NCT03952338

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
285

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 16, 2019

Completed
18 days until next milestone

Study Start

First participant enrolled

June 3, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
4.7 years until next milestone

Results Posted

Study results publicly available

December 16, 2024

Completed
Last Updated

December 16, 2024

Status Verified

June 1, 2020

Enrollment Period

10 months

First QC Date

May 10, 2019

Results QC Date

January 22, 2024

Last Update Submit

October 30, 2024

Conditions

Diet, HealthyHealth Risk Behaviors

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    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)

    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)

    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)

    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)

    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)

    post-intervention (10-15 weeks).

  • +9 more secondary outcomes

Other Outcomes (12)

  • Difference Between Intervention and Control Groups in Mean Subjective Social Status by the MacArthur Scale of Subjective Social Status Community Ladder Immediately Post-intervention (10-15 Weeks)

    post-intervention (10-15 weeks).

  • Difference Between Intervention and Control Groups in Mean Subjective Social Status by the MacArthur Scale of Subjective Social Status Community Ladder at 16 Weeks Post-intervention (26-31 Weeks)

    16 weeks post-intervention (26-31 weeks)

  • Subgroup Analysis for Impact of Intervention on Overall Diet Quality (Assessed by Healthy Eating Index-2015) by Sex Immediately Post-intervention (10-15 Weeks)

    post-intervention (10-15 weeks)

  • +9 more other outcomes

Study Arms (2)

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).

Other: Food couponsOther: 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).

Interventions

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 Coupons
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.

Nutrition Coupons

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Community Partners

Rural and Urban, British Columbia, Canada

Location

Related Publications (2)

  • Aktary 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.

    PMID: 36804420DERIVED

  • Aktary 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.

    PMID: 32371514DERIVED

Related Links

MeSH Terms

Conditions

Health Risk Behaviors

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Limitations and Caveats

Dietary intake data were self-reported and may be affected by misreporting; Data were obtained only from the primary food shopper in the household; Insufficient data to examine participant-specific coupon distribution and redemption; This study was powered to detect a change in diet quality (the primary outcome) and may have been underpowered to detect changes in the secondary and exploratory outcomes.

Results Point of Contact

Title
Dr. Dana Lee Olstad
Organization
University of Calgary
dana.olstad@ucalgary.ca
403-210-8673

Study Officials

  • Dana Olstad, PhD, RD

    University of Calgary

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
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 objectives.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2019

First Posted

May 16, 2019

Study Start

June 3, 2019

Primary Completion

March 31, 2020

Study Completion

March 31, 2020

Last Updated

December 16, 2024

Results First Posted

December 16, 2024

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)