A Lifestyle Physical Activity Intervention for Older Sedentary Women

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Arkansas
Sponsor:
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT01707693
First received: October 12, 2012
Last updated: May 19, 2014
Last verified: May 2014

October 12, 2012
May 19, 2014
April 2012
March 2015   (final data collection date for primary outcome measure)
Accelerometer (energy expenditure) [ Time Frame: Baseline, 3 month, six month and completion ] [ Designated as safety issue: Yes ]
This activity monitor uses a solid-state triaxial accelerometer to collect motion data on three axes for the highest level of analytic capabilities.
Same as current
Complete list of historical versions of study NCT01707693 on ClinicalTrials.gov Archive Site
Functional health [ Time Frame: 3 and 6 months ] [ Designated as safety issue: Yes ]
SF-36
Same as current
  • Self-Efficacy [ Time Frame: 3 and 6 month ] [ Designated as safety issue: Yes ]
    Self-Efficacy for Exercise Scale
  • Stage of Change [ Time Frame: 3 and 6 months ] [ Designated as safety issue: Yes ]
    Exercise Stage of Change
Same as current
 
A Lifestyle Physical Activity Intervention for Older Sedentary Women
A Lifestyle Physical Activity Intervention for Older Sedentary Women

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Coronary Heart Disease
  • Behavioral: Lifestyle Physical Activity Intervention
    Behavioral counseling
  • Behavioral: Information / Attention Comparison
    Information and attention comparison
  • Experimental: Lifestyle Physical Activity Intervention
    the women will be randomized to either the LPA Intervention (n=60) or Information/Attention Comparison (I/A, n=60) 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.
    Intervention: Behavioral: Lifestyle Physical Activity Intervention
  • Active Comparator: Information/Attention Comparison
    the women will be randomized to either the LPA Intervention (n=60) or Information/Attention Comparison (I/A, n=60) 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.
    Intervention: Behavioral: Information / Attention Comparison
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
145
March 2015
March 2015   (final data collection date for primary outcome measure)

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
Female
60 Years and older
Yes
United States
 
NCT01707693
135603
Yes
University of Arkansas
University of Arkansas
Not Provided
Principal Investigator: Leanne L Lefler, PhD University of Arkansas
University of Arkansas
May 2014

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