Clinical trial NCT01282944: Encouraging Walking in Older Adults
Official title: Encouraging Walking in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Keywords: physical activity in adults 65 or older
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2011-01-25
Enrollment: 92
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this pilot randomized controlled trial is to evaluate whether financial incentives and peer networks delivered through a novel computer platform utilizing a digital pedometer-internet interface can effectively encourage sustained increases in walking among older adults.

Detailed description: This pilot study is a randomized controlled trial of incentive schemes delivered through a novel internet-based platform to promote walking in older adults. The four arms consist of the following: financial incentives, peer network, combined arm (financial incentive \& peer network), and control.

Participation in the study will last approximately 26 weeks, including the 2-week run-in period, 4-month intervention period, and 2-month follow-up period.

The primary goals of the study are:

1. To test the effects of financial incentives on older adults uptake and retention of increased levels of walking.

   Hypothesis1a: Participants receiving financial incentives will increase their number of steps per day more than participants not receiving financial incentives.
2. To test the effects of connection to a new peer network on older adults uptake and retention of increased levels of walking.

   Hypothesis 2a: Participants connected to a new peer network of other participants will increase their number of steps per day more than participants not connected to a new network.

   Hypothesis 2b: Participants connected to a new peer network of other participants will retain increases in their number of steps per day more than participants not connected to a new network.
3. To test the combined effects of financial incentives and peer networks on older adults' uptake and retention of increased levels of walking.

   Hypothesis 3a: Participants who receive financial incentives and are connected to a peer network will increase their number of steps per day more than participants who are only connected to a peer network.

   Hypothesis 3b: Participants who receive financial incentives and are connected to a peer network will more effectively maintain increases in number of steps per day as compared with participants who only receive financial incentives.
4. To develop internet, text and email messaging, and pedometer-internet interface technologies to build peer networks and provide regular feedback to subjects.

Hypothesis 4: The study platform will provide an effective mechanism for subject recruitment, data collection, communication and regular feedback.

Eligibility criteria: Inclusion Criteria:

* Adult 65 years of age or older
* Communicates primarily in English
* Personal computer with high-speed internet connection and functional Universal Serial Bus (USB) port
* Able to walk 1/4 mile (i.e., 2 to 3 blocks) without stopping
* Currently engaging in less than 150 minutes moderate intensity exercise \& less than 75 minutes vigorous intensity exercise each week
* No pedometer use in last 30 days
* Planning to stay in area for study duration

Exclusion Criteria:

* Myocardial infarction, stroke, transient ischemic attack, major cardiovascular surgery, deep venous thrombosis, or pulmonary embolus in the last 6 months
* New York Heart Association Class III or IV heart failure; severe aortic stenosis; history of cardiac arrest, use of cardiac defibrillator; or severe angina
* Hip fracture, total hip replacement, total knee replacement or spinal surgery in the last 6 months
* Uncontrolled hypertension
* Lung disease requiring supplemental oxygen
* Diabetes mellitus requiring insulin therapy
* Severe osteoarthritis or rheumatoid arthritis
* End stage renal disease requiring hemodialysis
* Movement disorder (e.g., Parkinson's disease)
* Dementia (e.g., Alzheimers Disease, Lewy-Body Dementia, Multi-Infarct Dementia, Picks Disease, Binswangers Disease, Frontotemporal Dementias, Parkinsons Disease Dementia, Huntingtons Disease, Dementia in HIV/AIDS, Wernicke-Korsakoff syndrome, Creutzfeldt-Jakob disease)
* Major psychiatric disorder (e.g., schizophrenia or bipolar disorder)
* Current consumption of ≥ 14 alcoholic drinks per week

Primary outcomes:
measure: mean proportion of days that step per day goals were attained
timeFrame: 16 weeks
Secondary outcomes:
measure: mean number of steps per day
timeFrame: 16 weeks
measure: mean proportion of days that step per day goals were attained during follow-up
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Jason Karlawish, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: kullgren@mail.med.edu
name: Jeffrey T Kullgren, MD, MPH
role: STUDY_DIRECTOR
References: