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Impact of BC Farmers' Market Nutrition Coupon Program on Diet Quality and Psychosocial Well-being of Low-income Adults

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ClinicalTrials.gov Identifier: NCT03952338
Recruitment Status : Not yet recruiting
First Posted : May 16, 2019
Last Update Posted : May 16, 2019
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
British Columbia Farmers' Market Nutrition Coupon Program
Information provided by (Responsible Party):
University of Calgary

Brief Summary:
The British Columbia (BC) Farmers' Market Nutrition Coupon Program (FMNCP) provides low-income households with $21/week in coupons to purchase healthy foods at farmers' markets and supportive nutrition skill-building activities. This randomized controlled trial will assess the impact of the BC FMNCP on the overall diet quality (primary outcome), diet quality subscores, mental well-being, sense of community, experiences of food insecurity, risk of malnutrition (secondary outcomes) and subjective social status (exploratory outcome) of low-income adults immediately post-intervention and 16 weeks post-intervention.

Condition or disease Intervention/treatment Phase
Diet, Healthy Health Risk Behaviors Other: Food coupons Other: Nutrition skill-building Not Applicable

Detailed Description:

Background: The British Columbia (BC) Farmers' Market Nutrition Coupon Program (FMNCP) is a healthy eating initiative funded by the BC Ministry of Health. The program provides low-income households with $21/week in coupons to purchase healthy foods at farmers' markets and supportive nutrition skill-building activities. It is not clear if the BC FMNCP is achieving its aims of improving the diet quality, well-being and health of low-income adults, as its outcomes have not been investigated, and studies of similar programs are limited by weak designs that cannot demonstrate causality. This randomized controlled trial will assess the impact of the FMNCP on the overall diet quality (primary outcome), diet quality subscores, mental well-being, sense of community, experiences of food insecurity, risk of malnutrition (secondary outcomes) and subjective social status (exploratory outcome) of low-income adults immediately post-intervention and 16 weeks post-intervention. A qualitative investigation will also explore mechanisms of action and strategies to maximize positive program impacts.

Methods: Low-income adults (≥ 18 years) from up to 15 rural and urban communities will be randomized to a FMNCP intervention (n=200) or a no-intervention control group (n=200), with a 1:1 allocation ratio. An independent statistician will allocate individuals to condition following baseline data collection using a computer-generated blocked randomization sequence stratified by demographic group (seniors, adults with young families), sex (male, female), and rural/urban location. The FMNCP intervention group will receive coupons valued at $21/week for 16 weeks to purchase fruits, vegetables, dairy, meat, fish, eggs, nuts and cut herbs at farmers' markets, and will be invited to participate in nutrition skill-building activities. At baseline (0 weeks), post-intervention (16 weeks) and 16 weeks post-intervention (32 weeks), participants will access a pilot-tested web-based platform to report sociodemographics, health-related variables, mental well-being, sense of community, experiences of food insecurity, risk of malnutrition and subjective social status. Dietary intake will be assessed via two 24-hour dietary recalls at each time point using the Automated Self-Administered Dietary Assessment Tool for Canada. Adherence to a healthful dietary pattern will be evaluated using the Healthy Eating Index-2015.

Data analysis: Repeated measures mixed-effect regression will be used to assess the impact of the FMNCP intervention on study endpoints between baseline and 32 weeks follow-up. Subgroup (by age group and sex) and dose-response analyses (based on number of coupons redeemed and number of nutrition skill-building activities attended) will also be conducted. The analyses will be intention-to-treat, in which participants will be analysed within the groups to which they were randomized, regardless of adherence (e.g. failure to redeem coupons) or drop-out. The analyses will include all participants who provided data at baseline and missing data will be handled using full information maximum likelihood. Interactions will be retained in statistical models where p < 0.10, while p < 0.05 will indicate statistically significant differences between groups.

Expected outcomes: Findings will show whether and how a scalable population-level policy that links the agricultural and health sectors influences diet quality, psychosocial well-being and other outcomes among low-income adults. Study findings will inform program adjustments to improve participant outcomes. Other jurisdictions can use these data to determine whether and how to initiate similar programs.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Investigators will be blinded to group allocation if participants elect to complete data collection by telephone. Participants cannot be blinded to group assignment but will be blinded to the study hypotheses.
Primary Purpose: Prevention
Official Title: Does the British Columbia Farmers' Market Nutrition Coupon Program Improve the Diet Quality and Psychosocial Well-being of Low-income Adults? A Randomized Controlled Trial
Estimated Study Start Date : May 13, 2019
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : March 31, 2020

Arm Intervention/treatment
Experimental: Nutrition Coupons
Participants will receive 16 weeks' worth of coupons valued at $21/week to purchase fruits, vegetables, dairy, meat, fish, eggs, nuts and cut herbs at BC farmers' markets during the current farmers' market season (i.e. June-October, 2019). Participants will be invited to participate in nutrition skill-building activities of varying types throughout the intervention period, however participation is not required (this is consistent with the real-world design of the program).
Other: Food coupons
Participants will receive 16 weeks' worth of coupons valued at $21/week to purchase fruits, vegetables, dairy, meat, fish, eggs, nuts and cut herbs at BC farmers' markets.

