Diet, HealthyNCT03952338
Impact of BC Farmers' Market Nutrition Coupon Program on Diet Quality and Psychosocial Well-being of Low-income Adults
A study testing Food coupons and Nutrition skill-building in people with Diet, Healthy and Health Risk Behaviors, run by University of Calgary at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diet, Healthy, Health Risk Behaviors
- What is being tested?
- Food coupons and Nutrition skill-building
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 285 participants
- Where
- 1 siteCanada
- Study dates
- 3 Jun 2019to 31 Mar 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Does not meet one or more inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of a Farmers' Market Nutrition Coupon Program on Diet Quality and Psychosocial Well-being Among Low-income Adults: A Randomized Controlled Trial
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.
Read the 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=132) or a no-intervention control group (n=132), with a 1:1 allocation ratio. An independent researcher from the Clinical Research Unit at the University of Calgary will generate a blocked randomization sequence that stratifies participants into blocks according to sex (male, female), geographic location (rural, urban), pregnancy (yes, no) and breastfeeding (yes, no). In the existing BC FMNCP, community partners distribute one to two sheets of coupons per week (each sheet contains $21 in coupons) to program participants for a total of 16 sheets. Coupons can be used over 16-20 weeks to purchase fruits, vegetables, dairy, meat/poultry/fish, eggs, nuts, and cut herbs at participating BC farmers' markets. However, to allow sufficient time to recruit participants for this study, community partners will distribute 16 coupon sheets to the FMNCP group over 10-15 weeks (households with 5-8 individuals will receive 32 coupon sheets). To ensure participants receive all 16 coupon sheets, community partners will provide two coupon sheets per household during the first 1-6 weeks of the intervention. Participants in the FMNCP group will also be invited to participate in nutrition skill-building activities (e.g., cooking classes). At baseline (0 weeks), immediately post-intervention (10-15 weeks) and 16 weeks post-intervention (26-31 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 (ASA24-Canada-2018). Diet quality scores will be calculated using the Healthy Eating Index-2015. In addition, immediately post-intervention only, participants will report whether they received FMNCP coupons and attended nutrition skill-building activities (to assess contamination of the control group), how often and how much of their own money was spent at farmers' markets during the intervention period and the types of foods purchased.
Data analysis: Descriptive analyses will be conducted to examine participant characteristics by group at each time point. Characteristics of study completers (i.e., provided data 16-weeks post-intervention) and non-completers will also be compared.
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 dropout. The analyses will include all participants who provided data at baseline. Repeated measures mixed-effect regression will assess differences in mean HEI-2015 scores, HEI-2015 subscores, mental well-being, sense of community, and subjective social status between the FMNCP and control groups immediately post-intervention and 16-weeks post-intervention. Repeated measures multinomial logistic regression will be used to assess differences in the odds of experiencing household food insecurity and risk of malnutrition for the FMNCP group compared to the control group immediately post-intervention and 16-weeks post-intervention. Statistical models will include intervention group (FMNCP vs control), time from baseline, intervention-by-time interaction, blocking variables (i.e., sex, rural/urban, pregnancy, breastfeeding), baseline values of the outcome, and household size as fixed effects covariates. Participant-specific (i.e., repeated measures) variations in outcomes will be modeled using random effects. Models will also include covariates specific to each outcome to increase the precision of estimates (86). For the primary outcome of overall diet quality, models will include the following: children living in the home (yes, no), sex, age, BMI, marital status, race/ethnicity, perceived health, smoking, day of data collection, and educational level. Adjusted group differences (i.e., FMNCP group vs control group) in outcomes will be estimated using 95% confidence intervals and corresponding p-values.
