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Clinical Trials/NCT02535169
NCT02535169
Completed
Not Applicable

Lifestyle-Related Health Outcomes in Prediabetes and Diabetes

Indiana University1 site in 1 country78 target enrollmentMay 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
Indiana University
Enrollment
78
Locations
1
Primary Endpoint
Changes in the oral disposition index measured by oral glucose tolerance test
Status
Completed
Last Updated
3 years ago

Overview

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: 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. 2. 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. 3. 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. 4. 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.

Registry
clinicaltrials.gov
Start Date
May 2014
End Date
May 31, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nana Gletsu Miller

Associate Professor

Indiana University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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).

Outcomes

Primary Outcomes

Changes in the oral disposition index measured by oral glucose tolerance test

Time Frame: 6 months

oral disposition index = insulinogenic index x 1/fasting insulin

Study Sites (1)

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