ObesityNCT02719730
Upgrade the Grains Study: Increasing Whole Grain Consumption in Low-income Children With Obesity
A study testing Reimbursement for whole grain purchases in people with Obesity, run by UCSF Benioff Children's Hospital Oakland at 1 site in United States.
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"). Read more about this study
- Who is it for?
- Ages 8 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Reimbursement for whole grain purchases
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jun 2016to 2 Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Benioff Children's Hospital Oakland
Oakland, California, 94609
About this study
Official title: The Metabolic Impact of Concurrent Food Insecurity and Obesity
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.
Read the 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
- Being tested
- Reimbursement for whole grain purchases
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reimbursement for whole grain purchasesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 3 months
Secondary outcomes (6)
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.
Measured: Baseline and 3 months
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.
Measured: Baseline and 3 months
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.
Measured: Baseline and 3 months
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.
Measured: Baseline and 3 months
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.
Measured: Baseline and 3 months
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.
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2016 (estimated)
- Study start22 Jun 2016
- Primary completion2 Aug 2016
- Study completion2 Aug 2016
Why it stopped: Change in study design to be a pilot with no randomization to intervention/control
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCSF Benioff Children's Hospital Oakland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- June Tester, MD MPH, Principal investigator, UCSF Benioff Children's Hospital Oakland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02719730
- Sponsor's protocol ID
- 2013-064
- Status last verified
- Feb 2018
- First submitted
- 15 Mar 2016
- Last updated
- 13 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Metabolic Impact of Concurrent Food Insecurity and Obesity
- ClinicalTrials.gov ID
- NCT02719730
- Acronym / sponsor ID
- 2013-064
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Change in study design to be a pilot with no randomization to intervention/control
- Enrolment
- 5 participants (actual)
- Lead sponsor
- UCSF Benioff Children's Hospital OaklandUniversity, hospital or other
- Study start
- 22 Jun 2016 (actual)
- Primary completion
- 2 Aug 2016 (actual)
- Study completion
- 2 Aug 2016 (actual)
- First posted
- 25 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reimbursement arm | Experimental | Behavioral: Reimbursement for whole grain purchasesParticipating 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. |
| 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. |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reimbursement for whole grain purchasesAll 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. | Behavioural | Reimbursement arm |
Primary outcome
Change in whole grains consumption (ounce equivalents)
Time frame: Baseline and 3 months
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.
6 secondary outcomes
Change in serum triglycerides (mg/dl)
Time frame: Baseline and 3 months
Change in TG/HDL ratio
Time frame: Baseline and 3 months
Change in body mass index (BMI, or kg/m2)
Time frame: Baseline and 3 months
Change in waist to height ratio (WHtR)
Time frame: Baseline and 3 months
Change in proportion of subjects with pre-diabetes
Time frame: Baseline and 3 months
Change in percent of monthly SNAP benefit spent on whole grain purchases (dollars)
Time frame: Baseline and 3 months
Results and safety
The study was stopped early (reason given: Change in study design to be a pilot with no randomization to intervention/control). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
June Tester, MD MPH principal investigator
UCSF Benioff Children's Hospital Oakland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reimbursement for whole grain purchases in people with Obesity, run by UCSF Benioff Children's Hospital Oakland at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Change in study design to be a pilot with no randomization to intervention/control). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in whole grains consumption (ounce equivalents) (time frame: Baseline and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2018.