The Metabolic Impact of Concurrent Food Insecurity and Obesity
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Change in whole grains consumption (ounce equivalents)
研究概览
简要总结
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.
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Reimbursement for whole grain purchases (Behavioral)
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.
结局指标
主要结局
Change in whole grains consumption (ounce equivalents)
时间窗: 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.
次要结局
- Change in serum triglycerides (mg/dl)(Baseline and 3 months)
- Change in TG/HDL ratio(Baseline and 3 months)
- Change in body mass index (BMI, or kg/m2)(Baseline and 3 months)
- Change in waist to height ratio (WHtR)(Baseline and 3 months)
- Change in proportion of subjects with pre-diabetes(Baseline and 3 months)
- Change in percent of monthly SNAP benefit spent on whole grain purchases (dollars)(Baseline and 3 months)