Subgroup analyses will examine whether the impact of the intervention on primary and secondary outcomes differs according to age group or sex. Dose-response analyses will examine whether the impact of the BC FMNCP on overall diet quality depends on the number of coupons redeemed and the number of nutrition skill-building activities attended. Interactions will be retained in statistical models if p<0.10. Analyses will be conducted in Stata (v15.1, Stata Corp, TX, USA), with p<0.05 indicating statistically significant differences between groups. Data interpretation will jointly consider effect sizes, confidence intervals and statistical significance.
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.
Post-hoc analysis: In a post-hoc analysis, a random forest model will be used to explore heterogeneity of program effects on diet quality (total HEI-2015 scores) among different subgroups of FMNCP study participants. Candidate predictors entered into the algorithm will include all variables examined at baseline, including sociodemographic characteristics (e.g., age, sex, and income) and health-related variables (e.g., self-rated health and smoking). The outcome of the random forest analysis will be total HEI-2015 scores for both the FMNCP and control groups.
- Conditions
- Diet, Healthy, Health Risk Behaviors
- Being tested
- Food coupons, Nutrition skill-building
- Medical subject headings
- Health Risk Behaviors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food couponsOther
Participants will receive 16 coupon sheets (each sheet contains $21 in coupons) over 10-15 weeks (households with 5-8 individuals will receive 32 coupon sheets) to purchase fruits, vegetables, dairy, meat/poultry/fish, eggs, nuts, and cut herbs at participating BC farmers' markets.
Nutrition skill-buildingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Nutrition Coupons | Experimental | Participants in the FMNCP group will receive 16 coupon sheets (each sheet contains $21 in coupons) over 10-15 weeks (households with 5-8 individuals will receive 32 coupon sheets) to purchase fruits, vegetables, dairy, meat/poultry/fish, eggs, nuts, and cut herbs at participating BC farmers' markets. To ensure participants receive all 16 coupon sheets, community partners will provide two coupon sheets per household during the first 1-6 weeks of the intervention. Participants in the FMNCP group will also be invited to participate in nutrition skill-building activities (e.g., cooking classes) offered by community partners throughout the intervention period, however participation is not required (this is consistent with the existing FMNCP). Receives: Other: Food coupons; Other: Nutrition skill-building |
| Control | No intervention | 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference Between Intervention and Control Groups in Mean Overall Diet Quality by Healthy Eating Index-2015 Scores Immediately Post-intervention (10-15 Weeks)
Difference between intervention and control groups in mean overall diet quality by Healthy Eating Index-2015 scores immediately post-intervention (10-15 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.
Measured: post-intervention (10-15 weeks).
Difference Between Intervention and Control Groups in Mean Overall Diet Quality by Healthy Eating Index-2015 Scores at 16 Weeks Post-intervention (26-31 Weeks)
Difference between intervention and control groups in mean overall diet quality by Healthy Eating Index-2015 scores at 16 weeks post-intervention (26-31 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.
Measured: 16 weeks post-intervention (26-31 weeks).
Secondary outcomes (14)
Difference Between Intervention and Control Groups in Mean Mental Well-being Scores by Warwick-Edinburgh Mental Well-Being Scale Immediately Post-intervention (10-15 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.
Measured: post-intervention (10-15 weeks).
Difference Between Intervention and Control Groups in Mean Mental Well-being Scores by Warwick-Edinburgh Mental Well-Being Scale at 16 Weeks Post-intervention (26-31 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.
Measured: 16 weeks post-intervention (26-31 weeks).
Difference Between Intervention and Control Groups in Mean Sense of Community by the Brief Sense of Community Scale Immediately Post-intervention (10-15 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.
Measured: post-intervention (10-15 weeks).
Difference Between Intervention and Control Groups in Mean Sense of Community by the Brief Sense of Community Scale at 16 Weeks Post-intervention (26-31 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.
Measured: 16 weeks post-intervention (26-31 weeks).
Difference Between Intervention and Control Groups in the Odds of Experiencing Household Food Insecurity Immediately Post-intervention (10-15 Weeks)
Difference between intervention and control groups in the odds of experiencing household food insecurity immediately post-intervention (10-15 weeks). Items on the 18-item Household Food Security Survey Module are self-reported in relation to experiences in the past month.
