Encouraging Walking in Older Adults

Physical Activity Clinical Trial

Official title:

Encouraging Walking in Older Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01282944
• Other study ID #: 812090
• Secondary ID: RC2AG036592
• Status: Completed
• Phase: N/A
• First received: January 21, 2011
• Last updated: March 4, 2014
• Start date: March 2011
• Est. completion date: August 2012

Study information

• Verified date: February 2014
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: August 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Physical Activity

Intervention

Behavioral:
• Financial Incentive
Lottery with an approximate 3 in 10 odds of earning $50 and an approximate 3 in 100 odds of earning $200.
• Peer Network
Subjects will be connected with 4 other participants in the same study arm to form a peer network of 5 individuals.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean proportion of days that step per day goals were attained		16 weeks	No
Secondary	mean number of steps per day		16 weeks	No
Secondary	mean proportion of days that step per day goals were attained during follow-up		8 weeks	No