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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
Study Summary
This trial will study the feasibility and acceptability of a family-oriented augmentation of the Diabetes Prevention Program lifestyle intervention (DPP), called the Family DPP. It will also preliminarily examine adult and child health and health behavior outcomes.
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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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
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Who is running the clinical trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,364 Previous Clinical Trials
4,315,368 Total Patients Enrolled
Johns Hopkins UniversityLead Sponsor
2,267 Previous Clinical Trials
14,837,573 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What goals are the team hoping to accomplish through this trial?
"Aspirational results from this clinical trial, evaluated over one year, include the feasibility of measuring child-related outcomes based on percentage of total participants for whom data is collected. Secondary aims encompass changes in fruit and vegetable consumption among all children enrolled; average duration per week of moderate to vigorous physical activity amongst adults reported by self assessment at 12 months; and whether or not adult participants met their program goal (150 minutes weekly) of similar intensity exercise."
Answered by AI
How many participants has this trial attracted so far?
"Affirmative. According to the information present on clinicaltrials.gov, this research study is actively seeking out volunteers. It was initially posted on July 8th 2022 and its most recent update took place October 14th 2022; 45 patients are needed from 1 medical centre only."
Answered by AI
Will new participants be accepted into this trial?
"Affirmative. Clinicaltrials.gov data states that this medical trial, which was initially posted on July 8th 2022, is actively enlisting patients in the study. 45 individuals need to be acquired from 1 research facility."
Answered by AI
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