Measured: post-intervention (10-15 weeks).
Difference Between Intervention and Control Groups in the Odds of Experiencing Household Food Insecurity at 16 Weeks Post-intervention (26-31 Weeks)
Difference between intervention and control groups in the odds of experiencing household food insecurity at 16 weeks post-intervention (26-31 weeks). Items on the 18-item Household Food Security Survey Module are self-reported in relation to experiences in the past month.
Measured: 16 weeks post-intervention (26-31 weeks).
Difference Between Intervention and Control Groups in the Odds of Malnutrition by Malnutrition Universal Screening Tool Immediately Post-intervention (10-15 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.
Measured: post-intervention (10-15 weeks).
Difference Between Intervention and Control Groups in the Odds of Malnutrition by Malnutrition Universal Screening Tool at 16 Weeks Post-intervention (26-31 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.
Measured: 16 weeks post-intervention (26-31 weeks).
Difference Between Intervention and Control Groups in Mean Diet Quality Subscores by Healthy Eating Index-2015 Immediately Post-intervention (10-15 Weeks)
Healthy Eating Index (HEI)-2015 scores are calculated from 24-hour dietary recalls. HEI-2015 total scores can range from 0-100, with a higher score indicating a higher diet quality. HEI-2015 total scores are calculated by summing subscores for adequacy components (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). Possible subscale scores are as follows:
Adequacy components (higher score indicates a higher intake):
Total vegetables (0-5) Greens and beans (0-5) Total fruits (0-5) Whole fruits (0-5) Whole grains (0-10) Dairy (0-10) Total protein foods (0-5) Seafood and plant proteins (0-5) Fatty acids (0-10)
Moderation components (higher score indicates a lower intake) Sodium (0-10) Refined grains (0-10) Saturated fats (0-10) Added sugars (0-10)
Measured: post-intervention (10-15 weeks).
Difference Between Intervention and Control Groups in Mean Diet Quality Subscores by Healthy Eating Index-2015 at 16 Weeks Post-intervention (26-31 Weeks)
Healthy Eating Index (HEI)-2015 scores are calculated from 24-hour dietary recalls. HEI-2015 total scores can range from 0-100, with a higher score indicating a higher diet quality. HEI-2015 total scores are calculated by summing subscores for adequacy components (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). Possible subscale scores are as follows:
Adequacy components (higher score indicates a higher intake):
Total vegetables (0-5) Greens and beans (0-5) Total fruits (0-5) Whole fruits (0-5) Whole grains (0-10) Dairy (0-10) Total protein foods (0-5) Seafood and plant proteins (0-5) Fatty acids (0-10)
Moderation components (higher score indicates a lower intake) Sodium (0-10) Refined grains (0-10) Saturated fats (0-10) Added sugars (0-10)
Measured: 16 weeks post-intervention (26-31 weeks).
Difference Between Intervention and Control Groups in the Risk of Experiencing Marginal, Moderate, or Severe Household Food Insecurity Immediately Post-intervention (10-15 Weeks)
Difference between intervention and control groups in the risk of experiencing marginal, moderate, or severe household food insecurity (relative to being food secure) immediately post-intervention (10-15 weeks). Items on the 18-item Household Food Security Survey Module are self-reported in relation to experiences in the past month.
Measured: post-intervention (10-15 weeks).
Difference Between Intervention and Control Groups in the Risk of Experiencing Marginal, Moderate, or Severe Household Food Insecurity at 16 Weeks Post-intervention (26-31 Weeks)
Difference between intervention and control groups in the risk of experiencing marginal, moderate, or severe household food insecurity (relative to being food secure) at 16 weeks post-intervention (26-31 weeks). Items on the 18-item Household Food Security Survey Module are self-reported in relation to experiences in the past month.
