NCT00487344

Brief 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. 1.FREE Nutritional Services will be provided to eligible participants, which normally have a business value of between $165.00 and $195.00.
  2. 2.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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for phase_1 obesity

Timeline
Completed

Started Jun 2007

Shorter than P25 for phase_1 obesity

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

June 15, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 18, 2007

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

July 3, 2007

Status Verified

May 1, 2007

First QC Date

June 15, 2007

Last Update Submit

July 2, 2007

Conditions

Keywords

medicaidinsuranceeducationclinicaltrialhealthcarereimbursepayfreeassiststudyoklahomaedmondOklahoma Citydietnutritionweight lossbodyfatobeseoverweighthealthmedicaltherapymeal planjenny craigweight watcherLA WeightlossBryan AtteberyResultsYMCAUCOOSUOUclinicsphysicianssurgerypillsfinancialmoney

Outcome Measures

Primary Outcomes (1)

  • Pre and Post-Bioelectrical Impedance Body Fat Analysis

    2 months

Interventions

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central FITT Inc

Edmond, Oklahoma, 73013, United States

RECRUITING

MeSH Terms

Conditions

ObesityHelping BehaviorWeight LossPlatelet Glycoprotein IV DeficiencyOverweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsSocial BehaviorBehaviorBody Weight Changes

Study Officials

  • Judith Brooks, Phd

    Eastern Michigan University CHHS Thesis Committee

    STUDY CHAIR
  • Anahita Mistry, PhD

    Eastern Michigan University-CHHS Thesis Committee

    STUDY CHAIR

Central Study Contacts

Stacy D Buzan, MS

CONTACT

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 15, 2007

First Posted

June 18, 2007

Study Start

June 1, 2007

Study Completion

November 1, 2007

Last Updated

July 3, 2007

Record last verified: 2007-05

Locations