Food SecurityVFFNCT03566095
Voices for Food: Food Policy Councils, Food Security and Healthy Food Choices
A study testing Coaching and Voices for Food Kit and Voices for Food Kit in people with Food Security and Nutritive Value, run by South Dakota State University.
Trial summary
This study evaluates the effectiveness of coaching and Voices for Food materials on establishing Food Policy Councils (FPCs) and using guided client choice in rural food pantries to improve food security and diet quality among food pantry clients, and to improve the food environment in rural, midwestern food pantries. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Food Security, Nutritive Value
- What is being tested?
- Coaching and Voices for Food Kit and Voices for Food Kit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,735 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2014to 15 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Food Pantry Clients must be current clientele by visiting the participating food pantry at least once in the last year, English-speaking.
- Food Pantry Directors must be 18 years or older (19 if in Nebraska), English-speaking and a director of a participating food pantry.
- Food Pantry Staff/Volunteers must be 18 years or older (19 if in Nebraska), English-speaking and a staff/volunteer of a participating food pantry.
- Community Stakeholders must be 18 years or older (19 if in Nebraska), English-speaking and reside in the participating community.
Who cannot join
- Under 18 years old (19 if in Nebraska)
- Non English- speaking
About this study
Official title: Voices for Food: Utilizing Food Policy Councils to Bridge the Gap Between Food Security and Healthy Food Choices
This study evaluates the effectiveness of coaching and Voices for Food materials on establishing Food Policy Councils (FPCs) and using guided client choice in rural food pantries to improve food security and diet quality among food pantry clients, and to improve the food environment in rural, midwestern food pantries. Half of the communities received coaching and the Voices for Food kit, the other half only received the Voices for Food kit.
Read the detailed description
Community coaching is a a strategy that helps community leaders plan for and overcome challenges to community development. Interventions at the community level are most effective when they are conceived and led by locals. Community coaches can aid the local community in the development of FPCs in rural communities. FPCs have the potential to improve the nutritional quality of available food, and connect a diverse network of food system stakeholders from the public, private and nonprofit sectors, which includes local food pantries. Food pantry users are food insecure and avoid hunger by consuming low cost and shelf stable food items. Guided client choice is a system of distribution that can be employed in food pantries and supported by FPCs. Guided client-choice is a model of distribution in which pantry clients choose the foods they would like from the pantry based upon family size and is formatted based upon USDA MyPlate. Guided client choice has been shown to meet the needs of the pantry client base better than the traditional model of distribution often found in food pantries. Food pantries have the opportunity to meet the nutritional needs of the food insecure population.
Voices for Food is a multi-leveled socio-ecological, longitudinal, matched treatment and comparison study to develop food policy councils (FPCs), and improve food security and diet quality in rural communities. Voices for Food was conducted in 24 rural, high poverty counties in South Dakota, Indiana, Missouri, Michigan, Nebraska and Ohio. Counties were assigned to a treatment (n=12) or comparison (n=12) group.
Intervention activities focus on three key components that impact food security: 1) community coaching by Extension Educators/field staff, 2) FPC development, and 3) development of a MyChoice (guided client choice) food pantry. Community coaching, along with the Voices for Food kit was only provided to treatment counties. Comparison communities only received the Voices for Food kit. Evaluation components focus on three levels of the intervention: 1) Community (FPCs), 2) Food Pantry Organization and Food Environment, and 3) Pantry Client \& Families. Participants in this study were community stakeholders, food pantry directors, staff/volunteers and food pantry clients. Pantry food access/availability including pantry food quality and quantity, household food security and pantry client dietary intake are dependent variables.
