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

Primary Purpose

Obesity

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Reimbursement for whole grain purchases
Sponsored by
UCSF Benioff Children's Hospital Oakland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

8 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UCSF Benioff Children's Hospital Oakland

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Reimbursement arm

Control arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
March 15, 2016
Last Updated
February 9, 2018
Sponsor
UCSF Benioff Children's Hospital Oakland
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1. Study Identification

Unique Protocol Identification Number
NCT02719730
Brief Title
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

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Terminated
Why Stopped
Change in study design to be a pilot with no randomization to intervention/control
Study Start Date
June 22, 2016 (Actual)
Primary Completion Date
August 2, 2016 (Actual)
Study Completion Date
August 2, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCSF Benioff Children's Hospital Oakland

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Reimbursement arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Control arm
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Reimbursement for whole grain purchases
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in whole grains consumption (ounce equivalents)
Description
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.
Time Frame
Baseline and 3 months
Secondary Outcome Measure Information:
Title
Change in serum triglycerides (mg/dl)
Description
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.
Time Frame
Baseline and 3 months
Title
Change in TG/HDL ratio
Description
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.
Time Frame
Baseline and 3 months
Title
Change in body mass index (BMI, or kg/m2)
Description
The change in BMI after the 3 month intervention period will be examined for intervention group compared to control group.
Time Frame
Baseline and 3 months
Title
Change in waist to height ratio (WHtR)
Description
Change in waist to height ratio at the end of the 3 month period will be examined for intervention group compared to control group.
Time Frame
Baseline and 3 months
Title
Change in proportion of subjects with pre-diabetes
Description
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.
Time Frame
Baseline and 3 months
Title
Change in percent of monthly SNAP benefit spent on whole grain purchases (dollars)
Description
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.
Time Frame
Baseline and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
June Tester, MD MPH
Organizational Affiliation
UCSF Benioff Children's Hospital Oakland
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSF Benioff Children's Hospital Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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