Trial Outcomes & Findings for Study of Produce Prescription Programs in Adults With Overweight or Obesity Experiencing Nutrition Insecurity (NCT NCT06751563)
NCT ID: NCT06751563
Last Updated: 2026-07-06
Results Overview
The investigators will track the number of number of screening completions, number of eligible participants, and number of randomized participants, in addition to number of participants retained.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
48 participants
Primary outcome timeframe
From screening up to 8 weeks
Results posted on
2026-07-06
Participant Flow
The recruitment and screening processes will be conducted at the Northeast Market. During interactions with community members, the research team will inform individuals of the current study and if interested, help them complete initial screening forms. If the individual remains eligible and interested, a nurse will complete the screening, including measuring height and weight, in a semi-private space at the market.
Participant milestones
| Measure |
Produce Boxes
Participants will receive fresh produce delivered directly to their home. These boxes will be tailored based on household size, cooking and preparation preferences, and produce they prefer to receive.
The research team will partner with Hungry Harvest, an organization that will assemble and deliver the produce boxes. Hungry Harvest will also help collect participant information, such as delivery instructions, allergies, etc., and send out text messages to participants once they are enrolled, when their box is in route, and once their box is delivered each week.
Participants will receive either a box that feeds a family of 1-2 each week, or a box that feeds a family of 3-4, based on their household size and box options provided by Hungry Harvest. Additionally, participants can choose between a standard box with food items that require some light-cooking, or a snacking box with ready-to-eat food items that require no cooking or kitchen preparation.
|
Produce Vouchers
Participants will receive weekly produce vouchers that are redeemable at a local vendor at Northeast Market. The vouchers will be eligible to redeem approximately $20 worth of produce, depending on household size.
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
25
|
|
Overall Study
4 Week Survey
|
21
|
23
|
|
Overall Study
8 Week Survey
|
23
|
23
|
|
Overall Study
8 Week Visit
|
20
|
22
|
|
Overall Study
COMPLETED
|
23
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Produce Prescription Programs in Adults With Overweight or Obesity Experiencing Nutrition Insecurity
Baseline characteristics by cohort
| Measure |
Produce Boxes
n=23 Participants
Participants will receive fresh produce delivered directly to their home. These boxes will be tailored based on household size, cooking and preparation preferences, and produce they prefer to receive.
The research team will partner with Hungry Harvest, an organization that will assemble and deliver the produce boxes. Hungry Harvest will also help collect participant information, such as delivery instructions, allergies, etc., and send out text messages to participants once they are enrolled, when their box is in route, and once their box is delivered each week.
Participants will receive either a box that feeds a family of 1-2 each week, or a box that feeds a family of 3-4, based on their household size and box options provided by Hungry Harvest. Additionally, participants can choose between a standard box with food items that require some light-cooking, or a snacking box with ready-to-eat food items that require no cooking or kitchen preparation.
|
Produce Vouchers
n=25 Participants
Participants will receive weekly produce vouchers that are redeemable at a local vendor at Northeast Market. The vouchers will be eligible to redeem approximately $20 worth of produce, depending on household size.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51 Years
STANDARD_DEVIATION 16 • n=9 Participants
|
49 Years
STANDARD_DEVIATION 17 • n=27 Participants
|
50 Years
STANDARD_DEVIATION 16 • n=267 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=9 Participants
|
15 Participants
n=27 Participants
|
31 Participants
n=267 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=9 Participants
|
10 Participants
n=27 Participants
|
17 Participants
n=267 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Black or African American
|
20 Participants
n=9 Participants
|
20 Participants
n=27 Participants
|
40 Participants
n=267 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
5 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=9 Participants
|
22 Participants
n=27 Participants
|
44 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
PRIMARY outcome
Timeframe: From screening up to 8 weeksPopulation: There were 221 individuals who were screened and completed the eligibility survey for the study.
The investigators will track the number of number of screening completions, number of eligible participants, and number of randomized participants, in addition to number of participants retained.
Outcome measures
| Measure |
Participant Recruitment
n=221 Participants
Participants reached for the study. The number of screening completions, number of eligible participants, and number of randomized participants, in addition to number of participants retained.
|
Produce Vouchers
Participants will receive weekly produce vouchers that are redeemable at a local vendor at Northeast Market. The vouchers will be eligible to redeem approximately $20 worth of produce, depending on household size.
|
|---|---|---|
|
Number of Participants Reached
Ineligible based on Eligibilty Survey
|
120 Participants
|
—
|
|
Number of Participants Reached
Eligible but did not complete enrollment
|
53 Participants
|
—
|
|
Number of Participants Reached
Eligible and Enrolled in Study
|
48 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline to 8 weeksPopulation: The number of participants analyzed in 8-week nutrition security is less than the baseline due to participants being lost to follow up.
Nutrition insecurity will be assessed using Center for Nutrition Health and Impact questionnaire with a 4-item scale. The higher the score, the greater the level of food security and control an individual has over their nutrition. The four items within the measure are scored from 0 to 4. Then, the measure's score is simply the mean of the responses.
