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

NCT02719730 | Terminated

• 1 other identifier: 2013-064
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Change in whole grains consumption (ounce equivalents)

  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.

  Baseline and 3 months

Secondary Outcomes (6)

• 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

Study Arms (2)

Reimbursement arm

EXPERIMENTAL

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.

Behavioral: Reimbursement for whole grain purchases

Control arm

NO INTERVENTION

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.

Interventions

Reimbursement for whole grain purchases 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.

Reimbursement arm

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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 may not qualify 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

Sponsors & Collaborators

• UCSF Benioff Children's Hospital Oakland: lead

Study Sites (1)

UCSF Benioff Children's Hospital Oakland

Oakland, California, 94609, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• June Tester, MD MPH

  UCSF Benioff Children's Hospital Oakland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2016
• First Posted: March 25, 2016
• Study Start: June 22, 2016
• Primary Completion: August 2, 2016
• Study Completion: August 2, 2016
• Last Updated: February 13, 2018

Record last verified: 2018-02

Locations

US (1)