Upgrade the Grains Study: Increasing Whole Grain Consumption in Low-income Children With Obesity

NCT ID: NCT02719730

Last Updated: 2018-02-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-22
• Study Completion Date: 2016-08-02

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Reimbursement for whole grain purchases

Intervention Type: BEHAVIORAL

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Reimbursement for whole grain purchases

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

UCSF Benioff Children's Hospital Oakland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

June Tester, MD MPH

Role: PRINCIPAL_INVESTIGATOR

UCSF Benioff Children's Hospital Oakland

Locations

UCSF Benioff Children's Hospital Oakland

Oakland, California, United States

Countries

United States

Other Identifiers

2013-064

Identifier Type: -

Identifier Source: org_study_id