Other: Nutrition skill-building
Participants will be invited to participate in nutrition skill-building activities throughout the intervention period. To be consistent with the real-world program, the frequency and types of skill-building activities offered will vary by community partner, and participation is not required.

No Intervention: Control
No intervention provided. Participants will be eligible to participate in the BC Farmers' Market Nutrition Coupon Program during the next farmers' market season (i.e. one year following the current intervention in June-October, 2020).



Primary Outcome Measures :
  1. Difference between intervention and control groups in mean overall diet quality by Healthy Eating Index-2015 scores at 16 weeks [ Time Frame: Assessed at each of the following time points: Baseline (0 weeks) and post-intervention (16 weeks) ]
    Healthy Eating Index-2015 scores are calculated from 24-hour dietary recalls and can range from 0-100, with a higher score indicating higher diet quality.

  2. Difference between intervention and control groups in mean overall diet quality by Healthy Eating Index-2015 scores at 32 weeks [ Time Frame: Assessed at each of the following time points: Baseline (0 weeks) and 16 weeks post-intervention (32 weeks) ]
    Healthy Eating Index-2015 scores are calculated from 24-hour dietary recalls and can range from 0-100, with a higher score indicating higher diet quality.


Secondary Outcome Measures :
  1. Difference between intervention and control groups in mean mental well-being scores by Warwick-Edinburgh Mental Well-Being Scale at 16 weeks [ Time Frame: Assessed once at each of the following time points: Baseline (0 weeks) and post-intervention (16 weeks) ]
    Items on the 14-item Warwick-Edinburgh Mental Well-Being Scale are self-reported over the past two weeks. There are 14 items with 5 response categories (1=none of the time; 5=all of the time), summed to provide a single score ranging from 14-70. A higher score indicates higher perceived mental well-being.

  2. Difference between intervention and control groups in mean mental well-being scores by Warwick-Edinburgh Mental Well-Being Scale at 32 weeks [ Time Frame: Assessed once at each of the following time points: Baseline (0 weeks) and 16 weeks post-intervention (32 weeks) ]
    Items on the 14-item Warwick-Edinburgh Mental Well-Being Scale are self-reported over the past two weeks. There are 14 items with 5 response categories (1=none of the time; 5=all of the time), summed to provide a single score ranging from 14-70. A higher score indicates higher perceived mental well-being.

  3. Difference between intervention and control groups in mean sense of community by the Brief Sense of Community scale at 16 weeks [ Time Frame: Assessed once at each of the following time points: Baseline (0 weeks) and post-intervention (16 weeks) ]
    Items on the 8-item Brief Sense of Community Scale are self-reported in which each item is scored using a Likert Scale of 1 (strongly disagree) to 5 (strongly agree). Scores can range from 8-40. A higher score indicates a stronger sense of community.

  4. Difference between intervention and control groups in mean sense of community by the Brief Sense of Community scale at 32 weeks [ Time Frame: Assessed once at each of the following time points: Baseline (0 weeks) and 16 weeks post-intervention (32 weeks) ]
    Items on the 8-item Brief Sense of Community Scale are self-reported in which each item is scored using a Likert Scale of 1 (strongly disagree) to 5 (strongly agree). Scores can range from 8-40. A higher score indicates a stronger sense of community.

  5. Difference between intervention and control groups in the odds of experiencing household food insecurity at 16 weeks [ Time Frame: Assessed once at each of the following time points: Baseline (0 weeks) and post-intervention (16 weeks) ]
    Items on the 18-item Household Food Security Survey Module are self-reported in relation to experiences in the past month. Food secure will be indicated by no affirmative answers, marginally food insecure by 1 affirmative answer, moderately food insecure by 2-5 affirmative answers and severely food insecure by greater than 5 affirmative answers.

  6. Difference between intervention and control groups in the odds of experiencing household food insecurity at 32 weeks [ Time Frame: Assessed once at each of the following time points: Baseline (0 weeks) and 16 weeks post-intervention (32 weeks) ]
    Items on the 18-item Household Food Security Survey Module are self-reported in relation to experiences in the past month. Food secure will be indicated by no affirmative answers, marginally food insecure by 1 affirmative answer, moderately food insecure by 2-5 affirmative answers and severely food insecure by greater than 5 affirmative answers.

