Diabetes Prevention Program for Obese Latino Youth
ELSC
Community-Based Diabetes Prevention Program for Obese Latino Youth: Every Little Step Counts
2 other identifiers
interventional
160
1 country
1
Brief Summary
The purpose of this study is to examine the effects of 12 week lifestyle intervention on diabetes risk in obese Latino adolescents.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable obesity
Started Apr 2012
Longer than P75 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 31, 2013
CompletedFirst Posted
Study publicly available on registry
January 17, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 4, 2016
CompletedFebruary 5, 2020
February 1, 2020
4.3 years
July 31, 2013
February 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Insulin Sensitivity / Glucose Tolerance, Measured at Baseline, Change 3-months, 6-months, and 12-months
Proximal indicator of diabetes risk
Baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
Change in Quality of Life Measured at Baseline, 3-months, 6-months, and 12-months
Generic and weight-specific quality of life
Baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
Secondary Outcomes (2)
Change in Self efficacy for healthy eating and exercise
Baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
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
Other Outcomes (1)
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.
Study Arms (2)
Every Little Step Counts Intervention
EXPERIMENTALExercise classes (3/week) Lifestyle sessions (1/week)
Delayed ELSC Intervention Group
NO INTERVENTIONControl group (delayed intervention group)
Interventions
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.
Eligibility Criteria
You may qualify if:
- Latino: self-report by parents
- Age: 14-16
- Obese: BMI percentile \>= 95th percentile for age and gender or BMI \>= 30 kg/m\^2
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Arizona State University
Phoenix, Arizona, 85003, United States
Related Publications (4)
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.
PMID: 28104469BACKGROUNDSoltero 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.
PMID: 30426694RESULTOlson 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.
PMID: 30342918RESULTRenteria-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.
PMID: 30588900RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gabriel Q Shaibi, PhD
Arizona State University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2013
First Posted
January 17, 2014
Study Start
April 1, 2012
Primary Completion
July 1, 2016
Study Completion
August 4, 2016
Last Updated
February 5, 2020
Record last verified: 2020-02