Lifestyle-Related Health Outcomes in Prediabetes and Diabetes

Not Applicable

Completed

• Conditions: Obesity; Prediabetic State; Type 2 Diabetes
• Interventions: Behavioral: Health Education and Coaching Strategy; Behavioral: Dietary consult

• Registration Number: NCT02535169
• Lead Sponsor: Indiana University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2015-08-24
• Study First Submitted QC: 2015-08-26
• Study First Posted: 2015-08-28
• Primary Completion: 2022-05-31
• Study Completion: 2022-05-31
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-03
• Last Update Posted: 2022-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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).

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Health Education and Coaching	Health Education and Coaching Strategy	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.
Usual Care	Dietary consult	1. Dietary consult only

Primary Outcome Measures

Name	Time	Method
Changes in the oral disposition index measured by oral glucose tolerance test	6 months	oral disposition index = insulinogenic index x 1/fasting insulin

Trial Locations

Locations (1)

Indiana University School of Medicine; 🇺🇸 Indianapolis, Indiana, United States