Lifestyle-Related Health Outcomes in Prediabetes and Diabetes

NCT ID: NCT02535169

Last Updated: 2022-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2022-05-31

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.

Conditions

Obesity; Prediabetic State; Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Health Education and Coaching

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.

Group Type: EXPERIMENTAL

Health Education and Coaching Strategy

Intervention Type: BEHAVIORAL

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.

Usual Care

1\. Dietary consult only

Group Type: PLACEBO_COMPARATOR

Dietary consult

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

Dietary consult

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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).

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Purdue University

OTHER

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Nana Gletsu Miller

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tamara Hannon, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

Indiana University School of Medicine

Indianapolis, Indiana, United States

Countries

United States

References

Wagner KA, Armah SM, Smith LG, Pike J, Tu W, Campbell WW, Boushey CJ, Hannon TS, Gletsu-Miller N. Associations between Diet Behaviors and Measures of Glycemia, in Clinical Setting, in Obese Adolescents. Child Obes. 2016 Oct;12(5):341-7. doi: 10.1089/chi.2015.0232. Epub 2016 May 2.

Reference Type: DERIVED

PMID: 27135792 (View on PubMed)

Other Identifiers

1403986016

Identifier Type: -

Identifier Source: org_study_id