Encourage Healthy Families

Completed · Not applicable

Conditions studied: Gestational Diabetes Mellitus, Pre-diabetes

In brief

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.

Key facts

Study ID

NCT01823367

Run by

Indiana University

People needed

335

Starts

2012-12-01

Expected to finish

2016-04-27

Last updated by the study team

2017-08-25

Who can join

Age: 8 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Indiana University School of Medicine — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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