Community-based Intervention Effects on Older Adults' Physical Activity
2 other identifiers
interventional
309
1 country
1
Brief Summary
The research team will conduct a 2 x 2 factorial experiment testing the individual and combined effects of two empirically and theoretically relevant sets of behavior change strategies on community-dwelling older adults' physical activity. To do this the investigators will randomize participants \>= 70 years old (n = 308) to 1 of 4 experimental conditions. All conditions include an evidence-based physical activity protocol endorsed by Centers for Disease Control and Prevention (CDC) for use by all older adults, including those with frailty and multiple co-morbidities and the commercially available physical activity monitor (e.g., Fitbit) to augment intervention delivery. Intervention components that are experimental and vary by condition are the sets of behavior change strategies which will be combined with the physical activity protocol and the physical activity monitor. Condition 1 has no specific behavior change strategies; Condition 2 includes an intervention component comprised of 5 interpersonal behavior change strategies, such as facilitating social support and social comparison; Condition 3 includes an intervention component comprised of 5 intrapersonal behavior change strategies, such as setting personally meaningful goals; and Condition 4 includes both sets of behavior change strategies -- 5 interpersonal strategies combined with 5 intrapersonal behavior change strategies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 1, 2017
CompletedFirst Posted
Study publicly available on registry
October 31, 2017
CompletedStudy Start
First participant enrolled
November 17, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2023
CompletedResults Posted
Study results publicly available
April 24, 2024
CompletedApril 24, 2024
March 1, 2024
6 years
September 1, 2017
January 28, 2024
March 28, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Quantity of Physical Activity Measured Objectively
Average weekly minutes of total physical activity per week (light, moderate and vigorous intensities) as captured from PAM data (Fitbit Charge-2)
Baseline and Post-Intervention (one week, six months, twelve months)
Physical Activity Scale for the Elderly (PASE)
Self-report Measure of Physical Activity. PASE is a validated questionnaire to measure the amount of physical activity in people over the age of 65 including types (e.g., walking, recreational, exercise, housework, care-giving). Scores, accounting for frequency, duration and intensity of physical activity are calculated and typically range from 0 to 793, with higher value representing more physical activity.
Baseline and Post-Intervention (one week, six months, twelve months)
Secondary Outcomes (3)
Fall Rate
12 months post intervention
Number of Participants With Moderate or Major Injuries From Falls
12 months post intervention
Patient Reported Outcomes Measurement Information System (PROMIS) Scale v1.2 Global Health
Baseline and post-intervention: one-week, six months, and 12 months
Study Arms (4)
Otago+PAM+Health / Wellness topics
ACTIVE COMPARATORCondition 1: Otago Exercise Program adapted for delivery to small groups; a physical activity monitor such as a Fitbit (PAM); and, information about health and wellness (8) topics guided by content in the National Institute on Aging (NIA) and Centers for Disease Control and Prevention websites.
Otago + PAM + Interpersonal strategies
EXPERIMENTALCondition 2: Otago Exercise Program adapted for delivery to small groups; a PAM (e.g.,Fitbit); 5 Interpersonal behavior change strategies; and, information about health and wellness topics (1) guided by content in the National Institute on Aging (NIA) and Centers for Disease Control and Prevention websites.
Otago, PAM, Intrapersonal strategies
EXPERIMENTALCondition 3: Otago Exercise Program adapted for delivery to small groups; a PAM (e.g.,Fitbit); 5 Intrapersonal behavior change strategies; and, health and wellness topics (1) guided by content in the National Institute on Aging (NIA) and Centers for Disease Control and Prevention websites.
Otago,PAM, Inter+Intra strategies
EXPERIMENTALCondition 4: Otago Exercise Program adapted for delivery to small groups; a PAM (e.g., Fitbit); 5 Interpersonal behavior change strategies; and, 5 Intrapersonal behavior change strategies
Interventions
The program has been adapted for groups and includes 5 flexibility movements (e.g., back extension and ankle, head, neck, trunk movements), 5 leg strengthening exercises (knee extensor, knee flexor, hip abductor, ankle plantar flexes, ankle dorsiflexes), 12 balance movements (knee bends, backwards walking, walking and turning, sideways walking, tandem stance, tandem walk, one leg stand, heel walking, toe walking, heel-toe walking backwards, sit to stand, stair walking), and a walking plan. The number, intensity and duration of movements are individualized according to preference and ability and they are gradually progressed.
We will use Fitbit Charge 2 (or an equivalent). Features essential for this research include built-in accelerometers that accurately measure steps and physical activity (PA) duration.Participants will have a brief orientation to these during baseline data collection and have the opportunity to return demonstrate. In addition, RAs will be available to help participants troubleshoot, as needed, via telephone and in person, after intervention meetings. Intervention meetings include discussions about the PAMs, but topics vary according to assigned study condition.
The interpersonal content will include facilitated discussed about including PA into social routines, identifying and problem-solving social and environmental barriers to PA, social support for exercise, and friendly social comparisons about practicing PA outside the small group setting and interpreting/ sharing data.
The intrapersonal content will include encouragement and guidance to identify baseline PA patterns, develop and refine personally meaningful goals and plans, identify and problem solve personal barriers to staying physically active, integrate PA into personal routines, and monitor goal outcomes
Information about health and wellness varies in dose, according to time spent in each condition that addresses behavior change. Topics in condition 1 include sleep, vaccinations, supplements, fall risk factors, memory, hearing and pain guided by information for older adults available on the NIA and CDC websites. Topics in conditions 2 and 3 include fall risk factors and sleep. Topics in condition 4 include fall risk factors.
Eligibility Criteria
You may qualify if:
- ≥70 years of age
- English speaking
- Low levels of PA (below recommended guidelines)
- Self-reported fall risk as guided by the CDC, Steadi fall risk screener
- One or more falls in the last year
- Unsteadiness when standing or walking
- Worries about falling
- Participants who self-report the following symptoms will require clearance from a primary provider (as guided by the Exercise and Screening for You Questionnaire)
- Pain, tightness or pressure in chest during PA (walking, climbing stairs, household chores, similar activities) that have not been checked and/ or treated by a healthcare provider
- Current dizziness that have not been checked and/ or treated by a healthcare provider
- Current, frequent falls that have not been checked and/ or treated by a healthcare provider
You may not qualify if:
- Lower extremity injury or surgery within the past 6 weeks
- Inability to walk
- Formal diagnosis of neurocognitive impairment or dementia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Minnesota - School of Nursing
Minneapolis, Minnesota, 55408, United States
Related Publications (1)
McMahon SK, Lewis BA, Guan W, Wang Q, Hayes SM, Wyman JF, Rothman AJ. Effect of Intrapersonal and Interpersonal Behavior Change Strategies on Physical Activity Among Older Adults: A Randomized Clinical Trial. JAMA Netw Open. 2024 Feb 5;7(2):e240298. doi: 10.1001/jamanetworkopen.2024.0298.
PMID: 38421648DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Siobhan McMahon
- Organization
- University of Minnesota
Study Officials
- PRINCIPAL INVESTIGATOR
Siobhan K McMahon, PhD
University of Minnesota
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The specific content of the intervention condition/arm that is assigned to each participant will be masked from data collectors/outcome assessors.
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 1, 2017
First Posted
October 31, 2017
Study Start
November 17, 2017
Primary Completion
October 31, 2023
Study Completion
October 31, 2023
Last Updated
April 24, 2024
Results First Posted
April 24, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- November 17, 2017 to September 2, 2022
- Access Criteria
- IRB approval
De-identified data from this study, including baseline characteristics and outcome variables, will be shared via Data Repository at the University of Minnesota after March 2024