Nutrition Clinical Trial
Official title:
Increasing Engagement With the Vitality HealthyFood Benefit: A Randomized Field Trial Proposal
NCT number | NCT02486588 |
Other study ID # | 822607 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2015 |
Est. completion date | April 30, 2017 |
Verified date | July 2020 |
Source | University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In collaboration with Vitality/Discovery in South Africa, an RCT amongst adult enrolled in the lowest tier of Vitality's HealthyFood benefit will be conducted. We will compare the effect of various messaging, and financial incentive strategies on healthy food purchasing behaviors in this population.
Status | Completed |
Enrollment | 7314 |
Est. completion date | April 30, 2017 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - For this study, we will focus on the following individuals: 1. Adult members of Vitality Health who have activated their HealthyFood benefit in 2014 but have not completed the Vitality Age calculation or Vitality Healthy Check, and therefore are on a 10% cash- back reward level on healthy food purchases. 2. Members who have chosen Woolworths as their preferred HealthyFood partner. 3. Members with an available email address and SMS-capable telephone 4. Members with meeting specified spending cutoff (R1000 total spend in the previous month, at least 90% of which was spent at Woolworth's.) Exclusion Criteria: - Anyone who does not meet all of the above inclusion criteria |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University of Pennsylvania |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Monthly % Healthy Food Expenditure | The difference in monthly healthy food expenditures between arms. This measure is defined as the monthly amount spent on healthy foods divided by the total monthly amount spent on food, multiplied by 100. For those individuals who had no recorded expenditure in a given month, they will be assigned 0% healthy food expenditure that month; in this way, this outcome can be considered a composite score of being engaged in the healthy food program (0%=not engaged) and the level of engagement (if monthly expenditure >0). Each individual's data will be averaged across the intervention period. |
Monthly over 6 month intervention period | |
Secondary | Monthly % Unhealthy Food Expenditure | The difference in monthly unhealthy food expenditures between arms. This measure is defined as the monthly amount spent on unhealthy foods divided by the total monthly amount spent on food, multiplied by 100. The average over the full intervention months will be calculated within an individual and compared between arms. To be complementary with the primary endpoint analysis, in a month where an individual is not engaged in the program (0 total monthly expenditure) the worst-score (100) is imputed for that month. A similar MI approach will also be conducted as a sensitivity analysis. |
Monthly over 6 month intervention period | |
Secondary | Monthly % Healthy Items | The difference in monthly healthy food items purchased between arms. This measure is defined as the monthly number of healthy food items divided by the total monthly number of food items. The average over the full intervention months will be calculated within an individual and compared between arms. To be complementary with the primary endpoint analysis, in a month where an individual is not engaged in the program (0 total monthly expenditure) the worst-score (0) is imputed for that month. A similar MI approach will also be conducted as a sensitivity analysis. |
Monthly over 6 month intervention period | |
Secondary | Monthly % Unhealthy Items | The difference in monthly unhealthy food items purchased between arms. This measure is defined as the monthly number of unhealthy food items divided by the total monthly number of food items. The average over the full intervention months will be calculated within an individual and compared between arms. To be complementary with the primary endpoint analysis, in a month where an individual is not engaged in the program (0 total monthly expenditure) the worst-score (100) is imputed for that month. A similar MI approach will also be conducted as a sensitivity analysis. |
Monthly over 6 month intervention period | |
Secondary | Percentage Change in Monthly % Healthy Food Expenditures Between Arms | Examining the difference in healthy food expenditure trends between arms where the % health food expenditure is defined as describe for outcome 1 (above) | During the 6 month intervention period | |
Secondary | Percent Change in Monthly %Unhealthy Food Expenditures Between Arms | Examining the difference in unhealthy food expenditure trends between arms where %unhealthy food expenditure is defined as described for Outcome 2 (above). | During the 6 month intervention period | |
Secondary | Percent Change for Monthly % Healthy Food Items Between Arms | Examining the difference in proportion healthy food item trends between arms where % healthy food items is defined as described for Outcome 3 (above) | During the 6 month intervention period | |
Secondary | Percent Change in Monthly %Unhealthy Food Items Between Arms | Examining the difference in proportion unhealthy food item trends between arms where % unhealthy food items is defined as described for Outcome 5 (above). | During the 6 month intervention period |
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