A Lifestyle Physical Activity Intervention for Older Sedentary Women

NCT ID: NCT01707693

Last Updated: 2019-10-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 121 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2015-03-31

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.

Detailed Description

Over 98% of older women do not meet national guidelines for physical activity (PA). There is clear evidence that a physically active lifestyle reduces the human and economic cost of heart disease in a dose-response relationship; but current efforts to increase long-term PA in older women are inadequate. The aims of this proposed research are to: 1) determine the feasibility of using an individually tailored motivational counseling intervention method to promote lifestyle physical activity (LPA) in older sedentary women; 2) examine intervention effects by comparing baseline to outcome measures at 3 and 6 months in treatment and information/attention comparison groups; and 3) explore stage of behavior change and self-efficacy and their relationship to LPA, along with functional health.

This will be a single blinded randomized controlled study of sedentary women aged 60 years and older. We will replace "structured aerobic exercise" with lifestyle physical activity (LPA), i.e., self-selected activities performed daily in a purposeful manner to meet the national PA guidelines. A total of 120 older women who are ambulatory and cognitively intact will be recruited from a senior health clinic and randomized to receive either the motivational LPA intervention or information/attention. Women will be assessed at baseline, 3 and 6 months. The theoretically based behavioral intervention is derived from the Transtheoretical Model and other evidence-based physical activity research. We will use a Motivational Interviewing counseling technique delivered by a social worker to individually tailor the LPA intervention to participant preferences, taking into consideration their functional ability and need for information, readiness to change, and self-efficacy. Outcomes of the LPA intervention sessions will include tailored goals and an LPA plan. Intervention participants will also receive the newly developed NIA "Exercise & You" LPA informational booklet with companion digital video disc (DVD) as well as motivational coaching via telephone calls, tapering in frequency for 6 months. The control group will receive the NIA LPA booklet with DVD and attention telephone calls. We will assess changes from baseline in LPA (primary outcome), readiness to change, self-efficacy and function (secondary outcomes) and examine the associations between primary and secondary outcomes in both groups. The allied disciplines of Nursing, Gerontology, Social Work, and Medicine will collaborate to promote PA and cardiovascular health of older women. Undergraduate and graduate student research assistants will contribute to this project. This research has the potential to increase PA of sedentary older women and reduce coronary heart disease risks. If we could increase physical activity in our rapidly growing older population -even modestly, we could make a significant impact to the health of our nation.

Conditions

Coronary Heart Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Lifestyle Physical Activity Intervention

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.

Group Type: EXPERIMENTAL

Lifestyle Physical Activity Intervention

Intervention Type: BEHAVIORAL

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

Information/Attention Comparison

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.

Group Type: ACTIVE_COMPARATOR

Information / Attention Comparison

Intervention Type: BEHAVIORAL

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

Interventions

Lifestyle Physical Activity Intervention

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

Intervention Type: BEHAVIORAL

Information / Attention Comparison

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Arkansas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leanne L Lefler, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Locations

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Countries

United States

Other Identifiers

135603

Identifier Type: -

Identifier Source: org_study_id