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WIC-Based Intervention to Promote Healthy Eating Among Low-Income Mothers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04038385
Recruitment Status : Active, not recruiting
First Posted : July 30, 2019
Last Update Posted : May 19, 2020
Sponsor:
Information provided by (Responsible Party):
Jennifer Di Noia, William Paterson University of New Jersey

Brief Summary:
Whole grains, non-starchy vegetables, fruit, and beans are a consistent feature of diets associated with a lower risk of cancer and other diet-related diseases. For cancer risk reduction, the American Cancer Society recommendation is to consume at least 2.5 cups of a variety of fruits and vegetables (FV) daily. Other than dietary choices, weight control and physical activity levels are important modifiable determinants of cancer risk. The proposed research will finalize a novel, theory-driven intervention developed in preliminary work to promote access to fresh, unprepared, locally grown FV and build knowledge and skills to increase purchases and consumption of these foods among low-income adults served by the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). In New Jersey (the location of the study), WIC provides participants up to $30 in seasonal Farmers' Market Nutrition Program (FMNP) vouchers and monthly cash value vouchers or CVV (valued at $11 for adults and $8 for children) redeemable at farmers' markets. The intervention will be finalized based on lessons learned in preliminary work. The program combines behaviorally-focused nutrition education with the establishment of a WIC-based farmers' market (to be implemented in 2019 during the FMNP voucher issuance period [June 19 to August 19]). Content to address other modifiable determinants of cancer risk will be added. To create additional opportunities for experiential and hands-on learning, monthly trips to an area farmers' market also are planned (between September 1, 2019 [after the WIC-based market is discontinued] and November 30, 2019 [the end of the local growing season]). The research will employ an experimental design to initially test the intervention in a sample of 244 adults. Program effects on objective biomarkers of FV intake, FMNP voucher redemption, and the redemption of CVV at farmers' markets will be examined 3 and 6 months after intervention. Mediation of intervention effects by targeted secondary outcomes, participant satisfaction with the program, and the cost-effectiveness of the intervention also will be examined.

Condition or disease Intervention/treatment Phase
Cancer Prevention Diet Modification Vegetable Intake Behavioral: Multilevel Behavioral Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 297 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: WIC-Based Intervention to Promote Healthy Eating Among Low-Income Mothers
Actual Study Start Date : June 3, 2019
Actual Primary Completion Date : January 31, 2020
Estimated Study Completion Date : August 31, 2020

Arm Intervention/treatment
Experimental: Intervention
This group will receive routine services provided by WIC and an intervention that will combine behaviorally-focused nutrition education with 1) the establishment of a WIC-based farmers' market (implemented in 2019 during the WIC Farmers' Market Nutrition Program voucher issuance period [June 19 to August 19]), and 2) monthly trips to an area farmers' market and local supermarket (between September 1, 2019 and November 30, 2019 [the end of the local growing season]).
Behavioral: Multilevel Behavioral Intervention
Behaviorally-focused intervention grounded in the Social Ecological Model and Social Cognitive Theory to promote vegetable intake and the redemption of seasonal Farmers' Market Nutrition Program vouchers and monthly Cash Value Vouchers provided to WIC participants to purchase fruits and vegetables.

No Intervention: Control
This group will receive routine services provided by WIC only.



Primary Outcome Measures :
  1. Change in objectively measured vegetable intake [ Time Frame: Pretest, posttest (3 months after the pretest), and follow-up (6 months after the pretest) ]
    Objectively assessed using reflection spectroscopy to measure the level of carotenoid pigments in the participant's skin (scores can range from 0 to 800).

  2. Farmers' Market Nutrition Program (FMNP) voucher redemption [ Time Frame: Whether participants redeemed any vouchers (yes/no) between pretest and follow-up (6 months after the pretest) ]
    Objectively assessed using data provided by the collaborating WIC agency (coded as redeemed any vouchers [yes/no] between baseline and 6-month follow-up)

  3. The redemption of WIC Cash Value Vouchers or CVV at farmers' markets [ Time Frame: Whether participants redeemed any CVV (yes/no) between pretest and follow-up (6 months after the pretest) ]
    Objectively assessed using data provided by the collaborating WIC agency (coded as redeemed any vouchers [yes/no] between baseline and 6-month follow-up)

  4. Change in self-reported vegetable intake [ Time Frame: Pretest, posttest (3 months after the pretest), and follow-up (6 months after the pretest) ]
    Assessed via a screening instrument developed by the National Cancer Institute (quantified as cups/day of fruits and vegetables consumed)


Secondary Outcome Measures :
  1. Change in knowledge of vegetable intake recommendations [ Time Frame: Pretest, posttest (3 months after the pretest), and follow-up (6 months after the pretest) ]
    Assessed using an item from the National Cancer Institute's Food, Attitudes, and Behaviors Survey (coded as knowledgeable of recommended cups per day [yes/no])

  2. Change in home vegetable availability [ Time Frame: Pretest, posttest (3 months after the pretest), and follow-up (6 months after the pretest) ]
    Assessed with items from the Healthy Home Survey querying the presence of fresh, frozen, and canned vegetables the participant has at home. Scores will be computed as the total number of items reported.