- Conditions
- Food Security, Nutritive Value
- Being tested
- Coaching and Voices for Food Kit, Voices for Food Kit
- Keywords
- Rural, Food Policy Councils, Food Pantry, Community Coaching
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coaching and Voices for Food KitBehavioural
Community Coaching and Voices for Food Kit
Voices for Food KitBehavioural
Voices for Food Kit
| Study group | Role | What they receive |
|---|---|---|
| Coaching and Voices for Food Kit | Active comparator | The treatment communities received community coaching from an Extension Professional or Educator in the use of the Voices for Food kit. Receives: Behavioral: Coaching and Voices for Food Kit |
| Voices for Food Kit | Sham comparator | The comparison community received the Voices for Food kit. Receives: Behavioral: Voices for Food Kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
The United States Household Food Security Survey Module
Change in food security of food pantry clients. Individuals will be classified as very low food secure, low food secure, marginal food secure and high food secure.
Measured: 4 years
Healthy Eating Index (HEI) Score
Change in diet quality of food pantry clients. The Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Too allows for calculation of the Healthy Eating Index score, which is a measure of diet quality.
Measured: 4 years
Secondary outcomes (2)
Food Policy Council Implementation Form
The Food Policy Council Implementation Form is a study developed assessment tool that assesses the degree of food policy council implementation. The Food Council Implementation Form documents changes occurring within the Food Policy Council.
Measured: 4 years
Food Pantry MyChoice Observation Tool
The Food Pantry MyChoice Observation Tool is a study developed assessment tool that assesses the degree of MyChoice (guided client choice) implementation. The tool documents the extent to which key components of the MyChoice food pantry model are physically in place at the pantry and part of the food, food display, and distribution process.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2018
- Study start1 Aug 2014
- Primary completion15 Mar 2018
- Study completion15 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Food SecurityStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- All data were collected from both treatment an comparison communities at the same time points.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,735 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Dakota State University
- Sponsor type
- University, hospital or other
- Collaborators
- Michigan State University, Ohio State University, University of Nebraska Lincoln, Purdue University, University of Missouri-Columbia
- Responsible party
- Sponsor
- Investigators
- Suzanne Stluka, PhD, RD, LN, Principal investigator, South Dakota State UniversityHeather Eicher- Miller, PhD, Principal investigator, Purdue UniversityRebecca Henne, MS, Principal investigator, Michigan State UniversityDonna Mehrle, MPH, RD, LD, Principal investigator, University of Missouri-ColumbiaLisa Franzen-Castle, PhD, Principal investigator, University of Nebraska LincolnDan Remley, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03566095
- Sponsor's protocol ID
- 2013-69004-20401
- Acronym
- VFF
- Status last verified
- Jun 2018
- First submitted
- 24 May 2018
- Last updated
- 21 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Publications
Wright BN, Vasquez-Mejia CM, Guenther PM, McCormack L, Stluka S, Franzen-Castle L, Henne B, Mehrle D, Remley D, Eicher-Miller HA. Fruit and Vegetable Healthy Eating Index Component Scores of Distributed Food Bags Were Positively Associated with Client Diet Scores in a Sample of Rural, Midwestern Food Pantries. J Acad Nutr Diet. 2021 Jan;121(1):74-83. doi: 10.1016/j.jand.2020.09.033. Epub 2020 Oct 21.
PubMed 33350943Wright BN, Tooze JA, Bailey RL, Liu Y, Rivera RL, McCormack L, Stluka S, Franzen-Castle L, Henne B, Mehrle D, Remley D, Eicher-Miller HA. Dietary Quality and Usual Intake of Underconsumed Nutrients and Related Food Groups Differ by Food Security Status for Rural, Midwestern Food Pantry Clients. J Acad Nutr Diet. 2020 Sep;120(9):1457-1468. doi: 10.1016/j.jand.2020.04.011. Epub 2020 Jul 20.
PubMed 32703690Liu Y, Tooze JA, Zhang Y, Leidy HJ, Bailey RL, Wright B, Ma M, Stluka S, Remley DT, McCormack LA, Franzen-Castle L, Henne R, Mehrle D, Eicher-Miller HA. Breakfast Consumption Is Positively Associated with Usual Nutrient Intakes among Food Pantry Clients Living in Rural Communities. J Nutr. 2020 Mar 1;150(3):546-553. doi: 10.1093/jn/nxz258.
