NCT00283452

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,049

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

January 27, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 30, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

March 10, 2010

Status Verified

March 1, 2010

Enrollment Period

4.3 years

First QC Date

January 27, 2006

Last Update Submit

March 9, 2010

Conditions

Physical Activity Maintenance

Keywords

Physical activity maintenanceInteractive phone and mail-based interventionOlder adults

Outcome Measures

Primary Outcomes (2)

  • 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 6, 12, 24 months.

Secondary Outcomes (2)

  • 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.

    Final endpoint - 24 months

  • 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.

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participation in phone/mail-based intervention to maintain physical activity.

Behavioral: Phone counseling with written materials

Control

NO INTERVENTION

No intervention; participation in surveys only

Interventions

Phone counseling with written materialsBEHAVIORAL

Participation in phone/mail counseling to maintain physical activity

Intervention Group

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Modified Charlson scores \>=3 (calculated using prior year diagnoses);
  • Nonskin cancer;
  • Congestive heart failure;
  • Coronary heart disease;
  • Psychotic Illness;
  • Substance abuse;
  • Terminal illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HealthPartners Research Foundation

Bloomington, Minnesota, 55426, United States

Location

Related Publications (2)

  • Senso MM, Anderson CP, Crain AL, Sherwood NE, Martinson BC. Self-reported activity and accelerometry in 2 behavior-maintenance trials. Am J Health Behav. 2014 Mar;38(2):254-64. doi: 10.5993/AJHB.38.2.11.

    PMID: 24629554DERIVED

  • Sherwood NE, Martinson BC, Crain AL, Hayes MG, Pronk NP, O'Connor PJ. A new approach to physical activity maintenance: rationale, design, and baseline data from the Keep Active Minnesota Trial. BMC Geriatr. 2008 Jul 25;8:17. doi: 10.1186/1471-2318-8-17.

    PMID: 18655709DERIVED

Study Officials

  • Brian C. Martinson, PhD

    HealthPartners Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 27, 2006

First Posted

January 30, 2006

Study Start

September 1, 2003

Primary Completion

January 1, 2008

Study Completion

September 1, 2009

Last Updated

March 10, 2010

Record last verified: 2010-03

Locations

US(1)