Outcome measures
| Measure |
Participant Recruitment
n=23 Participants
Participants reached for the study. The number of screening completions, number of eligible participants, and number of randomized participants, in addition to number of participants retained.
|
Produce Vouchers
n=25 Participants
Participants will receive weekly produce vouchers that are redeemable at a local vendor at Northeast Market. The vouchers will be eligible to redeem approximately $20 worth of produce, depending on household size.
|
|---|---|---|
|
Nutrition Insecurity as Assessed by the 4-item Nutrition Security Screening Questionnaire
Baseline Nutrition Security
|
2.0 score on a scale
Interval 1.5 to 2.5
|
2.0 score on a scale
Interval 1.75 to 2.5
|
|
Nutrition Insecurity as Assessed by the 4-item Nutrition Security Screening Questionnaire
8-Week Nutrition Security
|
2.88 score on a scale
Interval 2.25 to 3.75
|
2.5 score on a scale
Interval 2.25 to 2.75
|
|
Nutrition Insecurity as Assessed by the 4-item Nutrition Security Screening Questionnaire
4-Week Nutrition Security
|
2.50 score on a scale
Interval 2.0 to 3.25
|
2.5 score on a scale
Interval 2.0 to 3.0
|
SECONDARY outcome
Timeframe: Baseline, 4 weeks, and 8 weeksPopulation: Participants with data collected
Consumption of food groups will be assessed using the 9-item Mini-Eating Assessment Tool (EAT) questionnaire. Evaluates consumption of key food groups. Fruit and vegetable consumption were each based on two questions within the MINI eat scale, not subscales. Fruit ranges from 1 to 7 where 1 = less than 1 serving per week, and 7 = 4 or more servings per day. Vegetables range from 1 to 6 where 1 = less than 3 servings per week, and 6 = 4 or more servings per day. Mini-EAT score range 0-90. Higher scores better consumption.
Outcome measures
| Measure |
Participant Recruitment
n=23 Participants
Participants reached for the study. The number of screening completions, number of eligible participants, and number of randomized participants, in addition to number of participants retained.
|
Produce Vouchers
n=25 Participants
Participants will receive weekly produce vouchers that are redeemable at a local vendor at Northeast Market. The vouchers will be eligible to redeem approximately $20 worth of produce, depending on household size.
|
|---|---|---|
|
Fruit and Vegetable Consumption as Assessed by the 9-item Mini-Eating Assessment Tool (EAT)
Baseline Mini-EAT Fruit Consumption
|
3.0 score on a scale
Interval 2.0 to 3.0
|
3.0 score on a scale
Interval 2.0 to 3.0
|
|
Fruit and Vegetable Consumption as Assessed by the 9-item Mini-Eating Assessment Tool (EAT)
4-Week Mini-EAT Fruit Consumption
|
4.0 score on a scale
Interval 3.0 to 5.0
|
4.0 score on a scale
Interval 3.0 to 6.0
|
|
Fruit and Vegetable Consumption as Assessed by the 9-item Mini-Eating Assessment Tool (EAT)
8-Week Mini-EAT Fruit Consumption
|
3.0 score on a scale
Interval 3.0 to 5.0
|
4.0 score on a scale
Interval 3.0 to 6.0
|
|
Fruit and Vegetable Consumption as Assessed by the 9-item Mini-Eating Assessment Tool (EAT)
Baseline Mini-EAT Vegetable Consumption
|
2.0 score on a scale
Interval 1.0 to 4.0
|
2.0 score on a scale
Interval 2.0 to 3.0
|
|
Fruit and Vegetable Consumption as Assessed by the 9-item Mini-Eating Assessment Tool (EAT)
4-Week Mini-EAT Vegetable Consumption
|
3.0 score on a scale
Interval 2.0 to 5.0
|
3.0 score on a scale
Interval 2.0 to 5.0
|
|
Fruit and Vegetable Consumption as Assessed by the 9-item Mini-Eating Assessment Tool (EAT)
8-Week Mini-EAT Vegetable Consumption
|
2.0 score on a scale
Interval 2.0 to 5.0
|
3.0 score on a scale
Interval 2.0 to 5.0
|
|
Fruit and Vegetable Consumption as Assessed by the 9-item Mini-Eating Assessment Tool (EAT)
Baseline Mini Eat
|
58.3 score on a scale
Interval 53.2 to 60.0
|
58.7 score on a scale
Interval 54.6 to 61.5
|
|
Fruit and Vegetable Consumption as Assessed by the 9-item Mini-Eating Assessment Tool (EAT)
4-Week Mini-EAT
|
62.1 score on a scale
Interval 57.4 to 67.0
|
63.3 score on a scale
Interval 59.4 to 69.0
|
|
Fruit and Vegetable Consumption as Assessed by the 9-item Mini-Eating Assessment Tool (EAT)
8-Week Mini-EAT
|
60.60 score on a scale
Interval 55.5 to 67.7
|
61.1 score on a scale
Interval 57.1 to 68.3
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksPopulation: The number of participants analyzed in the 8-week measurement is less than the baseline due to participants being lost to follow up.
Weight will be taken by study staff and measured to the nearest 0.1 kg.