Measured: 16 weeks post-intervention (26-31 weeks).
Difference Between Intervention and Control Groups in the Risk of Being at a Medium or High Risk of Malnutrition by Malnutrition Universal Screening Tool Immediately Post-intervention (10-15 Weeks)
Difference between intervention and control groups in the risk of being at a medium or high risk of malnutrition (relative to being at low risk of malnutrition) by Malnutrition Universal Screening Tool immediately post-intervention (10-15 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 was scored as 0=low risk, 1= medium risk, and >= 2= high risk.
Measured: post-intervention (10-15 weeks).
Difference Between Intervention and Control Groups in the Risk of Being at a Medium or High Risk of Malnutrition by Malnutrition Universal Screening Tool at 16 Weeks Post-intervention (26-31 Weeks)
Difference between intervention and control groups in the risk of being at a medium or high risk of malnutrition (relative to being at low risk of malnutrition) by Malnutrition Universal Screening Tool at 16 weeks post-intervention (26-31 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 was scored as 0=low risk, 1= medium risk, and >= 2= high risk.
Measured: 16 weeks post-intervention (26-31 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2019
- Study start3 Jun 2019
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
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 (3)Papers the sponsor has linked to this study.
- Other trials for Diet, HealthyStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 285 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), British Columbia Farmers' Market Nutrition Coupon Program
- Responsible party
- Sponsor
- Investigators
- Dana Olstad, PhD, RD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03952338
- Sponsor's protocol ID
- REB18-0508
- Status last verified
- Jun 2020
- First submitted
- 10 May 2019
- Last updated
- 16 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aktary ML, Lalani I, Chen Y, Shakeri Z, McCormack GR, Dunn S, Sajobi T, O'Hara H, Leblanc P, Godley J, Doan N, Lee Olstad D. Causal Forests in Practice: Lessons on Detecting Heterogeneous Treatment Effects in a Randomized Controlled Trial of a Healthy Food Subsidy Program in Canada. J Nutr. 2026 Jun;156(6):101529. doi: 10.1016/j.tjnut.2026.101529. Epub 2026 Apr 8.
PubMed 41962903Aktary ML, Dunn S, Sajobi T, O'Hara H, Leblanc P, McCormack GR, Caron-Roy S, Ball K, Lee YY, Nejatinamini S, Reimer RA, Pan B, Minaker LM, Raine KD, Godley J, Downs S, Nykiforuk CI, Olstad DL. Impact of a farmers' market healthy food subsidy on the diet quality of adults with low incomes in British Columbia, Canada: a pragmatic randomized controlled trial. Am J Clin Nutr. 2023 Apr;117(4):766-776. doi: 10.1016/j.ajcnut.2023.01.017. Epub 2023 Feb 1.
PubMed 36804420Aktary ML, Caron-Roy S, Sajobi T, O'Hara H, Leblanc P, Dunn S, McCormack GR, Timmins D, Ball K, Downs S, Minaker LM, Nykiforuk CI, Godley J, Milaney K, Lashewicz B, Fournier B, Elliott C, Raine KD, Prowse RJ, Olstad DL. Impact of a farmers' market nutrition coupon programme on diet quality and psychosocial well-being among low-income adults: protocol for a randomised controlled trial and a longitudinal qualitative investigation. BMJ Open. 2020 May 5;10(5):e035143. doi: 10.1136/bmjopen-2019-035143.
