Community-Based Participatory Research to Improve Health and Quality of Life of Latino Youth: Every Little Step Counts (ELSC)
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lifestyle Education Sessions and Youth Exercise Sessions
Sponsored by

About this trial
This is an interventional prevention trial for Diabetes Mellitus, Type 2
Eligibility Criteria
Inclusion Criteria:
- Hispanic Ethnicity (Child and Parent)
- Age 14-16 (Child) and Parent age < 85
- BMI Percentile above the 85th (child)
- Ability to read and speak English (child)
Exclusion Criteria:
- Taking medication(s) or diagnosed with a condition that could influence exercise ability or carbohydrate metabolism (e.g., polycystic ovarian syndrome, exercise induced asthma, orthopedic limitations) (Child and (Parent OGTT only))
- Involved in any formal weight-loss program in the past 6 months (Child)
- Diagnosed diabetes (type 1 or type 2 Child)
- Weight is less than 110 Ibs (Child and Parent)
Sites / Locations
- Arizona State University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lifestyle and Exercise Intervention
Arm Description
Outcomes
Primary Outcome Measures
Insulin Sensitivity
Insulin sensitivity will be determined using a insulin and glucose values collected during a 2-hour oral glucose tolerance test.
Secondary Outcome Measures
QOL
Weight-specific quality of Life will be determined by self report using a multicultural quality of life instrument for adolescents
Full Information
NCT ID
NCT01236794
First Posted
September 14, 2010
Last Updated
January 31, 2019
Sponsor
Arizona State University
Collaborators
National Institutes of Health (NIH), St. Vincent de Paul Medical and Dental Clinic
1. Study Identification
Unique Protocol Identification Number
NCT01236794
Brief Title
Community-Based Participatory Research to Improve Health and Quality of Life of Latino Youth: Every Little Step Counts
Acronym
ELSC
Official Title
Community-Based Participatory Research to Improve Health and Quality of Life of Latino Youth: Every Little Step Counts
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
May 2010 (Actual)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arizona State University
Collaborators
National Institutes of Health (NIH), St. Vincent de Paul Medical and Dental Clinic
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to examine the effects of a lifestyle intervention program on type 2 diabetes risk factors and quality of life in overweight Latino youth.
Detailed Description
With the increasing prevalence of obesity, the incidence of obesity-related co-morbidities including depression and type 2 diabetes have emerged as critical public health conditions. Furthermore, Latinos experience a disproportionately greater burden of these obesity-related disorders. Therefore, we have developed a 12-week community-based lifestyle intervention that includes weekly education sessions for children and their parents and 3 exercise sessions per week for youth. The program will be delivered at a local YMCA in the greater Phoenix Metropolitan area.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lifestyle and Exercise Intervention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle Education Sessions and Youth Exercise Sessions
Other Intervention Name(s)
ELSC, Every Little Step Counts
Intervention Description
The intervention will include a ~1-2 hour weekly education session to address the following constructs: health awareness, healthy eating, physical activity, roles and responsibilities, self-esteem, self-efficacy, diabetes knowledge, communication, and peer / family relationships. In addition to the education classes youth will participate in 3 exercise sessions per week (~1-1.5 hrs) that will consist of individual and group physical activities to include both aerobic and resistance exercises. The exercise intensity will progressively increase over the 12-week intervention. Both the education and activity sessions will be delivered at the Lincoln Family YMCA.
Primary Outcome Measure Information:
Title
Insulin Sensitivity
Description
Insulin sensitivity will be determined using a insulin and glucose values collected during a 2-hour oral glucose tolerance test.
Time Frame
About 12 Weeks
Secondary Outcome Measure Information:
Title
QOL
Description
Weight-specific quality of Life will be determined by self report using a multicultural quality of life instrument for adolescents
Time Frame
About 12 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Hispanic Ethnicity (Child and Parent)
Age 14-16 (Child) and Parent age < 85
BMI Percentile above the 85th (child)
Ability to read and speak English (child)
Exclusion Criteria:
Taking medication(s) or diagnosed with a condition that could influence exercise ability or carbohydrate metabolism (e.g., polycystic ovarian syndrome, exercise induced asthma, orthopedic limitations) (Child and (Parent OGTT only))
Involved in any formal weight-loss program in the past 6 months (Child)
Diagnosed diabetes (type 1 or type 2 Child)
Weight is less than 110 Ibs (Child and Parent)
Facility Information:
Facility Name
Arizona State University
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85287
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22585870
Citation
Shaibi GQ, Konopken Y, Hoppin E, Keller CS, Ortega R, Castro FG. Effects of a culturally grounded community-based diabetes prevention program for obese Latino adolescents. Diabetes Educ. 2012 Jul-Aug;38(4):504-12. doi: 10.1177/0145721712446635. Epub 2012 May 14.
Results Reference
result
PubMed Identifier
21461141
Citation
Shaibi GQ, Greenwood-Ericksen MB, Chapman CR, Konopken Y, Ertl J. Development, implementation, and effects of community-based diabetes prevention program for obese latino youth. J Prim Care Community Health. 2010 Oct 1;1(3):206-12. doi: 10.1177/2150131910377909.
Results Reference
result
PubMed Identifier
23576420
Citation
Ryder JR, Vega-Lopez S, Ortega R, Konopken Y, Shaibi GQ. Lifestyle intervention improves lipoprotein particle size and distribution without weight loss in obese Latino adolescents. Pediatr Obes. 2013 Oct;8(5):e59-63. doi: 10.1111/j.2047-6310.2013.00162.x. Epub 2013 Apr 10.
Results Reference
result
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Community-Based Participatory Research to Improve Health and Quality of Life of Latino Youth: Every Little Step Counts
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