Multilevel Intervention for Physical Activity in Retirement Communities (MIPARC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of California, San Diego
Sponsor:
Information provided by (Responsible Party):
Jacqueline Kerr, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01155011
First received: June 30, 2010
Last updated: March 13, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Physical Activity
Blood Pressure
Physical Functioning
Quality of Life
Sedentary
Behavioral: Physical Activity
Behavioral: Group educational sessions
Behavioral: Phone counseling call
Behavioral: Peer Mentoring
Behavioral: Policy Change
Behavioral: Psychosocial support
Behavioral: Tailored environmental resources
Behavioral: Group educational lectures
Behavioral: Health check phone call
Behavioral: Pedometer

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: MIPARC - Multilevel Intervention for Physical Activity in Retirement Communities

Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Minutes of light to moderate physical activity [ Time Frame: baseline ] [ Designated as safety issue: No ]
    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.

  • Minutes of light to moderate physical activity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.

  • Minutes of light to moderate physical activity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.

  • Minutes of light to moderate physical activity [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    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.

  • Minutes of light to moderate physical activity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Blood pressure [ Time Frame: baseline ] [ Designated as safety issue: No ]
    A secondary outcome is to assess the efficacy of the MIPARC intervention to decrease systolic blood pressure (mmHg.

  • Physical functioning [ Time Frame: baseline ] [ Designated as safety issue: No ]
    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.

  • Quality of Life [ Time Frame: baseline ] [ Designated as safety issue: No ]
    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.

  • Blood pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    A secondary outcome is to assess the efficacy of the MIPARC intervention to decrease systolic blood pressure (mmHg.

  • Physical functioning [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.

  • Physical functioning [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.

  • Quality of Life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 320
Study Start Date: January 2011
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MIPARC intervention

Sixteen Continuing Care Retirement Communities will be randomized to either the MIPARC intervention or an attention-control condition. The intervention will focus on increasing light to moderate PA, primarily promoting walking by gradually increasing participants' daily step counts.

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.

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. The telephone counseling calls will be eliminated after 3 months.

Behavioral: Physical Activity

MIPARC will focus on 3 physical activity goals:

  1. increasing walking behavior through gradually increasing step goals
  2. increasing attendance at available on-site and local aerobic, strength and flexibility classes, as well as prompting stair use,
  3. 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.
Behavioral: 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.
Behavioral: 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:

  1. health check
  2. step goal check
  3. barrier identification
  4. problem solving
  5. 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.
Behavioral: 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.

Behavioral: 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.
Behavioral: 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.
Behavioral: 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.
Active Comparator: 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.
Behavioral: 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.
Behavioral: 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.
Behavioral: 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.

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01155011

Contacts
Contact: Katie Crist, MPH 858-534-9306 kcrist@ucsd.edu
Contact: Jacqueline Kerr, PhD 858-534-9305 jkerr@ucsd.edu

Locations
United States, California
University of California, San Diego Recruiting
La Jolla, California, United States, 92093
Contact: Katie Crist, MPH    858-534-9306    kcrist@ucsd.edu   
Principal Investigator: Jacqueline Kerr, PhD         
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Jacqueline Kerr, PhD University of California, San Diego
  More Information

Publications:
Responsible Party: Jacqueline Kerr, Assistant Professor, Department of Family and Preventive Medicine, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01155011     History of Changes
Other Study ID Numbers: 3134795, 1R01HL098425-01
Study First Received: June 30, 2010
Last Updated: March 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:
Older adults
physical activity
sedentary
retirement communities
advocacy
built environment
peer mentoring
walkability

ClinicalTrials.gov processed this record on October 29, 2014