Clinical trial NCT02535169: Lifestyle-Related Health Outcomes in Prediabetes and Diabetes
Official title: Lifestyle-Related Health Outcomes in Prediabetes and Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Prediabetic State
Type 2 Diabetes
Keywords: at risk for type 2 diabetes
currently has type 2 diabetes
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Purdue University
First posted: 2015-08-28
Enrollment: 78
Sex: ALL
Minimum age (years): 10
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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).

Primary outcomes:
measure: Changes in the oral disposition index measured by oral glucose tolerance test
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
Study officials:
affiliation: Indiana University
name: Tamara Hannon, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.