NCT02700503

Brief Summary

This study uses patient engagement to develop a diabetes prevention program focused on adolescents and families.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Nov 2015

Longer than P75 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 7, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

August 7, 2019

Status Verified

August 1, 2019

Enrollment Period

3.6 years

First QC Date

February 23, 2016

Last Update Submit

August 5, 2019

Conditions

Diabetes Mellitus, Type 2Prediabetic State

Keywords

Diabetes preventiontype 2 diabetesprediabetesfamily

Outcome Measures

Primary Outcomes (1)

  • Subject's BMI calculation Charted on CDC Stature for Age and Weight for Age Percentiles chart

    12 months

Secondary Outcomes (5)

  • Hemoglobin A1C

    12 months

  • Physical activity

    12 months

  • Quality of life

    12 months

  • Intervention group session attendance

    12 months

  • Dietary records

    12 months

Study Arms (1)

Intervention

EXPERIMENTAL

Participants will be enrolled in the ENCOURAGE 2.0 family-based diabetes prevention intervention that was designed through our work in Aims 1 and 2 of the study. It is this modified population-level ENCOURAGE 2.0 family-based diabetes prevention intervention that will be studied.

Behavioral: Encourage 2.0

Interventions

Encourage 2.0BEHAVIORAL

Participants will be enrolled in the ENCOURAGE 2.0 family-based diabetes prevention intervention that was designed through our work in Aims 1 and 2 of the study. It is this modified population-level ENCOURAGE 2.0 family-based diabetes prevention intervention that will be studied.

Intervention

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Overweight (BMI \>85th percentile for age and sex, weight for height \>85th percentile, or weight \>120% of ideal \[50th percentile\] for height)
  • At least two of the following risk factors:
  • Have been diagnosed with prediabetes;
  • Have a family history of T2DM in first- and second-degree relatives;
  • Belong to a minority race/ethnic group (Native Americans, African-Americans, Hispanic Americans, Asians/South Pacific Islanders);
  • Have conditions associated with insulin resistance; and/or
  • Have had gestational diabetes or were exposed to gestational diabetes in utero.
  • A family support person who is also willing to participate in the study. This person would preferably be a parent also at risk for diabetes (history of gestational diabetes, prediabetes, or with T2D).

You may not qualify if:

  • \. Type 2 diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Riley Children's Specialties

Carmel, Indiana, 46032, United States

Location

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

Riley Children's Hospital

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Tamara Hannon, MD

    Indiana University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pediatrics

Study Record Dates

First Submitted

February 23, 2016

First Posted

March 7, 2016

Study Start

November 1, 2015

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

August 7, 2019

Record last verified: 2019-08

Locations

US(3)