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Lifestyle-Related Health Outcomes in Prediabetes and Diabetes

Lifestyle-Related Health Outcomes in Prediabetes and Diabetes

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02535169
Enrollment
78
Registered
2015-08-28
Start date
2014-05-31
Completion date
2022-05-31
Last updated
2022-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Prediabetic State, Type 2 Diabetes

Keywords

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

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.

Interventions

BEHAVIORALHealth 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.

BEHAVIORALDietary consult

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

Sponsors

Purdue University
CollaboratorOTHER
Indiana University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
10 Years to 21 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Changes in the oral disposition index measured by oral glucose tolerance test6 monthsoral disposition index = insulinogenic index x 1/fasting insulin

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026