Keep Active Minnesota
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|ClinicalTrials.gov Identifier: NCT00283452|
Recruitment Status : Completed
First Posted : January 30, 2006
Last Update Posted : March 10, 2010
|Condition or disease||Intervention/treatment||Phase|
|Physical Activity Maintenance||Behavioral: Phone counseling with written materials||Not Applicable|
The benefits of physical activity for adults are well established, but less than one-third of older adults in the U.S. have achieved recommended levels of physical activity despite widespread clinical recommendations to increase physical activity in recent years. Clinic-based approaches to increasing physical activity are expensive, difficult to implement in busy practice settings, and have limited reach. Moreover, evidence of the efficacy of such approaches is equivocal. A population based approach may be a more effective and less costly strategy to increase levels of physical activity in older adults. Population studies of physical activity have demonstrated that each year, many sedentary older adults initiate physical activity, but a nearly equal number of those who were active become sedentary. Among older adults initiating physical activity, only half continue to be active 3 months later.
We hypothesize that a population based approach that emphasizes physical activity maintenance can substantially increase physical activity levels in a defined populations of older adults. This hypothesis is tested in a 24-month randomized trial evaluating an innovative, theory-based behavioral intervention to maintain physical activity in a random sample of 50-70 year old adults who have recently become at least moderately active. One thousand (1000) subjects will be randomized to one of two experimental groups: 1) a "usual care" control group, and 2) an interactive phone- and mail-based intervention program tailored to maintaining physical activity in older adults. The primary outcome measures are: 1) physical activity, assessed as kcals/wk expenditure; and 2) physical activity maintenance, assessed as follow-up kcals/wk expenditure relative to baseline. Careful measurement of the penetration of the intervention into a well characterized older adult population, and the costs of the intervention, will be assessed. Psychosocial and behavioral mediators of physical activity maintenance will also be examined.
Study results will be relevant to policy makers, health promotion practitioners and health plans, and will provide practical information on the effectiveness, population penetration, and costs of an intervention designed to maximize population levels of physical activity among older adults.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1049 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Maintaining Physical Activity in Older Adult MCO Members|
|Study Start Date :||September 2003|
|Actual Primary Completion Date :||January 2008|
|Actual Study Completion Date :||September 2009|
Experimental: Intervention Group
Participation in phone/mail-based intervention to maintain physical activity.
Behavioral: Phone counseling with written materials
Participation in phone/mail counseling to maintain physical activity
No Intervention: Control
No intervention; participation in surveys only
- Absolute level of physical activity: [ Time Frame: Assessed at baseline, 6, 12 and 24-month follow-up as kcals/wk expenditure based on survey self-report, validated against activity monitor data in a random sub-sample. ]
- Maintenance of physical activity [ Time Frame: Physical activity level relative to baseline assessed at all follow-ups 6, 12, 24 months. ]
- Population penetration: Proportion of those eligible who agree to join the study, and proportion of those randomized to the intervention condition who complete the intervention protocol. [ Time Frame: Final endpoint - 24 months ]
- Mediating factors [ Time Frame: Level of physical activity self-efficacy, social support for physical activity, and perceived benefits and barriers to activity will also be assessed at baseline and the 6, 12 and 24-month follow-ups. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00283452
|United States, Minnesota|
|HealthPartners Research Foundation|
|Bloomington, Minnesota, United States, 55426|
|Principal Investigator:||Brian C. Martinson, PhD||HealthPartners Institute|