Upgrade the Grains Study: Increasing Whole Grain Consumption in Low-income Children With Obesity
2018年2月9日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
5
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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California
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Oakland、California、アメリカ、94609
- UCSF Benioff Children's Hospital Oakland
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
8年～16年 (子)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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介入なし：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in whole grains consumption (ounce equivalents)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in serum triglycerides (mg/dl)
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：June Tester, MD MPH、UCSF Benioff Children's Hospital Oakland
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2016年6月22日
一次修了 (実際)
2016年8月2日
研究の完了 (実際)
2016年8月2日
試験登録日
最初に提出
2016年3月15日
QC基準を満たした最初の提出物
2016年3月21日
最初の投稿 (見積もり)
2016年3月25日
学習記録の更新
投稿された最後の更新 (実際)
2018年2月13日
QC基準を満たした最後の更新が送信されました
2018年2月9日
最終確認日
2018年2月1日
詳しくは
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