Trial Outcomes & Findings for Multilevel Intervention for Physical Activity in Retirement Communities (NCT NCT01155011)
NCT ID: NCT01155011
Last Updated: 2017-08-31
Results Overview
Measured by 7 day accelerometry with a 760 cpm cutpoint.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
307 participants
Primary outcome timeframe
Baseline
Results posted on
2017-08-31
Participant Flow
Participant milestones
| Measure |
MIPARC Intervention
The intervention will focus on increasing light to moderate PA, primarily promoting walking by gradually increasing participants' daily step counts.
Participants will monitor their steps with a pedometer, daily step logs and progress charts. All participants will have a gradually increasing fixed step goal for each week that will result in an total increase of 3000 steps after 3 months, which they will be supported to maintain for an additional 3 months. Participants will attend group educational sessions and group walks, receive phone counseling calls from UCSD counselors, receive support from peer mentors, In order to increase the sustainability of the project, MIPARC will focus on addressing on-site policies and neighborhood factors that are barriers to physical activity.
|
Health Education Control
The control group will receive an active health education intervention. The education curriculum will involve both lectures and mailed materials. The lectures will be delivered to match the MIPARC intervention schedule. Sessions will include information on general health and healthy aging. Physical activity will not be discussed in these sessions but participants will receive information on the benefits of PA. Control participants will also receive a health check phone call to match the individual attention paid to participants in the MIPARC intervention sites.
|
|---|---|---|
|
Baseline to 6 Months
STARTED
|
151
|
156
|
|
Baseline to 6 Months
COMPLETED
|
129
|
131
|
|
Baseline to 6 Months
NOT COMPLETED
|
22
|
25
|
|
6 to 12 Months
STARTED
|
129
|
131
|
|
6 to 12 Months
COMPLETED
|
120
|
121
|
|
6 to 12 Months
NOT COMPLETED
|
9
|
10
|
Reasons for withdrawal
| Measure |
MIPARC Intervention
The intervention will focus on increasing light to moderate PA, primarily promoting walking by gradually increasing participants' daily step counts.
Participants will monitor their steps with a pedometer, daily step logs and progress charts. All participants will have a gradually increasing fixed step goal for each week that will result in an total increase of 3000 steps after 3 months, which they will be supported to maintain for an additional 3 months. Participants will attend group educational sessions and group walks, receive phone counseling calls from UCSD counselors, receive support from peer mentors, In order to increase the sustainability of the project, MIPARC will focus on addressing on-site policies and neighborhood factors that are barriers to physical activity.
|
Health Education Control
The control group will receive an active health education intervention. The education curriculum will involve both lectures and mailed materials. The lectures will be delivered to match the MIPARC intervention schedule. Sessions will include information on general health and healthy aging. Physical activity will not be discussed in these sessions but participants will receive information on the benefits of PA. Control participants will also receive a health check phone call to match the individual attention paid to participants in the MIPARC intervention sites.
|
|---|---|---|
|
Baseline to 6 Months
Withdrawal by Subject
|
18
|
19
|
|
Baseline to 6 Months
investigator decision, moved
|
4
|
5
|
|
Baseline to 6 Months
Death
|
0
|
1
|
|
6 to 12 Months
Withdrawal by Subject
|
8
|
5
|
|
6 to 12 Months
Death
|
1
|
5
|
Baseline Characteristics
Multilevel Intervention for Physical Activity in Retirement Communities
Baseline characteristics by cohort
| Measure |
MIPARC Intervention
n=151 Participants
Intervention participants engage in group education session, individual phone counseling calls and group walks for the first 6 months. The telephone counseling calls will be eliminated after 3 months.
Participants monitor their steps with a pedometer, daily step logs and progress charts. All participants will have a gradually increasing fixed step goal for each week that will result in an total increase of 3000 steps after 3 months, which they will be supported to maintain for an additional 3 months. They receive support from peer leaders. The peer leaders also receive advocacy training from a non-profit advocacy organization to conduct walk audits of their CCRC and help mobilize participants to make changes to their community that will increase or improve the opportunities for physical activity.
|
Health Education Control
n=156 Participants
The control group will receive an active health education intervention. The lectures will be delivered to match the MIPARC intervention schedule. Sessions will include information on general health and healthy aging. Physical activity will not be discussed in these sessions but participants will receive information on the benefits of PA. Control participants will also receive a health check phone call to match the individual attention paid to participants in the MIPARC intervention sites.
|
Total
n=307 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
85.3 years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
81.9 years
STANDARD_DEVIATION 5.9 • n=7 Participants
|
83.6 years
STANDARD_DEVIATION 6.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
107 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
222 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
148 Participants
n=5 Participants
|
151 Participants
n=7 Participants
|
299 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
132 Participants
n=5 Participants
|
150 Participants
n=7 Participants
|
282 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Education
|
91 participants
n=5 Participants
|
108 participants
n=7 Participants
|
199 participants
n=5 Participants
|
|
Marital Status
|
45 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: BaselineMeasured by 7 day accelerometry with a 760 cpm cutpoint.
