Exposure to Fruit and Vegetable Prescription Program
Conditions
Brief summary
The objective of this study is to address gaps in knowledge related to the influence of pediatric fruit and vegetable prescription programs on food security, child dietary patterns, and weight status. To do this, we will compare demographically similar pediatric patient groups from three large clinics in a low-income urban city based on their exposure to a fruit and vegetable prescription program (FVPP) that provides one $15 prescription for fresh fruits and vegetable to every child at every office visit. Three clusters will be identified based on child exposure to the pediatric FVPP at baseline: high exposure (\>24 months), moderate exposure (12-24 months), and no previous exposure. We will then introduce the FVPP to never exposed patients and collect, record, and compare changes in dietary intake, food security, and weight status over time. We will test the hypothesis that exposure to the FVPP is associated with higher intake of fruits and vegetables, better food security, and lower rates of obesity among children. The first aim will compare baseline dietary intake, food security, and weight status between high exposure, moderate exposure, no exposure groups. The second aim will measure changes in diet, food security, and weight status at 6-, 12-, 18-, and 24-months among children newly exposed to the FVPP. The third aim will compare follow-up measures of dietary intake, food security, and weight status in the initial no exposure group to baseline measures in the high exposure group.
Detailed description
This study will evaluate a Fruit and Vegetable Prescription Program (FVPP). The program provides one $15 prescription for fresh produce to every child at every office visit. Prescriptions are redeemable at a local farmers' market and mobile market. To determine whether exposure to the FVPP is associated with improvements in dietary intake, food security, and health status, we will compare demographically similar pediatric patient groups with varying levels of exposure to the FVPP at baseline: high exposure (\>24 months), moderate exposure (12-24 months), and no previous exposure. We will then introduce the FVPP to never exposed patients and collect, record, and compare changes in dietary intake, food security, and weight status over time. The central hypothesis is that exposure to the FVPP is associated with higher intake of fruits and vegetables, better food security, and lower rates of childhood obesity over time. We propose the following three specific aims to test our hypothesis: Aim 1 - Compare baseline dietary intake, food security, and weight status between pediatric patients with varying levels of exposure to the FVPP. Aim 2 - Measure changes in diet, food security, and weight status when never exposed children are introduced to the FVPP. Aim 3 - Compare mean follow-up measures of dietary intake, food security, and weight status in the initial no exposure group to baseline measures in the high exposure group.
Interventions
$15 voucher for fruit and vegetables
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Hurley Medical Center
Akpinar Children's Clinic
Mott Children's Health Center
Hurley Children's Center
Michigan State University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
A fruit and vegetable prescription is written by pediatricians to exchange for $15 of fresh produce. Prescriptions are redeemable at a local farmers' market and mobile market.
Eligibility
Sex/Gender
ALL
Age
8 Years to 16 Years
Healthy volunteers
Yes
Inclusion criteria
* Child between age 8 and 16 years and their caregiver; * Child active patient at clinic; * Child received at least one fruit and vegetable prescription; * Child and caregiver English-speaking
Exclusion criteria
* Caregiver or child not English speaking; * Legal guardian not present at enrollment; * Child assent refused; * Sibling previously enrolled (one caregiver and one child per household); * Movement between participating clinics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Odds Ratio Evaluating the Longitudinal Trend of High Food Security for the Household at 6, 12, 18 and 24 Months Relative to Baseline Among Caregivers Newly Introduced to the FVPP | Baseline, 6 months, 12 months, 18 months, 24 months | Household food security was assessed using the US Household Food Security Module: Six Item Short Form (National Center for Health Statistics) via caregiver report. The sum of affirmative responses to six questions served as the household's raw score. Food security status was assigned based on a calculated raw score (0-1=high/marginal food security; 2-4=low food security; 5-6 very low food security). High food security (outcome analyzed) was assigned to those with raw scores less than or equal to 1. |
| Odds Ratio Evaluating the Longitudinal Trend of High Food Security for the Household at 6 and 12 Months Relative to Baseline Among Caregivers Newly Introduced to the FVPP | Baseline, 6 months,12 months | Household food security was assessed using the US Household Food Security Module: Six Item Short Form (National Center for Health Statistics) via caregiver report. The sum of affirmative responses to six questions served as the household's raw score. Food security status was assigned based on a calculated raw score (0-1=high/marginal food security; 2-4=low food security; 5-6 very low food security). High food security (outcome analyzed) was assigned to those with raw scores less than or equal to 1. |
