Diabetes Prevention Program for Obese Latino Youth

NCT ID: NCT02039141

Last Updated: 2020-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2016-08-04

Brief Summary

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

Detailed Description

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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.

Conditions

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Obesity Insulin Resistance Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Every Little Step Counts Intervention

Exercise classes (3/week) Lifestyle sessions (1/week)

Group Type EXPERIMENTAL

Every Little Step Counts Intervention

Intervention Type 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.

Delayed ELSC Intervention Group

Control group (delayed intervention group)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Every Little Step Counts Intervention

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.

Intervention Type OTHER

Other Intervention Names

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ELSC Intervention DPP-ELSC ASU ELSC

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

Arizona State University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gabriel Q Shaibi, PhD

Role: PRINCIPAL_INVESTIGATOR

Arizona State University

Locations

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Arizona State University

Phoenix, Arizona, United States

Site Status

Countries

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United States

References

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Williams AN, Konopken YP, Keller CS, Castro FG, Arcoleo KJ, Barraza E, Patrick DL, Olson ML, Shaibi GQ. Culturally-grounded diabetes prevention program for obese Latino youth: Rationale, design, and methods. Contemp Clin Trials. 2017 Mar;54:68-76. doi: 10.1016/j.cct.2017.01.004. Epub 2017 Jan 16.

Reference Type BACKGROUND
PMID: 28104469 (View on PubMed)

Soltero EG, Olson ML, Williams AN, Konopken YP, Castro FG, Arcoleo KJ, Keller CS, Patrick DL, Ayers SL, Barraza E, Shaibi GQ. Effects of a Community-Based Diabetes Prevention Program for Latino Youth with Obesity: A Randomized Controlled Trial. Obesity (Silver Spring). 2018 Dec;26(12):1856-1865. doi: 10.1002/oby.22300. Epub 2018 Nov 14.

Reference Type RESULT
PMID: 30426694 (View on PubMed)

Olson ML, Renteria-Mexia A, Connelly MA, Vega-Lopez S, Soltero EG, Konopken YP, Williams AN, Castro FG, Keller CS, Yang HP, Todd MW, Shaibi GQ. Decreased GlycA after lifestyle intervention among obese, prediabetic adolescent Latinos. J Clin Lipidol. 2019 Jan-Feb;13(1):186-193. doi: 10.1016/j.jacl.2018.09.011. Epub 2018 Sep 22.

Reference Type RESULT
PMID: 30342918 (View on PubMed)

Renteria-Mexia A, Vega-Lopez S, Olson ML, Swan PD, Lee CD, Williams AN, Shaibi GQ. Effects of a lifestyle intervention on markers of cardiometabolic risk and oxidized lipoproteins among obese adolescents with prediabetes. Public Health Nutr. 2019 Mar;22(4):706-713. doi: 10.1017/S1368980018003476. Epub 2018 Dec 27.

Reference Type RESULT
PMID: 30588900 (View on PubMed)

Related Links

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Other Identifiers

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5P20MD002316-07

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1203007572

Identifier Type: -

Identifier Source: org_study_id

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