PubMed 31711170Stluka S, Moore L, Eicher-Miller HA, Franzen-Castle L, Henne B, Mehrle D, Remley D, McCormack L. Voices for food: methodologies for implementing a multi-state community-based intervention in rural, high poverty communities. BMC Public Health. 2018 Aug 23;18(1):1055. doi: 10.1186/s12889-018-5957-9.
PubMed 30139336
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Voices for Food: Utilizing Food Policy Councils to Bridge the Gap Between Food Security and Healthy Food Choices
- ClinicalTrials.gov ID
- NCT03566095
- Acronym / sponsor ID
- VFF / 2013-69004-20401
- Conditions
- Food Security, Nutritive Value
- Keywords
- Rural, Food Policy Councils, Food Pantry, Community Coaching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,735 participants (actual)
- Lead sponsor
- South Dakota State UniversityUniversity, hospital or other
- Collaborators
- Michigan State University, Ohio State University, University of Nebraska Lincoln, Purdue University, University of Missouri-Columbia
- Study start
- 1 Aug 2014 (actual)
- Primary completion
- 15 Mar 2018 (actual)
- Study completion
- 15 Mar 2018 (actual)
- First posted
- 21 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the effectiveness of coaching and Voices for Food materials on establishing Food Policy Councils (FPCs) and using guided client choice in rural food pantries to improve food security and diet quality among food pantry clients, and to improve the food environment in rural, midwestern food pantries. Half of the communities received coaching and the Voices for Food kit, the other half only received the Voices for Food kit.
Detailed description
Community coaching is a a strategy that helps community leaders plan for and overcome challenges to community development. Interventions at the community level are most effective when they are conceived and led by locals. Community coaches can aid the local community in the development of FPCs in rural communities. FPCs have the potential to improve the nutritional quality of available food, and connect a diverse network of food system stakeholders from the public, private and nonprofit sectors, which includes local food pantries. Food pantry users are food insecure and avoid hunger by consuming low cost and shelf stable food items. Guided client choice is a system of distribution that can be employed in food pantries and supported by FPCs. Guided client-choice is a model of distribution in which pantry clients choose the foods they would like from the pantry based upon family size and is formatted based upon USDA MyPlate. Guided client choice has been shown to meet the needs of the pantry client base better than the traditional model of distribution often found in food pantries. Food pantries have the opportunity to meet the nutritional needs of the food insecure population.
Voices for Food is a multi-leveled socio-ecological, longitudinal, matched treatment and comparison study to develop food policy councils (FPCs), and improve food security and diet quality in rural communities. Voices for Food was conducted in 24 rural, high poverty counties in South Dakota, Indiana, Missouri, Michigan, Nebraska and Ohio. Counties were assigned to a treatment (n=12) or comparison (n=12) group.
Intervention activities focus on three key components that impact food security: 1) community coaching by Extension Educators/field staff, 2) FPC development, and 3) development of a MyChoice (guided client choice) food pantry. Community coaching, along with the Voices for Food kit was only provided to treatment counties. Comparison communities only received the Voices for Food kit. Evaluation components focus on three levels of the intervention: 1) Community (FPCs), 2) Food Pantry Organization and Food Environment, and 3) Pantry Client \& Families. Participants in this study were community stakeholders, food pantry directors, staff/volunteers and food pantry clients. Pantry food access/availability including pantry food quality and quantity, household food security and pantry client dietary intake are dependent variables.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- All data were collected from both treatment an comparison communities at the same time points.
| Arm | Type | Receives |
|---|---|---|
| Coaching and Voices for Food Kit | Active comparator | Behavioral: Coaching and Voices for Food KitThe treatment communities received community coaching from an Extension Professional or Educator in the use of the Voices for Food kit. |
| Voices for Food Kit | Sham comparator | Behavioral: Voices for Food KitThe comparison community received the Voices for Food kit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Food Pantry Clients must be current clientele by visiting the participating food pantry at least once in the last year, English-speaking.
