Lifestyle-Related Health Outcomes in Prediabetes and Diabetes

NCT02535169 | Completed

• 1 other identifier: 1403986016
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obesity; Prediabetic State; Type 2 Diabetes

Keywords

at risk for type 2 diabetes; currently has type 2 diabetes

Outcome Measures

Primary Outcomes (1)

• Changes in the oral disposition index measured by oral glucose tolerance test

  oral disposition index = insulinogenic index x 1/fasting insulin

  6 months

Study Arms (2)

Health Education and Coaching

EXPERIMENTAL

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

Usual Care

PLACEBO COMPARATOR

1\. Dietary consult only

Behavioral: Dietary consult

Interventions

Health Education and Coaching Strategy 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.

Health Education and Coaching

Dietary consult BEHAVIORAL

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

Usual Care

Eligibility Criteria

• Age: 10 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Indiana University: lead
• Purdue University: collaborator

Study Sites (1)

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

• 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.

  PMID: 27135792 DERIVED

MeSH Terms

Conditions

Obesity; Prediabetic State; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Tamara Hannon, MD, MS

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 24, 2015
• First Posted: August 28, 2015
• Study Start: May 1, 2014
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: August 5, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)