Diabetes, Insulin Resistance, Obesity
Conditions
Keywords
diabetes prevention program, community based interventions, childhood obesity, insulin resistance, glucose tolerance, quality of life, Latino youth, physical activity, nutrition
Brief summary
The purpose of this study is to examine the effects of 12 week lifestyle intervention on diabetes risk in obese Latino adolescents.
Detailed description
Obesity in the United States has reached epidemic proportions and Latinos youth are disproportionally impacted. Pediatric obesity is associated with several chronic health conditions including insulin resistance and type 2 diabetes. However, very few interventions specifically targeting diabetes prevention for obese Latino adolescents have been developed. Therefore, the purpose of this study is to examine the effects a culturally-grounded, community-based lifestyle intervention on psychosocial and health outcomes among obese Latino adolescents. Eligible participants of this study will be randomly selected to the intervention group or the delayed-intervention group (control group) after an initial health screening for eligibility. Participants selected to the intervention group will attend weekly healthy lifestyle education sessions with their parent(s)/guardian(s) and three physical activity sessions / week with other youth. After which, participants will attend monthly booster group meetings for three months. All participants will be assessed at baseline, 3 months, 6 months, and 12 months for insulin sensitivity, glucose tolerance, quality of life, fitness, and nutrition and physical activity behaviors.
Interventions
OTHEREvery Little Step Counts Intervention
Youth participants randomized to participate in the experimental group will attend weekly healthy lifestyles education session with their parent(s)/guardian(s) and will also attend exercise sessions 3 times a week for 12 weeks. The education sessions will cover topics such as healthy eating choices, roles and responsibilities of both parents and youth in the realm of the family unit as well as in youth's own health, and self esteem among other topics. The exercise sessions will incorporate both aerobic and resistance training as well as other free-play physical activities i.e. basketball, volleyball etc.
Sponsors
National Institutes of Health (NIH)
National Institute on Minority Health and Health Disparities (NIMHD)
Arizona State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 16 Years
Healthy volunteers
Yes
Inclusion criteria
* Latino: self-report by parents * Age: 14-16 * Obese: BMI percentile \>= 95th percentile for age and gender or BMI \>= 30 kg/m\^2
Exclusion criteria
* Taking medication(s) or diagnosed with a condition that could influence carbohydrate metabolism, physical activity, and/or cognition * Type 2 diabetes: Fasting plasma glucose \>= 126 mg/dL or 2-hour plasma glucose \>= 200 mg/dL (youth found to be diabetic through study's procedures will be referred for follow up care and excluded) * Recent hospitalizations (previous 2 months) * Currently enrolled in (or with in previous 6 months) a formal weight loss program * Diagnosed depression or other condition that may impact QoL
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Insulin Sensitivity / Glucose Tolerance, Measured at Baseline, Change 3-months, 6-months, and 12-months | Baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline | Proximal indicator of diabetes risk |
| Change in Quality of Life Measured at Baseline, 3-months, 6-months, and 12-months | Baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline | Generic and weight-specific quality of life |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Self efficacy for healthy eating and exercise | Baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline | These secondary outcomes measures aim to explore the mechanisms of the intervention by assessing the mediated effect on the outcomes of insulin sensitivity and weight-specific QoL through the following putative mediators targeted in the program: self-efficacy for healthy eating and exercise. |
| Change in Social support from family and friends on healthy eating and exercise. | Baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline | These secondary outcomes measures aim to explore the mechanisms of the intervention by assessing the mediated effect on the outcomes of insulin sensitivity and weight-specific QoL through the following putative mediators targeted in the program: Social support from family and friends on healthy eating and exercise. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Initial incremental cost effectiveness of intervention vs. standard care | Analysis for the outcome is expected to occur approximately 4 years after the initial baseline testing. Data for analysis will be consist of one year ELSC cost. | Analysis will be conducted on the initial incremental cost effectiveness of the intervention compared to no intervention on changes in insulin sensitivity and prevention of diabetes. |
Countries
United States
Outcome results
None listed