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

January 31, 2019 updated by: Arizona State University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tempe, Arizona, United States, 85287
        • Arizona State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 85 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lifestyle and Exercise 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.
Other Names:
  • ELSC
  • Every Little Step Counts

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insulin Sensitivity
Time Frame: About 12 Weeks
Insulin sensitivity will be determined using a insulin and glucose values collected during a 2-hour oral glucose tolerance test.
About 12 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
QOL
Time Frame: About 12 Weeks
Weight-specific quality of Life will be determined by self report using a multicultural quality of life instrument for adolescents
About 12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arizona State University

Collaborators

National Institutes of Health (NIH)
St. Vincent de Paul Medical and Dental Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2010

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

September 14, 2010

First Submitted That Met QC Criteria

November 5, 2010

First Posted (Estimate)

November 9, 2010

Study Record Updates

Last Update Posted (Actual)

February 4, 2019

Last Update Submitted That Met QC Criteria

January 31, 2019

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P20MD002316ELSC
  • P20MD002316 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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