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Encourage Healthy Families (Encourage)

Primary Purpose

Gestational Diabetes Mellitus, Pre-diabetes

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Diabetes Prevention Program (DPP)

About this trial

This is an interventional prevention trial for Gestational Diabetes Mellitus focused on measuring type 2 diabetes mellitus prevention, gestational diabetes mellitus, pre-diabetes, lifestyle interventions, pediatric primary prevention of type 2 diabetes

Eligibility Criteria

8 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Indiana University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Lifestyle counseling mom only

Lifestyle counseling mom and child

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Changes in weight

Weight taken during data collection visits

Secondary Outcome Measures

Changes in diet

Assessed by the Food Frequency Questionnaire (FFQ)

Full Information

NCT ID

NCT01823367

First Posted

March 27, 2013

Last Updated

August 24, 2017

Sponsor

Indiana University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT01823367

Brief Title

Encourage Healthy Families

Acronym

Encourage

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Completed

Study Start Date

December 2012 (undefined)

Primary Completion Date

April 27, 2016 (Actual)

Study Completion Date

April 27, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Indiana University

Collaborators

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

4. Oversight

Data Monitoring Committee

5. Study Description

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 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gestational Diabetes Mellitus, Pre-diabetes

Keywords

type 2 diabetes mellitus prevention, gestational diabetes mellitus, pre-diabetes, lifestyle interventions, pediatric primary prevention of type 2 diabetes

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

335 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lifestyle counseling mom only

Arm Type

Experimental

Arm Description

Arm Title

Lifestyle counseling mom and child

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Diabetes Prevention Program (DPP)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Changes in weight

Description

Weight taken during data collection visits

Time Frame

3, 6, and 12 months after the beginning of the assigned intervention program

Secondary Outcome Measure Information:

Title

Changes in diet

Description

Assessed by the Food Frequency Questionnaire (FFQ)

Time Frame

3, 6, and 12 months after the beginning of the assigned intervention program

10. Eligibility

Sex

All

Minimum Age & Unit of Time

8 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David G Marrero, PhD.

Organizational Affiliation

Inidana University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Indiana University School of Medicine

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

32770443

Citation

Palmer KNB, Garr Barry VE, Marrero DG, McKinney BM, Graves AN, Winters CK, Hannon TS. Intervention Delivery Matters: What Mothers at High Risk for Type 2 Diabetes Want in a Diabetes Prevention Program-Results from a Comparative Effectiveness Trial. Diabetes Ther. 2020 Oct;11(10):2411-2418. doi: 10.1007/s13300-020-00891-1. Epub 2020 Aug 8.

Results Reference

derived

PubMed Identifier

25457793

Citation

Hannon TS, Carroll AE, Palmer KN, Saha C, Childers WK, Marrero DG. Rationale and design of a comparative effectiveness trial to prevent type 2 diabetes in mothers and children: the ENCOURAGE healthy families study. Contemp Clin Trials. 2015 Jan;40:105-11. doi: 10.1016/j.cct.2014.11.016. Epub 2014 Nov 29.

Results Reference

derived

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