Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00005749 |
| Other study ID # |
5061 |
| Secondary ID |
R18HL052704 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
May 25, 2000 |
| Last updated |
January 11, 2016 |
| Start date |
July 1996 |
| Est. completion date |
December 2002 |
Study information
| Verified date |
August 2004 |
| Source |
San Diego State University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Federal Government |
| Study type |
Observational
|
Clinical 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.
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.
