Trial Outcomes & Findings for A Lifestyle Physical Activity Intervention for Older Sedentary Women (NCT NCT01707693)
NCT ID: NCT01707693
Last Updated: 2019-10-11
Results Overview
motion data counts calculated from three axes
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
121 participants
Primary outcome timeframe
3 and 6 months
Results posted on
2019-10-11
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study Allocation
STARTED
|
59
|
62
|
|
Overall Study Allocation
COMPLETED
|
46
|
54
|
|
Overall Study Allocation
NOT COMPLETED
|
13
|
8
|
|
Time 3 Measures @ 6 Mth
STARTED
|
46
|
54
|
|
Time 3 Measures @ 6 Mth
COMPLETED
|
46
|
49
|
|
Time 3 Measures @ 6 Mth
NOT COMPLETED
|
0
|
5
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study Allocation
Withdrawal by Subject
|
9
|
5
|
|
Overall Study Allocation
Protocol Violation
|
4
|
3
|
|
Time 3 Measures @ 6 Mth
Lost to Follow-up
|
0
|
3
|
|
Time 3 Measures @ 6 Mth
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
A Lifestyle Physical Activity Intervention for Older Sedentary Women
Baseline characteristics by cohort
| Measure |
Lifestyle Physical Activity Intervention
n=59 Participants
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
|
Information/Attention Comparison
n=62 Participants
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
|
Total
n=121 Participants
Total of all reporting groups
|
|---|---|---|---|
|
employment status
Full time (40 hours/week)
|
10 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Age, Continuous
|
69.9 years
STANDARD_DEVIATION 6.1 • n=99 Participants
|
68.3 years
STANDARD_DEVIATION 6.8 • n=107 Participants
|
69.1 years
STANDARD_DEVIATION 6.5 • n=206 Participants
|
|
Sex/Gender, Customized
Female
|
59 Participants
n=99 Participants
|
62 Participants
n=107 Participants
|
121 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
77 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Total Household Yearly Income
<10K
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Total Household Yearly Income
10-20K
|
8 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Total Household Yearly Income
20K-30K
|
12 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Total Household Yearly Income
30K-40K
|
9 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Total Household Yearly Income
40-50K
|
6 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Total Household Yearly Income
>50K
|
14 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Total Household Yearly Income
Refused/DK
|
6 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
My living status
Married (live with spouse)
|
29 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
My living status
Live alone
|
20 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
My living status
Live with children/relative/friend
|
10 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Highest Grade Level
Grade School
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Highest Grade Level
Some HS
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Highest Grade Level
HS Graduate/GED
|
4 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Highest Grade Level
Vocation or Trade School
|
1 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Highest Grade Level
Some College
|
30 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
|
Highest Grade Level
College Graduate
|
12 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Highest Grade Level
Graduate School
|
9 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Number of people in household
0
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Number of people in household
1
|
26 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
|
Number of people in household
2
|
29 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
|
Number of people in household
3
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Number of people in household
4
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Number of people in household
5
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Smoker Category
1_Current Smoker
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Smoker Category
2_Past Smoker
|
20 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Smoker Category
3_Non-Smoker, with 2nd-Hand Exposure
|
25 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
|
Smoker Category
4_Non-Smoker, without 2nd-Hand Exposure
|
11 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Cardiovascular Disease History
Yes
|
8 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Cardiovascular Disease History
No
|
51 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
100 Participants
n=206 Participants
|
|
History of High Blood Pressure
Yes
|
44 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
86 Participants
n=206 Participants
|
|
History of High Blood Pressure
No
|
15 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
History of Diabetes/Borderline Diabetes
Yes
|
15 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
History of Diabetes/Borderline Diabetes
No
|
44 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
91 Participants
n=206 Participants
|
|
Heart Diseases/Angina
Yes
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Heart Diseases/Angina
No
|
53 Participants
n=99 Participants
|
57 Participants
n=107 Participants
|
110 Participants
n=206 Participants
|
|
Peripheral Vascular Diseases (Poor Circulation)
Yes
|
1 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Peripheral Vascular Diseases (Poor Circulation)
No
|
58 Participants
n=99 Participants
|
55 Participants
n=107 Participants
|
113 Participants
n=206 Participants
|
|
Kidney or Renal Failure
Yes
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Kidney or Renal Failure
No
|
57 Participants
n=99 Participants
|
62 Participants
n=107 Participants
|
119 Participants
n=206 Participants
|
|
Stroke
Yes
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Stroke
No
|
57 Participants
n=99 Participants
|
59 Participants
n=107 Participants
|
116 Participants
n=206 Participants
|
|
Abdominal Aortic Aneurysm
Yes
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Abdominal Aortic Aneurysm
No
|
59 Participants
n=99 Participants
|
61 Participants
n=107 Participants
|
120 Participants
n=206 Participants
|
|
High Cholesterol
Yes
|
33 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
|
High Cholesterol
No
|
26 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
62 Participants
n=206 Participants
|
|
No History of Relevant Issues
Yes
|
9 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
No History of Relevant Issues
No
|
50 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
99 Participants
n=206 Participants
|
|
Family hx: heart attack or stroke
Yes
|
