Upgrade the Grains Study: Increasing Whole Grain Consumption in Low-income Children With Obesity
9 février 2018 mis à jour par: 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.
Aperçu de l'étude
Statut
Résilié
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
5
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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California
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Oakland, California, États-Unis, 94609
- UCSF Benioff Children's Hospital Oakland
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
8 ans à 16 ans (Enfant)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Aucune intervention: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in whole grains consumption (ounce equivalents)
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in serum triglycerides (mg/dl)
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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)
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: June Tester, MD MPH, UCSF Benioff Children's Hospital Oakland
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
22 juin 2016
Achèvement primaire (Réel)
2 août 2016
Achèvement de l'étude (Réel)
2 août 2016
Dates d'inscription aux études
Première soumission
15 mars 2016
Première soumission répondant aux critères de contrôle qualité
21 mars 2016
Première publication (Estimation)
25 mars 2016
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
13 février 2018
Dernière mise à jour soumise répondant aux critères de contrôle qualité
9 février 2018
Dernière vérification
1 février 2018
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2013-064
Plan pour les données individuelles des participants (IPD)
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INDÉCIS
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