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| ID | Type | Description | Link |
|---|---|---|---|
| 5U54CA280804-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The purpose of this study is to examine the effects of the (Brighter Bites (BB) intervention compared to a wait-list control group 9 months after the intervention on changes in primary child outcomes (HbA1c, and vegetable intake), on changes in secondary outcomes (household food security status, parent and child dietary behaviors, and home access/availability of fruits and vegetables (FV)), and the mediational influence of changes in food security status, parent outcomes, and home environment measures on changes in child outcomes.
The purpose of this study is to examine the effects of the (Brighter Bites (BB) intervention compared to wait-list control at post intervention on changes in primary child outcomes (HbA1c, and vegetable intake), to examine the effects of the BB intervention compared to wait-list control at 9-month post intervention on changes in secondary outcomes (household food security status, parent and child dietary behaviors, and home access/availability of fruits and vegetables (FV)),to examine the mediational influence of changes in food security status, parent outcomes, and home environment measures on changes in child outcomes at 9-month post-intervention, using within-subject analyses, examine and compare the long-term and dose-response effects of the BB intervention strategies on diet, adiposity, and metabolic outcomes at 21-month follow-up in the children and to explore the moderating effects of social and environmental variables on program effectiveness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brighter Bites | Experimental | This group will receive the Brighter Bites intervention throughout the study implementation. The intervention includes fruit and vegetable distributions of ~20lbs. for teachers and families, healthy recipe tastings, and nutrition education. |
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| Control group | No Intervention | This delayed intervention group will receive the Brighter Bites intervention after concluding their participation in the study. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brighter Bites | Other | Families will receive a distribution of fresh fruits and vegetables (FV) (~20lbs., 50 servings/family/distribution) for ~16 weeks during the school year using primarily donated produce from local food banks. Nutrition education will be implemented for children using the evidence-based Coordinated Approach to Child Health (CATCH) program and for parents using bilingual nutrition handbooks and fun food experiences such as healthy FV recipe tastings for families during produce pick-up time will be conducted. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in level of child Glycosylated hemoglobin (HbA1c) | We will utilize the portable HbA1c analyzers (DCA Vantage analyzer) to assess HbA1c, during biometric events. | baseline, post intervention (9 months after baseline) |
| Change in amount of child vegetable intake as assessed by the VEGGIE METER® | The VEGGIE METER® is used to obtain a child's quantitative metric of skin carotenoids, a proxy measure of FV intake for children. The VEGGIE METER® measures skin carotenoids as an indicator of FV intake. Higher number of carotenoid levels indicate more FV intake. | baseline, post intervention (9 months after baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in household food security status as assessed by a parent survey | Household Food Insecurity will be measured using 2-item Hunger Vital Sign food security survey and 4-items adapted from the Center for Nutrition and Health Impact, for a total of 6-items. The items are scored from 0 (if the participant selects "Always") to 4 (if the participant selects "Never") and the measure's score is the mean of the responses. The higher the participant's score, the greater degree of the household nutrition security. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shreela Sharma, PhD | Contact | (713) 500-9344 | Shreela.V.Sharma@uth.tmc.edu | |
| Emily Adlparvar | Contact | (713) 500 9608 | Emily.M.Adlparvar@uth.tmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Shreela Sharma, PhD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Recruiting | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42229798 | Derived | Sharma S, Senn M, Chuang RJ, Perkison WB, Crichlow K, Markham C, Ramphul R, Shete S, Basen-Engquist K, McNeill L, Rechis R. Design for a cluster randomized controlled trial to evaluate the impact of a school-based fruit and vegetable co-op on cardiometabolic health of children and parents in a persistent poverty area. Contemp Clin Trials. 2026 Jun 1;167:108361. doi: 10.1016/j.cct.2026.108361. Online ahead of print. |
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| baseline, post intervention (9 months after baseline) |
| Number of servings consumed by the parent as assessed by the Adapted Health of Houston Survey (HHS) on processed food/drinks 4-items, and fruit and vegetable intake 2 items. | This is a 6-item questionnaire. The parent responds the number of servings they consumed during the time period. Servings are calculated based on the servings per day. | baseline, post intervention (9 months after baseline) |
| Number of servings consumed by the Child as assessed by the NIH's Eating at America's Table questionnaire (All Day) and the Dietary Screener Questionnaires | This is a 6-item questionnaire. The parent responds the number of servings their child consumed during the time period. Servings are calculated based on the servings per day. | baseline, post intervention (9 months after baseline) |
| Child systolic blood pressure | Child's systolic blood pressure will be obtained with an automatic cuff according to recommendations of the American Heart Association. This will be measure during biometric events. | baseline |
| Child systolic blood pressure | Child's systolic blood pressure will be obtained with an automatic cuff. This will be measure during biometric events. | Post intervention (9 months after baseline) |
| Child diastolic blood pressure | Child's diastolic blood pressure will be obtained with an automatic cuff. This will be measure during biometric events. | baseline |
| Child diastolic blood pressure | Child's diastolic blood pressure will be obtained with an automatic cuff. This will be measure during biometric events. | post intervention (9 months after baseline) |
| Change in home access/availability of fruits and vegetables as assessed by the Nutrition security measures questionnaire | Nutrition security measures assess factors associated with a household's ability to obtain foods that meet their nutritional and health needs. Household Food Insecurity will be measured using 2-item Hunger Vital Sign food security survey and 4-items adapted from the Center for Nutrition and Health Impact, for a total of 6-items. The items are scored from 0 (if the participant selects "Always") to 4 (if the participant selects "Never") and the measure's score is the mean of the responses. The higher the participant's score, the greater degree of the household nutrition security. | baseline, post intervention (9 months after baseline) |
| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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