Clinical trial NCT02039141: Diabetes Prevention Program for Obese Latino Youth
Official title: Community-Based Diabetes Prevention Program for Obese Latino Youth: Every Little Step Counts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Insulin Resistance
Diabetes
Keywords: diabetes prevention program
community based interventions
childhood obesity
insulin resistance
glucose tolerance
quality of life
Latino youth
physical activity
nutrition
Lead sponsor: Arizona State University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2014-01-17
Enrollment: 160
Sex: ALL
Minimum age (years): 14
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Insulin Sensitivity / Glucose Tolerance, Measured at Baseline, Change 3-months, 6-months, and 12-months
timeFrame: Baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
measure: Change in Quality of Life Measured at Baseline, 3-months, 6-months, and 12-months
timeFrame: Baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
Secondary outcomes:
measure: Change in Self efficacy for healthy eating and exercise
timeFrame: Baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
measure: Change in Social support from family and friends on healthy eating and exercise.
timeFrame: Baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
Other outcomes:
measure: Initial incremental cost effectiveness of intervention vs. standard care
timeFrame: 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.
Locations:
city: Phoenix
country: United States
facility: Arizona State University
state: Arizona
Study officials:
affiliation: Arizona State University
name: Gabriel Q Shaibi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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 (Silver Spring). 2018 Dec;26(12):1856-1865. doi: 10.1002/oby.22300. Epub 2018 Nov 14.
citation: 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.
citation: 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.