Encourage Healthy Families



Status:Completed
Conditions:Endocrine, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:8 - Any
Updated:8/26/2017
Start Date:December 2012
End Date:April 27, 2016

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Primary Prevention of Diabetes in Children and Mothers at Increased Risk: Encourage Healthy Families.

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.

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.

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
We found this trial at
1
site
340 W 10th St #6200
Indianapolis, Indiana 46202
(317) 274-3772
Indiana University School of Medicine With more than 2,000 students in 2013, the Indiana University...
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from
Indianapolis, IN
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