NCT01236794

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started May 2010

Geographic Reach
1 country

1 active site

Status
completed

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

May 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 9, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

February 4, 2019

Status Verified

June 1, 2018

Enrollment Period

1.4 years

First QC Date

September 14, 2010

Last Update Submit

January 31, 2019

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • QOL

    About 12 Weeks

Study Arms (1)

Lifestyle and Exercise Intervention

EXPERIMENTAL
Behavioral: Lifestyle Education Sessions and Youth Exercise Sessions

Interventions

Lifestyle Education Sessions and Youth Exercise SessionsBEHAVIORAL

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.

Also known as: ELSC, Every Little Step Counts
Lifestyle and Exercise Intervention

Eligibility Criteria

Age14 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arizona State University

Tempe, Arizona, 85287, United States

Location

Related Publications (3)

  • 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.

    PMID: 22585870RESULT

  • 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.

    PMID: 21461141RESULT

  • 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.

    PMID: 23576420RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2010

First Posted

November 9, 2010

Study Start

May 1, 2010

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

February 4, 2019

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)