- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01099007
Healthy Bodies, Healthy Hearts: A Physical Activity Intervention Trial (HBHH)
May 20, 2014 updated by: University of Pittsburgh
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
99
Phase
- Phase 1
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
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15213
- UPMC Montefiore Hospital
-
-
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
45 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Not able to walk 1/2 mile or 1 flight of stairs without assistance from another person or an assistive device
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
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: At Home
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.
|
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.
|
Experimental: In Person
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).
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight loss
Time Frame: 6 months
|
The goal of the intervention is for participants to have a 10% reduction in body weight
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Increase physical activity
Time Frame: 3 months
|
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.
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
June 1, 2009
Primary Completion (Actual)
February 1, 2010
Study Completion (Actual)
February 1, 2011
Study Registration Dates
First Submitted
April 2, 2010
First Submitted That Met QC Criteria
April 5, 2010
First Posted (Estimate)
April 6, 2010
Study Record Updates
Last Update Posted (Estimate)
May 22, 2014
Last Update Submitted That Met QC Criteria
May 20, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HL085405
- 5K23HL085405-03 (U.S. NIH Grant/Contract)
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.
Clinical Trials on Obesity
-
Central Hospital, Nancy, FranceNot yet recruiting
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
The Hospital for Sick ChildrenCompleted
-
Ihuoma EneliCompletedObesity, ChildhoodUnited States
-
Fundació Sant Joan de DéuRecruitingObesity, Childhood | Obesity, AdolescentSpain
Clinical Trials on At Home
-
Brigham and Women's HospitalSpire Health, Inc.; Reflexion Health, Inc.Completed
-
Holland Bloorview Kids Rehabilitation HospitalRecruiting
-
University of North Carolina, Chapel HillBristol-Myers Squibb; Duke University; Wake Forest UniversityEnrolling by invitationAtrial FibrillationUnited States
-
Radboud University Medical CenterCompletedCancer | MalnutritionNetherlands
-
Carlos III Health InstituteSpanish Society of Pneumology and Thoracic SurgeryUnknown
-
Electromedical Products International, Inc.University of North Carolina, Chapel HillRecruiting
-
American Medical Group AssociationJohns Hopkins University; Brown University; National Institute on Aging (NIA); CommonSpirit... and other collaboratorsActive, not recruitingDementiaUnited States
-
Hopeful AgingActive, not recruitingDementia | Alzheimer Disease | Dementia, Vascular | Dementia, MixedUnited States
-
Palo Alto Veterans Institute for ResearchNational Center for Complementary and Integrative Health (NCCIH)CompletedMusculoskeletal Pain | Chronic Pain | Alzheimer DiseaseUnited States
-
University of TorontoUniversity of Manitoba; University Health Network, Toronto; University of Alberta and other collaboratorsNot yet recruitingMobility Limitation