Encourage Healthy Families

Pre-diabetes Clinical Trial

— Encourage  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01823367
• Other study ID #: 1207009188
• Status: Completed
• Phase: N/A
• First received: March 27, 2013
• Last updated: August 24, 2017
• Start date: December 2012
• Est. completion date: April 27, 2016

Study information

• Verified date: August 2017
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 335
• Est. completion date: April 27, 2016
• Est. primary completion date: April 27, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus
• Glucose Intolerance
• Pre-diabetes
• Prediabetic State

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Indiana University School of Medicine	Indianapolis	Indiana

Sponsors (5)

Lead Sponsor	Collaborator
Indiana University	Indiana Clinical and Translational Sciences Institute, Regenstrief Institute, Inc., The JPB Foundation, The YMCA of Greater Indianapolis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in weight	Weight taken during data collection visits	3, 6, and 12 months after the beginning of the assigned intervention program
Secondary	Changes in diet	Assessed by the Food Frequency Questionnaire (FFQ)	3, 6, and 12 months after the beginning of the assigned intervention program