Encourage Healthy Families (Encourage)

August 24, 2017 updated by: David Marrero, Indiana University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Actual)

335

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lifestyle counseling mom only
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.
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.
Experimental: Lifestyle counseling mom and child
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in weight
Time Frame: 3, 6, and 12 months after the beginning of the assigned intervention program
Weight taken during data collection visits
3, 6, and 12 months after the beginning of the assigned intervention program

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in diet
Time Frame: 3, 6, and 12 months after the beginning of the assigned intervention program
Assessed by the Food Frequency Questionnaire (FFQ)
3, 6, and 12 months after the beginning of the assigned intervention program

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Collaborators

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

Investigators

  • Principal Investigator: David G Marrero, PhD., Inidana University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

April 27, 2016

Study Completion (Actual)

April 27, 2016

Study Registration Dates

First Submitted

March 27, 2013

First Submitted That Met QC Criteria

March 29, 2013

First Posted (Estimate)

April 4, 2013

Study Record Updates

Last Update Posted (Actual)

August 25, 2017

Last Update Submitted That Met QC Criteria

August 24, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1207009188

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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