PubMed 32371514
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Farmers' Market Nutrition Coupon Program on Diet Quality and Psychosocial Well-being Among Low-income Adults: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03952338
- Acronym / sponsor ID
- REB18-0508
- Conditions
- Diet, Healthy, Health Risk Behaviors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 285 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), British Columbia Farmers' Market Nutrition Coupon Program
- Study start
- 3 Jun 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 16 May 2019 (actual)
- Results
- Posted 16 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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=132) or a no-intervention control group (n=132), with a 1:1 allocation ratio. An independent researcher from the Clinical Research Unit at the University of Calgary will generate a blocked randomization sequence that stratifies participants into blocks according to sex (male, female), geographic location (rural, urban), pregnancy (yes, no) and breastfeeding (yes, no). In the existing BC FMNCP, community partners distribute one to two sheets of coupons per week (each sheet contains $21 in coupons) to program participants for a total of 16 sheets. Coupons can be used over 16-20 weeks to purchase fruits, vegetables, dairy, meat/poultry/fish, eggs, nuts, and cut herbs at participating BC farmers' markets. However, to allow sufficient time to recruit participants for this study, community partners will distribute 16 coupon sheets to the FMNCP group over 10-15 weeks (households with 5-8 individuals will receive 32 coupon sheets). To ensure participants receive all 16 coupon sheets, community partners will provide two coupon sheets per household during the first 1-6 weeks of the intervention. Participants in the FMNCP group will also be invited to participate in nutrition skill-building activities (e.g., cooking classes). At baseline (0 weeks), immediately post-intervention (10-15 weeks) and 16 weeks post-intervention (26-31 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 (ASA24-Canada-2018). Diet quality scores will be calculated using the Healthy Eating Index-2015. In addition, immediately post-intervention only, participants will report whether they received FMNCP coupons and attended nutrition skill-building activities (to assess contamination of the control group), how often and how much of their own money was spent at farmers' markets during the intervention period and the types of foods purchased.
Data analysis: Descriptive analyses will be conducted to examine participant characteristics by group at each time point. Characteristics of study completers (i.e., provided data 16-weeks post-intervention) and non-completers will also be compared.
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 dropout. The analyses will include all participants who provided data at baseline. Repeated measures mixed-effect regression will assess differences in mean HEI-2015 scores, HEI-2015 subscores, mental well-being, sense of community, and subjective social status between the FMNCP and control groups immediately post-intervention and 16-weeks post-intervention. Repeated measures multinomial logistic regression will be used to assess differences in the odds of experiencing household food insecurity and risk of malnutrition for the FMNCP group compared to the control group immediately post-intervention and 16-weeks post-intervention. Statistical models will include intervention group (FMNCP vs control), time from baseline, intervention-by-time interaction, blocking variables (i.e., sex, rural/urban, pregnancy, breastfeeding), baseline values of the outcome, and household size as fixed effects covariates. Participant-specific (i.e., repeated measures) variations in outcomes will be modeled using random effects. Models will also include covariates specific to each outcome to increase the precision of estimates (86). For the primary outcome of overall diet quality, models will include the following: children living in the home (yes, no), sex, age, BMI, marital status, race/ethnicity, perceived health, smoking, day of data collection, and educational level. Adjusted group differences (i.e., FMNCP group vs control group) in outcomes will be estimated using 95% confidence intervals and corresponding p-values.
Subgroup analyses will examine whether the impact of the intervention on primary and secondary outcomes differs according to age group or sex. Dose-response analyses will examine whether the impact of the BC FMNCP on overall diet quality depends on the number of coupons redeemed and the number of nutrition skill-building activities attended. Interactions will be retained in statistical models if p<0.10. Analyses will be conducted in Stata (v15.1, Stata Corp, TX, USA), with p<0.05 indicating statistically significant differences between groups. Data interpretation will jointly consider effect sizes, confidence intervals and statistical significance.
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.
