DiabetesNCT02462057
Testing Different Messaging Approaches to Increase Activation of a HealthyFood Benefit in Adults With Diabetes
A study testing Email message regarding the HealthyFood benefit in people with Diabetes and Diet, run by University of Pennsylvania.
Trial summary
The Vitality HealthyFood benefit is a three-tiered incentive program designed to encourage healthier food choices amongst members of Discovery Health's Vitality program. Once enrolled in the benefit, participating members can receive 10%, 15%, or 25% cash-back on the healthy foods they purchase at selected grocers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Diet, Incentives
- What is being tested?
- Email message regarding the HealthyFood benefit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,467 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Jul 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults over age 18
- Vitality health members who have not yet enrolled in the Vitality HealthyFood benefit
- Diagnosis of type 2 diabetes (based on registration for chronic benefits for type 2 diabetes)
- Have registered on to Discovery Health/Vitality website in the past (marker of Internet access and availability of email address)
Who cannot join
- Anyone who does not meet above criteria
About this study
Official title: Testing the Effectiveness of Different Messaging Approaches to Increase Activation of a HealthyFood Benefit Amongst Individuals With Diabetes: A Randomised, Controlled Trial
The Vitality HealthyFood benefit is a three-tiered incentive program designed to encourage healthier food choices amongst members of Discovery Health's Vitality program. Once enrolled in the benefit, participating members can receive 10%, 15%, or 25% cash-back on the healthy foods they purchase at selected grocers. And, while overall enrollment in the program is high, there is particular interest in increasing enrollment in the benefit amongst Vitality members with diabetes. One presumed barrier to enrollment in the benefit amongst members with diabetes is a misperception of the particular relevance of the benefit and healthier food choices for their personal health. Improved messaging regarding the HealthyFood benefit and its particular salience for individuals with diabetes may be an effective means of increasing activation of the benefit in this population. The proposed study will be a collaboration between Discovery Health/Vitality and researchers at the Perelman School of Medicine at the University of Pennsylvania. In the proposed RCT, Vitality members with diabetes will be randomised to different types of messages regarding the HealthyFood benefit. The investigators will then compare the effectiveness of these different messaging strategies at increasing activation of the HealthyFood benefit amongst Vitality members with diabetes.
- Conditions
- Diabetes, Diet, Incentives, Messaging
- Being tested
- Email message regarding the HealthyFood benefit
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Email message regarding the HealthyFood benefitOther
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | No intervention | This arm will represent current practice. This group will receive no contact from the research team. They may receive information regarding the benefit from the Vitality marketing team during the intervention period and can enroll in the benefit at any time during the study period. |
| Diabetes-specific | Active comparator | This group will receive a message which simply cites the two specific benefits of the eating more healthy foods for individuals with diabetes. This message contains a link to start the enrolment process. Receives: Other: Email message regarding the HealthyFood benefit |
| Experience of another member | Active comparator | This group will receive a message that includes a quote from the perspective of a Vitality member with diabetes who uses the HealthyFood benefit. Given the need to standardise message content across study arms, the quote was written by the study team and not an actual member. The quote emphasizes the positive impact the benefit has had for the member-both the financial benefit, as well as the two specific diabetes health benefits. Receives: Other: Email message regarding the HealthyFood benefit |
| Input from a diabetes expert | Active comparator | This group will receive a message that includes a quote from a South African physician who specializes in diabetes. The quote emphasises the financial benefit and the two specific diabetes health benefits of the HealthyFood program included in the other messages. It concludes with the doctor's recommendation of the benefit for all individuals with diabetes. Receives: Other: Email message regarding the HealthyFood benefit |
| Enhanced active choice | Active comparator | This group will receive a message whose first portion is identical to those in the diabetes-specific message group. The second portion of the message differs in that instead of just asking recipients to click on the provided link if interested, the message asks people to choose and click on one of following possible responses:
1. Yes! I want to active the HealthyFood benefit and get up to 25% cash back on the healthy food I buy at Pick n Pay or Woolworths
2. No, I'd prefer not to activate and continue paying full price for my healthy food purchases Receives: Other: Email message regarding the HealthyFood benefit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment in 10% Level of Benefit
Rates of enrolment in 10% cash-back level (the most basic level, requires online activation only) of the HealthyFood Benefit amongst members with diabetes
Measured: One month from initial emailed messages
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5,467 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Discovery Health
- Responsible party
- Principal investigator, Anjali Gopalan, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02462057
- Sponsor's protocol ID
- 821895
- Status last verified
- Apr 2018
- First submitted
- 30 May 2015
- Last updated
- 9 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Gopalan A, Paramanund J, Shaw PA, Patel D, Friedman J, Brophy C, Buttenheim AM, Troxel AB, Asch DA, Volpp KG. Randomised controlled trial of alternative messages to increase enrolment in a healthy food programme among individuals with diabetes. BMJ Open. 2016 Nov 30;6(11):e012009. doi: 10.1136/bmjopen-2016-012009.