| Odds Ratio Evaluating the Longitudinal Trend of High Food Security at 6 and 12 Months Relative to Baseline Among Youth 12 Years of Age and Older Who Were Newly Introduced to the FVPP. | Baseline, 6 months,12 months | Child food security status was assessed via the Self-Administered Food Security Survey Module for Youth only with children aged 12 years and older based on prior research recommendations. The sum of affirmative responses (a lot or sometimes) to nine questions represented the respondent's raw score on the scale. Food security status was assigned by raw score (0-1=high/marginal food security; 2-5=low food security; 6-9=very low food security). High food security (outcome analyzed) was assigned to those with raw scores less than or equal to 1. |
| Odds Ratio Evaluating the Longitudinal Trend of High Food Security at 6, 12, 18 and 24 Months Relative to Baseline Among Youth 12 Years of Age and Older at Newly Introduced to the FVPP | Baseline, 6 months, 12 months, 18 months, 24 months | Child food security status was assessed via the Self-Administered Food Security Survey Module for Youth only with children aged 12 years and older based on prior research recommendations. The sum of affirmative responses (a lot or sometimes) to nine questions represented the respondent's raw score on the scale. Food security status was assigned by raw score (0-1=high/marginal food security; 2-5=low food security; 6-9=very low food security). High food security (outcome analyzed) was assigned to those with raw scores less than or equal to 1. |
| Change From Baseline Child-reported Mean Daily Intake of Fruits and Vegetables at 6, 12, 18 and 24 Months Among Youth Participants Newly Introduced to the FVPP | Baseline, 6 months, 12 months, 18 months, 24 months | Eating behaviors reported here were assessed via child-report using the 41-item Block Kids Food Screener (BKFS), chosen for low respondent burden and acceptable psychometric values. Dietary analysis, using Block Online Analysis System, provided nutrient estimates and number of servings by food groups. This data was used to determine mean daily intake (in cup equivalents) of total vegetables, total fruits, and whole fruits. |
| Change From Baseline Child-reported Mean Daily Intake of Fruits and Vegetables at 6 and 12 Months Among Youth Participants Newly Introduced to the FVPP | Baseline, 6 months,12 months | Eating behaviors reported here were assessed via child-report using the 41-item Block Kids Food Screener (BKFS), chosen for low respondent burden and acceptable psychometric values. Dietary analysis, using Block Online Analysis System, provided nutrient estimates and number of servings by food groups. This data was used to determine mean daily intake (in cup equivalents) of total vegetables, total fruits, and whole fruits. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline BMI at 6, 12, 18 and 24 Months Among Youth Participants Newly Introduced to the FVPP | Baseline, 6 months, 12 months, 18 months, 24 months | Body mass index (BMI) was calculated from child weight and height (weight (kg)/\[height (m)\]2). BMI was then categorized into percentiles by sex and age to serve as an indicator of overweight and obesity. Child overweight and obesity status were categorized as follows: overweight (95th percentile for age and sex \> BMI ≥ 85th percentile for age and sex), obese (BMI ≥ 95th percentile for age and sex). Because achievement of healthy weight in youth (85th percentile for age and sex ≥ BMI \> 5th percentile for age and sex) was a secondary objective, a negative change in BMI percentile represents a desirable outcome. |
| Change From Caregiver-reported Baseline Mean Daily Intake of Fruits and Vegetables at 6 and 12 Months Among Caregivers Newly Introduced to the FVPP | Baseline, 6 months, 12 months | To investigate whether exposure to the pediatric fruit and vegetable prescription program is associated with increased fruit and vegetable consumption among caregivers, dietary data from caregivers was collected using the National Cancer Institute Fruit & Vegetable Intake All Day Screener which asks frequency and portion size questions about nine food items. This will be used to calculate mean daily intake of vegetables and total fruits. |
| Change From Caregiver-reported Baseline Mean Daily Intake of Fruits and Vegetables at 6, 12, 18 and 24 Months Among Caregivers Newly Introduced to the FVPP | Baseline, 6 months, 12 months, 18 months, 24 months | To investigate whether exposure to the pediatric fruit and vegetable prescription program is associated with increased fruit and vegetable consumption among caregivers, dietary data from caregivers was collected using the National Cancer Institute Fruit & Vegetable Intake All Day Screener which asks frequency and portion size questions about nine food items. This will be used to calculate mean daily intake of vegetables and total fruits. |
| Change From Baseline Child BMI at 6 and 12 Months Among Youth Participants Newly Introduced to the FVPP | Baseline, 6 months,12 months | Body mass index (BMI) was calculated from child weight and height (weight (kg)/\[height (m)\]2). BMI was then categorized into percentiles by sex and age to serve as an indicator of overweight and obesity. Child overweight and obesity status were categorized as follows: overweight (95th percentile for age and sex \> BMI ≥ 85th percentile for age and sex), obese (BMI ≥ 95th percentile for age and sex). Because achievement of healthy weight in youth (85th percentile for age and sex ≥ BMI \> 5th percentile for age and sex) was a secondary objective, a negative change in BMI percentile represents a desirable outcome. |
Countries
United States
Participant flow
Recruitment details
Caregiver-child dyads were recruited from February 2021 through June 2022 at pediatric clinics in Flint, Michigan. The high exposure clinic is a large pediatric clinic that introduced Michigan's first pediatric fruit and vegetable prescription program in February 2016. The moderate exposure clinic is one of the largest private-practice pediatric clinics in Flint serving over 3,000 patients. The no/low exposure clinic is the largest pediatric clinic in Flint.
