Upgrade the Grains Study: Increasing Whole Grain Consumption in Low-income Children With Obesity
2018년 2월 9일 업데이트: UCSF Benioff Children's Hospital Oakland
The Metabolic Impact of Concurrent Food Insecurity and Obesity
This study will assess the impact of a randomized intervention aimed at increasing consumption of whole grain foods among children from low-income households that participate in the Special Nutrition Assistance Program (SNAP, or "food stamps").
A total of 60 obese children (8 to 16 years) will be recruited from a clinical population (Healthy Eating Active Living Program) at University of California San Francisco (UCSF) Benioff Children's Hospital Oakland.
Participants and their caregivers will all receive education about whole grain foods, and will be randomized to either an intervention or control group.
The intervention group will receive a monthly reimbursement allotment of up to 10% of their usual SNAP benefit for specific whole grain foods purchased during the three month study period.
The control group will not have the financial incentive for purchasing whole grain foods during the 12 week study period.
The investigators will assess the feasibility of the intervention, the impact of the intervention on household grocery purchases, and the impact on the child's anthropometrics, dietary intake of whole grain foods (24-hour recall), and markers of metabolic risk.
연구 개요
상세 설명
RUN-IN PHASE (Weeks -4 to 0)
- Participants will participate in a "run-in phase" where they will be asked to keep all grocery receipts for a 4 week period
RANDOMIZATION (Week 0)
- Child participants with caregivers who are able to successfully complete the run-in phase are then randomized at that point to be either in the intervention arm or the control arm.
- Patients will be block randomized by age group (8-11 and 12-16).
ACTIVE PHASE (Weeks 0-12)
- Participants will be given education about whole grains and whole grain preparation. Intervention and control participant activities described elsewhere.
RETURN VISIT (Week 24)
- 12 weeks after the completion of the active phase of the study, patients will be asked to return for a final visit at the research center, during which they will also have blood tests and other study activities repeated for one final time.
연구 유형
중재적
등록 (실제)
5
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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California
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Oakland, California, 미국, 94609
- UCSF Benioff Children's Hospital Oakland
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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
8년 (어린이)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
Inclusion Criteria:
- Obese (BMI greater than 95th percentile for age and gender)
- Low-income family currently participating in SNAP ("food stamps")
- Participant and caregiver speaks either English or Spanish
Exclusion Criteria:
- medications to lower lipid levels (statins), which would affect insulin sensitivity (e.g. metformin, abilify) or which are known to affect serum cholesterol (e.g. carbamazepine).
- Type II diabetes
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Reimbursement arm
Participating caregivers will turn in receipts from grocery store purchases.
At each of three study visits, participants in the reimbursement arm will receive reimbursement of up to 10% of their usual SNAP benefits for specific whole grain foods purchased at one of two chain stores in the previous month.
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All participants will receive education about whole grain foods.
Those in the experimental arm will have a monthly financial incentive for purchases of specific whole grain foods foods during the 12-week study period, whereas the control group will not have a financial incentive for whole grain purchases during the study period.
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간섭 없음: Control arm
Participating caregivers will mail in receipts from grocery store purchases.
Participants in the control arm will also be given the same guidance about preferred whole grain foods and whole grain products but will have no specific financial incentive related to purchases of whole grain foods during the 12-week study period.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in whole grains consumption (ounce equivalents)
기간: Baseline and 3 months
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Using the Nutrition Data System for Research (NDSR) for 24-hour food recall, intake of whole grains (and refined grains, and proportion of grains that are whole) will be assessed.
The change in this dietary outcome at the end of 3 months will be evaluated for intervention participants compared to controls.
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Baseline and 3 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in serum triglycerides (mg/dl)
기간: Baseline and 3 months
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Fasting lipid panel at the end of three month period will be compared to baseline lipid panel: serum triglycerides will be an outcome of particular interest given the intervention.
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Baseline and 3 months
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Change in TG/HDL ratio
기간: Baseline and 3 months
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Fasting lipid panel at the end of three month period will be compared to baseline lipid panel: the ratio of serum triglycerides (TG) to high-density lipoprotein (HDL-C) will be an outcome of particular interest given the intervention.
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Baseline and 3 months
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Change in body mass index (BMI, or kg/m2)
기간: Baseline and 3 months
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The change in BMI after the 3 month intervention period will be examined for intervention group compared to control group.
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Baseline and 3 months
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Change in waist to height ratio (WHtR)
기간: Baseline and 3 months
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Change in waist to height ratio at the end of the 3 month period will be examined for intervention group compared to control group.
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Baseline and 3 months
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Change in proportion of subjects with pre-diabetes
기간: Baseline and 3 months
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The proportion of subjects with prediabetes (using both criteria of Hemoglobin A1c greater than or equal to 5.7% and fasting glucose greater than or equal to 100 mg/dl) after the 3 month intervention period will be compared for intervention and control groups.
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Baseline and 3 months
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Change in percent of monthly SNAP benefit spent on whole grain purchases (dollars)
기간: Baseline and 3 months
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Using collected grocery receipts, monthly expenditure (as a percentage of the household's monthly SNAP benefit) for whole grain foods in the third month of the intervention period will be compared to the percent of the SNAP benefit during the baseline month (run-in phase).
The change in this expenditure amount will be evaluated for intervention participants compared to controls.
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Baseline and 3 months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: June Tester, MD MPH, UCSF Benioff Children's Hospital Oakland
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 (실제)
2016년 6월 22일
기본 완료 (실제)
2016년 8월 2일
연구 완료 (실제)
2016년 8월 2일
연구 등록 날짜
최초 제출
2016년 3월 15일
QC 기준을 충족하는 최초 제출
2016년 3월 21일
처음 게시됨 (추정)
2016년 3월 25일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 2월 13일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 2월 9일
마지막으로 확인됨
2018년 2월 1일
추가 정보
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