Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Diabetes Prevention Program for Obese Latino Youth (ELSC)

3. februar 2020 opdateret af: Arizona State University

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

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

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

160

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85003
        • Arizona State University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

14 år til 16 år (Barn)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Every Little Step Counts Intervention
Exercise classes (3/week) Lifestyle sessions (1/week)
Andet: 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.
Andre navne:
  • ELSC Intervention
  • DPP-ELSC
  • ASU ELSC
Ingen indgriben: Delayed ELSC Intervention Group
Control group (delayed intervention group)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Insulin Sensitivity / Glucose Tolerance, Measured at Baseline, Change 3-months, 6-months, and 12-months
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Self efficacy for healthy eating and exercise
Tidsramme: 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.
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Initial incremental cost effectiveness of intervention vs. standard care
Tidsramme: 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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Arizona State University

Samarbejdspartnere

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

Efterforskere

  • Ledende efterforsker: Gabriel Q Shaibi, PhD, Arizona State University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. april 2012

Primær færdiggørelse (Faktiske)

1. juli 2016

Studieafslutning (Faktiske)

4. august 2016

Datoer for studieregistrering

Først indsendt

31. juli 2013

Først indsendt, der opfyldte QC-kriterier

16. januar 2014

Først opslået (Skøn)

17. januar 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. februar 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. februar 2020

Sidst verificeret

1. februar 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 1203007572
  • 5P20MD002316-07 (U.S. NIH-bevilling/kontrakt)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Every Little Step Counts Intervention

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Qatar

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner