ClinicalTrials.gg
CompletedNCT03246997Updated Jul 26, 2019

Project Powerfood: Promoting Food Security, Equity, and Health

An interventional study of Autumn Group and Spring Group in Diabetes and Obesity, sponsored by Icahn School of Medicine at Mount Sinai. Completed at 1 site in United States. Open to participants aged 5 Years to 18 Years. Per ClinicalTrials.gov, last updated 2019-07-26.

Sponsored by Icahn School of Medicine at Mount Sinai · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
95
Allocation
Randomized
Ages
5 Years to 18 Years
Sex
All
01

Study 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. Implement screening for food insecurity in adult and pediatric primary care practices at Mount Sinai.
  2. 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.
  3. 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:

    1. Feasibility of program in a busy primary care practice
    2. Outcomes before and after the intervention (at baseline, 6 and 12 months), including diet, diabetes control, and body mass index (BMI)
    3. Outcomes in a comparison group (that will receive the food prescriptions beginning at 6 months)
02

Conditions studied

  • Diabetes
  • Obesity

Keywords

  • Food Insecure
03

In context

Diabetes Mellitus

11,089 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 95 is above the median of 80 across 8,491 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Icahn School of Medicine at Mount Sinai is the lead sponsor of 773 studies on the registry; 176 are open to participants now.

Of its 124 completed or terminated interventional studies of FDA-regulated products, 83 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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)
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
95 participants (actual)

Study arms

  • Other
    Autumn Group

    Intervention Group

    Other: Autumn Group

  • Other
    Spring Group

    Delayed Intervention

    Other: Spring Group

Interventions

  • OtherAutumn Group

    The intervention is participating in a fruit and vegetable farm share for 6 months.

    Also known as: Fresh fruit and vegetable subsidy

  • OtherSpring Group

    The intervention is participating in a fruit and vegetable farm share for 6 months.

    Also known as: Fresh fruit and vegetable subsidy

06

What researchers measure

Primary outcomes

  1. Number of farm shares picked-up

    Number of farm shares picked-up

    Time frame: up to 12 months

  2. 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

    Time frame: up to 12 months

Secondary outcomes

  1. Health Eating Index

    Diet quality, defined by the Health Eating Index which will be derived from the completion of 2 24-hour dietary recalls

    Time frame: up to 12 months

  2. BMI

    The child participant's body mass index

    Time frame: up to 12 months

  3. 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.

    Time frame: up to 12 months

  4. Hemoglobin A1c level

    The adult participant's glycemic control (as measured by hemoglobin A1c)

    Time frame: up to 12 months

  5. 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).

    Time frame: up to 12 months

  6. 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.

    Time frame: up to 12 months

07

Study locations

1 site
  • Icahn School of Medicine at Mount Sinai
    New York, New York 10029, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2017 to primary completion in Mar 2019, 21 months.

Of 2,196 non-industry interventional studies with no phase under Diabetes Mellitus, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 38. This study's 21 months is close to that.

Counting every sponsor, half of 2,388 studies reached it within 20 months; a quarter within 9 and three quarters within 37.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 8, 2017
First posted
Aug 11, 2017
StartActual
Jun 21, 2017
Primary completionActual
Mar 29, 2019
CompletionActual
Mar 29, 2019
Last update
Jul 26, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 26, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03246997
Collaborators
New York Common Pantry, Corbin Hill Food Project, Wholesome Wave
Responsible party
Sponsor
First posted
Aug 11, 2017
Start date
Jun 21, 2017
Primary completion
Mar 29, 2019
Completion
Mar 29, 2019
Last update
Jul 26, 2019

Study contacts

Victoria Mayer, MD, MS
principal investigator · Icahn School of Medicine at Mount Sinai

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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