Post-hoc analysis: In a post-hoc analysis, a random forest model will be used to explore heterogeneity of program effects on diet quality (total HEI-2015 scores) among different subgroups of FMNCP study participants. Candidate predictors entered into the algorithm will include all variables examined at baseline, including sociodemographic characteristics (e.g., age, sex, and income) and health-related variables (e.g., self-rated health and smoking). The outcome of the random forest analysis will be total HEI-2015 scores for both the FMNCP and control groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutrition Coupons | Experimental | Other: Food coupons, Other: Nutrition skill-buildingParticipants in the FMNCP group will receive 16 coupon sheets (each sheet contains $21 in coupons) over 10-15 weeks (households with 5-8 individuals will receive 32 coupon sheets) to purchase fruits, vegetables, dairy, meat/poultry/fish, eggs, nuts, and cut herbs at participating BC farmers' markets. To ensure participants receive all 16 coupon sheets, community partners will provide two coupon sheets per household during the first 1-6 weeks of the intervention. Participants in the FMNCP group will also be invited to participate in nutrition skill-building activities (e.g., cooking classes) offered by community partners throughout the intervention period, however participation is not required (this is consistent with the existing FMNCP). |
| Control | No intervention | –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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Does not meet one or more inclusion 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 |
|---|---|---|
| Food couponsParticipants will receive 16 coupon sheets (each sheet contains $21 in coupons) over 10-15 weeks (households with 5-8 individuals will receive 32 coupon sheets) to purchase fruits, vegetables, dairy, meat/poultry/fish, eggs, nuts, and cut herbs at participating BC farmers' markets. | Other | Nutrition Coupons |
| Nutrition skill-buildingParticipants 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. | Other | Nutrition Coupons |
Primary outcome
Difference Between Intervention and Control Groups in Mean Overall Diet Quality by Healthy Eating Index-2015 Scores Immediately Post-intervention (10-15 Weeks)
Time frame: post-intervention (10-15 weeks).
Difference between intervention and control groups in mean overall diet quality by Healthy Eating Index-2015 scores immediately post-intervention (10-15 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.
Difference Between Intervention and Control Groups in Mean Overall Diet Quality by Healthy Eating Index-2015 Scores at 16 Weeks Post-intervention (26-31 Weeks)
Time frame: 16 weeks post-intervention (26-31 weeks).
Difference between intervention and control groups in mean overall diet quality by Healthy Eating Index-2015 scores at 16 weeks post-intervention (26-31 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.
14 secondary outcomes
Difference Between Intervention and Control Groups in Mean Mental Well-being Scores by Warwick-Edinburgh Mental Well-Being Scale Immediately Post-intervention (10-15 Weeks)
Time frame: post-intervention (10-15 weeks).
Difference Between Intervention and Control Groups in Mean Mental Well-being Scores by Warwick-Edinburgh Mental Well-Being Scale at 16 Weeks Post-intervention (26-31 Weeks)
Time frame: 16 weeks post-intervention (26-31 weeks).
Difference Between Intervention and Control Groups in Mean Sense of Community by the Brief Sense of Community Scale Immediately Post-intervention (10-15 Weeks)
Time frame: post-intervention (10-15 weeks).
Difference Between Intervention and Control Groups in Mean Sense of Community by the Brief Sense of Community Scale at 16 Weeks Post-intervention (26-31 Weeks)
Time frame: 16 weeks post-intervention (26-31 weeks).
Difference Between Intervention and Control Groups in the Odds of Experiencing Household Food Insecurity Immediately Post-intervention (10-15 Weeks)
Time frame: post-intervention (10-15 weeks).
Difference Between Intervention and Control Groups in the Odds of Experiencing Household Food Insecurity at 16 Weeks Post-intervention (26-31 Weeks)
Time frame: 16 weeks post-intervention (26-31 weeks).
Difference Between Intervention and Control Groups in the Odds of Malnutrition by Malnutrition Universal Screening Tool Immediately Post-intervention (10-15 Weeks)
Time frame: post-intervention (10-15 weeks).
Difference Between Intervention and Control Groups in the Odds of Malnutrition by Malnutrition Universal Screening Tool at 16 Weeks Post-intervention (26-31 Weeks)
Time frame: 16 weeks post-intervention (26-31 weeks).
