DiabetesNCT03246997
Project Powerfood: Promoting Food Security, Equity, and Health
A study testing Autumn Group and Spring Group in people with Diabetes and Obesity, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
Project Powerfood is a pilot program aimed at addressing food insecurity and food access in primary care through the implementation of a food prescription program in collaboration with a number of community partners. The objectives of this project are: 1. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- What is being tested?
- Autumn Group and Spring Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2017to 29 Mar 2019
- 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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Food insecure and/or receive SNAP and/or WIC
- Adult patients: poorly-controlled diabetes (hemoglobin A1c greater than 8.0%)
- Pediatric patients: obesity, ages 5-11
- Speak English or Spanish
Who cannot join
- Food secure and do not receive SNAP or WIC
- Adult Patients: do not have diabetes
- Pediatric Patients: not obese, under 5 years old or between 11 and 18
- Speak neither English or Spanish
- Severe kidney disease (Chronic Kidney Disease (CKD Stage IV or V)
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Project Powerfood is a pilot program aimed at addressing food insecurity and food access in primary care through the implementation of a food prescription program in collaboration with a number of community partners. The objectives of this project are:
- Implement screening for food insecurity in adult and pediatric primary care practices at Mount Sinai.
- Provide fresh fruit and vegetable "prescriptions" to be redeemed for farm shares from local partner, the Corbin Hill Food Project. Prescriptions will provide 50% off of a fruit and vegetable box. Participants will have the option to purchase 2 boxes per month for 6 months.
- Pilot prescriptions with 50 adult patients with poorly-controlled diabetes and 50 obese children who are food insecure and/or receive SNAP and/or WIC benefits. Examine/evaluate:
- Feasibility of program in a busy primary care practice
- Outcomes before and after the intervention (at baseline, 6 and 12 months), including diet, diabetes control, and body mass index (BMI)
- Outcomes in a comparison group (that will receive the food prescriptions beginning at 6 months)
- Being tested
- Autumn Group, Spring Group
- Keywords
- Food Insecure
- Medical subject headings
- Diabetes Mellitus, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autumn GroupOther
Also called Fresh fruit and vegetable subsidy
The intervention is participating in a fruit and vegetable farm share for 6 months.
Spring GroupOther
Also called Fresh fruit and vegetable subsidy
The intervention is participating in a fruit and vegetable farm share for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Autumn Group | Other | Intervention Group Receives: Other: Autumn Group |
| Spring Group | Other | Delayed Intervention Receives: Other: Spring Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of farm shares picked-up
Number of farm shares picked-up
Measured: up to 12 months
Overall satisfaction score
overall satisfaction with the program measured by likelihood of recommending the program to a friend on a 4 point scale 1 = not likely at all, 2 = somewhat likely, 3 = likely 4 = very likely
Measured: up to 12 months
Secondary outcomes (6)
Health Eating Index
Diet quality, defined by the Health Eating Index which will be derived from the completion of 2 24-hour dietary recalls
Measured: up to 12 months
BMI
The child participant's body mass index
Measured: up to 12 months
USDA US Household Food Security Survey
Food Insecurity as measured by an 18-item Self reported concern about being able to afford food or have access to food at the end of a given month. Responses to the questions in the food security survey module are combined into a scale using non-linear statistical methods based on the Rasch measurement model.
Measured: up to 12 months
Hemoglobin A1c level
The adult participant's glycemic control (as measured by hemoglobin A1c)
Measured: up to 12 months
The Stanford Patient Education Research Center Diabetes Self-Efficacy Scale
Diabetes Self Efficacy as measured by Self reported feelings on one's ability to control and manage their diabetes. 8-item survey, total range from 8 (not at all confident) to 80 (totally confident).
Measured: up to 12 months
Self Efficacy for Eating/Cooking Fruit and Vegetables by Condrasky
Cooking attitudes as measured by self reported attitudes about cooking and the use of the provided fresh fruits and vegetables to provide food to themselves and or their families.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2017
- Study start21 Jun 2017
- Primary completion29 Mar 2019
- Study completion29 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are enrolled in the study and randomly assigned to the immediate intervention or the delayed intervention group. Participants in the immediate intervention group will receive the intervention for 6 months with a 6-month and 12-month follow-up starting from day one of enrollment. Participants in the delayed intervention group will receive the intervention beginning 6 months after enrollment with a 6-month and 12-month follow-up starting from day one of enrollment.