  3. Change in vegetable taste preferences [ Time Frame: Pretest, posttest (3 months after the pretest), and follow-up (6 months after the pretest) ]
    Assessed with a single item (the Preference Rating Measure) querying overall, how much the participant likes the taste of vegetables (on a 7-point scale ranging from not at all to a lot). Scores can range from 1 to 7. Higher scores represent a better outcome (stronger vegetable taste preferences).

  4. Change in vegetable preparation skills [ Time Frame: Pretest, posttest (3 months after the pretest), and follow-up (6 months after the pretest) ]
    Assessed via a single item (the Preparation Skills Rating Measure) querying how the participant would rate his or her overall skill in preparing vegetables (on a 7-point scale ranging from poor to excellent). Scores can range from 1 to 7. Higher scores represent a better outcome (greater vegetable preparation skills).

  5. Change in vegetable preparation practices [ Time Frame: Pretest, posttest (3 months after the pretest), and follow-up (6 months after the pretest) ]
    Assessed via items (from the Eating Among Teens and Young Adults Study (EAT)-II Survey [Laska et al., 2011]) assessing behaviors related to home food preparation. Participants report how often, in the past month, they 1) bought fresh vegetables, 2) prepared a vegetable salad, and 3) prepared a dinner with vegetables. Responses are on a 5-point scale ranging from never to more than once a week. Item ratings are summed to derive a total score. Scores can range from 1 to 15. Higher scores represent a better outcome (frequent use of the practices).

  6. Change in social support for vegetable consumption [ Time Frame: Pretest, posttest (3 months after the pretest), and follow-up (6 months after the pretest) ]
    Assessed via a single item (the Social Support Rating Measure) querying how much others support the participant to consume vegetables (on a 7-point scale ranging from not at all to a lot). Scores can range from 1 to 7. Higher scores represent a better outcome (greater social support for vegetable consumption).

  7. Change in self-efficacy for vegetable consumption [ Time Frame: Pretest, posttest (3 months after the pretest), and follow-up (6 months after the pretest) ]
    Assessed with a validated measure (used to evaluate the Stellar Farmers' Market program [Dannefer et al., 2015]). Participants rate how much they agree or disagree with statements designed to measure the participant's confidence in his or her ability to prepare and consume fresh produce. Item ratings are on a 4-point scale ranging from strongly disagree (1) to strongly agree (4). Item ratings are summed to derive a total score. Scores can range from 5 to 20. Higher scores represent a better outcome (greater self-efficacy for vegetable consumption).

  8. Change in whether participants are meeting current physical activity guidelines [ Time Frame: Pretest, posttest (3 months after the pretest), and follow-up (6 months after the pretest) ]
    Assessed with a validated 2-item measure (the Brief Physical Activity Assessment Tool or BPATT [Marshall et al., 2005]). The instrument consists of two questions, one that assesses the frequency and duration of vigorous intensity physical activity and one that assesses the frequency and duration of moderate intensity physical activities undertaken in a usual week. A scoring algorithm is used to combine the results of the two questions to identify whether participants are meeting the current physical activity guidelines or not. Scores can range from 0 (not meeting guidelines) to 1 (meeting guidelines). Higher scores represent a better outcome (meeting current physical activity guidelines).

  9. Change in weight status [ Time Frame: Pretest, posttest (3 months after the pretest), and follow-up (6 months after the pretest) ]
    Measured as body mass index (calculated based on anthropometric data collected during the study)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • English- or Spanish-speaking
  • Farmers' Market Nutrition Program (FMNP) voucher recipient or caregiver of a child FMNP voucher recipient
  • Not less than 3 months from expected delivery date (pregnant women)
  • Eligible to receive WIC benefits for 6 months after study entry

Exclusion Criteria:

● Restrictions of food intake (has food allergies or foods that cannot be eaten)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04038385


Locations
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United States, New Jersey
Saint Joseph's WIC Program
Paterson, New Jersey, United States, 07524
Sponsors and Collaborators
William Paterson University of New Jersey
Investigators
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Principal Investigator: Jennifer Di Noia, PhD William Paterson University
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Responsible Party: Jennifer Di Noia, Professor, Department of Sociology, William Paterson University of New Jersey
ClinicalTrials.gov Identifier: NCT04038385    
Other Study ID Numbers: 1R21CA230476-01 ( U.S. NIH Grant/Contract )
First Posted: July 30, 2019    Key Record Dates
Last Update Posted: May 19, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No