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Encouraging Walking in Older Adults

4 maart 2014 bijgewerkt door: University of Pennsylvania
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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

92

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Pennsylvania
      • Philadelphia, Pennsylvania, Verenigde Staten, 19104
        • University of Pennsylvania

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

65 jaar en ouder (Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Onderzoek naar gezondheidsdiensten
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Combined Financial Incentive & Peer Network Arm

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

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.
Experimenteel: Financial Incentive Arm
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.
Gedragsmatig: Financial Incentive
Lottery with an approximate 3 in 10 odds of earning $50 and an approximate 3 in 100 odds of earning $200.
Experimenteel: Peer Network Arm

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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
mean proportion of days that step per day goals were attained
Tijdsspanne: 16 weeks
16 weeks

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
mean number of steps per day
Tijdsspanne: 16 weeks
16 weeks
mean proportion of days that step per day goals were attained during follow-up
Tijdsspanne: 8 weeks
8 weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Pennsylvania

Medewerkers

National Institute on Aging (NIA)

Onderzoekers

  • Hoofdonderzoeker: Jason Karlawish, MD, University of Pennsylvania
  • Studie directeur: Jeffrey T Kullgren, MD, MPH, kullgren@mail.med.edu

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 maart 2011

Primaire voltooiing (Werkelijk)

1 juni 2012

Studie voltooiing (Werkelijk)

1 augustus 2012

Studieregistratiedata

Eerst ingediend

21 januari 2011

Eerst ingediend dat voldeed aan de QC-criteria

24 januari 2011

Eerst geplaatst (Schatting)

25 januari 2011

Updates van studierecords

Laatste update geplaatst (Schatting)

5 maart 2014

Laatste update ingediend die voldeed aan QC-criteria

4 maart 2014

Laatst geverifieerd

1 februari 2014

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • 812090
  • RC2AG036592 (Subsidie/contract van de Amerikaanse NIH)

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