37 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
74 Participants
n=206 Participants
|
|
Family hx: heart attack or stroke
No
|
22 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
Family hx: High Blood Pressure
Yes
|
45 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
91 Participants
n=206 Participants
|
|
Family hx: High Blood Pressure
No
|
14 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Follows heart-healthy or low fat/sodium diet
Yes
|
23 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Follows heart-healthy or low fat/sodium diet
No
|
36 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
83 Participants
n=206 Participants
|
|
Cholesterol check in last 2 years
Yes
|
53 Participants
n=99 Participants
|
60 Participants
n=107 Participants
|
113 Participants
n=206 Participants
|
|
Cholesterol check in last 2 years
No
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Cholesterol check in last 2 years
DK
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Currently works outside the home
Yes
|
23 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Currently works outside the home
No
|
36 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
83 Participants
n=206 Participants
|
|
employment status
No/Not Answered for 1
|
37 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
84 Participants
n=206 Participants
|
|
employment status
Part time
|
12 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Major provider of care for another person
Yes
|
13 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Major provider of care for another person
No
|
46 Participants
n=99 Participants
|
52 Participants
n=107 Participants
|
98 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 3 and 6 monthsPopulation: Number of participants with completed data
motion data counts calculated from three axes
Outcome measures
| Measure |
Physical Activity Motivational Interviewing Counseling INTERV
n=46 Participants
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
|
Information/Attention Without Counseling CONTROL
n=54 Participants
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
|
|---|---|---|
|
Accelerometer Vector Magnitude Counts
3 Months
|
345,000 Vector Magnitude Counts
|
324,000 Vector Magnitude Counts
|
|
Accelerometer Vector Magnitude Counts
6 months
|
324,000 Vector Magnitude Counts
|
309,000 Vector Magnitude Counts
|
SECONDARY outcome
Timeframe: 3 and 6 monthsPopulation: Attrition of 5 participants
Number of steps that a person takes per day
Outcome measures
| Measure |
Physical Activity Motivational Interviewing Counseling INTERV
n=46 Participants
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
|
Information/Attention Without Counseling CONTROL
n=54 Participants
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
|
|---|---|---|
|
Step of Counts (Per Day)
3 month
|
3982 Steps per day
Interval 2787.0 to 5157.0
|
3476 Steps per day
Interval 2691.0 to 4683.0
|
|
Step of Counts (Per Day)
6 month
|
3783 Steps per day
Interval 2840.0 to 4727.0
|
3160 Steps per day
Interval 2634.0 to 3891.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 3mths, 6mthsPopulation: 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
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.
Outcome measures
| Measure |
Physical Activity Motivational Interviewing Counseling INTERV
n=59 Participants
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
|
Information/Attention Without Counseling CONTROL
n=62 Participants
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
|
|---|---|---|
|
Self-Efficacy
Baseline
|
7.8 mean score on a (0-10) scale
Standard Deviation 2.4
|
7.0 mean score on a (0-10) scale
Standard Deviation 2.3
|
|
Self-Efficacy
3-month
|
7.7 mean score on a (0-10) scale
Standard Deviation 1.5
|
5.9 mean score on a (0-10) scale
Standard Deviation 2.1
|
|
Self-Efficacy
6- month
|
7.2 mean score on a (0-10) scale
Standard Deviation 2.3
|
5.9 mean score on a (0-10) scale
Standard Deviation 2.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 3 and 6 monthsPopulation: 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
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
Outcome measures
| Measure |
Physical Activity Motivational Interviewing Counseling INTERV
n=59 Participants
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
|
Information/Attention Without Counseling CONTROL
n=62 Participants
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
|
|---|---|---|
|
Stage of Change (SOC)
Baseline SOC · Pre-Contemplation
|
9 Participants
|
7 Participants
|
|
Stage of Change (SOC)
Baseline SOC · Contemplation
|
1 Participants
|
5 Participants
|
|
Stage of Change (SOC)
Baseline SOC · Preparation
|
48 Participants
|
50 Participants
|
|
Stage of Change (SOC)
Baseline SOC · Action
|
1 Participants
|
0 Participants
|
|
Stage of Change (SOC)
Baseline SOC · Maintenance
|
0 Participants
|
0 Participants
|
|
Stage of Change (SOC)
3 Month SOC · Pre-Contemplation
|
0 Participants
|
3 Participants
|
|
Stage of Change (SOC)
3 Month SOC · Contemplation
|
0 Participants
|
1 Participants
|
|
Stage of Change (SOC)
3 Month SOC · Preparation
|
4 Participants
|
17 Participants
|
|
Stage of Change (SOC)
3 Month SOC · Action
|
36 Participants
|
28 Participants
|
|
Stage of Change (SOC)
3 Month SOC · Maintenance
|
6 Participants
|
5 Participants
|
|
Stage of Change (SOC)
6 month SOC · Pre-Contemplation
|
2 Participants
|
3 Participants
|
|
Stage of Change (SOC)
6 month SOC · Contemplation
|
1 Participants
|
4 Participants
|
|
Stage of Change (SOC)
6 month SOC · Preparation
|
2 Participants
|
13 Participants
|
|
Stage of Change (SOC)
6 month SOC · Action
|
0 Participants
|
5 Participants
|
|
Stage of Change (SOC)
6 month SOC · Maintenance
|
41 Participants
|
24 Participants
|
Adverse Events
Physical Activitiy Motiviational Interviewing Counseling INTER
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Information/Attention Without Counseling CONTROL
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Physical Activitiy Motiviational Interviewing Counseling INTER
n=59 participants at risk
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
|
Information/Attention Without Counseling CONTROL
n=62 participants at risk
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
|
|---|---|---|
|
Surgical and medical procedures
Back Injury
|
0.00%
0/59 • 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.
|
1.6%
1/62 • Number of events 1 • 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.
|
Other adverse events
Adverse event data not reported
Additional Information
Leanne L. Lefler, PhD, APN, RN Principal Investigator
University of Arkansas for Medical Sciences
Phone: 5012961939
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place