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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle Physical Activity Intervention | Behavioral | Physical Activity Information given plus Behavioral counseling using motivational interviewing & follow-up |
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| Measure | Description | Time Frame |
|---|---|---|
| Accelerometer Vector Magnitude Counts | motion data counts calculated from three axes | 3 and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Step of Counts (Per Day) | Number of steps that a person takes per day | 3 and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Self-Efficacy | Self-Efficacy for Exercise Scale used to estimate the strength of self-efficacy beliefs; The tool contains 9 items with an 0-10 answer format from "Not Confident to Very Confident" and summed numerical ratings; higher scores indicate greater self-efficacy. | Baseline, 3mths, 6mths |
| Stage of Change (SOC) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leanne L Lefler, PhD | University of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Physical Activity Motivational Interviewing Counseling INTERV | Received educational material on physical activity from the NIH (Physical Activity & You booklet and Go4Life DVD) Received motivational interviewing behavioral counseling intervention times 2 in month Received motivational interviewing counseling and follow-up over the telephone for 6 months, decreasing in frequency. This is the active intervention group |
| FG001 | Information/Attention Without Counseling CONTROL | Received informational/educational material on physical activity from the NIH (Physical Activity & You booklet and Go4Life DVD) Received attention phone calls and follow up over 6 months with theme of "overall health" (without counseling). This is the Control Group |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study Allocation |
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| Time 3 Measures @ 6 Mth |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Lifestyle Physical Activity Intervention: Behavioral counseling |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Accelerometer Vector Magnitude Counts | motion data counts calculated from three axes | Number of participants with completed data | Posted | Median | Inter-Quartile Range | Vector Magnitude Counts | 3 and 6 months |
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From enrollment to 3 months to 6 months
Staff assessed presence of adverse events via regular contact with participants from both study arms throughout the duration of the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Physical Activitiy Motiviational Interviewing Counseling INTER | Received educational material on physical activity from the NIH (Physical Activity & You booklet and Go4Life DVD) Received motivational interviewing behavioral counseling intervention times 2 in month Received motivational interviewing counseling and follow-up over the telephone for 6 months, decreasing in frequency. This is the active intervention group |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back Injury | Surgical and medical procedures | Systematic Assessment | Patient was diagnosed with L1 compression fracture & underwent vertebroplasty. Past medical history of osteoporosis. Chart review did not support that compression fracture was related to study activities (control group) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Leanne L. Lefler, PhD, APN, RN Principal Investigator | University of Arkansas for Medical Sciences | 5012961939 | LeflerLeanne@uams.edu |
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| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| Information / Attention Comparison | Behavioral | Physical Activity information given & follow-up, no behavioral counseling |
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Exercise Stage of Change information on how ready an individual is to make a change related to participating in physical activity. It consists of four questions (Yes or No response format) in which the individual is rated on current stage of change |
| Baseline, 3 and 6 months |
| NOT COMPLETED |
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| BG001 | 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. Information / Attention Comparison: Information and attention comparison |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Total Household Yearly Income | Count of Participants | Participants |
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| My living status | Count of Participants | Participants |
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| Highest Grade Level | Count of Participants | Participants |
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| Number of people in household | Count of Participants | Participants |
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| Smoker Category | Count of Participants | Participants |
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| Cardiovascular Disease History | Count of Participants | Participants |
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| History of High Blood Pressure | Count of Participants | Participants |
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| History of Diabetes/Borderline Diabetes | Count of Participants | Participants |
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| Heart Diseases/Angina | Count of Participants | Participants |
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| Peripheral Vascular Diseases (Poor Circulation) | Count of Participants | Participants |
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| Kidney or Renal Failure | Count of Participants | Participants |
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| Stroke | Count of Participants | Participants |
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| Abdominal Aortic Aneurysm | Count of Participants | Participants |
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| High Cholesterol | Count of Participants | Participants |
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| No History of Relevant Issues | Count of Participants | Participants |
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| Family hx: heart attack or stroke | Count of Participants | Participants |
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| Family hx: High Blood Pressure | Count of Participants | Participants |
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| Follows heart-healthy or low fat/sodium diet | Count of Participants | Participants |
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| Cholesterol check in last 2 years | Count of Participants | Participants |
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| Currently works outside the home | Count of Participants | Participants |
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| employment status | Count of Participants | Participants |
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| Major provider of care for another person | Count of Participants | Participants |
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Received informational/educational material on physical activity from the NIH (Physical Activity & You booklet and Go4Life DVD) Received attention phone calls and follow up over 6 months with theme of "overall health" (without counseling). This is the Control Group |
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| Secondary | Step of Counts (Per Day) | Number of steps that a person takes per day | Attrition of 5 participants | Posted | Median | Inter-Quartile Range | Steps per day | 3 and 6 months |
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| Other Pre-specified | Self-Efficacy | Self-Efficacy for Exercise Scale used to estimate the strength of self-efficacy beliefs; The tool contains 9 items with an 0-10 answer format from "Not Confident to Very Confident" and summed numerical ratings; higher scores indicate greater self-efficacy. | 8 participants withdrew from the control group and 13 withdrew from the PA intervention at 3 months. At 6 months 5 participants withdrew from the control group and no withdrawals from the PA intervention group | Posted | Mean | Standard Deviation | mean score on a (0-10) scale | Baseline, 3mths, 6mths |
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| Other Pre-specified | Stage of Change (SOC) | Exercise Stage of Change information on how ready an individual is to make a change related to participating in physical activity. It consists of four questions (Yes or No response format) in which the individual is rated on current stage of change | 8 participants withdrew from the control group and 13 withdrew from the PA intervention at 3 months. At 6 months 5 participants withdrew from the control group and no withdrawals from the PA intervention group | Posted | Count of Participants | Participants | Baseline, 3 and 6 months |
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| 0 |
| 59 |
| 0 |
| 59 |
| 0 |
| 59 |
| EG001 | Information/Attention Without Counseling CONTROL | Received informational/educational material on physical activity from the NIH (Physical Activity & You booklet and Go4Life DVD) Received attention phone calls and follow up over 6 months with theme of "overall health" (without counseling). This is the Control Group | 0 | 62 | 1 | 62 | 0 | 62 |
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| D001519 |
| Behavior |
| 6 month |
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| 3-month |
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| 6- month |
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| Contemplation |
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| Preparation |
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| Action |
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| Maintenance |
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| 3 Month SOC |
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| 6 month SOC |
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