Difference Between Intervention and Control Groups in Mean Diet Quality Subscores by Healthy Eating Index-2015 Immediately Post-intervention (10-15 Weeks)
Time frame: post-intervention (10-15 weeks).
Difference Between Intervention and Control Groups in Mean Diet Quality Subscores by Healthy Eating Index-2015 at 16 Weeks Post-intervention (26-31 Weeks)
Time frame: 16 weeks post-intervention (26-31 weeks).
Difference Between Intervention and Control Groups in the Risk of Experiencing Marginal, Moderate, or Severe Household Food Insecurity Immediately Post-intervention (10-15 Weeks)
Time frame: post-intervention (10-15 weeks).
Difference Between Intervention and Control Groups in the Risk of Experiencing Marginal, Moderate, or Severe Household Food Insecurity at 16 Weeks Post-intervention (26-31 Weeks)
Time frame: 16 weeks post-intervention (26-31 weeks).
Difference Between Intervention and Control Groups in the Risk of Being at a Medium or High Risk of Malnutrition by Malnutrition Universal Screening Tool Immediately Post-intervention (10-15 Weeks)
Time frame: post-intervention (10-15 weeks).
Difference Between Intervention and Control Groups in the Risk of Being at a Medium or High Risk of Malnutrition by Malnutrition Universal Screening Tool at 16 Weeks Post-intervention (26-31 Weeks)
Time frame: 16 weeks post-intervention (26-31 weeks).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41962903Aktary ML, Lalani I, Chen Y, Shakeri Z, McCormack GR, Dunn S, Sajobi T, O'Hara H, Leblanc P, Godley J, Doan N, Lee Olstad D. Causal Forests in Practice: Lessons on Detecting Heterogeneous Treatment Effects in a Randomized Controlled Trial of a Healthy Food Subsidy Program in Canada. J Nutr. 2026 Jun;156(6):101529. doi: 10.1016/j.tjnut.2026.101529. Epub 2026 Apr 8.
- Derived from this study: PubMed 36804420Aktary ML, Dunn S, Sajobi T, O'Hara H, Leblanc P, McCormack GR, Caron-Roy S, Ball K, Lee YY, Nejatinamini S, Reimer RA, Pan B, Minaker LM, Raine KD, Godley J, Downs S, Nykiforuk CI, Olstad DL. Impact of a farmers' market healthy food subsidy on the diet quality of adults with low incomes in British Columbia, Canada: a pragmatic randomized controlled trial. Am J Clin Nutr. 2023 Apr;117(4):766-776. doi: 10.1016/j.ajcnut.2023.01.017. Epub 2023 Feb 1.
- Derived from this study: PubMed 32371514Aktary ML, Caron-Roy S, Sajobi T, O'Hara H, Leblanc P, Dunn S, McCormack GR, Timmins D, Ball K, Downs S, Minaker LM, Nykiforuk CI, Godley J, Milaney K, Lashewicz B, Fournier B, Elliott C, Raine KD, Prowse RJ, Olstad DL. Impact of a farmers' market nutrition coupon programme on diet quality and psychosocial well-being among low-income adults: protocol for a randomised controlled trial and a longitudinal qualitative investigation. BMJ Open. 2020 May 5;10(5):e035143. doi: 10.1136/bmjopen-2019-035143.
- BC Farmers' Market Nutrition Coupon ProgramLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Dana Olstad, PhD, RD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food coupons and Nutrition skill-building in people with Diet, Healthy and Health Risk Behaviors, run by University of Calgary at 1 site in Canada.
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 0 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 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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 16 Dec 2024). 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?
Difference Between Intervention and Control Groups in Mean Overall Diet Quality by Healthy Eating Index-2015 Scores Immediately Post-intervention (10-15 Weeks) (time frame: post-intervention (10-15 weeks).). The study lists 2 primary outcomes in all. 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 NCT03952338, which also lists 3 linked publications.
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 16 Dec 2024; AzTrials last refreshed its copy on 8 Nov 2026.