  7. Difference between intervention and control groups in the odds of malnutrition by Malnutrition Universal Screening Tool at 16 weeks [ Time Frame: Assessed once at each of the following time points: Baseline (0 weeks) and post-intervention (16 weeks) ]
    Items on the Malnutrition Universal Screening Tool are self-reported and based on BMI (scored as 0= >20, 1= 18.5-20, 2 = <18.5) and percent of unplanned weight loss in the past 3-4 months (scored as 0 = <5%, 1 = 5-10%, 2 = >10%). Overall risk of malnutrition will be scored as 0=low risk, 1= medium risk, and >= 2= high risk.

  8. Difference between intervention and control groups in the odds of malnutrition by Malnutrition Universal Screening Tool at 32 weeks [ Time Frame: Assessed once at each of the following time points: Baseline (0 weeks) and 16 weeks post-intervention (32 weeks) ]
    Items on the Malnutrition Universal Screening Tool are self-reported and based on BMI (scored as 0= >20, 1= 18.5-20, 2 = <18.5) and percent of unplanned weight loss in the past 3-4 months (scored as 0 = <5%, 1 = 5-10%, 2 = >10%). Overall risk of malnutrition will be scored as 0=low risk, 1= medium risk, and >= 2= high risk.

  9. Difference between intervention and control groups in mean diet quality subscores by Healthy Eating Index-2015 at 16 weeks [ Time Frame: Assessed at each of the following time points: Baseline (0 weeks) and post-intervention (16 weeks) ]
    Healthy Eating Index-2015 scores are calculated from 24-hour dietary recalls. Subscores include adequacy (total fruits, whole fruits, total vegetables, greens and beans, whole grains, dairy, total protein foods, seafood and plant proteins, fatty acids) and moderation components (refined grains, sodium, added sugars, saturated fats), each of which are scored from 0-5 or 0-10.

  10. Difference between intervention and control groups in mean diet quality subscores by Healthy Eating Index-2015 at 32 weeks [ Time Frame: Assessed at each of the following time points: Baseline (0 weeks) and 16 weeks post-intervention (32 weeks) ]
    Healthy Eating Index-2015 scores are calculated from 24-hour dietary recalls. Subscores include adequacy (total fruits, whole fruits, total vegetables, greens and beans, whole grains, dairy, total protein foods, seafood and plant proteins, fatty acids) and moderation components (refined grains, sodium, added sugars, saturated fats), each of which are scored from 0-5 or 0-10.


Other Outcome Measures:
  1. Difference between intervention and control groups in mean subjective social status by the MacArthur Scale of Subjective Social Status community scale at 16 weeks [ Time Frame: Assessed once at each of the following time points: Baseline (0 weeks) and post-intervention (16 weeks) ]
    The MacArthur Scale of Subjective Social Status consists of a self-reported visual analog scale. Responses can take a value from 1-10, with a higher score indicating higher perceived social status in relation to others' within ones' community.

  2. Difference between intervention and control groups in mean subjective social status by the MacArthur Scale of Subjective Social Status community scale at 32 weeks [ Time Frame: Assessed once at each of the following time points: Baseline (0 weeks) and 16 weeks post-intervention (32 weeks) ]
    The MacArthur Scale of Subjective Social Status consists of a self-reported visual analog scale. Responses can take a value from 1-10, with a higher score indicating higher perceived social status in relation to others' within ones' community.

  3. Dose response for impact of intervention on overall diet quality (by Health Eating Index-2015) by number of food coupons redeemed at 16 weeks [ Time Frame: Coupon redemption assessed weekly from baseline (0 weeks) to post-intervention (16 weeks). Diet quality assessed twice at each of the following time points: Baseline (0 weeks) and post-intervention (16 weeks). ]
    Objective data on number of coupons redeemed (0-112) over 16 weeks. Healthy Eating Index-2015 scores are calculated from 24-hour dietary recalls.

  4. Dose response for impact of intervention on overall diet quality (by Healthy Eating Index-2015) by number of skill-building activities attended at 16 weeks [ Time Frame: Participation in skill-building assessed weekly from baseline (0 weeks) to post-intervention (16 weeks). Dietary intake assessed twice at each of the following time points: Baseline (0 weeks) and post-intervention (16 weeks). ]
    Objective data on number of nutrition skill-building activities attended over 16 weeks. Healthy Eating Index-2015 scores are calculated from 24-hour dietary recalls.

  5. Subgroup analysis for impact of intervention on overall diet quality (assessed by Healthy Eating Index-2015) by sex at 16 weeks [ Time Frame: Sex assessed once at baseline. Dietary intake assessed at each of the following time points: Baseline (0 weeks) and post-intervention (16 weeks). ]
    Self-reported sex (male, female). Healthy Eating Index-2015 scores are calculated from 24-hour dietary recalls.