Pre-assignment details
Exposure to the pediatric fruit and vegetable prescription program was based on length of time a child was a patient at one of three partnering clinics that offered the fruit and vegetable prescription program. Number of participants started represents the number of individual participants (caregivers and children).
Participants by arm
| Arm | Count |
|---|---|
| Moderate Exposure to the FVPP Participants with Moderate Exposure to the FVPP | 350 |
| High Exposure to the FVPP Participants with High Exposure to the FVPP | 402 |
| No/Low Expsoure to the FVPP Participants with No/Low Exposure to the FVPP | 608 |
| Total | 1,360 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Duplicate household previously enrolled | 2 | 0 | 8 |
| Overall Study | Refused or did not begin surveys | 6 | 2 | 2 |
| Overall Study | Survey comprehension challenges | 4 | 0 | 0 |
| Overall Study | Unable to confirm legal guardian | 0 | 2 | 8 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 6 |
Baseline characteristics
| Characteristic | Moderate Exposure to the FVPP | High Exposure to the FVPP | No/Low Expsoure to the FVPP | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 175 Participants | 201 Participants | 300 Participants | 676 Participants |
| Age, Categorical >=65 years | 6 Participants | 3 Participants | 8 Participants | 17 Participants |
| Age, Categorical Between 18 and 65 years | 167 Participants | 198 Participants | 291 Participants | 656 Participants |
| Age, Continuous Age | 26.99 years STANDARD_DEVIATION 15.61 | 25.92 years STANDARD_DEVIATION 14.87 | 25.72 years STANDARD_DEVIATION 15.54 | 26.11 years STANDARD_DEVIATION 15.36 |
| Age of Study Participants Age of adult participants | 41.22 Years STANDARD_DEVIATION 9.02 | 39.74 Years STANDARD_DEVIATION 8.53 | 39.51 Years STANDARD_DEVIATION 9.89 | 39.91 Years STANDARD_DEVIATION 9.3 |
| Age of Study Participants Age of youth participants | 12.93 Years STANDARD_DEVIATION 2.34 | 12.47 Years STANDARD_DEVIATION 2.63 | 11.98 Years STANDARD_DEVIATION 2.39 | 12.37 Years STANDARD_DEVIATION 2.48 |
| Ethnicity (NIH/OMB) Caregivers Hispanic or Latino | 3 Participants | 1 Participants | 7 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Caregivers Not Hispanic or Latino | 169 Participants | 200 Participants | 290 Participants | 659 Participants |
| Ethnicity (NIH/OMB) Caregivers Unknown or Not Reported | 3 Participants | 0 Participants | 7 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Children Hispanic or Latino | 2 Participants | 0 Participants | 5 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Children Not Hispanic or Latino | 172 Participants | 201 Participants | 289 Participants | 662 Participants |
| Ethnicity (NIH/OMB) Children Unknown or Not Reported | 1 Participants | 0 Participants | 10 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Total Hispanic or Latino | 5 Participants | 1 Participants | 12 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Total Not Hispanic or Latino | 341 Participants | 401 Participants | 579 Participants | 1321 Participants |
| Ethnicity (NIH/OMB) Total Unknown or Not Reported | 4 Participants | 0 Participants | 17 Participants | 21 Participants |
| Race (NIH/OMB) Caregivers American Indian or Alaska Native | 2 Participants | 2 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) Caregivers Asian | 0 Participants | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) Caregivers Black or African American | 125 Participants | 165 Participants | 202 Participants | 492 Participants |
| Race (NIH/OMB) Caregivers More than one race | 4 Participants | 4 Participants | 11 Participants | 19 Participants |
| Race (NIH/OMB) Caregivers Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Caregivers Unknown or Not Reported | 3 Participants | 0 Participants | 7 Participants | 10 Participants |
| Race (NIH/OMB) Caregivers White | 38 Participants | 28 Participants | 72 Participants | 138 Participants |
| Race (NIH/OMB) Children American Indian or Alaska Native | 1 Participants | 3 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) Children Asian | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Children Black or African American | 128 Participants | 165 Participants | 212 Participants | 505 Participants |
| Race (NIH/OMB) Children More than one race | 11 Participants | 13 Participants | 16 Participants | 40 Participants |
| Race (NIH/OMB) Children Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Children Unknown or Not Reported | 1 Participants | 0 Participants | 10 Participants | 11 Participants |
| Race (NIH/OMB) Children White | 30 Participants | 19 Participants | 57 Participants | 106 Participants |
| Race (NIH/OMB) Total American Indian or Alaska Native | 3 Participants | 5 Participants | 3 Participants | 11 Participants |
