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Cardiovascular DiseasesNCT00005749

Project Andale--Increasing Exercise in Hispanic Women

An observational study of Cardiovascular Diseases and Heart Diseases, run by San Diego State University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

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.

  1. First posted26 May 2000 (estimated)
  2. Study startJul 1996
  3. Study completionDec 2002

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
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

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.

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