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NCT Number: NCT06407284

Brighter Bites/Legacy Produce Rx Program

The purpose of this study is to assess the effectiveness of the produce prescription program at improving weight status and obesity-related health outcomes of participants, to examine the impacts of the program on household food insecurity and nutrition security, to examine the impacts of the program on participating adolescents' dietary behavioral outcomes, their home nutrition environment and feeding practices and to examine the impacts of the program in reducing healthcare use and associated costs

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Key information

Conditions

Child Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must be a patient at one of the four Legacy Community Health School-based clinics in Galena Park, Texas
  • BMI greater than or equal to 85th percentile
  • reside within a 10-mile radius of Houston Food Bank
  • Medicaid recipients or low-income uninsured
  • parents must be able to read and write in English or Spanish to complete surveys
  • patient and parents must confirm their willingness to complete the participant's well-child visit for the entire period of the study (approximately one year).

Exclusion criteria

  • currently participating in Brighter Bites
  • with a family member/sibling currently participating in Brighter Bites

Treatment and study plan

Produce Prescription Group

Other

Participants will receive 16 produce bags, each containing approximately 50 servings of F&V. The produce bags will be assembled by Brighter Bites at school sites using donated produce and delivered to houses using DoorDash. F&V bags will be distributed to families every 2 weeks for 16 distributions (over approximately 32 weeks). Participants will also receive nutrition education, including MyPlate.gov's Start Simple App for adolescents, and a Virtual Culinary Medicine Program for parents; these nutrition education programs are theory-driven, tailored to diverse populations, and proven to support behavior change.

Control Group

Other

Participants in this group will be selected from de-identified Electronic Health Record (EHR) provided by Legacy Community Health with a 1-to-1 match to the intervention group participant's demographic characteristics and Medicaid eligibility.

Primary outcomes

  1. Change in body mass index (BMI)

    Time frame: baseline , post intervention (32 weeks after baseline)

    This will be collected from chart reviews as these measures are routinely collected for all pediatric patients in this weight classification based on the American Association of Pediatric recommendations.

  2. Change in systolic blood pressure

    Time frame: baseline , post intervention (32 weeks after baseline)

    This will be collected from chart reviews as these measures are routinely collected for all pediatric patients in this weight classification based on the American Association of Pediatric recommendations.

  3. Change in diastolic blood pressure

    Time frame: baseline , post intervention (32 weeks after baseline)

    This will be collected from chart reviews as these measures are routinely collected for all pediatric patients in this weight classification based on the American Association of Pediatric recommendations.

  4. Change in hemoglobin A1c as assessed by blood work

    Time frame: baseline , post intervention (32 weeks after baseline)

    This will be collected from chart reviews as these measures are routinely collected for all pediatric patients in this weight classification based on the American Association of Pediatric recommendations.

  5. Change in Aspartate transaminase (AST) assessed by blood work

    Time frame: baseline , post intervention (32 weeks after baseline)

    This will be collected from chart reviews as these measures are routinely collected for all pediatric patients in this weight classification based on the American Association of Pediatric recommendations.

  6. Change in Alanine transaminase (ALT) assessed by blood work

    Time frame: baseline , post intervention (32 weeks after baseline)

    This will be collected from chart reviews as these measures are routinely collected for all pediatric patients in this weight classification based on the American Association of Pediatric recommendations.

  7. Change in lipid panels assessed by blood work

    Time frame: baseline , post intervention (32 weeks after baseline)

    This will be collected from chart reviews as these measures are routinely collected for all pediatric patients in this weight classification based on the American Association of Pediatric recommendations.

Secondary outcomes

  1. Change in household food insecurity prevalence among participants (measured as a percentage) as assessed by the two item Hunger Vital Sign screening tool

    Time frame: baseline , post intervention (32 weeks after baseline)

    This is a 2 item questionnaire and each is categorically scored as often true, sometimes true or never true, higher number indicating higher prevalence of household food insecurity

  2. Change in household food insecurity as assessed by the U.S. Household Food Security Survey Module: Six-Item Short Form Economic Research Service

    Time frame: baseline , post intervention (32 weeks after baseline)

    This is a 6 item questionnaire and raw scores range from 0-6, higher score indicating worse outcome

  3. Change in nutrition security as assessed by the self reported Perceived Limited Ability validated screener

    Time frame: baseline , post intervention (32 weeks after baseline)

    This is a 4 item questionnaire, each is scored from 0-4, higher score indicating better outcome

  4. Change in amount of fruit and vegetable intake

    Time frame: baseline , post intervention (32 weeks after baseline)

  5. Change in amount of junk food consumed

    Time frame: baseline , post intervention (32 weeks after baseline)

  6. Change in number of times subject eats out at restaurants

    Time frame: baseline , post intervention (32 weeks after baseline)

  7. Change in parent feeding practices as assessed by the number of times parent has cooked food from scratch

    Time frame: baseline , post intervention (32 weeks after baseline)

  8. Change in parent feeding practices as assessed by the number of times parent has used nutrition facts labels to make purchasing decisions

    Time frame: baseline , post intervention (32 weeks after baseline)

  9. Change in parent feeding practices as assessed by the number of times parent has eaten meals with their referent child

    Time frame: baseline , post intervention (32 weeks after baseline)

  10. Change in impact of the Produce Prescription intervention on adolescent patients' behavioral and emotional health as assessed by the Patient Health Questionnaire for Adolescents (PHQ-A)

    Time frame: baseline , post intervention (32 weeks after baseline)

    This is a 9 item questionnaire and each is scored from 0(not at all) to 3(nearly every day), for a maximum score of 27, higher score indicating worse outcome

  11. Healthcare usage as assessed by the number of well-visits

    Time frame: post intervention (32 weeks after baseline)

  12. Healthcare usage as assessed by the number of visits due to illness

    Time frame: post intervention (32 weeks after baseline)

  13. Healthcare usage as assessed by the number of no shows to clinic appointments

    Time frame: From 6 months prior to the intervention to two months post-intervention

Study contacts

Contact information is provided by the study sponsor or research team.

Mallika Mathur

CONTACT

[email protected]

Ru-Jye Chuang, DrPH, M.S.

CONTACT

[email protected]

713-500-9244

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • USDA The Gus Schumacher Nutrition Incentive Program (GusNIP)

Registry information

Official study title

Brighter Bites & Legacy Community Health Produce Rx: Evaluating the Feasibility and Effectiveness of a School-based Clinical Nutrition Program With Produce Prescription

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 9, 2024
Registry last updated
Jan 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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