Outcome measures
| Measure |
MIPARC Intervention
n=151 Participants
Participants received group educations sessions, group walks, phone counseling, support from peer leaders.
|
Health Education Control
n=156 Participants
The control group will receive an active health education intervention.. The lectures will be delivered to match the MIPARC intervention schedule.
|
|---|---|---|
|
Daily Minutes of Physical Activity
|
50.03 minutes
Standard Deviation 29.02
|
39.19 minutes
Standard Deviation 28.3
|
PRIMARY outcome
Timeframe: 6 monthsMeasured by 7 day accelerometry in adults, ≥65, with a 760 CPM cutpoint.
Outcome measures
| Measure |
MIPARC Intervention
n=124 Participants
Participants received group educations sessions, group walks, phone counseling, support from peer leaders.
|
Health Education Control
n=127 Participants
The control group will receive an active health education intervention.. The lectures will be delivered to match the MIPARC intervention schedule.
|
|---|---|---|
|
Daily Minutes of Physical Activity
|
59.46 minutes
Standard Deviation 40.05
|
39.24 minutes
Standard Deviation 25.11
|
PRIMARY outcome
Timeframe: 12 monthsMeasured by 7 day accelerometry in adults, ≥65, using a 760 CPM cutpoint.
Outcome measures
| Measure |
MIPARC Intervention
n=110 Participants
Participants received group educations sessions, group walks, phone counseling, support from peer leaders.
|
Health Education Control
n=107 Participants
The control group will receive an active health education intervention.. The lectures will be delivered to match the MIPARC intervention schedule.
|
|---|---|---|
|
Minutes of Light to Moderate Physical Activity
|
56.79 minutes
Standard Deviation 38.32
|
38.70 minutes
Standard Deviation 26.50
|
Adverse Events
MIPARC Intervention
Serious events: 38 serious events
Other events: 23 other events
Deaths: 1 deaths
Health Education Control
Serious events: 30 serious events
Other events: 12 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
MIPARC Intervention
n=151 participants at risk
Intervention participants received group education sessions, group walks, phone counseling and support from peer leaders.
|
Health Education Control
n=156 participants at risk
The control group will receive an active health education intervention. The lectures will be delivered to match the MIPARC intervention schedule. Sessions will include information on general health and healthy aging. Physical activity will not be discussed in these sessions but participants will receive information on the benefits of PA.
|
|---|---|---|
|
General disorders
Death
|
0.66%
1/151 • Number of events 1
|
3.2%
5/156 • Number of events 5
|
|
General disorders
Fall
|
13.2%
20/151 • Number of events 20
|
10.3%
16/156 • Number of events 16
|
|
Musculoskeletal and connective tissue disorders
Serious physical injury
|
3.3%
5/151 • Number of events 5
|
0.64%
1/156 • Number of events 1
|
|
General disorders
Persistent or significant physical or cognitive disability or incapacity
|
2.0%
3/151 • Number of events 3
|
1.9%
3/156 • Number of events 3
|
|
General disorders
Overnight hospitalization
|
6.6%
10/151 • Number of events 10
|
3.2%
5/156 • Number of events 5
|
Other adverse events
| Measure |
MIPARC Intervention
n=151 participants at risk
Intervention participants received group education sessions, group walks, phone counseling and support from peer leaders.
|
Health Education Control
n=156 participants at risk
The control group will receive an active health education intervention. The lectures will be delivered to match the MIPARC intervention schedule. Sessions will include information on general health and healthy aging. Physical activity will not be discussed in these sessions but participants will receive information on the benefits of PA.
|
|---|---|---|
|
General disorders
Change in care status
|
0.66%
1/151 • Number of events 1
|
0.00%
0/156
|
|
General disorders
Emergency room visit
|
2.0%
3/151 • Number of events 3
|
1.9%
3/156 • Number of events 3
|
|
General disorders
Other
|
12.6%
19/151 • Number of events 19
|
5.1%
8/156 • Number of events 8
|
|
General disorders
Decreased cognition
|
0.00%
0/151
|
0.64%
1/156 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place