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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03299348
Other study ID # 3437
Secondary ID 5R01AG051723-05
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2018
Est. completion date May 31, 2023

Study information

Verified date September 2023
Source Colorado State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study examines the efficacy of a psycho-educational intervention program, AgingPLUS, with regard to increasing middle-aged and older adults' engagement in physical activity.


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.


Recruitment information / eligibility

Status Completed
Enrollment 402
Est. completion date May 31, 2023
Est. primary completion date May 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 45 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
AgingPLUS
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.
Active Control Group
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.

Locations

Country Name City State
United States Colorado State University Fort Collins Colorado

Sponsors (3)

Lead Sponsor Collaborator
Colorado State University Johns Hopkins University, National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Increased physical activity 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.
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