Exposure to Fruit and Vegetable Prescription Program Clinical Trial
Official title:
Innovative Nutrition Practices in Pediatric Health Care: Assessment of a Fruit and Vegetable Prescription Program for Children in Need
| Verified date | October 2023 |
| Source | Michigan State University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 1362 |
| Est. completion date | August 31, 2024 |
| Est. primary completion date | July 31, 2024 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 8 Years to 16 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Akpinar Children's Clinic | Flint | Michigan |
| United States | Hurley Children's Clinic | Flint | Michigan |
| United States | Mott Children's Health Center | Flint | Michigan |
| Lead Sponsor | Collaborator |
|---|---|
| Michigan State University | Akpinar Children's Clinic, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Hurley Children's Center, Hurley Medical Center, Mott Children's Health Center |
United States,
Saxe-Custack A, LaChance J, Hanna-Attisha M, Ceja T. Fruit and Vegetable Prescriptions for Pediatric Patients Living in Flint, Michigan: A Cross-Sectional Study of Food Security and Dietary Patterns at Baseline. Nutrients. 2019 Jun 25;11(6):1423. doi: 10.3390/nu11061423. — View Citation
Saxe-Custack A, LaChance J, Hanna-Attisha M. Child Consumption of Whole Fruit and Fruit Juice Following Six Months of Exposure to a Pediatric Fruit and Vegetable Prescription Program. Nutrients. 2019 Dec 20;12(1):25. doi: 10.3390/nu12010025. — View Citation
Saxe-Custack A, Lofton HC, Hanna-Attisha M, Victor C, Reyes G, Ceja T, LaChance J. Caregiver perceptions of a fruit and vegetable prescription programme for low-income paediatric patients. Public Health Nutr. 2018 Sep;21(13):2497-2506. doi: 10.1017/S1368980018000964. Epub 2018 Apr 18. — View Citation
Saxe-Custack A, Sadler R, LaChance J, Hanna-Attisha M, Ceja T. Participation in a Fruit and Vegetable Prescription Program for Pediatric Patients is Positively Associated with Farmers' Market Shopping. Int J Environ Res Public Health. 2020 Jun 12;17(12):4202. doi: 10.3390/ijerph17124202. — View Citation
Saxe-Custack A, Todem D, Anthony JC, Kerver JM, LaChance J, Hanna-Attisha M. Effect of a pediatric fruit and vegetable prescription program on child dietary patterns, food security, and weight status: a study protocol. BMC Public Health. 2022 Jan 21;22(1):150. doi: 10.1186/s12889-022-12544-y. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from baseline child-reported mean daily intake of fruits and vegetables at 12 months | Dietary data from children will be collected via two non-consecutive dietary recalls and one validated food frequency questionnaire. Two non-consecutive 24-hour dietary recalls will be collected using the Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool. We will also administer Block Kids Food Screener, a food frequency questionnaire, to allow for the assessment of usual and long-term eating behaviors. The Block Kids Food Screener will provide nutrient estimates and number of servings by food groups. We will use this data to determine change in child-reported mean daily intake of total fruits and vegetables, total vegetables, total fruits, and whole fruits. | 12 months | |
| Primary | Change from baseline household food security at 12 months | Caregivers will complete the US Household Food Security Survey Module: 6 Item Short Form (National Center for Health Statistics) to measure household food insecurity and hunger. | 12 months | |
| Primary | Change from baseline child-reported food security at 12 months | The Self-Administered Food Security Survey Module for Youth will be used to estimate perceived food security among youth 12 years of age and older. | 12 months | |
| Primary | Change from baseline child-reported food security at 24 months | The Self-Administered Food Security Survey Module for Youth will be used to estimate perceived food security among youth 12 years of age and older. | 24 months | |
| Primary | Change from baseline child-reported mean daily intake of fruits and vegetables at 24 months | Dietary data from children will be collected via two non-consecutive dietary recalls and one validated food frequency questionnaire. Two non-consecutive 24-hour dietary recalls will be collected using the Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool. We will also administer Block Kids Food Screener, a food frequency questionnaire, to allow for the assessment of usual and long-term eating behaviors. The Block Kids Food Screener will provide nutrient estimates and number of servings by food groups. We will use this data to determine change in child-reported mean daily intake of total fruits and vegetables, total vegetables, total fruits, and whole fruits. | 24 months | |
| Primary | Change from baseline household food security at 24 months | Caregivers will complete the US Household Food Security Survey Module: 6 Item Short Form (National Center for Health Statistics) to measure household food insecurity and hunger. | 24 months | |
| Secondary | Change from baseline child BMI at 12 months | Youth weight and height will be measured without shoes or heavy outer garments. On each occasion two measures will be made, and the averages will be recorded. Height will be measured to the closest 0.1 cm using a portable stadiometer. Weight will be measured to the closest 0.2 kg on a digital platform scale accurate to 200 kg. Weight and height will be combined to report BMI in kg/m^2. | 12 months | |
| Secondary | Change from baseline child BMI at 24 months | Youth weight and height will be measured without shoes or heavy outer garments. On each occasion two measures will be made, and the averages will be recorded. Height will be measured to the closest 0.1 cm using a portable stadiometer. Weight will be measured to the closest 0.2 kg on a digital platform scale accurate to 200 kg. Weight and height will be combined to report BMI in kg/m^2. | 24 months | |
| Secondary | Change from caregiver-reported baseline mean daily intake of fruits and vegetables at 12 months | Dietary information will be collected from caregivers using the National Cancer Institute Fruit & Vegetable Intake "All Day" Screener which asks frequency and portion size questions about nine food items. | 12 months | |
| Secondary | Change from caregiver-reported baseline mean daily intake of fruits and vegetables at 24 months | Dietary information will be collected from caregivers using the National Cancer Institute Fruit & Vegetable Intake "All Day" Screener which asks frequency and portion size questions about nine food items. | 24 months |