- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02039141
Diabetes Prevention Program for Obese Latino Youth (ELSC)
Community-Based Diabetes Prevention Program for Obese Latino Youth: Every Little Step Counts
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
Arizona
-
Phoenix, Arizona, Spojené státy, 85003
- Arizona State University
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Experimentální: Every Little Step Counts Intervention
Exercise classes (3/week) Lifestyle sessions (1/week)
|
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.
Ostatní jména:
|
Žádný zásah: Delayed ELSC Intervention Group
Control group (delayed intervention group)
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Change in Insulin Sensitivity / Glucose Tolerance, Measured at Baseline, Change 3-months, 6-months, and 12-months
Časové okno: Baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
|
Proximal indicator of diabetes risk
|
Baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
|
Change in Quality of Life Measured at Baseline, 3-months, 6-months, and 12-months
Časové okno: Baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
|
Generic and weight-specific quality of life
|
Baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Change in Self efficacy for healthy eating and exercise
Časové okno: 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.
|
Baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
|
Change in Social support from family and friends on healthy eating and exercise.
Časové okno: 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.
|
Baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Initial incremental cost effectiveness of intervention vs. standard care
Časové okno: 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.
|
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.
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Gabriel Q Shaibi, PhD, Arizona State University
Publikace a užitečné odkazy
Obecné publikace
- 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.
- 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.
- 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.
- 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.
Užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 1203007572
- 5P20MD002316-07 (Grant/smlouva NIH USA)
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