Cardiovascular DiseasesNCT00005749
Project Andale--Increasing Exercise in Hispanic Women
An observational study of Cardiovascular Diseases and Heart Diseases, run by San Diego State University.
Trial summary
To determine the differential effectiveness of a culturally tailored program to shape and maintain moderate intensity physical activity and to improve cardiorespiratory fitness among low SES sedentary Latino women. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jul 1996to Dec 2002
- Phase
- Observational
- 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 Up to 100 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To determine the differential effectiveness of a culturally tailored program to shape and maintain moderate intensity physical activity and to improve cardiorespiratory fitness among low SES sedentary Latino women.
Read the detailed description
BACKGROUND:
Latino women are at high risk for cardiovascular (CVD) and other chronic diseases, in part, due to sedentary lifestyle, obesity, and poor fitness. Few studies assess long-term physical activity, fewer observe maintenance and none have demonstrated effective procedures for sustaining exercise. Only one study has demonstrated increased moderate exercise and none has demonstrated maintenance of physical activity among Latino women. Theoretically-based procedures (shaping, contingency management, relapse prevention, and social reinforcement) hypothesized as necessary to maintain physical activity had not yet been tested experimentally.
DESIGN NARRATIVE:
The 210 Latinas were assigned at random to one of three groups: one six month physical activity intervention, one physical activity plus maintenance intervention, and one safety education control. Exercise training emphasized walking. Bilingual exercise leaders, aided by peer models from the community, used shaping procedures to establish daily walking in participants. In the maintenance program, family incentives reinforced transfer to community exercise and were used to establish positive feedback loops to promote activity within the family. Peer led community exercise sessions, and community activism were also used to establish social networks which reinforced sustained physical activity.
Program support was faded out as naturally occurring social support for Community exercise was established. Four (baseline, post-intervention, post-maintenance, follow-up), repeated measures over 24 months assessed fitness (VO2max), physical activity (PAR), and CVD risk factors. Theoretically important mediating variables, such as self-efficacy, social support, stage of change for exercise, decisional balance, and home exercise environment were explored. Repeated measures analyses were used to determine significant differences among groups, time and group by time main effects. This study was the first to attempt to engineer maintenance of physical activity among minority women. Results will provide a model to be used to sustain physical activity and reduce the risk of cardiovascular and other diseases. If effective, this analysis will also serve as a model for designing programs to sustain physical activity in the increasingly sedentary general population.
The study was renewed in January 2000 to continue through December 2001.
- Conditions
- Cardiovascular Diseases, Heart Diseases
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startJul 1996
- Study completionDec 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by San Diego State UniversityThe 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
- Observational
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Investigators
- Melbourne Hovell, San Diego State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005749
- Sponsor's protocol ID
- 5061
- Other IDs
- R18HL052704
- Status last verified
- Aug 2004
- First submitted
- 25 May 2000
- Last updated
- 12 Jan 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project Andale--Increasing Exercise in Hispanic Women
- ClinicalTrials.gov ID
- NCT00005749
- Acronym / sponsor ID
- 5061
- Conditions
- Cardiovascular Diseases, Heart Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jul 1996
- Study completion
- Dec 2002
- First posted
- 26 May 2000 (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.
To determine the differential effectiveness of a culturally tailored program to shape and maintain moderate intensity physical activity and to improve cardiorespiratory fitness among low SES sedentary Latino women.
Detailed description
BACKGROUND:
Latino women are at high risk for cardiovascular (CVD) and other chronic diseases, in part, due to sedentary lifestyle, obesity, and poor fitness. Few studies assess long-term physical activity, fewer observe maintenance and none have demonstrated effective procedures for sustaining exercise. Only one study has demonstrated increased moderate exercise and none has demonstrated maintenance of physical activity among Latino women. Theoretically-based procedures (shaping, contingency management, relapse prevention, and social reinforcement) hypothesized as necessary to maintain physical activity had not yet been tested experimentally.
DESIGN NARRATIVE:
The 210 Latinas were assigned at random to one of three groups: one six month physical activity intervention, one physical activity plus maintenance intervention, and one safety education control. Exercise training emphasized walking. Bilingual exercise leaders, aided by peer models from the community, used shaping procedures to establish daily walking in participants. In the maintenance program, family incentives reinforced transfer to community exercise and were used to establish positive feedback loops to promote activity within the family. Peer led community exercise sessions, and community activism were also used to establish social networks which reinforced sustained physical activity.
Program support was faded out as naturally occurring social support for Community exercise was established. Four (baseline, post-intervention, post-maintenance, follow-up), repeated measures over 24 months assessed fitness (VO2max), physical activity (PAR), and CVD risk factors. Theoretically important mediating variables, such as self-efficacy, social support, stage of change for exercise, decisional balance, and home exercise environment were explored. Repeated measures analyses were used to determine significant differences among groups, time and group by time main effects. This study was the first to attempt to engineer maintenance of physical activity among minority women. Results will provide a model to be used to sustain physical activity and reduce the risk of cardiovascular and other diseases. If effective, this analysis will also serve as a model for designing programs to sustain physical activity in the increasingly sedentary general population.
The study was renewed in January 2000 to continue through December 2001.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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 12 Jan 2016.
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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.
Melbourne Hovell
San Diego State University
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by San Diego State University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 12 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
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 12 Jan 2016.