Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02975232 |
| Other study ID # |
2016-68001-24961 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 2016 |
| Est. completion date |
March 31, 2021 |
Study information
| Verified date |
May 2021 |
| Source |
University of New England |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Through research, education and extension, this project will promote fruit and vegetable
(F&V) purchases and consumption by families in under-resourced communities, thus reducing
health disparities, improving human nutrition, and preventing unhealthy weight gain among
children. Specifically, this project aims to evaluate the success of promoting F&V purchases
among low- income and Supplemental Nutrition Assistance Program (SNAP)-eligible families and
children living in a rural Maine community through a double value coupon, supermarket- based
incentive program combined with Cooking Matters at the Store education. Education and
extension efforts based on the study findings will contribute to meeting USDA Childhood
Obesity Prevention Challenge Area Goals of generating new knowledge; developing, assessing
and expanding effective interventions; and increasing the number of skilled and informed
professionals and consumers to address the complex problem of childhood obesity. The research
team will partner with a large national retail grocery chain (Hannaford Brothers), Cooking
Matters, University of Maine Cooperative Extension, eXtension Communities of Practice, Maine
SNAP-Ed, and The Food Trust to accomplish the project objectives.
Description:
Through research, education and extension, this project will promote fruit and vegetable
(F&V) purchases and consumption by families in under-resourced communities, thus reducing
health disparities, improving human nutrition, and preventing unhealthy weight gain among
children. Specifically, this project aims to evaluate the success of promoting F&V purchases
among low- income and SNAP-eligible families and children living in a rural Maine community.
The project will use a multipronged approach in the supermarket setting, including
implementation methods from the highly effective, double value coupon incentive program used
at farmers' markets, as well as the Cooking Matters at the Store educational program to
incentivize the purchase and consumption of fresh produce, and healthful frozen and canned
F&V (without syrup or salt), nutrient-rich and affordable year- round alternatives to fresh
produce.
Education and extension efforts based on the study findings will contribute to meeting United
States Department of Agriculture (USDA) Childhood Obesity Prevention Challenge Area Goals of
generating new knowledge; developing, assessing and expanding effective interventions; and
increasing the number of skilled and informed professionals and consumers to address the
complex problem of childhood obesity. The project team will partner with a large national
retail grocery chain (Hannaford Brothers), Cooking Matters, University of Maine (UMaine)
Cooperative Extension, eXtension Communities of Practice, Maine SNAP-Education (SNAP-Ed), and
The Food Trust to accomplish its objectives.
Methods:
Research Strategy: The study will enroll 600 shoppers (and assume 70% retention, with an
initial N of 600: n=210 per study arm) entering the store in months 6-7. If a customer has
interest in participating and meets enrollment criteria (having a child between ages 2 and 18
years of age living in the household, and use of the Hannaford store as the primary grocery
shopping venue), then the customer will be asked to enroll. At enrollment, research
assistants will obtain informed consent, instruct participants about how to join
"MyHannaford" in order to receive a unique study ID for tracking of all purchases, and give
participants a MyHannaford "study loyalty" card and Guiding Stars information. A short survey
will be administered to collect information about demographics (age, gender, family size,
ethnicity), shopping habits (e.g. percent of total grocery shopping done at this Hannaford
and person doing most of the shopping in the household), best method to communicate incentive
changes once randomization has occurred, and F&V promotion reminders (e.g. text, email,
mail), SNAP eligibility, and SNAP participation. Through the loyalty card and study ID, all
participants will receive a 5% discount on all purchases at the participating Hannaford store
during months 6-16 of the project.
Semi-quantitative Food Frequency Questionnaire (FFQ): The FFQ consists of approximately 130
food items and is regularly updated to account for changes in the availability of foods. At
baseline and post intervention, participants will be emailed a link to the FFQ administered
online through Qualtrics, which will take approximately 20 minutes to complete. Participant
who complete the survey will be emailed an e-gift card. Participants will be asked to
identify one index child in the household closest to the age range of 6-10 yrs (where
children may be most receptive and influenced by parents eating patterns). Participants will
be provided an excerpted section of the FFQ with only F&V listed for the respondent to
complete, representing the child's average at-home consumption.
Randomization: After the 2-month baseline run-in period, study participants will be randomly
assigned to double value coupon incentive program + Cooking Matters intervention, or control.
