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Completed

NCT Number: NCT01236794

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

14 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arizona State University

Tempe, Arizona, 85287, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Lifestyle Education Sessions and Youth Exercise Sessions

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Arizona State University

Other

Collaborators

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

Registry information

Acronym: ELSC

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 9, 2010
Registry last updated
Feb 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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