NCT01707693

Brief Summary

Making physical activity an integral part of daily life is imperative to the health and well-being of our nation's older adults. However, no intervention strategy to encourage daily physical activity for older adults, especially older women, has been effective. This feasibility study will test a multi-tailored motivational intervention to increase usual lifestyle physical activity of older sedentary women to reduce their coronary heart disease risks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
121

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2012

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 16, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
4.6 years until next milestone

Results Posted

Study results publicly available

October 11, 2019

Completed
Last Updated

October 11, 2019

Status Verified

September 1, 2019

Enrollment Period

2.9 years

First QC Date

October 12, 2012

Results QC Date

June 20, 2019

Last Update Submit

September 24, 2019

Conditions

Coronary Heart Disease

Keywords

physical activitypreventioncoronary heart diseasewomen

Outcome Measures

Primary Outcomes (1)

  • Accelerometer Vector Magnitude Counts

    motion data counts calculated from three axes

    3 and 6 months

Secondary Outcomes (1)

  • Step of Counts (Per Day)

    3 and 6 months

Other Outcomes (2)

  • Self-Efficacy

    Baseline, 3mths, 6mths

  • Stage of Change (SOC)

    Baseline, 3 and 6 months

Study Arms (2)

Lifestyle Physical Activity Intervention

EXPERIMENTAL

the women will be randomized to either the LPA Intervention or Information/Attention Comparison groups using a permuted block randomization scheme. Participants in both groups will be followed longitudinally with repeated assessments of LPA (accelerometer \& LPA diary), stage of change, and self-efficacy at baseline and 3 and 6 months; and functional health and well-being (SF36) at baseline and 6 months.

Behavioral: Lifestyle Physical Activity Intervention

Information/Attention Comparison

ACTIVE COMPARATOR

the women will be randomized to either the LPA Intervention or Information/Attention Comparison groups using a permuted block randomization scheme. Participants in both groups will be followed longitudinally with repeated assessments of LPA (accelerometer \& LPA diary), stage of change, and self-efficacy at baseline and 3 and 6 months; and functional health and well-being (SF36) at baseline and 6 months.

Behavioral: Information / Attention Comparison

Interventions

Lifestyle Physical Activity InterventionBEHAVIORAL

Physical Activity Information given plus Behavioral counseling using motivational interviewing \& follow-up

Lifestyle Physical Activity Intervention
Information / Attention ComparisonBEHAVIORAL

Physical Activity information given \& follow-up, no behavioral counseling

Information/Attention Comparison

Eligibility Criteria

Age60 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • women \> 60 years of age who are Senior Health clinic patients
  • health care provider's approval to participate
  • ability to speak/read English
  • access to a telephone

You may not qualify if:

  • report participation in a regular physical activity program
  • report an unresolved acute illness, such as pneumonia or flu
  • fail screening for capacity to provide informed consent
  • fail a simple functional screen or are currently nonambulatory
  • are unable to complete activities of daily living
  • have uncorrectable severe hearing or vision deficits
  • have a history of falls in the past 3 months
  • have other unforeseen pathology that precludes safe participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Coronary DiseaseMotor Activity

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesBehavior

Results Point of Contact

Title
Leanne L. Lefler, PhD, APN, RN Principal Investigator
Organization
University of Arkansas for Medical Sciences
LeflerLeanne@uams.edu
5012961939

Study Officials

  • Leanne L Lefler, PhD

    University of Arkansas

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2012

First Posted

October 16, 2012

Study Start

April 1, 2012

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

October 11, 2019

Results First Posted

October 11, 2019

Record last verified: 2019-09

Locations

US(1)