfast consumption is associated with weight loss success. Therefore, the objective of the proposed study is to investigate the effect of portion size on consumption of provided breakfast foods in the context of a behavioral weight loss program. Participants will be randomized to 1 of 2 standard 12-week behavioral obesity interventions. The first intervention, serving as a control, will provide participants with breakfast foods in non-portioned containers (Standard). A second intervention will provide participants with the same type and quantity of breakfast foods but they will be provided in pre-portioned single servings (Portion). Dependent variables include the number of calories consumed from the provided foods as well as overall caloric and fat consumption. If the provision of food in pre-portioned servings is effective at decreasing intake, future directions include conducting longer interventions to improve long-term weight loss outcomes in standard behavioral interventions.
- Conditions
- Obesity
- Being tested
- Eating breakfast with portion and unportioned foods
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eating breakfast with portion and unportioned foodsBehavioural
Behavioral: eating breakfast with portion and unportioned foods
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Behavioral: eating breakfast from portioned and unportioned foods Receives: Behavioral: Eating breakfast with portion and unportioned foods |
| 2 | Experimental | Behavioral: eating breakfast with portioned and unportioned foods Receives: Behavioral: Eating breakfast with portion and unportioned foods |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intake of breakfast foods
Measured: 8 weeks
Secondary outcomes (1)
Weight loss
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionJul 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hollie A Raynor, PhD, Principal investigator, University of Tennessee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00200239
- Sponsor's protocol ID
- 2047-05
- Status last verified
- Dec 2007
- First submitted
- 12 Sep 2005
- Last updated
- 20 Apr 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Provision of Breakfast Food in Behavioral Weight Loss
- ClinicalTrials.gov ID
- NCT00200239
- Acronym / sponsor ID
- 2047-05
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 20 Sep 2005 (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.
A contributing factor to the rising prevalence of obesity may be increased portion sizes. However, the effect of portion size has not been studied independent of the effect of quantity of food in the context of a behavioral weight loss program. Providing pre-portioned single servings of food may make it easier to reduce caloric and dietary fat intake improving weight loss. In addition, breakfast skipping is associated with obesity and breakfast consumption is associated with weight loss success. Therefore, the objective of the proposed study is to investigate the effect of portion size on consumption of provided breakfast foods in the context of a behavioral weight loss program. Participants will be randomized to 1 of 2 standard 12-week behavioral obesity interventions. The first intervention, serving as a control, will provide participants with breakfast foods in non-portioned containers (Standard). A second intervention will provide participants with the same type and quantity of breakfast foods but they will be provided in pre-portioned single servings (Portion). Dependent variables include the number of calories consumed from the provided foods as well as overall caloric and fat consumption. If the provision of food in pre-portioned servings is effective at decreasing intake, future directions include conducting longer interventions to improve long-term weight loss outcomes in standard behavioral interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Eating breakfast with portion and unportioned foodsBehavioral: eating breakfast from portioned and unportioned foods |
| 2 | Experimental | Behavioral: Eating breakfast with portion and unportioned foodsBehavioral: eating breakfast with portioned and unportioned foods |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 21 and 65 years. Older adults may have more medical co-morbidities and may require greater medical supervision.
- Body mass index (BMI) between 25 and 40 kg/m2. Based upon the Evidence Report (National Heart, Lung, and Blood Institute [NHLBI], 1998), weight loss is recommended for individuals with a BMI > 25. However, individuals with a BMI of > 40 have more medical co-morbidities and require greater medical supervision.
- Average current consumption of breakfast on four days or fewer.
Key exclusion criteria (6 listed)
- Report allergies to any of the foods provided in the treatment or report lactose intolerance due to the high lactose content of some of the foods provided.
- Report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q) (Thomas, Reading, \& Shephard, 1992). Individuals endorsing joint problems, prescription medication usage, or other medical conditions that could limit exercise will be required to obtain written physician consent to participate.
- Report major psychiatric diseases or organic brain syndromes.
- Are currently participating in a weight loss program and/or taking weight loss medication or lost > 5% of body weight during the past 6 months.
- Intend to move to another city within the time frame of the investigation or will be out of town and unavailable for meetings for more than one week during the treatment program.
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 |
|---|---|---|
| Eating breakfast with portion and unportioned foodsBehavioral: eating breakfast with portion and unportioned foods | Behavioural | 1, 2 |
Primary outcome
Intake of breakfast foods
Time frame: 8 weeks
1 secondary outcome
Weight loss
Time frame: 8 weeks
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 20 Apr 2012.
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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 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?
A study testing Eating breakfast with portion and unportioned foods in people with Obesity, run by The Miriam Hospital 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 3 inclusion and 6 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 20 Apr 2012. 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?
Intake of breakfast foods (time frame: 8 weeks). 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 20 Apr 2012.