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ClinicalTrials.gov Identifier: NCT00283452
Recruitment Status : Completed
First Posted : January 30, 2006
Last Update Posted : March 10, 2010
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by:
HealthPartners Institute

Tracking Information
First Submitted Date  ICMJE January 27, 2006
First Posted Date  ICMJE January 30, 2006
Last Update Posted Date March 10, 2010
Study Start Date  ICMJE September 2003
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 17, 2008)
  • 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. ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 27, 2006)
  • •Absolute level of physical activity: 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: Physical activity level relative to baseline assessed at all follow-ups.
Change History Complete list of historical versions of study NCT00283452 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 17, 2008)
  • 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. ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 27, 2006)
  • •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.
  • •Mediating factors: 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Keep Active Minnesota
Official Title  ICMJE Maintaining Physical Activity in Older Adult MCO Members
Brief Summary 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE Physical Activity Maintenance
Intervention  ICMJE Behavioral: Phone counseling with written materials
Participation in phone/mail counseling to maintain physical activity
Study Arms  ICMJE
  • Experimental: Intervention Group
    Participation in phone/mail-based intervention to maintain physical activity.
    Intervention: Behavioral: Phone counseling with written materials
  • No Intervention: Control
    No intervention; participation in surveys only
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 17, 2008)
1049
Original Enrollment  ICMJE
 (submitted: January 27, 2006)
1050
Actual Study Completion Date  ICMJE September 2009
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00283452
Other Study ID Numbers  ICMJE 03-024
1R01AG023410-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Brian Martinson, PhD, HealthPartners Research Foundation
Study Sponsor  ICMJE HealthPartners Institute
Collaborators  ICMJE National Institute on Aging (NIA)
Investigators  ICMJE
Principal Investigator: Brian C. Martinson, PhD HealthPartners Institute
PRS Account HealthPartners Institute
Verification Date March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP