Overview

This trial is active, not recruiting.

Conditions gestational diabetes mellitus, pre-diabetes
Treatment diabetes prevention program (dpp)
Sponsor Indiana University
Collaborator The JPB Foundation
Start date December 2012
End date May 2016
Trial size 350 participants
Trial identifier NCT01823367, 1207009188

Summary

This study is a randomized intervention that will test two different approaches reflecting diverse levels of both intensity and cost, to achieving risk reduction of T2D. This will help address a critical question in the translation of primary prevention research into the public health: how much intensity (and thus cost) is required to achieve an effective outcome? In addition, the proposed study will address a critical need in diabetes prevention that has not received sufficient scholarly attention: the prevention of T2D in children. No studies of diabetes prevention similar in scope to the DPP have been performed in school-aged children; however, reducing childhood obesity is widely accepted as the primary pathway to decreasing the growing prevalence of T2D in the pediatric population.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
This intervention, delivered to groups of mothers only, builds upon the evidence-based curriculum used in the Diabetes Prevention Program (DPP) and incorporates into the curriculum detailed education regarding ways to help their children adopt healthier lifestyle behaviors.
diabetes prevention program (dpp)
Diabetes Prevention Program (DPP): This is an evidence-based curriculum that has shown that it is possible to prevent or delay Type 2 Diabetes (T2D) in individuals if they keep a healthy weight, eat a nutritious diet, and stay physically active.
(Experimental)
The second intervention is delivered to both mothers and children in separate groups using the same parent Diabetes Prevention Program (DPP) curriculum, but adds a group program for children that directly teach these children strategies for eating better and increasing physical activity.
diabetes prevention program (dpp)
Diabetes Prevention Program (DPP): This is an evidence-based curriculum that has shown that it is possible to prevent or delay Type 2 Diabetes (T2D) in individuals if they keep a healthy weight, eat a nutritious diet, and stay physically active.

Primary Outcomes

Measure
Changes in weight
time frame: 3, 6, and 12 months after the begining of the assigned intervention program

Secondary Outcomes

Measure
Changes in diet
time frame: 3, 6, and 12 months after the begining of the assigned intervention program

Eligibility Criteria

Male or female participants at least 8 years old.

Inclusion Criteria: - Adult females, age 18 or greater - Body-mass index of ≥ 25 kg/m2 - Is a biological mother to a child between 8 and 15 years of age (child must live with biological mom) - Is a biological mother with past diagnosis or history of gestational diabetes, prediabetes or gave birth to a child who weighed 9 pounds or greater at delivery - Child, ages 8 to 15 years, to biological mother meeting inclusion criteria for Adult Females Exclusion Criteria: - Biological mother or biological child with diagnosis of Type 1 or 2 Diabetes Mellitus - Biological mother or biological child with current A1c > 6.5% - Biological mother or biological child current casual capillary blood glucose > 220mg/dl - Biological mother or biological child with uncontrolled hypertension (Systolic Blood Pressure (SBP) >180 mmHg or Diastolic Blood Pressure (DBP) >105 mmHg) - Biological mother or biological child with heart attack, stroke, or transient ischemic attack in the past 6 months - Biological mother or biological child with chest pain, dizziness, or fainting with physical exertion - Biological mother or biological child with Chronic Obstructive Pulmonary Disease (COPD) or asthma requiring home oxygen - Biological mother or biological child with cancer treatment in the last 5 years - Biological mother or biological child with any other known condition that could limit ability to become physically active or limit life span to <5 years - Biological mother or biological child with history of anti-diabetic medication use (oral agents or insulin) except during past gestational diabetes - Biological mother or biological child with self-report of any other condition associated with disordered glucose metabolism (including but not limited to):pregnancy; Cushing's syndrome; acromegaly; pheochromocytoma; chronic pancreatitis - Biological mother or biological child with conditions or behaviors likely to affect the conduct of the study (including but not limited to): any reported developmental problems, unable or unwilling to provide informed consent/assent, unable or unwilling to communicate with study staff or engage in learning activities

Additional Information

Official title Primary Prevention of Diabetes in Children and Mothers at Increased Risk: Encourage Healthy Families.
Principal investigator David G Marrero, PhD.
Description The proposed interventions will target mothers with a history of Gestational Diabetes (GDM), who gave birth to babies 9 pounds or greater, or who have prediabetes who are thus at very high risk for developing diabetes, and by virtue of their GDM/prediabetes, their children are also at high risk. Because of the genetic components involved, all children born by a woman afflicted with gestational diabetes mellitus or prediabetes have elevated risk of developing Type 2 Diabetes. This first intervention builds upon the evidence-based curriculum used in the DPP and incorporates into the curriculum detailed education regarding ways to help their children adopt healthier lifestyle behaviors. It will be delivered in groups of mothers only at community sites using trained laypeople. The second intervention will use the same parent curriculum, but adds a group program for children that teach them (directly) strategies for eating better and increasing physical activity. This program will be delivered to both mothers and children in separate groups. The group sessions will take place at the same time and in the same location by a trained facilitator.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Indiana University.