NCT01528761

Brief Summary

The purpose of this 12-month study is to compare how well two programs help older adults make physical activity a regular habit.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
317

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 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

Study Start

First participant enrolled

August 15, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 8, 2012

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2017

Completed
Last Updated

August 14, 2018

Status Verified

August 1, 2018

Enrollment Period

5.6 years

First QC Date

January 31, 2012

Last Update Submit

August 10, 2018

Conditions

Physical Activity

Keywords

physical activityolder adultsphysical functionhealth-related quality of lifeprosocial behaviorsocial cognitive theory

Outcome Measures

Primary Outcomes (1)

  • physical activity

    Self-reported physical activity will be assessed using a questionnaire at 4 time points among all participants; (1) at baseline before randomization; (2) 3 months after the interventions begin; (3) 6 months after the interventions begin; and (4) 12 months after the interventions begin

    12 months

Secondary Outcomes (1)

  • physical function

    12 months

Study Arms (2)

Prosocial Behavior Physical Activity

EXPERIMENTAL

The PBPA condition involves a cognitive-behavioral intervention to teach participants the behavioral skills to engage in independent physical activity. Participants will engage in supervised physical activity delivered two times a week during months 1 to 3 at the William G. White, Jr. Family YMCA in Winston-Salem, NC. During months 4 to 6, supervised sessions will be held once per week, and sessions will be held once per month in months 7 to 9. Participants will engage in completely independent physical activity in months 10 to 12. PBPA participants will also be able to earn boxes of food for donation to the Second Harvest Food Bank (SHFB) of Northwest North Carolina based upon their weekly physical activity. Lowe's Foods, a regional grocery chain, will donate the food. Participants in the PBPA intervention also will receive a 12-month membership to the William G. White, Jr. Family YMCA at no cost.

Behavioral: Prosocial Behavior Physical Activity (PBPA)

Healthy Aging (HA)

ACTIVE COMPARATOR

Behavioral: Healthy Aging (HA) The HA group will receive a health education intervention based on topics from several sources, including the National Institute on Aging's Age Pages, University of Pittsburgh's 10 Keys to Healthy Aging; and Stanford University's Successful Aging program, among other topics . The HA intervention will receive ongoing staff contact, and will provide participants with excellent information on health-related topics. Biweekly 45-minute lectures will be given during months 1 to 6, and once per month during months 7 to 9. After each session, participants will engage in a 15-minute stretching routine. During months 10 to 12, no lectures will be given. After completion of the 12-month assessments, participants will receive a 12-month membership to the YMCA at no cost.

Other: Healthy Aging (HA)

Interventions

Prosocial Behavior Physical Activity (PBPA)BEHAVIORAL

The PBPA condition involves a cognitive-behavioral intervention to teach participants the behavioral skills to engage in independent physical activity. Participants will engage in supervised physical activity delivered two times a week during months 1 to 3 at the William G. White, Jr. Family YMCA in Winston-Salem, NC. During months 4 to 6, supervised sessions will be held once per week, and sessions will be held once per month in months 7 to 9. Participants will engage in completely independent physical activity in months 10 to 12. PBPA participants will also be able to earn boxes of food for donation to the Second Harvest Food Bank (SHFB) of Northwest North Carolina based upon their weekly physical activity. Lowe's Foods, a regional grocery chain, will donate the food. Participants in the PBPA intervention also will receive a 12-month membership to the William G. White, Jr. Family YMCA at no cost.

Prosocial Behavior Physical Activity
Healthy Aging (HA)OTHER

The HA group will receive a health education intervention based on topics from several sources, including the National Institute on Aging's Age Pages, University of Pittsburgh's 10 Keys to Healthy Aging; and Stanford University's Successful Aging program, among other topics . The HA intervention will receive ongoing staff contact, and will provide participants with excellent information on health-related topics. Biweekly 45-minute lectures will be given during months 1 to 6, and once per month during months 7 to 9. After each session, participants will engage in a 15-minute stretching routine. During months 10 to 12, no lectures will be given. After completion of the 12-month assessments, participants will receive a 12-month membership to the YMCA at no cost.

Healthy Aging (HA)

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 55 years or older
  • physically underactive
  • no evidence of any major psychological illness
  • residence within 20 miles of study site
  • plans to remain in area for duration of study

You may not qualify if:

  • currently engaging in regular physical activity
  • self-reported evidence of cardiovascular disease
  • self-reported evidence of diabetes
  • self-reported falling within the past year
  • alcohol consumption greater than 14 drinks per week
  • inability to understand English
  • plans to move from area
  • participation in another medical intervention study
  • severe hearing or sight impairments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (2)

  • Foy CG, Vitolins MZ, Case LD, Harris SJ, Massa-Fanale C, Hopley RJ, Gardner L, Rudiger N, Yamamoto K, Swain B, Goff DC Jr, Danhauer SC, Booth D, Gaspari J. Incorporating prosocial behavior to promote physical activity in older adults: rationale and design of the Program for Active Aging and Community Engagement (PACE). Contemp Clin Trials. 2013 Sep;36(1):284-97. doi: 10.1016/j.cct.2013.07.004. Epub 2013 Jul 19.

    PMID: 23876672BACKGROUND

  • Drahota A, Udell JE, Mackenzie H, Pugh MT. Psychological and educational interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2024 Oct 3;10(10):CD013480. doi: 10.1002/14651858.CD013480.pub2.

    PMID: 39360568DERIVED

MeSH Terms

Conditions

Motor ActivityAltruism

Condition Hierarchy (Ancestors)

BehaviorSocial Behavior

Study Officials

  • Capri G Foy, Ph.D.

    Wake Forest University Baptist Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2012

First Posted

February 8, 2012

Study Start

August 15, 2011

Primary Completion

March 28, 2017

Study Completion

March 28, 2017

Last Updated

August 14, 2018

Record last verified: 2018-08

Locations

US(1)