Pilot of Food Is Medicine Interventions to Reduce Cardiovascular Disease Risk in Children With Food Insecurity and Diabetes
2026년 5월 12일 업데이트: Katelyn Fox
Food Is Medicine Interventions to Reduce Cardiovascular Disease Risk in Children With Food Insecurity and Diabetes
Study Design: This two-arm parallel trial will randomize 12 families to receive 6-weeks of medically tailored meals or produce prescriptions.
Both groups will receive nutrition coaching, weekly during the intervention.
The hypothesis is that both interventions to have a positive impact on food security and fruit and vegetable intake.
However, medically tailored meals also reduce the logistic barriers of planning, preparing, and calculating the carbohydrate content of nutritionally balanced meals essential for DM management.
Therefore, the medically tailored meal intervention will result in greater improvements in the co-primary outcomes of diet quality and glucose stability after the intervention.
연구 개요
상태
아직 모집하지 않음
정황
연구 유형
중재적
등록 (추정된)
12
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Rhode Island
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Providence, Rhode Island, 미국, 02903
- Hasbro Children's Hospital
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연락하다:
- Katelyn Fox, PhD
- 전화번호: 401-793-8251 4017870821
- 이메일: katelyn_fox@brown.edu
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연락하다:
- Rivkah Cohen
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부수사관:
- Lisa Swartz Topor, MD
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Families of school-age children (ages 5-12 years) with T1DM and food insecurity
- fluent in English or Spanish.
- child uses a continuous glucose monitor (CGM)
- willing to provide consent for the research team to access CGM data
Exclusion Criteria:
- recent diagnosis of T1DM (<6 months)
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Medically tailored meal kits + nutrition coaching
Medically Tailored Meals: Each family in this arm will receive medically tailored meal kits (3 semi-prepared meals and recipes per week x 6 weeks).Nutrition Coaching: Nutrition coaches will provide families with weekly phone check-ins using brief motivational interviewing and applied problem solving.
During the first half of the intervention (weeks 1-3), coaches will assess barriers to preparing and consuming the prescribed foods (meal kits or produce), with the goal of improving diet quality.
The second half of the intervention (weeks 4-6) will focus on building self-efficacy, skills, and resources required to plan and prepare meals on a budget and strategies to increase fruit and vegetable intake.
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Medically Tailored Meals: Families will receive 3 semi-prepared medically tailored meal kits and recipes per week x 6 weeks.
Nutrition Coaching: Nutrition coaches will provide families with weekly phone check-ins using brief motivational interviewing and applied problem solving.
During the first half of the intervention (weeks 1-3), coaches will assess barriers to preparing and consuming the prescribed foods (meal kits or produce), with the goal of improving diet quality.
The second half of the intervention (weeks 4-6) will focus on building self-efficacy, skills, and resources required to plan and prepare meals on a budget and strategies to increase fruit and vegetable intake.
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활성 비교기: Produce prescription + nutrition coaching
Produce prescriptions: Each family in this arm will receive weekly boxes of fresh produce. Similar to the USDA's TEFAP (The Emergency Food Assistance Program), boxes include 10-12 lbs of fresh fruits and vegetables per month (adjustable based on family size). Boxes will also include recipes and examples of how to incorporate the produce into family meals Nutrition Coaching: Nutrition coaches will provide families with weekly phone check-ins using brief motivational interviewing and applied problem solving. During the first half of the intervention (weeks 1-3), coaches will assess barriers to preparing and consuming the prescribed foods (meal kits or produce), with the goal of improving diet quality. The second half of the intervention (weeks 4-6) will focus on building self-efficacy, skills, and resources required to plan and prepare meals on a budget and strategies to increase fruit and vegetable intake. |
Nutrition Coaching: Nutrition coaches will provide families with weekly phone check-ins using brief motivational interviewing and applied problem solving.
During the first half of the intervention (weeks 1-3), coaches will assess barriers to preparing and consuming the prescribed foods (meal kits or produce), with the goal of improving diet quality.
