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Lifestyle-Related Health Outcomes in Prediabetes and Diabetes

Primary Purpose

Obesity, Prediabetic State, Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Health Education and Coaching Strategy
Dietary consult
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Obesity focused on measuring at risk for type 2 diabetes, currently has type 2 diabetes

Eligibility Criteria

10 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. male and female adolescents/young adults,
  2. age 10-21,
  3. Tanner stage II-V,
  4. overweight or obese (body mass index ≥85th percentile for age and sex).

Exclusion Criteria:

  1. pregnancy,
  2. use of medications that adversely affect glucose metabolism (such as glucocorticoid-containing medications or atypical antipsychotics), and
  3. syndromic obesity (such as Prader Willi, hypothalamic obesity, or Laurence- Moon-Biedl).

Sites / Locations

  • Indiana University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Health Education and Coaching

Usual Care

Arm Description

1. To evaluate whether a health education and coaching strategy in overweight and obese adolescents (≥85th percentile) with high risk for type 2 diabetes is superior to usual care (single nutrition consultation) for weight management, clinical health outcomes (measures of glucose tolerance), lifestyle behavior outcomes (diet and physical activity) and outcomes of importance to patients such as satisfaction with the health care team, treatment goals, and psychosocial functioning.

1. Dietary consult only

Outcomes

Primary Outcome Measures

Changes in the oral disposition index measured by oral glucose tolerance test
oral disposition index = insulinogenic index x 1/fasting insulin

Secondary Outcome Measures

Full Information

First Posted
August 24, 2015
Last Updated
August 3, 2022
Sponsor
Indiana University
Collaborators
Purdue University
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1. Study Identification

Unique Protocol Identification Number
NCT02535169
Brief Title
Lifestyle-Related Health Outcomes in Prediabetes and Diabetes
Official Title
Lifestyle-Related Health Outcomes in Prediabetes and Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
May 31, 2022 (Actual)
Study Completion Date
May 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
Purdue University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study looks as how a health education intervention strategy effects health outcomes in overweight and obese adolescents.
Detailed Description
This study aims to do the following: To evaluate whether a health education and coaching strategy in overweight and obese adolescents (≥85th percentile) with high risk for type 2 diabetes is superior to usual care (single nutrition consultation) for weight management, clinical health outcomes (measures of glucose tolerance), lifestyle behavior outcomes (diet and physical activity) and outcomes of importance to patients such as satisfaction with the health care team, treatment goals, and psychosocial functioning. To evaluate whether a health education and coaching strategy in obese adolescents with diabetes (type 1 or type 2) is superior to usual care (single nutrition consultation) for weight management, clinical health outcomes (measures of diabetes control), lifestyle behavior outcomes (diet and physical activity) and outcomes of importance to patients such as satisfaction with the health care team, treatment goals, and psychosocial functioning. At baseline, before the interventions described in Aims 1 and 2, to identify key diet and physical activity factors, patient characteristics, or biomarkers which are predictive of diabetes risk. At baseline, before the interventions described in Aims 1 and 2, can associations between glycemia, cardiometabolic risk factors, and diet and physical activity behaviors in overweight and obese adolescents who are at risk for type 2 diabetes be identified using the Bright Futures questionnaire, a survey for lifestyle behavior which is normally used in the clinic setting.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Prediabetic State, Type 2 Diabetes
Keywords
at risk for type 2 diabetes, currently has type 2 diabetes

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Health Education and Coaching
Arm Type
Experimental
Arm Description
1. To evaluate whether a health education and coaching strategy in overweight and obese adolescents (≥85th percentile) with high risk for type 2 diabetes is superior to usual care (single nutrition consultation) for weight management, clinical health outcomes (measures of glucose tolerance), lifestyle behavior outcomes (diet and physical activity) and outcomes of importance to patients such as satisfaction with the health care team, treatment goals, and psychosocial functioning.
Arm Title
Usual Care
Arm Type
Placebo Comparator
Arm Description
1. Dietary consult only
Intervention Type
Behavioral
Intervention Name(s)
Health Education and Coaching Strategy
Intervention Description
Utilizing health education and health coaching to intervene with adolescents who are at high risk for type 2 diabetes or prediabetes regarding nutrition and physical activity. A 16-week curriculum will be utilized and phone-based coaching visits will be performed.
Intervention Type
Behavioral
Intervention Name(s)
Dietary consult
Intervention Description
A routine clinic-based dietary consult will be performed (approximately 1-hour).
Primary Outcome Measure Information:
Title
Changes in the oral disposition index measured by oral glucose tolerance test
Description
oral disposition index = insulinogenic index x 1/fasting insulin
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: male and female adolescents/young adults, age 10-21, Tanner stage II-V, overweight or obese (body mass index ≥85th percentile for age and sex). Exclusion Criteria: pregnancy, use of medications that adversely affect glucose metabolism (such as glucocorticoid-containing medications or atypical antipsychotics), and syndromic obesity (such as Prader Willi, hypothalamic obesity, or Laurence- Moon-Biedl).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tamara Hannon, MD, MS
Organizational Affiliation
Indiana University
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

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be shared via presentations and publications.
Citations:
PubMed Identifier
27135792
Citation
Wagner KA, Armah SM, Smith LG, Pike J, Tu W, Campbell WW, Boushey CJ, Hannon TS, Gletsu-Miller N. Associations between Diet Behaviors and Measures of Glycemia, in Clinical Setting, in Obese Adolescents. Child Obes. 2016 Oct;12(5):341-7. doi: 10.1089/chi.2015.0232. Epub 2016 May 2.
Results Reference
derived

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Lifestyle-Related Health Outcomes in Prediabetes and Diabetes

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