NCT01155011

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
307

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 1, 2010

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

July 31, 2017

Completed
Last Updated

August 31, 2017

Status Verified

August 1, 2017

Enrollment Period

3.5 years

First QC Date

June 30, 2010

Results QC Date

April 10, 2017

Last Update Submit

August 1, 2017

Conditions

Keywords

Older adultsphysical activitysedentaryretirement communitiesadvocacybuilt environmentpeer mentoringwalkability

Outcome Measures

Primary Outcomes (3)

  • Daily Minutes of Physical Activity

    Measured by 7 day accelerometry with a 760 cpm cutpoint.

    Baseline

  • Daily Minutes of Physical Activity

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

    6 months

  • Minutes of Light to Moderate Physical Activity

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

    12 months

Study Arms (2)

MIPARC intervention

EXPERIMENTAL

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.

Behavioral: Physical ActivityBehavioral: Group educational sessionsBehavioral: Phone counseling callBehavioral: Peer MentoringBehavioral: Policy ChangeBehavioral: SupportBehavioral: Tailored environmental resources

Health Education Control

ACTIVE COMPARATOR

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.

Behavioral: Group educational sessionsBehavioral: Health check phone callBehavioral: Pedometer

Interventions

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.

MIPARC intervention

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.

MIPARC intervention

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.

MIPARC intervention
Peer MentoringBEHAVIORAL

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.

MIPARC intervention
Policy ChangeBEHAVIORAL

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.

MIPARC intervention
SupportBEHAVIORAL

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.

MIPARC intervention

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.

MIPARC intervention

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.

Health Education Control
PedometerBEHAVIORAL

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.

Health Education Control

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Diego

La Jolla, California, 92093, United States

Location

Related Publications (8)

  • 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.

    PMID: 18502164BACKGROUND
  • 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.

    PMID: 22921641BACKGROUND
  • 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.

    PMID: 26296095BACKGROUND
  • 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.

    PMID: 24219194BACKGROUND
  • 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.

    PMID: 25415205BACKGROUND
  • 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.

    PMID: 26273024BACKGROUND
  • 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.

MeSH Terms

Conditions

Motor ActivitySedentary Behavior

Interventions

ExercisePalliative Care

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaPatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Results Point of Contact

Title
Jacqueline Kerr
Organization
UCSD

Study Officials

  • Jacqueline Kerr, PhD

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Department of Family and Preventive Medicine

Study Record Dates

First Submitted

June 30, 2010

First Posted

July 1, 2010

Study Start

January 1, 2011

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

August 31, 2017

Results First Posted

July 31, 2017

Record last verified: 2017-08

Locations