Diabetes Prevention Program for Obese Latino Youth (ELSC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Arizona State University
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Arizona State University
ClinicalTrials.gov Identifier:
NCT02039141
First received: July 31, 2013
Last updated: January 16, 2014
Last verified: January 2014
  Purpose

The purpose of this study is to examine the effects of 12 week lifestyle intervention on diabetes risk in obese Latino adolescents.


Condition Intervention
Obesity
Insulin Resistance
Diabetes
Other: Every Little Step Counts Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Community-Based Diabetes Prevention Program for Obese Latino Youth: Every Little Step Counts

Resource links provided by NLM:


Further study details as provided by Arizona State University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Generic and weight-specific quality of life


Secondary Outcome Measures:
  • Change in Self efficacy for healthy eating and exercise [ Time Frame: Baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 160
Study Start Date: April 2012
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Names:
  • ELSC Intervention
  • DPP-ELSC
  • ASU ELSC
No Intervention: Delayed ELSC Intervention Group
Control group (delayed intervention group)

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.

  Eligibility

Ages Eligible for Study:   14 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02039141

Contacts
Contact: Allison N Williams, MSW 602.496.0147 Allison.Nagle@asu.edu
Contact: Gabriel Q Shaibi, PhD 602.496.0909 Gabriel.Shaibi@asu.edu

Locations
United States, Arizona
Arizona State University Recruiting
Phoenix, Arizona, United States, 85003
Contact: Allison N Williams, MSW    602-496-0147    Allison.Nagle@asu.edu   
Principal Investigator: Gabriel Q Shaibi, PhD         
Sub-Investigator: Daria McClain, PhD         
Sub-Investigator: Sonia Vega-Lopez, PhD         
Sub-Investigator: Colleen Keller, PhD, FNP         
Sponsors and Collaborators
Arizona State University
Investigators
Principal Investigator: Gabriel Q Shaibi, PhD Arizona State University
  More Information

Additional Information:
Publications:
Responsible Party: Arizona State University
ClinicalTrials.gov Identifier: NCT02039141     History of Changes
Other Study ID Numbers: 1203007572, 5P20MD002316-07
Study First Received: July 31, 2013
Last Updated: January 16, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Arizona State University:
diabetes prevention program
community based interventions
childhood obesity
insulin resistance
glucose tolerance
quality of life
Latino youth
physical activity
nutrition

Additional relevant MeSH terms:
Diabetes Mellitus
Insulin Resistance
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 09, 2014