Status:
COMPLETED
Encourage Healthy Families
Lead Sponsor:
Indiana University
Collaborating Sponsors:
The JPB Foundation
The YMCA of Greater Indianapolis
Conditions:
Gestational Diabetes Mellitus
Pre-diabetes
Eligibility:
All Genders
8+ years
Phase:
NA
Brief 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 criti...
Detailed 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 de...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 27 2016
Estimated Enrollment :
335 Patients enrolled
Trial Details
Trial ID
NCT01823367
Start Date
December 1 2012
End Date
April 27 2016
Last Update
August 25 2017
Active Locations (1)
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1
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202