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- New York Common Pantry, Corbin Hill Food Project, Wholesome Wave
- Responsible party
- Sponsor
- Investigators
- Victoria Mayer, MD, MS, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03246997
- Sponsor's protocol ID
- GCO 16-0031
- Status last verified
- Jul 2019
- First submitted
- 8 Aug 2017
- Last updated
- 26 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project Powerfood: Promoting Food Security, Equity, and Health
- ClinicalTrials.gov ID
- NCT03246997
- Acronym / sponsor ID
- GCO 16-0031
- Keywords
- Food Insecure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- New York Common Pantry, Corbin Hill Food Project, Wholesome Wave
- Study start
- 21 Jun 2017 (actual)
- Primary completion
- 29 Mar 2019 (actual)
- Study completion
- 29 Mar 2019 (actual)
- First posted
- 11 Aug 2017 (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.
Project Powerfood is a pilot program aimed at addressing food insecurity and food access in primary care through the implementation of a food prescription program in collaboration with a number of community partners. The objectives of this project are:
- Implement screening for food insecurity in adult and pediatric primary care practices at Mount Sinai.
- Provide fresh fruit and vegetable "prescriptions" to be redeemed for farm shares from local partner, the Corbin Hill Food Project. Prescriptions will provide 50% off of a fruit and vegetable box. Participants will have the option to purchase 2 boxes per month for 6 months.
- Pilot prescriptions with 50 adult patients with poorly-controlled diabetes and 50 obese children who are food insecure and/or receive SNAP and/or WIC benefits. Examine/evaluate:
- Feasibility of program in a busy primary care practice
- Outcomes before and after the intervention (at baseline, 6 and 12 months), including diet, diabetes control, and body mass index (BMI)
- Outcomes in a comparison group (that will receive the food prescriptions beginning at 6 months)
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are enrolled in the study and randomly assigned to the immediate intervention or the delayed intervention group. Participants in the immediate intervention group will receive the intervention for 6 months with a 6-month and 12-month follow-up starting from day one of enrollment. Participants in the delayed intervention group will receive the intervention beginning 6 months after enrollment with a 6-month and 12-month follow-up starting from day one of enrollment.
| Arm | Type | Receives |
|---|---|---|
| Autumn Group | Other | Other: Autumn GroupIntervention Group |
| Spring Group | Other | Other: Spring GroupDelayed Intervention |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Food insecure and/or receive SNAP and/or WIC
- Adult patients: poorly-controlled diabetes (hemoglobin A1c greater than 8.0%)
- Pediatric patients: obesity, ages 5-11
- Speak English or Spanish
Key exclusion criteria (5 listed)
- Food secure and do not receive SNAP or WIC
- Adult Patients: do not have diabetes
- Pediatric Patients: not obese, under 5 years old or between 11 and 18
- Speak neither English or Spanish
- Severe kidney disease (Chronic Kidney Disease (CKD Stage IV or V)
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 |
|---|---|---|
| Autumn GroupAlso: Fresh fruit and vegetable subsidyThe intervention is participating in a fruit and vegetable farm share for 6 months. | Other | Autumn Group |
| Spring GroupAlso: Fresh fruit and vegetable subsidyThe intervention is participating in a fruit and vegetable farm share for 6 months. | Other | Spring Group |
Primary outcome
Number of farm shares picked-up
Time frame: up to 12 months
Number of farm shares picked-up
Overall satisfaction score
Time frame: up to 12 months
overall satisfaction with the program measured by likelihood of recommending the program to a friend on a 4 point scale 1 = not likely at all, 2 = somewhat likely, 3 = likely 4 = very likely
6 secondary outcomes
Health Eating Index
Time frame: up to 12 months
BMI
Time frame: up to 12 months
USDA US Household Food Security Survey
Time frame: up to 12 months
Hemoglobin A1c level
Time frame: up to 12 months
The Stanford Patient Education Research Center Diabetes Self-Efficacy Scale
Time frame: up to 12 months
Self Efficacy for Eating/Cooking Fruit and Vegetables by Condrasky
Time frame: up to 12 months
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 26 Jul 2019.
- 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.
Victoria Mayer, MD, MS principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autumn Group and Spring Group in people with Diabetes and Obesity, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
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 5 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 26 Jul 2019. 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 United States. 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?
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?
Number of farm shares picked-up (time frame: up to 12 months). 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?
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 26 Jul 2019.