- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00544245
Is Monitoring Activity Important for Short- and Long-term Weight Loss? (UHPAWS)
August 14, 2011 updated by: University of Hawaii
This study is comparing the effectiveness of two techniques for monitoring physical activity and energy balance on long-term weight management (two years).
The focus is on weight loss, prevention of weight gain, and the maintenance of a healthy weight over time.
It is expected that both techniques will benefit long-term weight management.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The major objective of this study is to determine if two techniques for monitoring physical activity and energy balance promote the maintenance of weight loss in healthy overweight and obese individuals.
The study compares two approaches designed to help individuals monitor physical activity and to adjust their calorie intake to maintain a reasonable energy balance (bodybugg® & Step Diet Book systems).
Full subject participation in the study spans two years.
Participants periodically report to a pre-arranged location to be measured by a qualified fitness professional for height, weight, circumferences, and estimated body fat using a bioelectric impedance scale (body fat scale).
Study Type
Interventional
Enrollment (Actual)
83
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hawaii
-
Honolulu, Hawaii, United States, 96822
- Univ of Hawaii Dept of Human Nutrition, Food & Animal Sci
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Desire to lose weight
- Height: 60-76 inches
- BMI 27-40
- Healthy
Exclusion Criteria:
- Currently enrolled in a weight loss program
- Currently under medical care for obesity treatment
- Using drug, supplement, or similar treatment to promote weight loss
- Have undergone bariatric surgery or have breast implants
- Intend to have surgery within the next 24 months
- Have had an eating disorder
- Are pregnant, breast-feeding, or plan to become pregnant within 24 months
- Are planning an extended vacation, absence, or relocation within 24 months
- Use tobacco products
- Frequently consume 2 or more alcoholic drinks per day
- Use illegal drugs, steroids, or growth hormone
- Use any appetite-affecting medications
- Are eating a physician-supervised diet
- Have other problems that might interfere with ability to participate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in measures of body weight, body circumferences, and estimated body composition
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Charles A Titchenal, PhD, Human Nutrition, Food & Animal Sci / Univ of Hawaii
- Principal Investigator: Joannie C Dobbs, PhD, Human Nutrition, Food & Animal Sci / Univ of Hawaii
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2007
Primary Completion (Actual)
September 1, 2010
Study Completion (Actual)
September 1, 2010
Study Registration Dates
First Submitted
October 12, 2007
First Submitted That Met QC Criteria
October 12, 2007
First Posted (Estimate)
October 16, 2007
Study Record Updates
Last Update Posted (Estimate)
August 16, 2011
Last Update Submitted That Met QC Criteria
August 14, 2011
Last Verified
August 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 437846
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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