Upgrade the Grains Study: Increasing Whole Grain Consumption in Low-income Children With Obesity
9 de fevereiro de 2018 atualizado por: 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.
Visão geral do estudo
Status
Rescindido
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Real)
5
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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California
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Oakland, California, Estados Unidos, 94609
- UCSF Benioff Children's Hospital Oakland
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
8 anos a 16 anos (Filho)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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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Sem intervenção: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in whole grains consumption (ounce equivalents)
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in serum triglycerides (mg/dl)
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: June Tester, MD MPH, UCSF Benioff Children's Hospital Oakland
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
22 de junho de 2016
Conclusão Primária (Real)
2 de agosto de 2016
Conclusão do estudo (Real)
2 de agosto de 2016
Datas de inscrição no estudo
Enviado pela primeira vez
15 de março de 2016
Enviado pela primeira vez que atendeu aos critérios de CQ
21 de março de 2016
Primeira postagem (Estimativa)
25 de março de 2016
Atualizações de registro de estudo
Última Atualização Postada (Real)
13 de fevereiro de 2018
Última atualização enviada que atendeu aos critérios de controle de qualidade
9 de fevereiro de 2018
Última verificação
1 de fevereiro de 2018
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2013-064
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
INDECISO
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