Upgrade the Grains Study: Increasing Whole Grain Consumption in Low-income Children With Obesity
9. Februar 2018 aktualisiert von: 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.
Studienübersicht
Status
Beendet
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
5
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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California
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Oakland, California, Vereinigte Staaten, 94609
- UCSF Benioff Children's Hospital Oakland
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
8 Jahre bis 16 Jahre (Kind)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: 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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Kein Eingriff: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Change in whole grains consumption (ounce equivalents)
Zeitfenster: Baseline and 3 months
|
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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Change in serum triglycerides (mg/dl)
Zeitfenster: Baseline and 3 months
|
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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Ermittler
- Hauptermittler: June Tester, MD MPH, UCSF Benioff Children's Hospital Oakland
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
22. Juni 2016
Primärer Abschluss (Tatsächlich)
2. August 2016
Studienabschluss (Tatsächlich)
2. August 2016
Studienanmeldedaten
Zuerst eingereicht
15. März 2016
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
21. März 2016
Zuerst gepostet (Schätzen)
25. März 2016
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
13. Februar 2018
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
9. Februar 2018
Zuletzt verifiziert
1. Februar 2018
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2013-064
Plan für individuelle Teilnehmerdaten (IPD)
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