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Family DPP for Prediabetes
N/A
Waitlist Available
Led By Maya S Venkataramani, MD, MPH
Research Sponsored by Johns Hopkins University
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 baseline, 6 and 12 months
Awards & highlights
Summary
This trial tests a family-focused version of a diabetes prevention program. It helps adults at risk for diabetes and their children learn healthy habits. The goal is to see if this approach can improve health outcomes for both adults and kids.
Who is the study for?
This trial is for families with children aged 5-12 who are not in a weight management program. Adults must be primary caregivers of an eligible child and meet criteria for the National Diabetes Prevention Program, which includes being at high risk for type 2 diabetes but not having it yet.
What is being tested?
The study tests a Family Diabetes Prevention Program (Family DPP) against the standard adult-only Diabetes Prevention Program (DPP). It aims to see if adding family-oriented sessions helps improve health behaviors and outcomes in both adults and their children.
What are the potential side effects?
Since this intervention involves lifestyle changes like diet modification and increased physical activity, side effects may include muscle soreness or injury from exercise, dietary changes discomforts, but no severe medical side effects are expected.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 6 and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 and 12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Adult participant attendance in program as assessed by percentage of program sessions attended, core
Adult participant attendance in program as assessed by percentage of program sessions attended, full program
Adult participant attendance in program as assessed by total number of program sessions attended, core
+8 moreSecondary study objectives
Adult participant physical activity achievement
Adult participant physical activity as assessed by average duration of activity per week
Change in Family Home Health Environment
+13 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Family Diabetes Prevention Program (Family DPP)Experimental Treatment1 Intervention
Adult participants will engage in the family-oriented Diabetes Prevention Program lifestyle intervention (Family DPP); this is an augmented version of the DPP lifestyle intervention. This 12-month, group-based lifestyle intervention will include all elements of the DPP lifestyle intervention as delivered by the Johns Hopkins Brancati Center using a CDC-approved curriculum, with additional child-focused sessions in which adult participants will learn about children's health-related behaviors. Children will be present at the child-focused sessions and family activities, and will be engaged in data collection. These groups will be "mixed," in that non-study participants (adults who are eligible for the DPP), may also participate.
Group II: Diabetes Prevention Program (DPP)Active Control1 Intervention
Adult participants who are engaged in the Centers for Disease Control and Prevention's (CDC) National Diabetes Prevention Program lifestyle intervention (DPP) as delivered by the Johns Hopkins Brancati Center; this is a 12-month long, group-based lifestyle intervention, delivered by a certified lifestyle coach using a CDC-approved curriculum. This "concurrent control" group will consist of adults who are enrolled in the Brancati Center's DPP within 6 months of the intervention group start dates, who have children less than 18 years of age living in their households.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Family Diabetes Prevention Program (Family DPP)
2022
N/A
~40
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Type 2 Diabetes include lifestyle modifications and pharmacologic therapies. Lifestyle modifications, such as those studied in the Family DPP trial, involve dietary changes, increased physical activity, and weight management.
These interventions improve insulin sensitivity, lower blood glucose levels, and enhance overall metabolic health. Pharmacologic treatments, like metformin, decrease hepatic glucose production and improve insulin sensitivity.
For Type 2 Diabetes patients, these treatments are crucial as they address both the underlying causes and symptoms of the disease, leading to better glycemic control and reduced risk of complications.
Meta-analysis of randomized educational and behavioral interventions in type 2 diabetes.Effects of lifestyle modifications on patients with type 2 diabetes: the Japan Diabetes Complications Study (JDCS) study design, baseline analysis and three year-interim report.
Meta-analysis of randomized educational and behavioral interventions in type 2 diabetes.Effects of lifestyle modifications on patients with type 2 diabetes: the Japan Diabetes Complications Study (JDCS) study design, baseline analysis and three year-interim report.
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Who is running the clinical trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,424 Previous Clinical Trials
4,324,901 Total Patients Enrolled
Johns Hopkins UniversityLead Sponsor
2,315 Previous Clinical Trials
14,872,689 Total Patients Enrolled
Maya S Venkataramani, MD, MPHPrincipal InvestigatorJohns Hopkins University
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Eligibility Criteria:
This trial includes the following eligibility criteria:- For ADULT participants, having severe kidney disease.You have type 1 or type 2 diabetes as an adult.Adults who meet the requirements for the CDC's National Diabetes Prevention Program lifestyle intervention.Children between 5 and 12 years old can participate.You are currently participating in the Brancati Center's Diabetes Prevention Program and started within 6 months of the other group in the study.
Research Study Groups:
This trial has the following groups:- Group 1: Family Diabetes Prevention Program (Family DPP)
- Group 2: Diabetes Prevention Program (DPP)
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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