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OpenTrials
Completed

NCT Number: NCT02535169

Lifestyle-Related Health Outcomes in Prediabetes and Diabetes

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

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Key information

Age range

10 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Dietary consult

Behavioral

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

Primary outcomes

  1. Changes in the oral disposition index measured by oral glucose tolerance test

    Time frame: 6 months

    oral disposition index = insulinogenic index x 1/fasting insulin

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Purdue University

Registry information

Important dates

Study start
2014
Primary completion
2022
Study completion
2022
First posted
Aug 28, 2015
Registry last updated
Aug 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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