Outcome measures
| Measure |
Participant Recruitment
n=23 Participants
Participants reached for the study. The number of screening completions, number of eligible participants, and number of randomized participants, in addition to number of participants retained.
|
Produce Vouchers
n=25 Participants
Participants will receive weekly produce vouchers that are redeemable at a local vendor at Northeast Market. The vouchers will be eligible to redeem approximately $20 worth of produce, depending on household size.
|
|---|---|---|
|
Weight (kg)
Participant 8-week weight
|
84.4 Kilograms (kg)
Interval 77.6 to 92.3
|
93.2 Kilograms (kg)
Interval 81.2 to 117.5
|
|
Weight (kg)
Participant Baseline Weight
|
86.2 Kilograms (kg)
Interval 79.4 to 98.0
|
93.0 Kilograms (kg)
Interval 80.7 to 114.7
|
SECONDARY outcome
Timeframe: Baseline, 8 WeeksPopulation: The number of participants analyzed in 8-week measurement is less than the baseline due to participants being lost to follow up.
Blood pressure was measured using the Omron 10 Series ® Upper Arm Blood Pressure Monitor. Participants were instructed to rest for five minutes before two blood pressure readings were taken on the upper arm, one minute apart. Measurements were averaged for analysis.
Outcome measures
| Measure |
Participant Recruitment
n=23 Participants
Participants reached for the study. The number of screening completions, number of eligible participants, and number of randomized participants, in addition to number of participants retained.
|
Produce Vouchers
n=25 Participants
Participants will receive weekly produce vouchers that are redeemable at a local vendor at Northeast Market. The vouchers will be eligible to redeem approximately $20 worth of produce, depending on household size.
|
|---|---|---|
|
Blood Pressure (mmHg)
Baseline Average Systolic BP
|
125.5 mmHg
Interval 122.0 to 138.0
|
129.5 mmHg
Interval 105.5 to 143.0
|
|
Blood Pressure (mmHg)
Baseline Average Diastolic BP
|
86 mmHg
Interval 72.0 to 93.5
|
80.0 mmHg
Interval 71.0 to 90.0
|
|
Blood Pressure (mmHg)
8-Week Average Systolic BP
|
121.75 mmHg
Interval 111.5 to 128.0
|
123.0 mmHg
Interval 111.0 to 127.5
|
|
Blood Pressure (mmHg)
8-Week Average Diastolic BP
|
82 mmHg
Interval 76.0 to 88.5
|
77.25 mmHg
Interval 69.25 to 87.0
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksPopulation: The number of participants analyzed in 8-week measurement is less than the baseline due to participants being lost to follow up.
Self-efficacy was measured using the 11-item Healthy Eating and Weight Self-Efficacy Scale. Responses were rated on a Likert scale that ranged from "Strongly Disagree" to "Strongly Agree". Responses were summed to create a total score ranging from 11 to 55, with higher scores representing greater self-efficacy.
Outcome measures
| Measure |
Participant Recruitment
n=23 Participants
Participants reached for the study. The number of screening completions, number of eligible participants, and number of randomized participants, in addition to number of participants retained.
|
Produce Vouchers
n=25 Participants
Participants will receive weekly produce vouchers that are redeemable at a local vendor at Northeast Market. The vouchers will be eligible to redeem approximately $20 worth of produce, depending on household size.
|
|---|---|---|
|
Health Self-Efficacy as Assessed by the 11-item Healthy Eating and Weight Self-Efficacy Scale
Baseline Participant Self-Efficacy subscale
|
36 score on a scale
Interval 28.0 to 39.0
|
32 score on a scale
Interval 30.0 to 36.0
|
|
Health Self-Efficacy as Assessed by the 11-item Healthy Eating and Weight Self-Efficacy Scale
8-Week Participant Self-efficacy subscale
|
37 score on a scale
Interval 33.0 to 41.0
|
36 score on a scale
Interval 32.0 to 41.0
|
Adverse Events
Produce Boxes
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Produce Vouchers
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Produce Boxes
n=23 participants at risk
Participants will receive fresh produce delivered directly to their home. These boxes will be tailored based on household size, cooking and preparation preferences, and produce they prefer to receive.
The research team will partner with Hungry Harvest, an organization that will assemble and deliver the produce boxes. Hungry Harvest will also help collect participant information, such as delivery instructions, allergies, etc., and send out text messages to participants once they are enrolled, when their box is in route, and once their box is delivered each week.
Participants will receive either a box that feeds a family of 1-2 each week, or a box that feeds a family of 3-4, based on their household size and box options provided by Hungry Harvest. Additionally, participants can choose between a standard box with food items that require some light-cooking, or a snacking box with ready-to-eat food items that require no cooking or kitchen preparation.
|
Produce Vouchers
n=25 participants at risk
Participants will receive weekly produce vouchers that are redeemable at a local vendor at Northeast Market. The vouchers will be eligible to redeem approximately $20 worth of produce, depending on household size.
|
|---|---|---|
|
Social circumstances
The participant fell and broke their leg.
|
0.00%
0/23 • From enrollment up to 8 week visit
|
4.0%
1/25 • From enrollment up to 8 week visit
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place