NCT01282944

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 25, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

March 5, 2014

Status Verified

February 1, 2014

Enrollment Period

1.3 years

First QC Date

January 21, 2011

Last Update Submit

March 4, 2014

Conditions

Physical Activity

Keywords

physical activity in adults 65 or older

Outcome Measures

Primary Outcomes (1)

  • mean proportion of days that step per day goals were attained

    16 weeks

Secondary Outcomes (2)

  • mean number of steps per day

    16 weeks

  • mean proportion of days that step per day goals were attained during follow-up

    8 weeks

Study Arms (4)

Combined Financial Incentive & Peer Network Arm

EXPERIMENTAL

Daily use of pedometer for 6 months. Walking goal set based on level of walking during 2 week run-in period. Subjects connected with 4 other participants in the same study arm to form a peer network of 5 individuals. Each peer network participant given access to a secure online message board that will allow the 5 participants in each peer network to communicate online. Participants also receive weekly feedback regarding which participants in the peer group achieved their walking goals during the previous week. Each week, if pedometer is used and walking goal is met for 5 out of 7 days, participant will be entered in lottery with an approximate 3 in 10 chance of winning $50 and an approximate 3 in 100 chance of winning $200. Financial incentive and peer network terminated after 4 months. Daily use of pedometer continues for an additional 2 months.

Behavioral: Financial IncentiveBehavioral: Peer Network

Active Control

NO INTERVENTION

Daily use of pedometer for 6 months. Walking goal set based on level of walking during 2 week run-in period. Weekly feedback provided on meeting walking goal - defined as achieving goal number of steps for 5 of 7 days per week. Subjects in the Control Group will only receive pedometers and weekly feedback on their performance through the same mechanisms and with the same frequency as participants in the other three study arms. There will be no financial incentives or peer networks in this group.

Financial Incentive Arm

EXPERIMENTAL

Daily use of pedometer for 6 months. Walking goal set based on level of walking during 2 week run-in period. Weekly feedback provided on meeting walking goal - defined as achieving goal number of steps for 5 of 7 days per week. Each week, if pedometer is used and walking goal is met for 5 out of 7 days, participant will be entered in lottery with an approximate 3 in 10 chance of winning $50 and an approximate 3 in 100 chance of winning $200. Financial incentive is terminated after 4 months. Daily use of pedometer continues for an additional 2 months.

Behavioral: Financial Incentive

Peer Network Arm

EXPERIMENTAL

Daily use of pedometer for 6 months. Walking goal set based on level of walking during 2 week run-in period. Weekly feedback provided on meeting walking goal - defined as achieving goal number of steps for 5 of 7 days per week. Subjects will be connected with 4 other participants in the same study arm to form a peer network of 5 individuals. Each peer network participant will be given access to a secure online message board that will allow the 5 participants in each peer network to communicate online. All participants in a peer network will receive a list of ways in which his or her new network could support each individual's walking goals. Participants will also receive weekly feedback regarding which participants in the peer group were successful in achieving their walking goals during the previous week. Peer network is terminated after 4 months. Daily use of pedometer continues for an additional 2 months.

Behavioral: Peer Network

Interventions

Financial IncentiveBEHAVIORAL

Lottery with an approximate 3 in 10 odds of earning $50 and an approximate 3 in 100 odds of earning $200.

Combined Financial Incentive & Peer Network ArmFinancial Incentive Arm
Peer NetworkBEHAVIORAL

Subjects will be connected with 4 other participants in the same study arm to form a peer network of 5 individuals.

Combined Financial Incentive & Peer Network ArmPeer Network Arm

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Jason Karlawish, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

  • Jeffrey T Kullgren, MD, MPH

    kullgren@mail.med.edu

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2011

First Posted

January 25, 2011

Study Start

March 1, 2011

Primary Completion

June 1, 2012

Study Completion

August 1, 2012

Last Updated

March 5, 2014

Record last verified: 2014-02

Locations

US(1)