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Behavioural Intervention
Brighter Bites for Childhood Obesity
N/A
Recruiting
Led By Shreela Sharma, PhD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post intervention (9 months after baseline)
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to see how the Brighter Bites intervention affects children's health and eating habits compared to a control group. They will look at things like blood sugar levels, vegetable intake, food security
Who is the study for?
This trial is for children and their parents living in areas of persistent poverty, who are facing issues with obesity and cardiometabolic health. The study aims to include families willing to participate in a fruit and vegetable co-op program. Specific medical criteria like HbA1c levels may be considered.
What is being tested?
The 'Brighter Bites' intervention is being tested against a wait-list control group to see if it improves kids' health by increasing vegetable intake, improving household food security, and changing dietary behaviors over nine months.
What are the potential side effects?
Since the intervention involves dietary changes through increased fruit and vegetable consumption, side effects might include adjustments in digestion or food preferences but no significant medical side effects are expected.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, post intervention (9 months after baseline)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, post intervention (9 months after baseline)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in amount of child vegetable intake as assessed by the VEGGIE METER®
Change in level of child Glycosylated hemoglobin (HbA1c)
Secondary study objectives
Change in home access/availability of fruits and vegetables as assessed by the Nutrition security measures questionnaire
Change in household food security status as assessed by a parent survey
Child diastolic blood pressure
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Brighter BitesExperimental Treatment1 Intervention
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.
Group II: Control groupActive Control1 Intervention
This delayed intervention group will receive the Brighter Bites intervention after concluding their participation in the study.
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center, HoustonLead Sponsor
949 Previous Clinical Trials
344,305 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,928 Previous Clinical Trials
41,017,318 Total Patients Enrolled
Shreela Sharma, PhDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
3 Previous Clinical Trials
1,836 Total Patients Enrolled
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