| Race (NIH/OMB) Total Asian | 1 Participants | 2 Participants | 4 Participants | 7 Participants |
| Race (NIH/OMB) Total Black or African American | 253 Participants | 330 Participants | 414 Participants | 997 Participants |
| Race (NIH/OMB) Total More than one race | 15 Participants | 17 Participants | 27 Participants | 59 Participants |
| Race (NIH/OMB) Total Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Total Unknown or Not Reported | 4 Participants | 0 Participants | 17 Participants | 21 Participants |
| Race (NIH/OMB) Total White | 68 Participants | 47 Participants | 129 Participants | 244 Participants |
| Region of Enrollment United States | 350 participants | 402 participants | 608 participants | 1360 participants |
| Sex: Female, Male Caregivers Female | 159 Participants | 179 Participants | 269 Participants | 607 Participants |
| Sex: Female, Male Caregivers Male | 16 Participants | 22 Participants | 31 Participants | 69 Participants |
| Sex: Female, Male Children Female | 91 Participants | 103 Participants | 159 Participants | 353 Participants |
| Sex: Female, Male Children Male | 84 Participants | 98 Participants | 145 Participants | 327 Participants |
| Sex: Female, Male Total Female | 250 Participants | 282 Participants | 428 Participants | 960 Participants |
| Sex: Female, Male Total Male | 100 Participants | 120 Participants | 176 Participants | 396 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 1,360 | 0 / 201 | 0 / 201 | 0 / 175 | 0 / 175 | 0 / 304 | 0 / 304 |
| other Total, other adverse events | 0 / 1,360 | 0 / 201 | 0 / 201 | 0 / 175 | 0 / 175 | 0 / 304 | 0 / 304 |
| serious Total, serious adverse events | 0 / 1,360 | 0 / 201 | 0 / 201 | 0 / 175 | 0 / 175 | 0 / 304 | 0 / 304 |
Outcome results
Primary
Change From Baseline Child-reported Mean Daily Intake of Fruits and Vegetables at 6, 12, 18 and 24 Months Among Youth Participants Newly Introduced to the FVPP
Eating behaviors reported here were assessed via child-report using the 41-item Block Kids Food Screener (BKFS), chosen for low respondent burden and acceptable psychometric values. Dietary analysis, using Block Online Analysis System, provided nutrient estimates and number of servings by food groups. This data was used to determine mean daily intake (in cup equivalents) of total vegetables, total fruits, and whole fruits.
Time frame: Baseline, 6 months, 12 months, 18 months, 24 months
Population: This outcome measure was pre-specified to only assess participants in the low/no exposure to FVPP groups. Analysis includes data from youth participants who were newly introduced to the FVPP and completed the Block Kids Food Screener.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| No/Low Exposure | Change From Baseline Child-reported Mean Daily Intake of Fruits and Vegetables at 6, 12, 18 and 24 Months Among Youth Participants Newly Introduced to the FVPP | Change in mean daily intake of total fruits (6 months versus baseline) | 0.21 cup equivalents per day |
| No/Low Exposure | Change From Baseline Child-reported Mean Daily Intake of Fruits and Vegetables at 6, 12, 18 and 24 Months Among Youth Participants Newly Introduced to the FVPP | Change in mean daily intake of total fruits (12 months versus baseline) | 0.17 cup equivalents per day |
| No/Low Exposure | Change From Baseline Child-reported Mean Daily Intake of Fruits and Vegetables at 6, 12, 18 and 24 Months Among Youth Participants Newly Introduced to the FVPP | Change in mean daily intake of total fruits (18 months versus baseline) | 0.37 cup equivalents per day |
| No/Low Exposure | Change From Baseline Child-reported Mean Daily Intake of Fruits and Vegetables at 6, 12, 18 and 24 Months Among Youth Participants Newly Introduced to the FVPP | Change in mean daily intake of total fruits (24 months versus baseline) | 0.09 cup equivalents per day |
| No/Low Exposure | Change From Baseline Child-reported Mean Daily Intake of Fruits and Vegetables at 6, 12, 18 and 24 Months Among Youth Participants Newly Introduced to the FVPP | Change in mean daily intake of whole fruits (6 months versus baseline) | 0.14 cup equivalents per day |
| No/Low Exposure | Change From Baseline Child-reported Mean Daily Intake of Fruits and Vegetables at 6, 12, 18 and 24 Months Among Youth Participants Newly Introduced to the FVPP | Change in mean daily intake of whole fruits (12 months versus baseline) | 0.05 cup equivalents per day |
| No/Low Exposure | Change From Baseline Child-reported Mean Daily Intake of Fruits and Vegetables at 6, 12, 18 and 24 Months Among Youth Participants Newly Introduced to the FVPP | Change in mean daily intake of whole fruits (18 months versus baseline) | 0.20 cup equivalents per day |
