ObesityNCT00011102
Prevention of Weight Gain
A study testing Weight Gain Prevention for Women Project in people with Obesity and Body Weight Changes, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
The purpose of this study is to test methods for preventing weight gain in normal-weight and overweight women aged 25 through 44. Participants will complete brief questionnaires about their health, eating and exercise habits, and use of weight control strategies. Read more about this study
- Who is it for?
- Ages 25 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Body Weight Changes
- What is being tested?
- Weight Gain Prevention for Women Project
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Feb 2001to Dec 2001
- 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 25 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index of 21 through 30
Who cannot join
- Presence of chronic disease that precludes regular physical activity or changes in dietary intake
- Currently receiving treatment for psychological disorder
- Currently pregnant or having given birth within last 12 months
- Use in last 3 months of weight loss medications or other drugs that affect body weight
- Participation in a weight loss program in last 12 months
- Planning to relocate outside the study area in the next 3 years
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Prevention of Weight Gain in Women Aged 25 Through 44
The purpose of this study is to test methods for preventing weight gain in normal-weight and overweight women aged 25 through 44. Participants will complete brief questionnaires about their health, eating and exercise habits, and use of weight control strategies. They will then be randomly assigned to 1 of 3 treatment conditions. All 3 treatments receive information on the importance of maintaining a healthy body weight, the components of a healthy diet, and ways to increase activity levels. The 3 treatment differ in how this information is delivered. At 12, 24 and 36 months after enrolling in the study, participants will attend assessment sessions. They will complete questionnaires and have body weight measured.
- Conditions
- Obesity, Body Weight Changes
- Being tested
- Weight Gain Prevention for Women Project
- Keywords
- weight gain
- Medical subject headings
- Obesity, Body Weight Changes, Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight Gain Prevention for Women ProjectBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2001 (estimated)
- Study startFeb 2001
- Study completionDec 2001
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.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00011102
- Sponsor's protocol ID
- Klem (completed)
- Other IDs
- DK53942
- Status last verified
- Jan 2010
- First submitted
- 9 Feb 2001
- Last updated
- 14 Jan 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Weight Gain in Women Aged 25 Through 44
- ClinicalTrials.gov ID
- NCT00011102
- Acronym / sponsor ID
- Klem (completed)
- Conditions
- Obesity, Body Weight Changes
- Keywords
- weight gain
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- Feb 2001
- Study completion
- Dec 2001
- First posted
- 9 Feb 2001 (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 test methods for preventing weight gain in normal-weight and overweight women aged 25 through 44. Participants will complete brief questionnaires about their health, eating and exercise habits, and use of weight control strategies. They will then be randomly assigned to 1 of 3 treatment conditions. All 3 treatments receive information on the importance of maintaining a healthy body weight, the components of a healthy diet, and ways to increase activity levels. The 3 treatment differ in how this information is delivered. At 12, 24 and 36 months after enrolling in the study, participants will attend assessment sessions. They will complete questionnaires and have body weight measured.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
Who may qualify
- Ages
- 25 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Body mass index of 21 through 30
Key exclusion criteria (6 listed)
- Presence of chronic disease that precludes regular physical activity or changes in dietary intake
- Currently receiving treatment for psychological disorder
- Currently pregnant or having given birth within last 12 months
- Use in last 3 months of weight loss medications or other drugs that affect body weight
- Participation in a weight loss program in last 12 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 |
|---|---|---|
| Weight Gain Prevention for Women Project | Behavioural | – |
Primary outcome
Not reported in the source record.
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 14 Jan 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight Gain Prevention for Women Project in people with Obesity and Body Weight Changes, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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 1 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 14 Jan 2010. 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.
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 14 Jan 2010.