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Food Packages + Health Education for Obesity
N/A
Waitlist Available
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0-6 months
Awards & highlights
Study Summary
This trial will evaluate if providing weekly food packages and health education to families can improve behavioral, social and health outcomes. #FoodPantry #HealthEducation
Who is the study for?
This trial is for families with at least one child aged 6-17 years, who are referred to the Revere Food Pantry. Participants must be able to speak English or Spanish. It's aimed at those dealing with obesity, metabolic issues, food insecurity, and cardiometabolic syndrome.Check my eligibility
What is being tested?
The study tests if weekly family food packages and group health sessions can improve lifestyle choices and health outcomes. Families will receive food from a pantry and attend six monthly sessions on healthy living and chronic disease management.See study design
What are the potential side effects?
There may not be direct medical side effects as this trial involves food distribution and educational sessions rather than medication. However, changes in diet could potentially lead to digestive adjustments or allergic reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0-6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in BMI at 6 months
Change in Diet Quality at 3 months
Change in Food Insecurity Status at 3 months
Secondary outcome measures
Change in Binge Eating Symptoms at 3 months
Change in Blood Pressure at 6 months
Change in Physical Activity at 3 months
+2 moreOther outcome measures
Change in abnormal ALT/AST lab values at 6 months
Change in abnormal glucose lab value at 6 months
Change in abnormal lipid lab values at 6 months
Trial Design
2Treatment groups
Experimental Treatment
Group I: Weekly Family Food PackagesExperimental Treatment1 Intervention
Group II: Family Health Group SessionsExperimental Treatment2 Interventions
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Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,943 Previous Clinical Trials
13,200,824 Total Patients Enrolled
70 Trials studying Obesity
290,969 Patients Enrolled for Obesity
American Academy of PediatricsOTHER
40 Previous Clinical Trials
1,016,343 Total Patients Enrolled
4 Trials studying Obesity
1,996 Patients Enrolled for Obesity
Ardmore FoundationUNKNOWN
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Eligibility Criteria:
This trial includes the following eligibility criteria:- This criterion means that individuals who are referred to a food pantry are excluded from the clinical trial.I cannot speak English or Spanish.I have a child aged 6-17 years.
Research Study Groups:
This trial has the following groups:- Group 1: Weekly Family Food Packages
- Group 2: Family Health Group Sessions
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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