Vitality Health Incentives for Physical Activity

August 17, 2016 updated by: University of Pennsylvania

A Prospective, Randomized Clinical Trial Comparing the Effectiveness of Different Types of Incentives in Increasing Physical Activity Behavior on the Vitality Health Promotion Programme

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
      • Cape Town, South Africa
        • University of Cape Town
      • Johannesburg, South Africa
        • Discovery Vitality
  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Carnegie Mellon University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years of age or older
  • enrolled in Vitality

Exclusion Criteria:

  • under 18 years of age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: A
These members will be offered no additional incentives
Behavioral: Discovery Vitality base program
The existing Discovery Vitality health promotion base program, which offers points for various levels of physical activity.
Experimental: B
These members will receive regular communications by Discovery Vitality.
Behavioral: Discovery Vitality base program
The existing Discovery Vitality health promotion base program, which offers points for various levels of physical activity.
Behavioral: 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).
Experimental: C
These members will nominate a charity which will benefit financially based on participants' level of physical activity.
Behavioral: Discovery Vitality base program
The existing Discovery Vitality health promotion base program, which offers points for various levels of physical activity.
Behavioral: 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.)
Experimental: D
These members are entered into a prize draw for a monthly cash prize if they achieve physical activity targets.
Behavioral: Discovery Vitality base program
The existing Discovery Vitality health promotion base program, which offers points for various levels of physical activity.
Behavioral: 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).
Experimental: E
These members will receive a direct payment.
Behavioral: Discovery Vitality base program
The existing Discovery Vitality health promotion base program, which offers points for various levels of physical activity.
Behavioral: 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.
Experimental: F
These members will be offered the opportunity to choose one of three incentive options at the time of enrollment in the study.
Behavioral: Discovery Vitality base program
The existing Discovery Vitality health promotion base program, which offers points for various levels of physical activity.
Behavioral: Free Choice
Members will be asked to choose one of the three aforementioned incentive options on enrollment to the study.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Engagement in physical activity
Time Frame: 6 months
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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fitness points earned
Time Frame: 6 months
The standard Vitality program offers members the ability to accumulate points for physical activity behavior through various means.
6 months
Gym visits
Time Frame: 6 months
Average number of gym visits over the six month period will be measured.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pennsylvania

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Deepak Patel, MD, Discovery Holdings, LTD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 12, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 14, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 19, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 811570

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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