Lifestyle-Related Health Outcomes in Prediabetes and Diabetes

Study Overview
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Brief Summary
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This study looks as how a health education intervention strategy effects health outcomes in overweight and obese adolescents.

Detailed Description
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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.

Official Title
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Lifestyle-Related Health Outcomes in Prediabetes and Diabetes

Conditions
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Obesity, Prediabetic State, Type 2 Diabetes

Intervention / Treatment
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* Behavioral: Health Education and Coaching Strategy
* Behavioral: Dietary consult


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Health Education and Coaching<br>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. | Behavioral: Health Education and Coaching Strategy<br>* 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.<br>|
| Placebo Comparator: Usual Care<br>1. Dietary consult only | Behavioral: Dietary consult<br>* A routine clinic-based dietary consult will be performed (approximately 1-hour).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the oral disposition index measured by oral glucose tolerance test | oral disposition index = insulinogenic index x 1/fasting insulin | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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at risk for type 2 diabetes, currently has type 2 diabetes