AzTrials
AzTrials

Physical ActivityMIPARCNCT01155011

Multilevel Intervention for Physical Activity in Retirement Communities

A study testing Physical Activity, Group educational sessions and Phone counseling call in people with Physical Activity and Blood Pressure, run by University of California, San Diego at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
What is being tested?
Physical Activity, Group educational sessions and Phone counseling call
Could I receive a placebo?
No, everyone receives an active treatment
How many people
307 participants
Where
1 siteUnited States
Study dates
Jan 2011to Jul 2014
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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.
Show all 12Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of California, San Diego

    La Jolla, California, 92093

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Physical Activity, Group educational sessions, Phone counseling call, Peer Mentoring, Policy Change
Keywords
Older adults, physical activity, sedentary, retirement communities, advocacy, built environment, peer mentoring, walkability
Medical subject headings
Motor Activity, Sedentary Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical ActivityBehavioural

    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.
  • Group educational sessionsBehavioural

    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 callBehavioural

    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.
  • Peer MentoringBehavioural

    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 ChangeBehavioural

    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.

  • SupportBehavioural

    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 resourcesBehavioural

    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 sessionsBehavioural

    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 callBehavioural

    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.

  • PedometerBehavioural

    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.

Study groups in NCT01155011
Study groupRoleWhat they receive
MIPARC interventionExperimentalEleven 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.
Receives: Behavioral: Physical Activity; Behavioral: Group educational sessions; Behavioral: Phone counseling call; Behavioral: Peer Mentoring; Behavioral: Policy Change; Behavioral: Support; Behavioral: Tailored environmental resources
Health Education ControlActive comparatorThe 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.
Receives: Behavioral: Group educational sessions; Behavioral: Health check phone call; Behavioral: Pedometer

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Daily Minutes of Physical Activity

    Measured by 7 day accelerometry with a 760 cpm cutpoint.

    Measured: Baseline

  2. Daily Minutes of Physical Activity

    Measured by 7 day accelerometry in adults, ≥65, with a 760 CPM cutpoint.

    Measured: 6 months

  3. Minutes of Light to Moderate Physical Activity

    Measured by 7 day accelerometry in adults, ≥65, using a 760 CPM cutpoint.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2010 (estimated)
  2. Study startJan 2011
  3. Primary completionJul 2014
  4. Study completionJul 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
307 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01155011
Sponsor's protocol ID
3134795
Other IDs
1R01HL098425
Acronym
MIPARC
Status last verified
Aug 2017
First submitted
30 Jun 2010
Last updated
31 Aug 2017
Data monitoring committee
Yes

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.

    PubMed 18502164
  • 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.

    PubMed 22921641
  • 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.

    PubMed 26296095
  • 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.

    PubMed 24219194
  • 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.

    PubMed 25415205
  • 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.

    PubMed 26273024
  • 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.

    PubMed 26528999
  • 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.

    PubMed 29609594

Questions about this trial

What is this clinical trial studying?

A study testing Physical Activity, Group educational sessions and Phone counseling call in people with Physical Activity and Blood Pressure, run by University of California, San Diego at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Daily Minutes of Physical Activity (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01155011, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2017; AzTrials last refreshed its copy on 1 Nov 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in