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

Obesity Clinical Trial

Official title:

The Metabolic Impact of Concurrent Food Insecurity and Obesity

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02719730
• Other study ID #: 2013-064
• Status: Terminated
• Phase: N/A
• First received: March 15, 2016
• Last updated: February 9, 2018
• Start date: June 22, 2016
• Est. completion date: August 2, 2016

Study information

• Verified date: February 2018
• Source: Children's Hospital & Research Center Oakland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: August 2, 2016
• Est. primary completion date: August 2, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	UCSF Benioff Children's Hospital Oakland	Oakland	California

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital & Research Center Oakland

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in serum triglycerides (mg/dl)	Fasting lipid panel at the end of three month period will be compared to baseline lipid panel: serum triglycerides will be an outcome of particular interest given the intervention.	Baseline and 3 months
Secondary	Change in TG/HDL ratio	Fasting lipid panel at the end of three month period will be compared to baseline lipid panel: the ratio of serum triglycerides (TG) to high-density lipoprotein (HDL-C) will be an outcome of particular interest given the intervention.	Baseline and 3 months
Secondary	Change in body mass index (BMI, or kg/m2)	The change in BMI after the 3 month intervention period will be examined for intervention group compared to control group.	Baseline and 3 months
Secondary	Change in waist to height ratio (WHtR)	Change in waist to height ratio at the end of the 3 month period will be examined for intervention group compared to control group.	Baseline and 3 months
Secondary	Change in proportion of subjects with pre-diabetes	The proportion of subjects with prediabetes (using both criteria of Hemoglobin A1c greater than or equal to 5.7% and fasting glucose greater than or equal to 100 mg/dl) after the 3 month intervention period will be compared for intervention and control groups.	Baseline and 3 months
Secondary	Change in percent of monthly SNAP benefit spent on whole grain purchases (dollars)	Using collected grocery receipts, monthly expenditure (as a percentage of the household's monthly SNAP benefit) for whole grain foods in the third month of the intervention period will be compared to the percent of the SNAP benefit during the baseline month (run-in phase). The change in this expenditure amount will be evaluated for intervention participants compared to controls.	Baseline and 3 months