Lifestyle-Related Health Outcomes in Prediabetes and Diabetes

Obesity Clinical Trial

Official title:

Lifestyle-Related Health Outcomes in Prediabetes and Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02535169
• Other study ID #: 1403986016
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Est. completion date: May 31, 2022

Study information

• Verified date: August 2022
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 21 Years

Eligibility

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).

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity
• Prediabetic State
• Type 2 Diabetes

Intervention

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.
• Dietary consult
A routine clinic-based dietary consult will be performed (approximately 1-hour).

Locations

Country	Name	City	State
United States	Indiana University School of Medicine	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	Purdue University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the oral disposition index measured by oral glucose tolerance test	oral disposition index = insulinogenic index x 1/fasting insulin	6 months