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Completed

NCT Number: NCT02039141

Diabetes Prevention Program for Obese Latino Youth

The purpose of this study is to examine the effects of 12 week lifestyle intervention on diabetes risk in obese Latino adolescents.

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Key information

Conditions

Obesity Behavior Body Weight Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

14 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arizona State University

Phoenix, Arizona, 85003, United States

About this study

Obesity in the United States has reached epidemic proportions and Latinos youth are disproportionally impacted. Pediatric obesity is associated with several chronic health conditions including insulin resistance and type 2 diabetes. However, very few interventions specifically targeting diabetes prevention for obese Latino adolescents have been developed.

Therefore, the purpose of this study is to examine the effects a culturally-grounded, community-based lifestyle intervention on psychosocial and health outcomes among obese Latino adolescents. Eligible participants of this study will be randomly selected to the intervention group or the delayed-intervention group (control group) after an initial health screening for eligibility.

Participants selected to the intervention group will attend weekly healthy lifestyle education sessions with their parent(s)/guardian(s) and three physical activity sessions / week with other youth. After which, participants will attend monthly booster group meetings for three months.

All participants will be assessed at baseline, 3 months, 6 months, and 12 months for insulin sensitivity, glucose tolerance, quality of life, fitness, and nutrition and physical activity behaviors.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Latino: self-report by parents
  • Age: 14-16
  • Obese: BMI percentile >= 95th percentile for age and gender or BMI >= 30 kg/m^2

Exclusion criteria

  • Taking medication(s) or diagnosed with a condition that could influence carbohydrate metabolism, physical activity, and/or cognition
  • Type 2 diabetes: Fasting plasma glucose >= 126 mg/dL or 2-hour plasma glucose >= 200 mg/dL (youth found to be diabetic through study's procedures will be referred for follow up care and excluded)
  • Recent hospitalizations (previous 2 months)
  • Currently enrolled in (or with in previous 6 months) a formal weight loss program
  • Diagnosed depression or other condition that may impact QoL

Treatment and study plan

Every Little Step Counts Intervention

Other

Youth participants randomized to participate in the experimental group will attend weekly healthy lifestyles education session with their parent(s)/guardian(s) and will also attend exercise sessions 3 times a week for 12 weeks. The education sessions will cover topics such as healthy eating choices, roles and responsibilities of both parents and youth in the realm of the family unit as well as in youth's own health, and self esteem among other topics. The exercise sessions will incorporate both aerobic and resistance training as well as other "free-play" physical activities i.e. basketball, volleyball etc.

Other names: ELSC Intervention, DPP-ELSC, ASU ELSC

Primary outcomes

  1. Change in Insulin Sensitivity / Glucose Tolerance, Measured at Baseline, Change 3-months, 6-months, and 12-months

    Time frame: Baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline

    Proximal indicator of diabetes risk

  2. Change in Quality of Life Measured at Baseline, 3-months, 6-months, and 12-months

    Time frame: Baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline

    Generic and weight-specific quality of life

Secondary outcomes

  1. Change in Self efficacy for healthy eating and exercise

    Time frame: Baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline

    These secondary outcomes measures aim to explore the mechanisms of the intervention by assessing the "mediated effect" on the outcomes of insulin sensitivity and weight-specific QoL through the following putative mediators targeted in the program: self-efficacy for healthy eating and exercise.

  2. Change in Social support from family and friends on healthy eating and exercise.

    Time frame: Baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline

    These secondary outcomes measures aim to explore the mechanisms of the intervention by assessing the "mediated effect" on the outcomes of insulin sensitivity and weight-specific QoL through the following putative mediators targeted in the program: Social support from family and friends on healthy eating and exercise.

Other outcomes

  1. Initial incremental cost effectiveness of intervention vs. standard care

    Time frame: Analysis for the outcome is expected to occur approximately 4 years after the initial baseline testing. Data for analysis will be consist of one year ELSC cost.

    Analysis will be conducted on the initial incremental cost effectiveness of the intervention compared to no intervention on changes in insulin sensitivity and prevention of diabetes.

Sponsors and collaborators

Lead sponsor

Arizona State University

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)
  • National Institutes of Health (NIH)

Registry information

Official study title

Community-Based Diabetes Prevention Program for Obese Latino Youth: Every Little Step Counts

Acronym: ELSC

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jan 17, 2014
Registry last updated
Feb 5, 2020

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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