Clinical trial NCT03299348: AgingPLUS: Promoting Physical Activity in Adults
Official title: Testing Psychological Mechanisms to Promote Physical Activity in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Keywords: Psychological Mechanisms
Social-Cognitive Mechanisms
Lead sponsor: Colorado State University
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
name: National Institute on Aging (NIA)
First posted: 2017-10-03
Enrollment: 402
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study has an active treatment group and an active control group
Primary purpose: BASIC_SCIENCE

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Increased physical activity
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Collins
country: United States
facility: Colorado State University
state: Colorado
Study officials:
affiliation: Colorado State University
name: Manfred K. Diehl, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.