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This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00283452
First Posted: January 30, 2006
Last Update Posted: March 10, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Aging (NIA)
Information provided by:
HealthPartners Institute
  Purpose
The purpose of this study is to determine whether a new phone and mail based coaching/support program that has been developed is more effective in helping people stay physically active than existing programs that are currently available to all HealthPartners members. We hypothesize that the intervention program will lead to a greater likelihood of physical activity maintenance among moderately active older adults than a usual care condition.

Condition Intervention
Physical Activity Maintenance Behavioral: Phone counseling with written materials

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Maintaining Physical Activity in Older Adult MCO Members

Resource links provided by NLM:


Further study details as provided by HealthPartners Institute:

Primary Outcome Measures:
  • 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. ]

Secondary Outcome Measures:
  • 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. ]

Enrollment: 1049
Study Start Date: September 2003
Study Completion Date: September 2009
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adults between the ages of 50 and 70;
  • Have HealthPartners insurance for 11 out of the past 12 months;
  • Engage in moderate physical activity for a total of 30 minutes at least two days per week;
  • Have increased activity level in the past year.

Exclusion Criteria:

  • Modified Charlson scores >=3 (calculated using prior year diagnoses);
  • Nonskin cancer;
  • Congestive heart failure;
  • Coronary heart disease;
  • Psychotic Illness;
  • Substance abuse;
  • Terminal illness.
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, Minnesota
HealthPartners Research Foundation
Bloomington, Minnesota, United States, 55426
Sponsors and Collaborators
HealthPartners Institute
National Institute on Aging (NIA)
Investigators
Principal Investigator: Brian C. Martinson, PhD HealthPartners Institute
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Brian Martinson, PhD, HealthPartners Research Foundation
ClinicalTrials.gov Identifier: NCT00283452     History of Changes
Other Study ID Numbers: 03-024
1R01AG023410-01 ( U.S. NIH Grant/Contract )
First Submitted: January 27, 2006
First Posted: January 30, 2006
Last Update Posted: March 10, 2010
Last Verified: March 2010

Keywords provided by HealthPartners Institute:
Physical activity maintenance
Interactive phone and mail-based intervention
Older adults