- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03299348
AgingPLUS: Promoting Physical Activity in Adults
Testing Psychological Mechanisms to Promote Physical Activity in Adults
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
AgingPLUS is a multi-component intervention program that addresses negative views of aging (NVOA), low internal control beliefs, and deficient goal planning as a risk cluster that keeps adults from engaging in health-promoting behavior. The program focuses on engagement in physical activity (PA) as the health behavior of choice. Engagement in PA is widely recognized as the best non-pharmacological, non-invasive, and cost-effective method of health promotion. Yet, only 20% of the adult population meets the recommended PA guidelines. This suggests that messages about the benefits of PA alone are not effective. Rather, it is essential to address the social-cognitive and motiva-tional mechanisms that prevent adults from adopting and maintaining a regular PA regimen. NVOA, low internal control beliefs, and deficient goal planning represent such a cluster of social-cognitive and motivational mechanisms.
Given this background, the specific aims and hypotheses of the proposed research are:
Aim 1: To conduct a randomized controlled trial examining the efficacy of the AgingPLUS program.
Aim 2: To test a conceptual model of the mechanisms underlying the intervention effects.
Aim 3: To conduct a 6-month follow-up to examine the longer-term effects of AgingPLUS.
Upon completion of this project, we expect to have successfully established evidence for the efficacy of the AgingPLUS program (Stage II of the NIH Stage Mode). The long-term goal is to develop AgingPLUS into a full-fledged evidence-based program that can be implemented in community settings (e.g., senior centers), and can serve as a fairly brief and cost-effective public health tool to promote healthy and successful aging.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Colorado
-
Fort Collins, Colorado, United States, 80523-1570
- Colorado State University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults who engage in less than 60 minutes of PA per week and who intend starting a physical exercise program.
- English speaking.
- Willingness to be randomized to one of two programs.
- Willingness to take part in the physical fitness tests and wear an accelerometer.
- Willingness to commit to follow-up testing (i.e., not moving out of the area during the study period).
- Physician clearance to take part in a submaximal exercise test and to begin an exercise program.
Exclusion Criteria:
- Signs of cognitive decline (defined as more than 4 errors on the Short Portable Mental Status Questionnaire).
- Severe vision and/or hearing loss (obtained by self-report).
- Serious problems with mobility.
- A history of neurological, mental, or substance abuse disorders.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Active Treatment Group
This group will get the AgingPLUS intervention program which addresses negative views on aging, low internal control beliefs, and deficient goal planning skills.
|
The program consists of 2-hour meetings for a total of 4 weeks (total of 8 hours) and discusses (a) how negative views on aging and negative age stereotypes undermine adults' health-promoting behaviors; (b) how adults can take control of their own aging; and (c) how personal goals can be achieved through more effective goal planning and action plans.
|
|
Placebo Comparator: Active Control Group
This group will get a generic health education program, called the "10 Keys to Healthy Aging".
The control program will control for the effect of social contact and will not address the intervention targets of the active treatment group.
The health education program will only provide information related to some of the most important health conditions, such as cardiovascular disease, cancer, type 2 diabetes, and clinical depression, and how these conditions can be managed.
|
The program consists of 2-hour meetings for a total of 4 weeks (total of 8 hours) and discusses (a) four major health conditions that affect the lives of many middle-aged and older adults (e.g., cardiovascular disease, cancer, type 2 diabetes; clinical depression); and (b) how these conditions can be managed successfully.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Increased physical activity
Time Frame: This effect should be observable (1) at the Week-4 post-test, (2) the Week-8 post-test, and (3) the 6-Month post-test.
|
We expect that participants significantly increase their engagement in physical activity as assessed by an accelerometer.
|
This effect should be observable (1) at the Week-4 post-test, (2) the Week-8 post-test, and (3) the 6-Month post-test.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Manfred K. Diehl, PhD, Colorado State University
Publications and helpful links
General Publications
- Brothers A, Diehl M. Feasibility and Efficacy of the AgingPlus Program: Changing Views on Aging to Increase Physical Activity. J Aging Phys Act. 2017 Jul;25(3):402-411. doi: 10.1123/japa.2016-0039. Epub 2016 Dec 5.
- Diehl M, Nehrkorn-Bailey A, Thompson K, Rodriguez D, Li K, Rebok GW, Roth DL, Chung SE, Bland C, Feltner S, Forsyth G, Hulett N, Klein B, Mars P, Martinez K, Mast S, Monasterio R, Moore K, Schoenberg H, Thomson E, Tseng HY. The AgingPLUS trial: Design of a randomized controlled trial to increase physical activity in middle-aged and older adults. Contemp Clin Trials. 2020 Sep;96:106105. doi: 10.1016/j.cct.2020.106105. Epub 2020 Aug 11.
- Nehrkorn-Bailey AM, Rodriguez D, Forsyth G, Braun B, Burke K, Diehl M. Change in Views of Aging, Physical Activity, and Physical Health Over 8 Weeks: Results From a Randomized Study. J Aging Phys Act. 2023 Jan 28;31(4):666-678. doi: 10.1123/japa.2022-0133. Print 2023 Aug 1.
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 (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 3437
- 5R01AG051723-05 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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
-
Universidade do PortoActive, not recruitingPhysical Activity | Physical Fitness | Well BeingPortugal
-
Odense University HospitalUniversity of Southern DenmarkRecruitingQuality of Life | Physical Activity | Physical Disability | Physical Function | ParticipationDenmark
-
Firat UniversityNot yet recruitingUniversity Students | Physical Activity Level | Postural Awareness | Physical Activity AttitudeTurkey
-
Pham Ngoc Thach University of MedicineCompletedModerate Physical Activity (MPA) | Vigorous Physical Activity (VPA) | Moderate to Vigorous Physical Activity (MVPA) | Total of Sleep Time (TST)Vietnam
-
Georgetown UniversityUniversity of PennsylvaniaCompletedPhysical Activity | Motor ActivityUnited States