Multilevel Intervention for Physical Activity in Retirement Communities

Quality of Life Clinical Trial

— MIPARC  

Official title:

MIPARC - Multilevel Intervention for Physical Activity in Retirement Communities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01155011
• Other study ID #: 3134795
• Secondary ID: 1R01HL098425
• Status: Completed
• Phase: N/A
• First received: June 30, 2010
• Last updated: May 11, 2016
• Start date: January 2011
• Est. completion date: July 2014

Study information

• Verified date: May 2016
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is 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=320)in 16 CCRCs will receive the multilevel MIPARC intervention or a control health education program for 6 months. A group randomized control design will be employed with site as the unit of randomization. The intervention is delivered through group sessions, phone calls, printed materials, tailored signage and mapping and targeted peer led advocacy efforts.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 307
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Over the age of 65

• Able to walk

• Able to speak and write 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 14 seconds

• Live within the selected retirement community (facility-dwelling)

• Will be in San Diego for the duration of the study

• Provision of consent to participate

• Willing to wear a pedometer and GPS device

• Willing to complete all surveys and attend weekly meetings

• Currently walking between 1000-5000 steps

• No history of falls in previous 3 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

• Daily physical activity of >1000 steps per day or <5000 steps per day during seven days

• Inability to speak and read English

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Blood Pressure
• Physical Activity
• Physical Functioning
• Quality of Life
• Sedentary

Intervention

Behavioral:
• Physical Activity
MIPARC will focus on 3 physical activity goals: increasing walking behavior through gradually increasing step goals increasing attendance at available on-site and local aerobic, strength and flexibility classes, as well as prompting stair use, reducing sedentary behavior. 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.
• Group educational sessions
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.
• Phone counseling call
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: health check step goal check barrier identification problem solving specific goals to achieve target step counts. Counselors will prompt participants to report any adverse events, illnesses, medication changes or counter indicative symptoms. The calls will cease during the second 3 months to allow participants to practice self help techniques while still supported by the group sessions and peer mentoring.
• Peer Mentoring
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.
• Policy Change
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.
• Psychosocial support
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.
• Tailored environmental resources
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.
• Group educational lectures
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.
• Health check phone call
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.
• Pedometer
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.

Locations

Country	Name	City	State
United States	University of California, San Diego	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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/ijerph12 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Minutes of light to moderate physical activity	The primary outcome of this study is to assess at 6 months the effect of the MIPARC intervention on minutes of physical activity (measured by 7 day accelerometry) in adults, =65, living in retirement communities.	baseline	No
Primary	Minutes of light to moderate physical activity	The primary outcome of this study is to assess at 6 months the effect of the MIPARC intervention on minutes of physical activity (measured by 7 day accelerometry) in adults, =65, living in retirement communities.	3 months	No
Primary	Minutes of light to moderate physical activity	The primary outcome of this study is to assess at 6 months the effect of the MIPARC intervention on minutes of physical activity (measured by 7 day accelerometry) in adults, =65, living in retirement communities.	6 months	No
Primary	Minutes of light to moderate physical activity	The primary outcome of this study is to assess at 6 months the effect of the MIPARC intervention on minutes of physical activity (measured by 7 day accelerometry) in adults, =65, living in retirement communities.	9 months	No
Primary	Minutes of light to moderate physical activity	The primary outcome of this study is to assess at 6 months the effect of the MIPARC intervention on minutes of physical activity (measured by 7 day accelerometry) in adults, =65, living in retirement communities.	12 months	No
Secondary	Blood pressure	A secondary outcome is to assess the efficacy of the MIPARC intervention to decrease systolic blood pressure (mmHg.	baseline	No
Secondary	Physical functioning	A secondary outcome is to assess the efficacy of the MIPARC intervention to increase physical functioning of participants (measured objectively by the short physical performance battery (SPPB.	baseline	No
Secondary	Quality of Life	A secondary outcome is to assess the efficacy of the MIPARC intervention to improve the quality of life of participants (measured with the Perceived Quality of Life Scale (PQAL.	baseline	No
Secondary	Blood pressure	A secondary outcome is to assess the efficacy of the MIPARC intervention to decrease systolic blood pressure (mmHg.	6 months	No
Secondary	Physical functioning	A secondary outcome is to assess the efficacy of the MIPARC intervention to increase physical functioning of participants (measured objectively by the short physical performance battery (SPPB.	6 months	No
Secondary	Physical functioning	A secondary outcome is to assess the efficacy of the MIPARC intervention to increase physical functioning of participants (measured objectively by the short physical performance battery (SPPB.	12 months	No
Secondary	Quality of Life	A secondary outcome is to assess the efficacy of the MIPARC intervention to improve the quality of life of participants (measured with the Perceived Quality of Life Scale (PQAL.	6 months	No