| No/Low Exposure | Change From Baseline Child-reported Mean Daily Intake of Fruits and Vegetables at 6, 12, 18 and 24 Months Among Youth Participants Newly Introduced to the FVPP | Change in mean daily intake of whole fruits (24 months versus baseline) | 0.12 cup equivalents per day |
| No/Low Exposure | Change From Baseline Child-reported Mean Daily Intake of Fruits and Vegetables at 6, 12, 18 and 24 Months Among Youth Participants Newly Introduced to the FVPP | Change in mean daily intake of total vegetables (6 months versus baseline) | 0.11 cup equivalents per day |
| No/Low Exposure | Change From Baseline Child-reported Mean Daily Intake of Fruits and Vegetables at 6, 12, 18 and 24 Months Among Youth Participants Newly Introduced to the FVPP | Change in mean daily intake of total vegetables (12 months versus baseline) | -0.01 cup equivalents per day |
| No/Low Exposure | Change From Baseline Child-reported Mean Daily Intake of Fruits and Vegetables at 6, 12, 18 and 24 Months Among Youth Participants Newly Introduced to the FVPP | Change in mean daily intake of total vegetables (18 months versus baseline) | 0.19 cup equivalents per day |
| No/Low Exposure | Change From Baseline Child-reported Mean Daily Intake of Fruits and Vegetables at 6, 12, 18 and 24 Months Among Youth Participants Newly Introduced to the FVPP | Change in mean daily intake of total vegetables (24 months versus baseline) | -0.02 cup equivalents per day |
Primary
Change From Baseline Child-reported Mean Daily Intake of Fruits and Vegetables at 6 and 12 Months Among Youth Participants Newly Introduced to the FVPP
Eating behaviors reported here were assessed via child-report using the 41-item Block Kids Food Screener (BKFS), chosen for low respondent burden and acceptable psychometric values. Dietary analysis, using Block Online Analysis System, provided nutrient estimates and number of servings by food groups. This data was used to determine mean daily intake (in cup equivalents) of total vegetables, total fruits, and whole fruits.
Time frame: Baseline, 6 months,12 months
Population: This outcome measure was pre-specified to only assess participants in the low/no exposure to FVPP group. Analysis includes data from youth participants with no/low exposure to the FVPP at baseline who completed the Block Kids Food Screener.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| No/Low Exposure | Change From Baseline Child-reported Mean Daily Intake of Fruits and Vegetables at 6 and 12 Months Among Youth Participants Newly Introduced to the FVPP | Change in mean daily intake of total fruits (6 months versus baseline) | 0.21 cup equivalents per day |
| No/Low Exposure | Change From Baseline Child-reported Mean Daily Intake of Fruits and Vegetables at 6 and 12 Months Among Youth Participants Newly Introduced to the FVPP | Change in mean daily intake of total fruits (12 months versus baseline) | 0.17 cup equivalents per day |
| No/Low Exposure | Change From Baseline Child-reported Mean Daily Intake of Fruits and Vegetables at 6 and 12 Months Among Youth Participants Newly Introduced to the FVPP | Change in mean daily intake of whole fruits (6 months versus baseline) | 0.14 cup equivalents per day |
| No/Low Exposure | Change From Baseline Child-reported Mean Daily Intake of Fruits and Vegetables at 6 and 12 Months Among Youth Participants Newly Introduced to the FVPP | Change in mean daily intake of whole fruits (12 months versus baseline) | 0.05 cup equivalents per day |
| No/Low Exposure | Change From Baseline Child-reported Mean Daily Intake of Fruits and Vegetables at 6 and 12 Months Among Youth Participants Newly Introduced to the FVPP | Change in mean daily intake of total vegetables (6 months versus baseline) | 0.11 cup equivalents per day |
| No/Low Exposure | Change From Baseline Child-reported Mean Daily Intake of Fruits and Vegetables at 6 and 12 Months Among Youth Participants Newly Introduced to the FVPP | Change in mean daily intake of total vegetables (12 months versus baseline) | -0.01 cup equivalents per day |
Primary
Odds Ratio Evaluating the Longitudinal Trend of High Food Security at 6, 12, 18 and 24 Months Relative to Baseline Among Youth 12 Years of Age and Older at Newly Introduced to the FVPP
Child food security status was assessed via the Self-Administered Food Security Survey Module for Youth only with children aged 12 years and older based on prior research recommendations. The sum of affirmative responses (a lot or sometimes) to nine questions represented the respondent's raw score on the scale. Food security status was assigned by raw score (0-1=high/marginal food security; 2-5=low food security; 6-9=very low food security). High food security (outcome analyzed) was assigned to those with raw scores less than or equal to 1.
