- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01155011
Multilevel Intervention for Physical Activity in Retirement Communities (MIPARC)
MIPARC - Multilevel Intervention for Physical Activity in Retirement Communities
The purpose of this study was to assess whether a 6-month multilevel physical activity intervention can significantly increase physical activity levels in sedentary adults, 65 and older, living in Continuing Care Retirement Communities (CCRCs).
Sedentary residents (N=307) in 11 CCRCs received the multilevel MIPARC intervention or a control health education program for 6 months. A group randomized control design was employed with site as the unit of randomization. The intervention was delivered through group sessions, phone calls, printed materials, tailored signage and mapping and targeted peer led advocacy efforts.
Study Overview
Status
Intervention / Treatment
- Behavioral: Physical Activity
- Behavioral: Group educational sessions
- Behavioral: Phone counseling call
- Behavioral: Peer Mentoring
- Behavioral: Policy Change
- Behavioral: Support
- Behavioral: Tailored environmental resources
- Behavioral: Group educational sessions
- Behavioral: Health check phone call
- Behavioral: Pedometer
Detailed Description
Objective monitoring of physical activity suggests that fewer than 3% of adults over age 60 meet current physical activity guidelines. Ecological models posit that behavioral interventions are most effective when they operate on multiple levels. The MIPARC study intervenes on four levels: individual (pedometer-based self monitoring, educational materials and monthly counseling calls), interpersonal (monthly group sessions and peer mentoring), environment (walking signage prompts, tailored walking maps, step counts)and policies (review of on-site activity opportunities and walkability, recommendations for change and peer led advocacy)to increase the activity levels of residents. The study promotes walking as the primary means to increase light to moderate PA, with a secondary focus on strength and flexibility and decreased sedentary behavior.
As most Continuing Care Retirement Communities have management structures that provide the opportunity to improve the social and built environments for physical activity and walking, this study also aims to train participants on how to advocate for improvements in the environment that would improve walkability.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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California
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La Jolla, California, United States, 92093
- University of California, San Diego
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Over the age of 65
- Able to walk 20 meters independently (without human assistance, can use cane/walker)
- Able to speak and read in English
- No cognitive, vision or hearing impairments that would prevent provision of informed consent, comprehension of instructions, completion of surveys and participation in phone conversations
- Able to complete the Timed Up and Go Test to assess falls risk within 30 seconds
- Live within the selected retirement community (facility-dwelling) Able to hold brief conversation over the telephone.
- Will be in San Diego for the duration of the study
- Provision of consent to participate
- Willing to wear a pedometer, accelerometer and GPS device
- Willing to complete all surveys and attend weekly meetings
- No history of falls in previous that resulted in an injury or hospitalization in the past 12 months
- Physician clearance to participate
Exclusion Criteria:
- Inability to give informed, voluntary consent
- Inability to complete assessments
- Lack of written physician consent to participate in unsupervised light-to-moderate intensity walking
- Inability to speak and read English
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: MIPARC intervention
Eleven Continuing Care Retirement Communities were randomized to either the MIPARC intervention or an attention-control condition. The intervention focused on increasing light to moderate PA. The MIPARC study intervenes on four levels: individual (pedometer self monitoring, educational materials and monthly counseling calls, support), interpersonal (monthly group educational sessions and peer mentoring), environment (walking signage prompts, tailored environmental resources, step counts)and policies (review of on-site activity opportunities and walkability, recommendations for policy change and peer led advocacy)to increase the activity levels of residents. For the first 3 months, intervention participants will engage in either a group educational session, phone counseling call, or a peer led session, on a rotating basis. |
MIPARC will focus on 3 physical activity goals:
Every three weeks, participants will be required to attend a group education session, where researchers will teach behavior change strategies and allow participants to share their experiences and offer support to each other.
The group sessions will follow a common format including: a group exercise (e.g.
quiz), group discussion of use of behavior change strategies (e.g.
overcoming barriers), and will end with a behavior change strategy instruction and goal setting component.
To support a tailored intervention delivery, participants will receive 4 individual phone calls (in weeks 2, 5, 8, and 11) from a trained health counselor. The phone call will follow the following format:
Three peer mentors at each CCRC will be trained in intervention content and delivery, measurement support, and advocacy. The peer mentors will lead a group session once every three weeks for the 6 month intervention period and once a month for the following 6 months. The peer mentors will formulate their own ideas for these sessions but we will suggest they include group walks, group activities and trips to active locations, etc. The peers will help study staff to answer questions from participants and assist with study compliance and retention. They will 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.
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.
Peers and staff will conduct site inspections to identify these barriers (e.g.
lack of facilities, limited opening hours, unsafe sidewalks, etc.) which will be prioritized and presented to CCRC management and community officials.
A binder of professionally prepared materials will be provided at the beginning of the intervention and are referred to by researchers in the group sessions and phone counseling calls.
The materials provide important information to encourage knowledge, self efficacy and realistic expectations.
Participants will be provided with a set of printed materials relating to the residential and neighborhood environment of their CCRC.
A list of step counts for key indoor routes will be provided as well as safe walking route maps for the site an local neighborhood.
Lectures will be delivered every three weeks to match the MIPARC intervention schedule.
