Overweight and ObesityUHPAWSNCT00544245
Is Monitoring Activity Important for Short- and Long-term Weight Loss?
A study testing Self monitoring of estimated energy balance in people with Overweight and Obesity, run by University of Hawaii at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Self monitoring of estimated energy balance
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Sep 2010
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Desire to lose weight
- Height: 60-76 inches
- BMI 27-40
- Healthy
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Univ of Hawaii Dept of Human Nutrition, Food & Animal Sci
Honolulu, Hawaii, 96822
About this study
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.
Read the 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).
- Conditions
- Overweight and Obesity
- Being tested
- Self monitoring of estimated energy balance
- Keywords
- overweight, obesity, accelerometer, pedometer, energy balance, weight loss, weight maintenance
- Medical subject headings
- Overweight, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self monitoring of estimated energy balanceBehavioural
Participant estimation of energy intake and energy expenditure
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in measures of body weight, body circumferences, and estimated body composition
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hawaii
- Sponsor type
- University, hospital or other
- Collaborators
- The Apex Fitness Group, Bookman Publishing Company
- Investigators
- Charles A Titchenal, PhD, Principal investigator, Human Nutrition, Food & Animal Sci / Univ of HawaiiJoannie C Dobbs, PhD, Principal investigator, Human Nutrition, Food & Animal Sci / Univ of Hawaii
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00544245
- Sponsor's protocol ID
- 437846
- Acronym
- UHPAWS
- Status last verified
- Aug 2011
- First submitted
- 12 Oct 2007
- Last updated
- 16 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Monitoring Activity Important for Short- and Long-term Weight Loss?
- ClinicalTrials.gov ID
- NCT00544245
- Acronym / sponsor ID
- UHPAWS / 437846
- Conditions
- Overweight and Obesity
- Keywords
- overweight, obesity, accelerometer, pedometer, energy balance, weight loss, weight maintenance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- University of HawaiiUniversity, hospital or other
- Collaborators
- The Apex Fitness Group, Bookman Publishing Company
- Study start
- Oct 2007
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 16 Oct 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.
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.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Desire to lose weight
- Height: 60-76 inches
- BMI 27-40
- Healthy
Key exclusion criteria (14 listed)
- 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
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 |
|---|---|---|
| Self monitoring of estimated energy balanceParticipant estimation of energy intake and energy expenditure | Behavioural | – |
Primary outcome
Change in measures of body weight, body circumferences, and estimated body composition
Time frame: 2 years
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 16 Aug 2011.
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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.
Charles A Titchenal, PhD principal investigator
Human Nutrition, Food & Animal Sci / Univ of Hawaii
Joannie C Dobbs, PhD principal investigator
Human Nutrition, Food & Animal Sci / Univ of Hawaii
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self monitoring of estimated energy balance in people with Overweight and Obesity, run by University of Hawaii 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 4 inclusion and 14 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 16 Aug 2011. 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?
Change in measures of body weight, body circumferences, and estimated body composition (time frame: 2 years). 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 16 Aug 2011.