Community-Based Participatory Research to Improve Health and Quality of Life of Latino Youth: Every Little Step Counts

Diabetes Mellitus, Type 2 Clinical Trial

— ELSC  

Official title:

Community-Based Participatory Research to Improve Health and Quality of Life of Latino Youth: Every Little Step Counts

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01236794
• Other study ID #: P20MD002316ELSC
• Secondary ID: P20MD002316
• Status: Completed
• Phase: N/A
• Start date: May 2010
• Est. completion date: October 2011

Study information

• Verified date: June 2018
• Source: Arizona State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Lifestyle Education Sessions and Youth Exercise Sessions
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.

Locations

Country	Name	City	State
United States	Arizona State University	Tempe	Arizona

Sponsors (3)

Lead Sponsor	Collaborator
Arizona State University	National Institutes of Health (NIH), St. Vincent de Paul Medical and Dental Clinic

Country where clinical trial is conducted

United States, 

References & Publications (3)

Ryder JR, Vega-López 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. — View 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: 10.1177/2150131910 — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin Sensitivity	Insulin sensitivity will be determined using a insulin and glucose values collected during a 2-hour oral glucose tolerance test.	About 12 Weeks
Secondary	QOL	Weight-specific quality of Life will be determined by self report using a multicultural quality of life instrument for adolescents	About 12 Weeks