ObesityPhase 1NCT00487344
Research Study of Nutritional Methods to Reduce Body Fat Percentages in Overweight and Obese Populations
A Phase 1 study testing Non-Personalized Meal Planning and Personalized Meal Planning and Dietetic Consultation in people with Obesity, run by Central FITT, Inc at 1 site in United States.
Trial summary
The purpose of this study is to compare the use of personalized low-fat meal plans vs. non-personalized low-fat meal plans and the results in body fat reduction in overweight and obese subjects 25 to 45 years of age. Compensation to Eligible Participants: 1. Read more about this study
- Who is it for?
- Ages 25 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Non-Personalized Meal Planning and Personalized Meal Planning and Dietetic Consultation
- Type of treatment
- Surgery or procedure
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Nov 2007
- Phase
- Phase 1
- 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 25 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between 25 to 45 years of age
- Classified as overweight or obese with body mass index (BMI) measurement between 25 and 50
- Limited to minor chronic health
Who cannot join
- Individuals with the following health conditions:
- Food allergies
- Food intolerances
- Cancer
- Debilitating joint conditions such as Degenerative Joint Disease (DJD) and Degenerative Disk Disease (DDD)
- Diabetes Mellitus receiving insulin therapy
Show all 15Show fewer
- Kidney problems
- Menopause
- Polycystic ovarian syndrome (PCOS)
- Currently pregnant or breast feeding
- Using diuretics, chromium, and/or diet pills
- Participants must:
- Live in the following Oklahoma Counties:
- Canadian, Cleveland, Logan, Lincoln, Oklahoma, and Pottawatomie
- Will to travel to Edmond and Oklahoma City, Oklahoma
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Central FITT Inc
Edmond, Oklahoma, 73013
Stacy D Buzan, MS, 405-503-2759, oktrial@yahoo.com
Michael J Buzan, BS, 405-503-2758, centralfitt@sbcglobal.net
About this study
Official title: Comparison of Body Fat Reduction in Overweight and Obese Subjects Utilizing Personalized Low-Fat Meal Plans vs. Non-Personalized Low-Fat Meal Plans.
The purpose of this study is to compare the use of personalized low-fat meal plans vs. non-personalized low-fat meal plans and the results in body fat reduction in overweight and obese subjects 25 to 45 years of age.
Compensation to Eligible Participants:
- FREE Nutritional Services will be provided to eligible participants, which normally have a business value of between $165.00 and $195.00.
- Each eligible participant will receive compensation for mileage directly related to this study up to 35 miles at the 2007 IRS Business Mileage Reimbursement Rate for medical purposes of $0.20 per mile. This compensation will be provided to each eligible participant in the form of a complimentary Wal-mart Gift Card in the amount of $7.00, contingent upon his or her completion in the study.
Read the detailed description
Study Rationale: This experiment on the effect that the use of personalized low-fat meal plans has on body fat reduction is important for several reasons. First, the details of this research study may equip the public with knowledge to select quality nutrition programs for weight loss responsibly. Second, it may encourage the wellness and fitness community to reconsider the practice of providing clientele with non-personalized meal plans for weight loss, which are not usually designed by accredited dietetic professionals. Third, this study may benefit dietetic professionals by opening the lines of communication between the wellness community and the dietetic community regarding standards of care, and protecting the public by dispelling harmful and erroneous nutrition advice.
- Conditions
- Obesity
- Being tested
- Non-Personalized Meal Planning, Personalized Meal Planning and Dietetic Consultation
- Keywords
- medicaid, insurance, education, clinical, trial, healthcare, reimburse, pay, free, assist, study, oklahoma, edmond, Oklahoma City, diet, nutrition, weight loss, body, fat, obese
- Medical subject headings
- Obesity, Helping Behavior, Weight Loss, Platelet Glycoprotein IV Deficiency, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Personalized Meal PlanningProcedure or surgery
Personalized Meal Planning and Dietetic ConsultationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre and Post-Bioelectrical Impedance Body Fat Analysis
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2007 (estimated)
- Study startJun 2007
- Study completionNov 2007 (estimated)
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 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central FITT, Inc
- Sponsor type
- University, hospital or other
- Investigators
- Judith Brooks, Phd, Study chair, Eastern Michigan University CHHS Thesis CommitteeAnahita Mistry, PhD, Study chair, Eastern Michigan University-CHHS Thesis Committee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00487344
- Sponsor's protocol ID
- CF-01-D-0001
- Status last verified
- May 2007
- First submitted
- 15 Jun 2007
- Last updated
- 3 Jul 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Body Fat Reduction in Overweight and Obese Subjects Utilizing Personalized Low-Fat Meal Plans vs. Non-Personalized Low-Fat Meal Plans.
- ClinicalTrials.gov ID
- NCT00487344
- Acronym / sponsor ID
- CF-01-D-0001
- Conditions
- Obesity
- Keywords
- medicaid, insurance, education, clinical, trial, healthcare, reimburse, pay
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Central FITT, IncUniversity, hospital or other
- Study start
- Jun 2007
- Study completion
- Nov 2007 (estimated)
- First posted
- 18 Jun 2007 (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 compare the use of personalized low-fat meal plans vs. non-personalized low-fat meal plans and the results in body fat reduction in overweight and obese subjects 25 to 45 years of age.
Compensation to Eligible Participants:
- FREE Nutritional Services will be provided to eligible participants, which normally have a business value of between $165.00 and $195.00.
- Each eligible participant will receive compensation for mileage directly related to this study up to 35 miles at the 2007 IRS Business Mileage Reimbursement Rate for medical purposes of $0.20 per mile. This compensation will be provided to each eligible participant in the form of a complimentary Wal-mart Gift Card in the amount of $7.00, contingent upon his or her completion in the study.
Detailed description
Study Rationale: This experiment on the effect that the use of personalized low-fat meal plans has on body fat reduction is important for several reasons. First, the details of this research study may equip the public with knowledge to select quality nutrition programs for weight loss responsibly. Second, it may encourage the wellness and fitness community to reconsider the practice of providing clientele with non-personalized meal plans for weight loss, which are not usually designed by accredited dietetic professionals. Third, this study may benefit dietetic professionals by opening the lines of communication between the wellness community and the dietetic community regarding standards of care, and protecting the public by dispelling harmful and erroneous nutrition advice.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Between 25 to 45 years of age
- Classified as overweight or obese with body mass index (BMI) measurement between 25 and 50
- Limited to minor chronic health
Key exclusion criteria (15 listed)
- Individuals with the following health conditions:
- Food allergies
- Food intolerances
- Cancer
- Debilitating joint conditions such as Degenerative Joint Disease (DJD) and Degenerative Disk Disease (DDD)
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 |
|---|---|---|
| Non-Personalized Meal Planning | Procedure or surgery | – |
| Personalized Meal Planning and Dietetic Consultation | Procedure or surgery | – |
Primary outcome
Pre and Post-Bioelectrical Impedance Body Fat Analysis
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2007.
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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.
Judith Brooks, Phd study chair
Eastern Michigan University CHHS Thesis Committee
Anahita Mistry, PhD study chair
Eastern Michigan University-CHHS Thesis Committee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Non-Personalized Meal Planning and Personalized Meal Planning and Dietetic Consultation in people with Obesity, run by Central FITT, Inc 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 15 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: status not confirmed, as of the sponsor's last update on 3 Jul 2007. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stacy D Buzan, MS (405-503-2759, oktrial@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre and Post-Bioelectrical Impedance Body Fat Analysis (time frame: 2 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 3 Jul 2007.