- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01528761
Prosocial Behavior and Volunteerism to Promote Physical Activity in Older Adults
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Although only a small percentage of older adults engage in habitual physical activity, previous studies have demonstrated interventions that include cognitive-behavioral strategies can enhance long-term, independent physical activity. In addition, there are episodic charity events, such as charity walks, that attract large numbers of participants of all age ranges to engage in moderate-intensity physical activity. These actions are a form of prosocial behavior, defined as voluntary, intentional behavior that results in benefits for another. The opportunity to help others seems to be a motive in inspiring these individuals to at least engage in one session of moderate physical activity. Thus, the current research project contemplates whether prosocial behavior may be implemented as a viable behavioral incentive for long-term physical activity.
Participants in the Prosocial Behavior Physical Activity (PBPA) intervention will receive a cognitive-behavioral intervention to teach participants the behavioral skills necessary to engage in long-term (12-month) independent physical activity. Participants in the Healthy Aging (HA) intervention will receive excellent educational sessions based on a number of topics of relevance to older adults. Both programs will provide supervised stretching sessions so that participants learn how to safely and effectively improve flexibility, which helps reduce the likelihood of falls and disability. However, the PBPA intervention will also allow participants to earn food for donation to Second Harvest Food Bank based on their regular physical activity and volunteer time.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
-
Winston-Salem, North Carolina, United States, 27157
- Wake Forest School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Prosocial Behavior Physical Activity
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.
|
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.
|
|
Active Comparator: Healthy Aging (HA)
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
physical activity
Time Frame: 12 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
physical function
Time Frame: 12 months
|
A series of 3 physical function tests will be administered to all participants at three time points: (1) at baseline before randomization; (2) 3 months after the interventions begin; and (3) 12 months after the interventions begin.
All of the tests are brief and uncomplicated to perform.
|
12 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Capri G Foy, Ph.D., Wake Forest University Baptist Health
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB00017741
- 1R01HL109429-04 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Physical Activity
-
Muğla Sıtkı Koçman UniversityEge UniversityCompletedPhysical Activity | Physical Activity Behavior | Physical Activity LevelsTurkey
-
Istinye UniversityCompletedPhysical Activity | Youth | Physical Activity Barriers | Physical Activity FacilitatorsTurkey
-
Universidad Pedagogica Nacional, ColombiaEnrolling by invitationPhysical Activity | Running | Running Performance | Running Endurance | Physical Activity in Adults | Physical Activity IntensityColombia
-
Istanbul Kültür UniversityWithdrawnPhysical Activity Level | Physical Activity Awareness
-
University of ManitobaResearch ManitobaCompletedPhysical Activity | Physical Activity Self-Definition
-
Odense University HospitalUniversity of Southern DenmarkRecruitingQuality of Life | Physical Activity | Physical Disability | Physical Function | ParticipationDenmark
-
Universidade do PortoActive, not recruitingPhysical Activity | Physical Fitness | Well BeingPortugal
-
Firat UniversityNot yet recruitingUniversity Students | Physical Activity Level | Postural Awareness | Physical Activity AttitudeTurkey
-
Assistance Publique - Hôpitaux de ParisTerminatedPhysical Activity | Physical DisabilityFrance
-
University of Colorado, DenverCompletedPhysical Activity | Physical ImpairmentUnited States
Clinical Trials on Prosocial Behavior Physical Activity (PBPA)
-
National Institute on Aging (NIA)UnknownPhysical Activity | Physical Function | Health-Related Quality of LifeUnited States
-
VA Office of Research and DevelopmentCompletedDiabetes Mellitus, Type 2 | Amputation | Peripheral Artery DiseaseUnited States
-
PXL University CollegeHasselt UniversityNot yet recruitingPhysical Activity - Digital Phenotyping - Activity Tracking
-
McMaster UniversityThe Ottawa Hospital Academic Medical Association; Hamilton Academic Health... and other collaboratorsCompleted
-
University of California, San FranciscoEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsTerminatedHiv | ContraceptionTanzania
-
Rio de Janeiro State UniversityUniversidade Federal do Rio de JaneiroCompleted
-
University of Colorado, DenverCompleted
-
University of Alabama at BirminghamCompleted
-
Stanford UniversityNational Heart, Lung, and Blood Institute (NHLBI)CompletedHeart Diseases | Cardiovascular Diseases | ObesityUnited States