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Eligibility
for people ages 8 years to 16 years
Healthy Volunteers
healthy people welcome
Location
at Oakland, California
Dates
study started
Principal Investigator
June Tester

Description

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.

Official Title

The Metabolic Impact of Concurrent Food Insecurity and Obesity

Details

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.

Keywords

Obesity

Eligibility

You can join if…

Open to people ages 8 years to 16 years

  • 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

You CAN'T join if...

  • 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

Location

Details

Status
accepting new patients by invitation only
Start Date
Sponsor
Children's Hospital & Research Center Oakland
ID
NCT02719730
Lead Scientist
June Tester
Study Type
Interventional
Last Updated
March 2016