ObesityPhase 1HBHHNCT01099007
Healthy Bodies, Healthy Hearts: A Physical Activity Intervention Trial
A Phase 1 study testing In Person and At Home in people with Obesity and Cardiovascular Disease, run by University of Pittsburgh at 1 site in United States.
Trial summary
The overall aim of Healthy Bodies, Healthy Hearts research study is to promote physical activity in women aged 45-65 years to promote reduced risk of cardiovascular disease. The investigators are conducting an intervention for 12 weeks that promotes physical activity through support groups, group exercise sessions or… Read more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Cardiovascular Disease, High Blood Pressure
- What is being tested?
- In Person and At Home
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Feb 2011
- 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 45 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Not currently exercising for at least 100 minutes per week
- Have a Body Mass Index (BMI) of 25 or greater
- Has a physician in one of the three participating practices
Who cannot join
- Not able to walk 1/2 mile or 1 flight of stairs without assistance from another person or an assistive device
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Montefiore Hospital
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Phase II: Healthy Bodies, Hearts After Menopause
The overall aim of Healthy Bodies, Healthy Hearts research study is to promote physical activity in women aged 45-65 years to promote reduced risk of cardiovascular disease. The investigators are conducting an intervention for 12 weeks that promotes physical activity through support groups, group exercise sessions or through information that is given at the baseline appointment. Participants will be randomly assigned to a group.
- Conditions
- Obesity, Cardiovascular Disease, High Blood Pressure
- Being tested
- In Person, At Home
- Keywords
- Women, Menopause, Cardiovascular Disease, Physical Activity, Weight Loss
- Medical subject headings
- Obesity, Cardiovascular Diseases, Hypertension, Motor Activity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In PersonBehavioural
Participants in the In Person group have weekly visits for the 12 weeks to the research office. The first visit can last up to one and a half hours and each subsequent visit can last approximately one hour. Group meetings provide appropriate nutrition and physical activity information as well as behavioral change strategies. Sessions also include some light physical activity (equal to brisk walking).
At HomeBehavioural
Participants in the At Home group receive a workbook from the research staff at their baseline visit that outlines an accepted nutrition and physical activity program to complete on their own.
| Study group | Role | What they receive |
|---|---|---|
| At Home | Active comparator | Participants in the At Home group receive a workbook from the research staff at their baseline visit that outlines an accepted nutrition and physical activity program to complete on their own. Receives: Behavioral: At Home |
| In Person | Experimental | Participants in the In Person group have weekly visits for the 12 weeks to the research office. The first visit can last up to one and a half hours and each subsequent visit can last approximately one hour. Group meetings provide appropriate nutrition and physical activity information as well as behavioral change strategies. Sessions also include some light physical activity (equal to brisk walking). Receives: Behavioral: In Person |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
The goal of the intervention is for participants to have a 10% reduction in body weight
Measured: 6 months
Secondary outcomes (1)
Increase physical activity
The goal of the study is for participants to reach and maintain an average of 150 minutes of moderate to brisk physical activity per week.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2010 (estimated)
- Study startJun 2009
- Primary completionFeb 2010
- Study completionFeb 2011
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 University of PittsburghThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01099007
- Sponsor's protocol ID
- HL085405
- Other IDs
- 5K23HL085405-03
- Acronym
- HBHH
- Status last verified
- May 2014
- First submitted
- 2 Apr 2010
- Last updated
- 22 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II: Healthy Bodies, Hearts After Menopause
- ClinicalTrials.gov ID
- NCT01099007
- Acronym / sponsor ID
- HBHH / HL085405
- Conditions
- Obesity, Cardiovascular Disease, High Blood Pressure
- Keywords
- Women, Menopause, Cardiovascular Disease, Physical Activity, Weight Loss
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jun 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 6 Apr 2010 (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 overall aim of Healthy Bodies, Healthy Hearts research study is to promote physical activity in women aged 45-65 years to promote reduced risk of cardiovascular disease. The investigators are conducting an intervention for 12 weeks that promotes physical activity through support groups, group exercise sessions or through information that is given at the baseline appointment. Participants will be randomly assigned to a group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| At Home | Active comparator | Behavioral: At HomeParticipants in the At Home group receive a workbook from the research staff at their baseline visit that outlines an accepted nutrition and physical activity program to complete on their own. |
| In Person | Experimental | Behavioral: In PersonParticipants in the In Person group have weekly visits for the 12 weeks to the research office. The first visit can last up to one and a half hours and each subsequent visit can last approximately one hour. Group meetings provide appropriate nutrition and physical activity information as well as behavioral change strategies. Sessions also include some light physical activity (equal to brisk walking). |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Not currently exercising for at least 100 minutes per week
- Have a Body Mass Index (BMI) of 25 or greater
- Has a physician in one of the three participating practices
Key exclusion criteria (1 listed)
- Not able to walk 1/2 mile or 1 flight of stairs without assistance from another person or an assistive device
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 |
|---|---|---|
| In PersonParticipants in the In Person group have weekly visits for the 12 weeks to the research office. The first visit can last up to one and a half hours and each subsequent visit can last approximately one hour. Group meetings provide appropriate nutrition and physical activity information as well as behavioral change strategies. Sessions also include some light physical activity (equal to brisk walking). | Behavioural | In Person |
| At HomeParticipants in the At Home group receive a workbook from the research staff at their baseline visit that outlines an accepted nutrition and physical activity program to complete on their own. | Behavioural | At Home |
Primary outcome
Weight loss
Time frame: 6 months
The goal of the intervention is for participants to have a 10% reduction in body weight
1 secondary outcome
Increase physical activity
Time frame: 3 months
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 22 May 2014.
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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 Phase 1 study testing In Person and At Home in people with Obesity and Cardiovascular Disease, run by University of Pittsburgh 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 1 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 22 May 2014. 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?
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?
Weight loss (time frame: 6 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 22 May 2014.