Clinical trial NCT02719730: Upgrade the Grains Study: Increasing Whole Grain Consumption in Low-income Children With Obesity
Official title: The Metabolic Impact of Concurrent Food Insecurity and Obesity
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obesity
Lead sponsor: UCSF Benioff Children's Hospital Oakland
Sponsor class: OTHER
First posted: 2016-03-25
Enrollment: 5
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in whole grains consumption (ounce equivalents)
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: Change in serum triglycerides (mg/dl)
timeFrame: Baseline and 3 months
measure: Change in TG/HDL ratio
timeFrame: Baseline and 3 months
measure: Change in body mass index (BMI, or kg/m2)
timeFrame: Baseline and 3 months
measure: Change in waist to height ratio (WHtR)
timeFrame: Baseline and 3 months
measure: Change in proportion of subjects with pre-diabetes
timeFrame: Baseline and 3 months
measure: Change in percent of monthly SNAP benefit spent on whole grain purchases (dollars)
timeFrame: Baseline and 3 months
Other outcomes:
Locations:
city: Oakland
country: United States
facility: UCSF Benioff Children's Hospital Oakland
state: California
Study officials:
affiliation: UCSF Benioff Children's Hospital Oakland
name: June Tester, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: