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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01277367
Other study ID # 811570
Secondary ID
Status Withdrawn
Phase Phase 3
First received January 12, 2011
Last updated August 17, 2016
Start date May 2010
Est. completion date February 2013

Study information

Verified date August 2016
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review BoardSouth Africa: Human Research Ethics Committee
Study type Interventional

Clinical Trial Summary

The aim of the study is to prospectively compare the effectiveness of diverse incentives on physical activity behaviour, in a cohort of newly-enrolled, adult members of the Vitality health promotion programme based in South Africa.


Description:

Newly enrolled adult members of the Discovery Health medical plan who have, themselves, prospectively registered for the Vitality health promotion programme will be eligible for the study, and will be invited to participate by Discovery Vitality. A final sample of 9000 adult members, who are recruited and have agreed to participate, will be randomly allocated by Discovery Vitality (with replacement) to one of six study (incentive) groups (n=1500 per group) and followed for six months.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date February 2013
Est. primary completion date February 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 18 years of age or older

- enrolled in Vitality

Exclusion Criteria:

- under 18 years of age

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Discovery Vitality base program
The existing Discovery Vitality health promotion base program, which offers points for various levels of physical activity.
Communication
Participants will be sent regular communications by Discovery Vitality -equivalent to the level of communications in the other incentive groups - which will provide information and tips about ways of accumulating Vitality points on the existing programme (concerning fitness-related activities, in particular).
Charitable Incentive
Members will be asked to nominate a charity, from a selection of charities, which will benefit financially (Discovery Vitality will make a direct payment to a nominated charity) based on their (member's) level of participation in points-earning physical activity. Individuals will receive one of four possible payouts, corresponding to their level of engagement, for their selected charity (amounts given below). In addition, members will be sent regular updates of activities by their nominated charities (This will be operationalised and facilitated by Vitality- and as such, no direct mailing from nominated charity will take place, to maintain confidentiality.)
Prize Draw Incentive
Members will be entered into a prize draw for a monthly cash-prize if they achieve physical activity targets. Four lottery payouts, corresponding to their levels of engagement, will be made on a monthly basis. All members will be sent information regarding the winnings of those that are drawn (unlinked to personal identifiers, but to motivate).
Direct Payment
Members will receive a direct payment (in the form of gift voucher) of one of four possible amounts depending on the level of participation in fitness-related activities equivalent in expected value to the payouts in arms 3 and 4.
Free Choice
Members will be asked to choose one of the three aforementioned incentive options on enrollment to the study.

Locations

Country Name City State
South Africa University of Cape Town Cape Town
South Africa Discovery Vitality Johannesburg
United States University of Pennsylvania Philadelphia Pennsylvania
United States Carnegie Mellon University Pittsburgh Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
University of Pennsylvania

Countries where clinical trial is conducted

United States,  South Africa, 

Outcome

Type Measure Description Time frame Safety issue
Primary Engagement in physical activity Levels of engagement in fitness related activities as measured by 1) continuous measure of Vitality fitness program points accrued, and 2) frequency count or proportion of members by fitness level groups 6 months No
Secondary Fitness points earned The standard Vitality program offers members the ability to accumulate points for physical activity behavior through various means. 6 months No
Secondary Gym visits Average number of gym visits over the six month period will be measured. 6 months No
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