Sessions will include topics such as medications, foot care and nutrition.
Physical activity will not e discussed in these sessions but participants will receive informational pamphlets on the benefits of physical activity.
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Active Comparator: Health Education Control
The control group received an active health education intervention.
The education curriculum will involve both lectures and mailed materials.
The lectures were delivered to match the MIPARC intervention schedule.
Sessions included information on general health and healthy aging.
Physical activity was not discussed in these sessions but participants received information on the benefits of PA.
Control participants also received health check phone calls to match the individual attention paid to participants in the MIPARC intervention sites.
|
Every three weeks, participants will be required to attend a group education session, where researchers will teach behavior change strategies and allow participants to share their experiences and offer support to each other.
The group sessions will follow a common format including: a group exercise (e.g.
quiz), group discussion of use of behavior change strategies (e.g.
overcoming barriers), and will end with a behavior change strategy instruction and goal setting component.
Lectures will be delivered every three weeks to match the MIPARC intervention schedule.
Sessions will include topics such as medications, foot care and nutrition.
Physical activity will not e discussed in these sessions but participants will receive informational pamphlets on the benefits of physical activity.
For the first 3 months, control participants will also receive a health check phone call to match the individual attention paid to participants in the MIPARC sites.
Participants will also keep the pedometer they wear during the baseline measurement week to satisfy any curiosity about the devices and the step entry criteria.
They will be given instructions on its use but will not be taught the benefits of self-monitoring.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Daily Minutes of Physical Activity
Time Frame: Baseline
|
Measured by 7 day accelerometry with a 760 cpm cutpoint.
|
Baseline
|
|
Daily Minutes of Physical Activity
Time Frame: 6 months
|
Measured by 7 day accelerometry in adults, ≥65, with a 760 CPM cutpoint.
|
6 months
|
|
Minutes of Light to Moderate Physical Activity
Time Frame: 12 months
|
Measured by 7 day accelerometry in adults, ≥65, using a 760 CPM cutpoint.
|
12 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jacqueline Kerr, PhD, University of California, San Diego
Publications and helpful links
General Publications
- Rosenberg D, Kerr J, Sallis JF, Patrick K, Moore DJ, King A. Feasibility and outcomes of a multilevel place-based walking intervention for seniors: a pilot study. Health Place. 2009 Mar;15(1):173-9. doi: 10.1016/j.healthplace.2008.03.010. Epub 2008 Apr 8.
- Kerr J, Rosenberg DE, Nathan A, Millstein RA, Carlson JA, Crist K, Wasilenko K, Bolling K, Castro CM, Buchner DM, Marshall SJ. Applying the ecological model of behavior change to a physical activity trial in retirement communities: description of the study protocol. Contemp Clin Trials. 2012 Nov;33(6):1180-8. doi: 10.1016/j.cct.2012.08.005. Epub 2012 Aug 17.
- Bellettiere J, Carlson JA, Rosenberg D, Singhania A, Natarajan L, Berardi V, LaCroix AZ, Sears DD, Moran K, Crist K, Kerr J. Gender and Age Differences in Hourly and Daily Patterns of Sedentary Time in Older Adults Living in Retirement Communities. PLoS One. 2015 Aug 21;10(8):e0136161. doi: 10.1371/journal.pone.0136161. eCollection 2015.
- Kerr J, Marshall SJ, Patterson RE, Marinac CR, Natarajan L, Rosenberg D, Wasilenko K, Crist K. Objectively measured physical activity is related to cognitive function in older adults. J Am Geriatr Soc. 2013 Nov;61(11):1927-31. doi: 10.1111/jgs.12524.
- Marshall S, Kerr J, Carlson J, Cadmus-Bertram L, Patterson R, Wasilenko K, Crist K, Rosenberg D, Natarajan L. Patterns of Weekday and Weekend Sedentary Behavior Among Older Adults. J Aging Phys Act. 2015 Oct;23(4):534-41. doi: 10.1123/japa.2013-0208. Epub 2014 Nov 21.
- Rosenberg DE, Bellettiere J, Gardiner PA, Villarreal VN, Crist K, Kerr J. Independent Associations Between Sedentary Behaviors and Mental, Cognitive, Physical, and Functional Health Among Older Adults in Retirement Communities. J Gerontol A Biol Sci Med Sci. 2016 Jan;71(1):78-83. doi: 10.1093/gerona/glv103. Epub 2015 Aug 13.
- Takemoto M, Carlson JA, Moran K, Godbole S, Crist K, Kerr J. Relationship between Objectively Measured Transportation Behaviors and Health Characteristics in Older Adults. Int J Environ Res Public Health. 2015 Oct 30;12(11):13923-37. doi: 10.3390/ijerph121113923.
- Kerr J, Rosenberg D, Millstein RA, Bolling K, Crist K, Takemoto M, Godbole S, Moran K, Natarajan L, Castro-Sweet C, Buchner D. Cluster randomized controlled trial of a multilevel physical activity intervention for older adults. Int J Behav Nutr Phys Act. 2018 Apr 2;15(1):32. doi: 10.1186/s12966-018-0658-4.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 3134795
- 1R01HL098425 (U.S. NIH Grant/Contract)
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