Time frame: Baseline, 6 months, 12 months, 18 months, 24 months
Population: This outcome measure was pre-specified to only assess participants in the low/no exposure to FVPP group. Analysis includes data from youth 12 years of age and older who were newly introduced to the FVPP and completed the Self-Administered Food Security Survey Module for Youth.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| No/Low Exposure | Odds Ratio Evaluating the Longitudinal Trend of High Food Security at 6, 12, 18 and 24 Months Relative to Baseline Among Youth 12 Years of Age and Older at Newly Introduced to the FVPP | Odds ratios for higher food security (6 months versus baseline) | 0.86 High Food Security Odds Ratio |
| No/Low Exposure | Odds Ratio Evaluating the Longitudinal Trend of High Food Security at 6, 12, 18 and 24 Months Relative to Baseline Among Youth 12 Years of Age and Older at Newly Introduced to the FVPP | Odds ratios for higher food security (12 months versus baseline) | 0.64 High Food Security Odds Ratio |
| No/Low Exposure | Odds Ratio Evaluating the Longitudinal Trend of High Food Security at 6, 12, 18 and 24 Months Relative to Baseline Among Youth 12 Years of Age and Older at Newly Introduced to the FVPP | Odds ratios for higher food security (18 months versus baseline) | 0.48 High Food Security Odds Ratio |
| No/Low Exposure | Odds Ratio Evaluating the Longitudinal Trend of High Food Security at 6, 12, 18 and 24 Months Relative to Baseline Among Youth 12 Years of Age and Older at Newly Introduced to the FVPP | Odds ratios for higher food security (24 months versus baseline) | 0.39 High Food Security Odds Ratio |
Primary
Odds Ratio Evaluating the Longitudinal Trend of High Food Security at 6 and 12 Months Relative to Baseline Among Youth 12 Years of Age and Older Who Were Newly Introduced to the FVPP.
Child food security status was assessed via the Self-Administered Food Security Survey Module for Youth only with children aged 12 years and older based on prior research recommendations. The sum of affirmative responses (a lot or sometimes) to nine questions represented the respondent's raw score on the scale. Food security status was assigned by raw score (0-1=high/marginal food security; 2-5=low food security; 6-9=very low food security). High food security (outcome analyzed) was assigned to those with raw scores less than or equal to 1.
Time frame: Baseline, 6 months,12 months
Population: This outcome measure was pre-specified to only assess participants in the low/no exposure to FVPP group. Analysis includes data from youth 12 years of age and older who were newly introduced to the FVPP and completed the Self-Administered Food Security Survey Module for Youth.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| No/Low Exposure | Odds Ratio Evaluating the Longitudinal Trend of High Food Security at 6 and 12 Months Relative to Baseline Among Youth 12 Years of Age and Older Who Were Newly Introduced to the FVPP. | Odds ratios for higher food security (6 months versus baseline) | 0.86 High Food Security Odds Ratio |
| No/Low Exposure | Odds Ratio Evaluating the Longitudinal Trend of High Food Security at 6 and 12 Months Relative to Baseline Among Youth 12 Years of Age and Older Who Were Newly Introduced to the FVPP. | Odds ratios for higher food security (12 months versus baseline) | 0.64 High Food Security Odds Ratio |
Primary
Odds Ratio Evaluating the Longitudinal Trend of High Food Security for the Household at 6, 12, 18 and 24 Months Relative to Baseline Among Caregivers Newly Introduced to the FVPP
Household food security was assessed using the US Household Food Security Module: Six Item Short Form (National Center for Health Statistics) via caregiver report. The sum of affirmative responses to six questions served as the household's raw score. Food security status was assigned based on a calculated raw score (0-1=high/marginal food security; 2-4=low food security; 5-6 very low food security). High food security (outcome analyzed) was assigned to those with raw scores less than or equal to 1.