- Food Pantry Directors must be 18 years or older (19 if in Nebraska), English-speaking and a director of a participating food pantry.
- Food Pantry Staff/Volunteers must be 18 years or older (19 if in Nebraska), English-speaking and a staff/volunteer of a participating food pantry.
- Community Stakeholders must be 18 years or older (19 if in Nebraska), English-speaking and reside in the participating community.
Key exclusion criteria (2 listed)
- Under 18 years old (19 if in Nebraska)
- Non English- speaking
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 |
|---|---|---|
| Coaching and Voices for Food KitCommunity Coaching and Voices for Food Kit | Behavioural | Coaching and Voices for Food Kit |
| Voices for Food KitVoices for Food Kit | Behavioural | Voices for Food Kit |
Primary outcome
The United States Household Food Security Survey Module
Time frame: 4 years
Change in food security of food pantry clients. Individuals will be classified as very low food secure, low food secure, marginal food secure and high food secure.
Healthy Eating Index (HEI) Score
Time frame: 4 years
Change in diet quality of food pantry clients. The Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Too allows for calculation of the Healthy Eating Index score, which is a measure of diet quality.
2 secondary outcomes
Food Policy Council Implementation Form
Time frame: 4 years
Food Pantry MyChoice Observation Tool
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2018.
- Derived from this study: PubMed 33350943Wright BN, Vasquez-Mejia CM, Guenther PM, McCormack L, Stluka S, Franzen-Castle L, Henne B, Mehrle D, Remley D, Eicher-Miller HA. Fruit and Vegetable Healthy Eating Index Component Scores of Distributed Food Bags Were Positively Associated with Client Diet Scores in a Sample of Rural, Midwestern Food Pantries. J Acad Nutr Diet. 2021 Jan;121(1):74-83. doi: 10.1016/j.jand.2020.09.033. Epub 2020 Oct 21.
- Derived from this study: PubMed 32703690Wright BN, Tooze JA, Bailey RL, Liu Y, Rivera RL, McCormack L, Stluka S, Franzen-Castle L, Henne B, Mehrle D, Remley D, Eicher-Miller HA. Dietary Quality and Usual Intake of Underconsumed Nutrients and Related Food Groups Differ by Food Security Status for Rural, Midwestern Food Pantry Clients. J Acad Nutr Diet. 2020 Sep;120(9):1457-1468. doi: 10.1016/j.jand.2020.04.011. Epub 2020 Jul 20.
- Derived from this study: PubMed 31711170Liu Y, Tooze JA, Zhang Y, Leidy HJ, Bailey RL, Wright B, Ma M, Stluka S, Remley DT, McCormack LA, Franzen-Castle L, Henne R, Mehrle D, Eicher-Miller HA. Breakfast Consumption Is Positively Associated with Usual Nutrient Intakes among Food Pantry Clients Living in Rural Communities. J Nutr. 2020 Mar 1;150(3):546-553. doi: 10.1093/jn/nxz258.
- Derived from this study: PubMed 30139336Stluka S, Moore L, Eicher-Miller HA, Franzen-Castle L, Henne B, Mehrle D, Remley D, McCormack L. Voices for food: methodologies for implementing a multi-state community-based intervention in rural, high poverty communities. BMC Public Health. 2018 Aug 23;18(1):1055. doi: 10.1186/s12889-018-5957-9.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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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.
Suzanne Stluka, PhD, RD, LN principal investigator
South Dakota State University
Heather Eicher- Miller, PhD principal investigator
Purdue University
Rebecca Henne, MS principal investigator
Michigan State University
Questions about this trial
What is this clinical trial studying?
A study testing Coaching and Voices for Food Kit and Voices for Food Kit in people with Food Security and Nutritive Value, run by South Dakota State University.
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 4 inclusion and 2 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 21 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The United States Household Food Security Survey Module (time frame: 4 years). 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 NCT03566095, which also lists 4 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 21 Jun 2018.