NCT02535169

Lifestyle-Related Health Outcomes in Prediabetes and Diabetes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 10 Years – 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obesity
• Prediabetic State
• Type 2 Diabetes

Interventions

Type	Name	Description
BEHAVIORAL	Health Education and Coaching Strategy	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.
BEHAVIORAL	Dietary consult	A routine clinic-based dietary consult will be performed (approximately 1-hour).

Timeline

• Start date: 2014-05-01
• Primary completion: 2022-05-31
• Completion: 2022-05-31
• First posted: 2015-08-28
• Last updated: 2022-08-05

Locations

1 site across 1 country: United States