Time frame: Baseline, 6 months, 12 months, 18 months, 24 months
Population: This outcome measure was pre-specified to only assess participants in the low/no exposure to FVPP group. Analysis includes data from caregivers newly introduced to the FVPP who completed the US Household Food Security Module.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| No/Low Exposure | Odds Ratio Evaluating the Longitudinal Trend of High Food Security for the Household at 6, 12, 18 and 24 Months Relative to Baseline Among Caregivers Newly Introduced to the FVPP | Odds ratios for higher food security (6 months versus baseline) | 0.87 High Food Security Odds Ratio |
| No/Low Exposure | Odds Ratio Evaluating the Longitudinal Trend of High Food Security for the Household at 6, 12, 18 and 24 Months Relative to Baseline Among Caregivers Newly Introduced to the FVPP | Odds ratios for higher food security (12 months versus baseline) | 0.92 High Food Security Odds Ratio |
| No/Low Exposure | Odds Ratio Evaluating the Longitudinal Trend of High Food Security for the Household at 6, 12, 18 and 24 Months Relative to Baseline Among Caregivers Newly Introduced to the FVPP | Odds ratios for higher food security (18 months versus baseline) | 0.71 High Food Security Odds Ratio |
| No/Low Exposure | Odds Ratio Evaluating the Longitudinal Trend of High Food Security for the Household at 6, 12, 18 and 24 Months Relative to Baseline Among Caregivers Newly Introduced to the FVPP | Odds ratios for higher food security (24 months versus baseline) | 0.92 High Food Security Odds Ratio |
Primary
Odds Ratio Evaluating the Longitudinal Trend of High Food Security for the Household at 6 and 12 Months Relative to Baseline Among Caregivers Newly Introduced to the FVPP
Household food security was assessed using the US Household Food Security Module: Six Item Short Form (National Center for Health Statistics) via caregiver report. The sum of affirmative responses to six questions served as the household's raw score. Food security status was assigned based on a calculated raw score (0-1=high/marginal food security; 2-4=low food security; 5-6 very low food security). High food security (outcome analyzed) was assigned to those with raw scores less than or equal to 1.
Time frame: Baseline, 6 months,12 months
Population: This outcome measure was pre-specified to only assess participants in the low/no exposure to FVPP group. Analysis includes data from caregivers with no/low exposure to th FVPP at baseline who completed the entire US Household Food Security Module.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| No/Low Exposure | Odds Ratio Evaluating the Longitudinal Trend of High Food Security for the Household at 6 and 12 Months Relative to Baseline Among Caregivers Newly Introduced to the FVPP | Odds ratios for higher food security (6 months versus baseline) | 0.87 High Food Security Odds Ratio |
| No/Low Exposure | Odds Ratio Evaluating the Longitudinal Trend of High Food Security for the Household at 6 and 12 Months Relative to Baseline Among Caregivers Newly Introduced to the FVPP | Odds ratios for higher food security (12 months versus baseline) | 0.92 High Food Security Odds Ratio |
Secondary
Change From Baseline BMI at 6, 12, 18 and 24 Months Among Youth Participants Newly Introduced to the FVPP
Body mass index (BMI) was calculated from child weight and height (weight (kg)/\[height (m)\]2). BMI was then categorized into percentiles by sex and age to serve as an indicator of overweight and obesity. Child overweight and obesity status were categorized as follows: overweight (95th percentile for age and sex \> BMI ≥ 85th percentile for age and sex), obese (BMI ≥ 95th percentile for age and sex). Because achievement of healthy weight in youth (85th percentile for age and sex ≥ BMI \> 5th percentile for age and sex) was a secondary objective, a negative change in BMI percentile represents a desirable outcome.
Time frame: Baseline, 6 months, 12 months, 18 months, 24 months
Population: This outcome measure was pre-specified to only assess participants in the low/no exposure to FVPP group. Pediatric patients with recorded height and weight measurements.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| No/Low Exposure | Change From Baseline BMI at 6, 12, 18 and 24 Months Among Youth Participants Newly Introduced to the FVPP | Change in BMI percentile (6 months versus baseline) | -0.48 BMI percentile |
| No/Low Exposure | Change From Baseline BMI at 6, 12, 18 and 24 Months Among Youth Participants Newly Introduced to the FVPP | Change in BMI percentile (12 months versus baseline) | -1.93 BMI percentile |
| No/Low Exposure | Change From Baseline BMI at 6, 12, 18 and 24 Months Among Youth Participants Newly Introduced to the FVPP | Change in BMI percentile (18 months versus baseline) | -1.98 BMI percentile |
| No/Low Exposure | Change From Baseline BMI at 6, 12, 18 and 24 Months Among Youth Participants Newly Introduced to the FVPP | Change in BMI percentile (24 months versus baseline) | -3.43 BMI percentile |
Secondary
Change From Baseline Child BMI at 6 and 12 Months Among Youth Participants Newly Introduced to the FVPP
Body mass index (BMI) was calculated from child weight and height (weight (kg)/\[height (m)\]2). BMI was then categorized into percentiles by sex and age to serve as an indicator of overweight and obesity. Child overweight and obesity status were categorized as follows: overweight (95th percentile for age and sex \> BMI ≥ 85th percentile for age and sex), obese (BMI ≥ 95th percentile for age and sex). Because achievement of healthy weight in youth (85th percentile for age and sex ≥ BMI \> 5th percentile for age and sex) was a secondary objective, a negative change in BMI percentile represents a desirable outcome.
