What side effects are associated with this type of intervention?

Lifestyle modification, including dietary changes, increased physical activity, and behavioral interventions, is a cornerstone of Type 2 Diabetes management. These interventions generally have minimal side effects, though some individuals may experience initial muscle soreness, fatigue, or dietary adjustment challenges. Pharmacologic treatments, such as metformin, are commonly used and can cause gastrointestinal issues like nausea and diarrhea. Sulfonylureas may lead to hypoglycemia and weight gain, while insulin therapy has been associated with an increased risk of cardiovascular events. DPP-4 inhibitors are generally well-tolerated but have been linked to a slight increase in the risk of acute pancreatitis.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Type 2 Diabetes that complement lifestyle modifications through education and behavior change. Notably, extended-release exenatide (Bydureon BCise) and dulaglutide have been approved for pediatric use, emphasizing their role alongside diet and exercise. These medications, along with metformin and insulin, form the cornerstone of pharmacologic therapy in adolescents and adults with Type 2 Diabetes. The Family DPP trial focuses on lifestyle interventions, which are crucial for managing diabetes and are often used in conjunction with these FDA-approved medications to optimize glycemic control and overall health outcomes.

What other types of research exist?

Promising, novel alternatives to the Family DPP for Type 2 Diabetes patients include: 1) Transform DPP, a digital therapeutic program incorporating interactive mobile computing, remote monitoring, and online peer support; 2) A digitally delivered DPP for low-income patients, which includes a 52-week educational curriculum, health coaching, and peer support; 3) Web-based DPP interventions tailored for specific cultural groups, such as Chinese Americans, which have shown high acceptability and feasibility.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 and 12 months for reporting.

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 more

Secondary 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 more

Trial 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

Do I qualify?Apply below to find out

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.

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,410 Previous Clinical Trials

4,324,857 Total Patients Enrolled

Johns Hopkins UniversityLead Sponsor

2,307 Previous Clinical Trials

14,861,875 Total Patients Enrolled

Maya S Venkataramani, MD, MPHPrincipal InvestigatorJohns Hopkins University

Media Library

Family Diabetes Prevention Program (Family DPP) Clinical Trial Eligibility Overview. Trial Name: NCT05358444 — N/A

Type 2 Diabetes Research Study Groups: Family Diabetes Prevention Program (Family DPP), Diabetes Prevention Program (DPP)

Type 2 Diabetes Clinical Trial 2023: Family Diabetes Prevention Program (Family DPP) Highlights & Side Effects. Trial Name: NCT05358444 — N/A

Family Diabetes Prevention Program (Family DPP) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05358444 — N/A

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