Intervention arm: Participants randomized to the intervention arm will receive 2 for 1 F&V
(double value max $10 benefit per household per shopping day) for purchasing either fresh or
2 and 3-star-rated frozen and canned F&V in months 10-13. These will be confirmed by linking
UPC codes with qualifying foods. All discounts (5% and incentive) will be given at checkout
through the use of the loyalty card with assigned study ID. Participants will be asked to
register and attend at least 1 of 5 Cooking Matters at the Store education program tours
scheduled during the first two months of the intervention period (months 10-11). On the day
and time of the Cooking Matters at the Store tour, there will be a Cooking Matters table set
up in the entrance of the lobby. All shoppers at the store, regardless of study
participation, are invited to join the tour. Study participants will be asked to sign in with
their name or study ID (for tracking purposes) and pick up their "passport" (a card that must
be stamped at each station in order to complete the tour) at the table in the lobby. The
passport must have stamps from each station in order for the participant to receive a
Hannaford gift card and participate in the $10 challenge (buying a healthy meal for a family
of four for under $10).
Control arm: Participants assigned to the control arm will not be eligible for F&V incentives
and will not be asked to attend Cooking Matters at the Store.
Post-intervention, all participants will continue to receive the 5% discount and we will
continue tracking purchases for three additional months (months 14-16) using the study ID to
examine retention of purchasing habits. During month 14 (1 year after baseline assessment),
participants will be emailed a link to the FFQ, including the child portion, to assess
average daily intake over the previous year. Reminders to complete and return the FFQ will be
sent by text.
Data and analysis plan--F&V Sales: Primary study outcomes will be compared within individuals
(pre- to post-intervention), and between individuals (intervention and control arms). Cooking
Matters education program attendance between intervention and control arms will be compared.
Mixed effects generalized linear models will be used to control for sex, primary household
shopper, family size, month of purchase, and SNAP status (ineligible, eligible, enrolled).
Education and Extension Activities (post research):
Maine SNAP-Ed: The Maine SNAP-Ed program will contribute to education and extension efforts
in years 3 and 4 of the grant by assisting with the development of resources, such as fact
sheets and webinar trainings. Direct education classes will be used to disseminate resource
materials developed through the grant. Maine SNAP-Ed can also help disseminate innovative
approaches to work with supermarkets and grocers through their work with the USDA Food and
Nutrition Service and the Association of SNAP Nutrition Education Administrators (ASNNA).
University of Maine Cooperative Extension: In year 3, UMaine Cooperative Extension staff will
work to develop and finalize educational materials that will be used in project dissemination
activities in year 4 of the project. In year 4, UMaine Cooperative Extension staff will
provide two webinars for two different Maine audiences. One webinar will be conducted for
Cooperative Extension's 4H Youth Development and nutrition staff, and the second will be
delivered to Healthy Maine Partnership/SNAP-Ed staff. UMaine Extension Staff will also assist
in creating and delivering an online training to both the eXtension Families, Food and
Fitness, and Community Nutrition Education Communities of Practice. Additionally, project
outcomes will be presented at the national Expanded Food and Nutrition Education Program
annual meeting in Washington, DC. The Community Nutrition Education Program Community of
Practice has also agreed to serve as host for materials developed through this project.
The Food Trust: In year 3, The Food Trust will prepare for education and extension efforts in
year 4. The Food Trust will use its experience as a national partner on a variety of healthy
food access policy and program efforts at the national, state, and local levels. In year 4,
The Food Trust will work with UNE and partners to lead the development of an educational
toolkit targeted at academic institutions, professional associations, and industry partners
(e.g. retail chains and industry associations) to support development and enhancement of
curricula and corresponding materials related to promoting healthy shopping behaviors in
low-income populations.
University of New England (UNE): The University of New England is in the late planning stages
of a Bachelor of Science in Nutrition degree. The study will provide a unique opportunity for
undergraduate students to be involved in the community on issues related to food access among
low-income populations.
Target Audiences Target audience for the research component: English-speaking, rural Maine
families with at least one child under 18 years of age living in the household, regularly
shopping at the study Hannaford store location. Westbrook is a low-income (median household
income was $44,465 compared to the state level of $48,453 in 2013), mostly white (92% white
in 2013), rural community in Southern Maine. The study Hannaford store in Westbrook has a
high SNAP-user customer base ($90+Million in sales and 10% SNAP sales representing ~20% of
UPC eligible sales in 2014).
Target audience for education and extension components: The Maine SNAP-Ed program staff;
Maine Cooperative Extension staff and partners, The Nutrition Education Program Community of
Practice, Food Trust staff and partners, University of New England Nutrition Program staff
and faculty and low income families shopping in supermarket settings.