PubMed 27903559
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Effectiveness of Different Messaging Approaches to Increase Activation of a HealthyFood Benefit Amongst Individuals With Diabetes: A Randomised, Controlled Trial
- ClinicalTrials.gov ID
- NCT02462057
- Acronym / sponsor ID
- 821895
- Conditions
- Diabetes, Diet, Incentives, Messaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,467 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Discovery Health
- Study start
- Jun 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 3 Jun 2015 (estimated)
- Results
- Posted 9 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Vitality HealthyFood benefit is a three-tiered incentive program designed to encourage healthier food choices amongst members of Discovery Health's Vitality program. Once enrolled in the benefit, participating members can receive 10%, 15%, or 25% cash-back on the healthy foods they purchase at selected grocers. And, while overall enrollment in the program is high, there is particular interest in increasing enrollment in the benefit amongst Vitality members with diabetes. One presumed barrier to enrollment in the benefit amongst members with diabetes is a misperception of the particular relevance of the benefit and healthier food choices for their personal health. Improved messaging regarding the HealthyFood benefit and its particular salience for individuals with diabetes may be an effective means of increasing activation of the benefit in this population. The proposed study will be a collaboration between Discovery Health/Vitality and researchers at the Perelman School of Medicine at the University of Pennsylvania. In the proposed RCT, Vitality members with diabetes will be randomised to different types of messages regarding the HealthyFood benefit. The investigators will then compare the effectiveness of these different messaging strategies at increasing activation of the HealthyFood benefit amongst Vitality members with diabetes.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Control Arm | No intervention | –This arm will represent current practice. This group will receive no contact from the research team. They may receive information regarding the benefit from the Vitality marketing team during the intervention period and can enroll in the benefit at any time during the study period. |
| Diabetes-specific | Active comparator | Other: Email message regarding the HealthyFood benefitThis group will receive a message which simply cites the two specific benefits of the eating more healthy foods for individuals with diabetes. This message contains a link to start the enrolment process. |
| Experience of another member | Active comparator | Other: Email message regarding the HealthyFood benefitThis group will receive a message that includes a quote from the perspective of a Vitality member with diabetes who uses the HealthyFood benefit. Given the need to standardise message content across study arms, the quote was written by the study team and not an actual member. The quote emphasizes the positive impact the benefit has had for the member-both the financial benefit, as well as the two specific diabetes health benefits. |
| Input from a diabetes expert | Active comparator | Other: Email message regarding the HealthyFood benefitThis group will receive a message that includes a quote from a South African physician who specializes in diabetes. The quote emphasises the financial benefit and the two specific diabetes health benefits of the HealthyFood program included in the other messages. It concludes with the doctor's recommendation of the benefit for all individuals with diabetes. |
| Enhanced active choice | Active comparator | Other: Email message regarding the HealthyFood benefitThis group will receive a message whose first portion is identical to those in the diabetes-specific message group. The second portion of the message differs in that instead of just asking recipients to click on the provided link if interested, the message asks people to choose and click on one of following possible responses: 1. Yes! I want to active the HealthyFood benefit and get up to 25% cash back on the healthy food I buy at Pick n Pay or Woolworths 2. No, I'd prefer not to activate and continue paying full price for my healthy food purchases |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults over age 18
- Vitality health members who have not yet enrolled in the Vitality HealthyFood benefit
- Diagnosis of type 2 diabetes (based on registration for chronic benefits for type 2 diabetes)
- Have registered on to Discovery Health/Vitality website in the past (marker of Internet access and availability of email address)
Key exclusion criteria (1 listed)
- Anyone who does not meet above criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Email message regarding the HealthyFood benefit | Other | Diabetes-specific, Enhanced active choice, Experience of another member, Input from a diabetes expert |
Primary outcome
Enrollment in 10% Level of Benefit
Time frame: One month from initial emailed messages
Rates of enrolment in 10% cash-back level (the most basic level, requires online activation only) of the HealthyFood Benefit amongst members with diabetes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27903559Gopalan A, Paramanund J, Shaw PA, Patel D, Friedman J, Brophy C, Buttenheim AM, Troxel AB, Asch DA, Volpp KG. Randomised controlled trial of alternative messages to increase enrolment in a healthy food programme among individuals with diabetes. BMJ Open. 2016 Nov 30;6(11):e012009. doi: 10.1136/bmjopen-2016-012009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Email message regarding the HealthyFood benefit in people with Diabetes and Diet, run by University of Pennsylvania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment in 10% Level of Benefit (time frame: One month from initial emailed messages). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02462057, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2018.