The second half of the intervention (weeks 4-6) will focus on building self-efficacy, skills, and resources required to plan and prepare meals on a budget and strategies to increase fruit and vegetable intake.
Produce prescriptions: Weekly boxes of fresh produce.
Similar to the USDA's TEFAP (The Emergency Food Assistance Program), boxes include 10-12 lbs of fresh fruits and vegetables per month (adjustable based on family size).
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Feasibility
기간: baseline, pre-intervention and immediately after the intervention
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Feasibility will be assessed using the following criteria: Recruitment of >50% of families screened eligible, retention of > 65% of randomized families at follow-up, >50% adherence to coaching protocol, and >50% preparation of the prescribed meals.
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baseline, pre-intervention and immediately after the intervention
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Acceptability
기간: immediately after the intervention
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Acceptability will be assessed using the following criteria: caregiver report of target child consuming prepared foods more than half of the time, and a net promotor score >20.
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immediately after the intervention
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Diet quality
기간: baseline, pre-intervention and immediately after the intervention
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The 24-hour dietary recalls will be collected by masked assessors using Nutrition Data System for Research (NDSR), a computer-based software application that facilitates the collection of recalls in a standardized fashion, using a multiple-pass interview approach to improve participant recall.51
Healthy Eating Index (HEI-2020) will be calculated using the NCI per person algorithm.HEI-2020 is scored on a scale from 0-100 with higher scores reflecting better diet quality.
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baseline, pre-intervention and immediately after the intervention
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Change in Glucose Stability
기간: baseline, pre-intervention and immediately after the intervention
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Glucose stability will be assessed using time in range (TIR), using CGM data.
We will calculate TIR as the percent of time an individual spends in a target BG range (% of readings with-in 70-180 mg/dL).
TIR is a strong indicator of DM management and future CVD risk.
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baseline, pre-intervention and immediately after the intervention
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Change in Food Security
기간: baseline, pre-intervention and immediately after the intervention
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United States Department of Agriculture Food Security Survey Module (USDA FSSM) 18-Item.
This survey is score on a scale of 0-18 with higher scores indicating higher food insecurity.
Categorically For households with one or more children a Raw score zero= High food security, Raw score 1-2=Marginal food security, Raw score 3-7=Low food security, Raw score 8-18=Very low food security
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baseline, pre-intervention and immediately after the intervention
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Engagement
기간: through study completion, an average of 6 weeks
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Redemption rate and adherence rate.
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through study completion, an average of 6 weeks
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Percent adherence to the study protocol
기간: through study completion, an average of 6 weeks
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adherence to the nutrition coaching protocol
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through study completion, an average of 6 weeks
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Cost
기간: through study completion, an average of 6 weeks
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cost per participant
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through study completion, an average of 6 weeks
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 5월 30일
기본 완료 (추정된)
2026년 6월 30일
연구 완료 (추정된)
2026년 6월 30일
연구 등록 날짜
최초 제출
2025년 9월 30일
QC 기준을 충족하는 최초 제출
2026년 5월 12일
처음 게시됨 (실제)
2026년 5월 15일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 15일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 12일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 25FIMPG1492233
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
Data to be generated during this study include surveys, interviews, 24-hour dietary recalls, participant height, weight, blood pressure, and continuous glucose monitor readings.
Once the data collection for this study has concluded, all direct respondent identifiers (e.g., names and addresses) will be removed from the data and a key maintained in a separate and separately stored and encrypted file for future contact purposes.
To ensure participant consent for data sharing, IRB paperwork and informed consent documents will include language describing plans for data management and sharing of data, describing the motivation for sharing, and explaining that personal identifying information will be removed.
Study respondents will be asked to consent to data collection and de-identified data sharing with the wider research community via deposit in the openICPSR repository.
IPD 공유 기간
06/26/2026
IPD 공유 액세스 기준
Researchers through the openICPSR repository.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- ANALYTIC_CODE
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .