search
Back to results

Diabetes Prevention Program for Obese Latino Youth (ELSC)

Primary Purpose

Obesity, Insulin Resistance, Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Every Little Step Counts Intervention
Sponsored by
Arizona State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring diabetes prevention program, community based interventions, childhood obesity, insulin resistance, glucose tolerance, quality of life, Latino youth, physical activity, nutrition

Eligibility Criteria

14 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Arizona State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Every Little Step Counts Intervention

Delayed ELSC Intervention Group

Arm Description

Exercise classes (3/week) Lifestyle sessions (1/week)

Control group (delayed intervention group)

Outcomes

Primary Outcome Measures

Change in Insulin Sensitivity / Glucose Tolerance, Measured at Baseline, Change 3-months, 6-months, and 12-months
Proximal indicator of diabetes risk
Change in Quality of Life Measured at Baseline, 3-months, 6-months, and 12-months
Generic and weight-specific quality of life

Secondary Outcome Measures

Change in Self efficacy for healthy eating and exercise
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.
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.

Full Information

First Posted
July 31, 2013
Last Updated
February 3, 2020
Sponsor
Arizona State University
Collaborators
National Institutes of Health (NIH), National Institute on Minority Health and Health Disparities (NIMHD)
search

1. Study Identification

Unique Protocol Identification Number
NCT02039141
Brief Title
Diabetes Prevention Program for Obese Latino Youth
Acronym
ELSC
Official Title
Community-Based Diabetes Prevention Program for Obese Latino Youth: Every Little Step Counts
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
April 2012 (Actual)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
August 4, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arizona State University
Collaborators
National Institutes of Health (NIH), National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Insulin Resistance, Diabetes
Keywords
diabetes prevention program, community based interventions, childhood obesity, insulin resistance, glucose tolerance, quality of life, Latino youth, physical activity, nutrition

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Every Little Step Counts Intervention
Arm Type
Experimental
Arm Description
Exercise classes (3/week) Lifestyle sessions (1/week)
Arm Title
Delayed ELSC Intervention Group
Arm Type
No Intervention
Arm Description
Control group (delayed intervention group)
Intervention Type
Other
Intervention Name(s)
Every Little Step Counts Intervention
Other Intervention Name(s)
ELSC Intervention, DPP-ELSC, ASU ELSC
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Insulin Sensitivity / Glucose Tolerance, Measured at Baseline, Change 3-months, 6-months, and 12-months
Description
Proximal indicator of diabetes risk
Time Frame
Baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
Title
Change in Quality of Life Measured at Baseline, 3-months, 6-months, and 12-months
Description
Generic and weight-specific quality of life
Time Frame
Baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
Secondary Outcome Measure Information:
Title
Change in Self efficacy for healthy eating and exercise
Description
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.
Time Frame
Baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
Title
Change in Social support from family and friends on healthy eating and exercise.
Description
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.
Time Frame
Baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
Other Pre-specified Outcome Measures:
Title
Initial incremental cost effectiveness of intervention vs. standard care
Description
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.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabriel Q Shaibi, PhD
Organizational Affiliation
Arizona State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona State University
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85003
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28104469
Citation
Williams AN, Konopken YP, Keller CS, Castro FG, Arcoleo KJ, Barraza E, Patrick DL, Olson ML, Shaibi GQ. Culturally-grounded diabetes prevention program for obese Latino youth: Rationale, design, and methods. Contemp Clin Trials. 2017 Mar;54:68-76. doi: 10.1016/j.cct.2017.01.004. Epub 2017 Jan 16. Erratum In: Contemp Clin Trials. 2018 Aug;71:205.
Results Reference
background
PubMed Identifier
30426694
Citation
Soltero EG, Olson ML, Williams AN, Konopken YP, Castro FG, Arcoleo KJ, Keller CS, Patrick DL, Ayers SL, Barraza E, Shaibi GQ. Effects of a Community-Based Diabetes Prevention Program for Latino Youth with Obesity: A Randomized Controlled Trial. Obesity (Silver Spring). 2018 Dec;26(12):1856-1865. doi: 10.1002/oby.22300. Epub 2018 Nov 14.
Results Reference
result
PubMed Identifier
30342918
Citation
Olson ML, Renteria-Mexia A, Connelly MA, Vega-Lopez S, Soltero EG, Konopken YP, Williams AN, Castro FG, Keller CS, Yang HP, Todd MW, Shaibi GQ. Decreased GlycA after lifestyle intervention among obese, prediabetic adolescent Latinos. J Clin Lipidol. 2019 Jan-Feb;13(1):186-193. doi: 10.1016/j.jacl.2018.09.011. Epub 2018 Sep 22.
Results Reference
result
PubMed Identifier
30588900
Citation
Renteria-Mexia A, Vega-Lopez S, Olson ML, Swan PD, Lee CD, Williams AN, Shaibi GQ. Effects of a lifestyle intervention on markers of cardiometabolic risk and oxidized lipoproteins among obese adolescents with prediabetes. Public Health Nutr. 2019 Mar;22(4):706-713. doi: 10.1017/S1368980018003476. Epub 2018 Dec 27.
Results Reference
result
Links:
URL
http://www.public.asu.edu/~gshaibi/
Description
PI's Research Webpage

Learn more about this trial

Diabetes Prevention Program for Obese Latino Youth

We'll reach out to this number within 24 hrs