Encourage Healthy Families

NCT ID: NCT01823367

Last Updated: 2017-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 335 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2016-04-27

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.

Conditions

Gestational Diabetes Mellitus; Pre-diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Diabetes Prevention Program (DPP)

Intervention Type: BEHAVIORAL

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.

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.

Group Type: EXPERIMENTAL

Diabetes Prevention Program (DPP)

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

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

• Minimum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The JPB Foundation

UNKNOWN

Sponsor Role: collaborator

The YMCA of Greater Indianapolis

UNKNOWN

Sponsor Role: collaborator

Regenstrief Institute, Inc.

OTHER

Sponsor Role: collaborator

Indiana Clinical and Translational Sciences Institute

OTHER

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

David Marrero

J.O Ritchey Professor of Medicine. Director, Diabetes Translational Research Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David G Marrero, PhD.

Role: PRINCIPAL_INVESTIGATOR

Inidana University School of Medicine

Locations

Indiana University School of Medicine

Indianapolis, Indiana, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 32770443 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25457793 (View on PubMed)

Other Identifiers

1207009188

Identifier Type: -

Identifier Source: org_study_id