Diabetes Prevention Program for Obese Latino Youth

Obesity Clinical Trial

— ELSC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02039141
• Other study ID #: 1203007572
• Secondary ID: 5P20MD002316-07
• Status: Completed
• Phase: N/A
• Start date: April 2012
• Est. completion date: August 4, 2016

Study information

• Verified date: February 2020
• Source: Arizona State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: August 4, 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Insulin Resistance
• Obesity

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Arizona State University	Phoenix	Arizona

Sponsors (3)

Lead Sponsor	Collaborator
Arizona State University	National Institute on Minority Health and Health Disparities (NIMHD), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (4)

Olson ML, Rentería-Mexía A, Connelly MA, Vega-López 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 — View Citation

Rentería-Mexía A, Vega-López 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. 2018 Dec 27:1 — View Citation

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 (S — View Citation

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. Erratum in: Contemp Clin Trials. 2018 Aug;71:205. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Initial incremental cost effectiveness of intervention vs. standard care	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.	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.
Primary	Change in Insulin Sensitivity / Glucose Tolerance, Measured at Baseline, Change 3-months, 6-months, and 12-months	Proximal indicator of diabetes risk	Baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
Primary	Change in Quality of Life Measured at Baseline, 3-months, 6-months, and 12-months	Generic and weight-specific quality of life	Baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
Secondary	Change in Self efficacy for healthy eating and exercise	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.	Baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
Secondary	Change in Social support from family and friends on healthy eating and exercise.	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.	Baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline

External Links

•   PI's Research Webpage