  6. Subgroup analysis for impact of intervention on overall diet quality (assessed by Healthy Eating Index-2015) by age group at 16 weeks [ Time Frame: Age group assessed once at baseline. Dietary intake assessed at each of the following time points: Baseline (0 weeks) and post-intervention (16 weeks). ]
    Self-reported age group (seniors, adults with families). Healthy Eating Index-2015 scores are calculated from 24-hour dietary recalls.

  7. Subgroup analysis for impact of intervention on overall diet quality (assessed by Healthy Eating Index-2015) by sex at 32 weeks [ Time Frame: Sex assessed once at baseline. Dietary intake assessed at each of the following time points: Baseline (0 weeks) and 16 weeks post-intervention (32 weeks) ]
    Self-reported sex (male, female). Healthy Eating Index-2015 scores are calculated from 24-hour dietary recalls.

  8. Subgroup analysis for impact of intervention on overall diet quality (assessed by Healthy Eating Index-2015) by age group at 32 weeks [ Time Frame: Age group assessed once at baseline. Dietary intake assessed at each of the following time points: Baseline (0 weeks) and 16 weeks post-intervention (32 weeks). ]
    Self-reported age group (seniors, adults with families). Healthy Eating Index-2015 scores are calculated from 24-hour dietary recalls.

  9. Subgroup analysis for impact of intervention on secondary outcomes by sex at 16 weeks [ Time Frame: Sex assessed once at baseline. Secondary outcomes assessed once at each of the following time points: Baseline (0 weeks) and post-intervention (16 weeks) ]
    Self-reported sex (male, female)

  10. Subgroup analysis for impact of intervention on secondary outcomes by age group at 16 weeks [ Time Frame: Age group assessed once at baseline. Secondary outcomes assessed once at each of the following time points: Baseline (0 weeks) and post-intervention (16 weeks) ]
    Self-reported age group (seniors, adults with families)

  11. Subgroup analysis for impact of intervention on secondary outcomes by age group at 32 weeks [ Time Frame: Age group assessed once at baseline. Secondary outcomes assessed once at each of the following time points: Baseline (0 weeks) and 16 weeks post-intervention (32 weeks) ]
    Self-reported age group (seniors, adults with families)

  12. Subgroup analysis for impact of intervention on secondary outcomes by sex at 32 weeks [ Time Frame: Sex assessed once at baseline. Secondary outcomes assessed once at each of the following time points: Baseline (0 weeks) and 16 weeks post-intervention (32 weeks) ]
    Self-reported sex (male, female)

  13. Food purchasing at farmers' markets [ Time Frame: Assessed weekly from baseline (0 weeks) to post-intervention (16 weeks) ]
    Self-reported and objective data on food purchasing using coupons and own money (including food type and dollar amount) at farmers' markets

  14. Nutrition skill-building activity attendance [ Time Frame: Assessed weekly from baseline (0 weeks) to post-intervention (16 weeks) ]
    Objective data on attendance to nutrition skill-building activities (including number and types of activities)



Information from the National Library of Medicine

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

Inclusion Criteria:

  • Adults (18-59 years) with one or more children (<19 years) living in the home OR seniors (60+) who live alone or with others
  • Meets community-specific low income thresholds
  • No expected change in annual household income prior to March 2020 (that would cause the participant to exceed low-income thresholds)
  • No previous participation in the BC Farmers' Market Nutrition Coupon Program
  • Age 18 years or older
  • The primary household food shopper
  • Not pregnant or breastfeeding
  • No plans to become pregnant or to breastfeed prior to March 2020
  • Four or fewer individuals in the household, including the participant
  • No planned changes to household composition prior to March 2020
  • No plans to move principal residence prior to March 2020
  • Able to speak, read, write in English or has someone able to translate for them
  • Does not have Alzheimer's disease or dementia
  • Willing to be randomly assigned to the coupon or control group
  • Willing to answer surveys at all three time points

Exclusion Criteria:

  • Does not meet one or more inclusion criteria

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): NCT03952338


Contacts
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Contact: Dana Olstad, PhD, RD 403-210-8673 dana.olstad@ucalgary.ca
Contact: Sharlette Dunn, MPH 403-210-7725 sharlette.dunn1@ucalgary.ca

Locations
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Canada, British Columbia
Up to 15 Community Partner Organizations Not yet recruiting
Up To 15 Rural And Urban Communities, British Columbia, Canada
Contact: Dana Olstad, PhD, RD    403-210-8673    dana.olstad@ucalgary.ca   
Sponsors and Collaborators
University of Calgary
Canadian Institutes of Health Research (CIHR)
British Columbia Farmers' Market Nutrition Coupon Program
Investigators
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Principal Investigator: Dana Olstad, PhD, RD University of Calgary

Additional Information:
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Responsible Party: University of Calgary
ClinicalTrials.gov Identifier: NCT03952338     History of Changes
Other Study ID Numbers: REB18-0508
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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