Lifestyle-Related Health Outcomes in Prediabetes and Diabetes

Indiana University

Status: Completed

Conditions: Prediabetic State; Obesity; Type 2 Diabetes

Treatments: Behavioral: Health Education and Coaching Strategy; Behavioral: Dietary consult

Study type: Interventional

Funder types: Other

Identifiers

NCT02535169

1403986016

Details and patient eligibility

About

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

Full 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.

Enrollment: 78 patients

Sex: All

Ages: 10 to 21 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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78 participants in 2 patient groups, including a placebo group

Health Education and Coaching

Experimental group

Description:

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.

Treatment:

Behavioral: Health Education and Coaching Strategy

Usual Care

Placebo Comparator group

Description:

1. Dietary consult only

Treatment:

Behavioral: Dietary consult