Diabetes Prevention Program for Obese Latino Youth (ELSC)
|ClinicalTrials.gov Identifier: NCT02039141|
Recruitment Status : Unknown
Verified August 2015 by Arizona State University.
Recruitment status was: Active, not recruiting
First Posted : January 17, 2014
Last Update Posted : September 2, 2015
|Condition or disease||Intervention/treatment||Phase|
|Obesity Insulin Resistance Diabetes||Other: Every Little Step Counts Intervention||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Community-Based Diabetes Prevention Program for Obese Latino Youth: Every Little Step Counts|
|Study Start Date :||April 2012|
|Estimated Primary Completion Date :||July 2016|
|Estimated Study Completion Date :||July 2017|
Experimental: Every Little Step Counts Intervention
Exercise classes (3/week) Lifestyle sessions (1/week)
Other: Every 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.
No Intervention: Delayed ELSC Intervention Group
Control group (delayed intervention group)
- Change in Insulin Sensitivity / Glucose Tolerance, Measured at Baseline, Change 3-months, 6-months, and 12-months [ Time Frame: 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 [ Time Frame: Baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline ]Generic and weight-specific quality of life
- Change in Self efficacy for healthy eating and exercise [ Time Frame: 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. [ Time Frame: 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.
- Initial incremental cost effectiveness of intervention vs. standard care [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02039141
|United States, Arizona|
|Arizona State University|
|Phoenix, Arizona, United States, 85003|
|Principal Investigator:||Gabriel Q Shaibi, PhD||Arizona State University|