Time frame: Baseline, 6 months,12 months
Population: This outcome measure was pre-specified to only assess participants in the low/no exposure to FVPP group. Pediatric patients with recorded height and weight measurements.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| No/Low Exposure | Change From Baseline Child BMI at 6 and 12 Months Among Youth Participants Newly Introduced to the FVPP | Change in BMI percentiles (6 months versus baseline) | -0.48 BMI percentile |
| No/Low Exposure | Change From Baseline Child BMI at 6 and 12 Months Among Youth Participants Newly Introduced to the FVPP | Change in BMI percentile (12 months versus baseline) | -1.93 BMI percentile |
Secondary
Change From Caregiver-reported Baseline Mean Daily Intake of Fruits and Vegetables at 6, 12, 18 and 24 Months Among Caregivers Newly Introduced to the FVPP
To investigate whether exposure to the pediatric fruit and vegetable prescription program is associated with increased fruit and vegetable consumption among caregivers, dietary data from caregivers was collected using the National Cancer Institute Fruit & Vegetable Intake All Day Screener which asks frequency and portion size questions about nine food items. This will be used to calculate mean daily intake of vegetables and total fruits.
Time frame: Baseline, 6 months, 12 months, 18 months, 24 months
Population: This outcome measure was pre-specified to only assess participants in the low/no exposure to FVPP group. Analysis includes data from caregivers newly introduced to the FVPP who completed the NCI All Day Screener.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| No/Low Exposure | Change From Caregiver-reported Baseline Mean Daily Intake of Fruits and Vegetables at 6, 12, 18 and 24 Months Among Caregivers Newly Introduced to the FVPP | Change in mean daily intake of fruits and vegetables (6 months versus baseline) | -0.21 cup equivalents per day |
| No/Low Exposure | Change From Caregiver-reported Baseline Mean Daily Intake of Fruits and Vegetables at 6, 12, 18 and 24 Months Among Caregivers Newly Introduced to the FVPP | Change in mean daily intake of fruits and vegetables (12 months versus baseline) | -0.56 cup equivalents per day |
| No/Low Exposure | Change From Caregiver-reported Baseline Mean Daily Intake of Fruits and Vegetables at 6, 12, 18 and 24 Months Among Caregivers Newly Introduced to the FVPP | Change in mean daily intake of fruits and vegetables (18 months versus baseline) | -0.90 cup equivalents per day |
| No/Low Exposure | Change From Caregiver-reported Baseline Mean Daily Intake of Fruits and Vegetables at 6, 12, 18 and 24 Months Among Caregivers Newly Introduced to the FVPP | Change in mean daily intake of fruits and vegetables (24 months versus baseline) | -0.50 cup equivalents per day |
Secondary
Change From Caregiver-reported Baseline Mean Daily Intake of Fruits and Vegetables at 6 and 12 Months Among Caregivers Newly Introduced to the FVPP
To investigate whether exposure to the pediatric fruit and vegetable prescription program is associated with increased fruit and vegetable consumption among caregivers, dietary data from caregivers was collected using the National Cancer Institute Fruit & Vegetable Intake All Day Screener which asks frequency and portion size questions about nine food items. This will be used to calculate mean daily intake of vegetables and total fruits.
Time frame: Baseline, 6 months, 12 months
Population: This outcome measure was pre-specified to only assess participants in the low/no exposure to FVPP group. Analysis includes data from caregivers newly introduced to the FVPP who completed the NCI All Day Screener.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| No/Low Exposure | Change From Caregiver-reported Baseline Mean Daily Intake of Fruits and Vegetables at 6 and 12 Months Among Caregivers Newly Introduced to the FVPP | Change in mean daily intake of fruits and vegetables (6 months versus baseline) | -0.21 cup equivalents per day |
| No/Low Exposure | Change From Caregiver-reported Baseline Mean Daily Intake of Fruits and Vegetables at 6 and 12 Months Among Caregivers Newly Introduced to the FVPP | Change in mean daily intake of fruits and vegetables (12 months versus baseline) | -0.56 cup equivalents per day |