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NEW Keiki Family Based Intervention to Combat Childhood Obesity

1. marts 2019 opdateret af: Malia Shimokawa, MD

N.E.W. Keiki - Nutrition + Exercise + Weight Management Programs: Family-based Intervention to Combat Childhood Obesity in Hawai'i

The purpose of this project is to create a database to collect information about the NEW Keiki Program. The information collected for this project will be used to evaluate the program. The NEW Keiki program promotes healthy lifestyles and behavior changes.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

A database containing pre and post program information will be developed. For the referred patients, this database will contain information related to the following:

  • Past medical history
  • Obesity-related Medical co-morbidities (HTN, hyperlipidemia, e.g.)
  • Lab values (fasting lipids, glucose, LFTs, HbA1c)
  • Anthropometric data (ht, weight, BMI) and select vital signs (BP, HR)
  • Fitness testing data
  • Demographic data (age, gender, ethnicity, socioeconomic status, geographical address)
  • Answers to a lifestyle, attitudes, and health habits survey
  • Answers to a program survey
  • Contact information for follow up

For participating family members (parents, grandparents, siblings, e.g.) this data base will contain information related to the following:

  • Past medical history
  • Obesity-related Medical co-morbidities (HTN, hyperlipidemia, e.g.)
  • Anthropometric data (ht, weight, BMI) and select vital signs (BP, HR)
  • Demographic data (age, gender, ethnicity, socioeconomic status, geographical address)
  • Answers to a lifestyle, attitudes, and health habits survey
  • Answers to a program survey
  • Contact information for follow up

Once the database is created a retrospective chart review will be done to collect data on patients that have completed the program. This information will be obtained from facility records and program records. Individuals who previously completed the program will be contacted and asked to provide consent to be included in the database. Only data from individuals who provide consent will be included in the database.

Participants in the program will be asked to provide consent when they enroll in the program or when they come for a follow up visit. Only data from individuals who provide consent will be included in the database.

Subjects will be followed to collect information on lifestyle maintenance and long term health outcomes.

The database will be queried regularly to provide information about the participants and program.

Descriptive statistics will be calculated to describe the study population pre and post program. Outcomes will be analyzed using appropriate statistical tests. Exploratory analysis will be conducted to detect trends.

Data will be stored in a secure location with limited access. All paper documents will be stored in a locked office in a locked cabinet. Electronic data will be stored on a limited access computer. The database will be password protected and encrypted.

All participants will be assigned a study ID number. The study ID will be used for transmission of data. Data collection forms will use the assigned study ID. All data that needs to be transmitted will be de-identified to the extent possible, password protected, and encrypted.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

213

Kontakter og lokationer

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

Studiesteder

    • Hawaii
      • Honolulu, Hawaii, Forenede Stater, 96826
        • Kapiolani Medical Center for Women and Children

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

6 år og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Subjects will be participants or family members of participants in the NEW Keiki program.

Beskrivelse

Inclusion Criteria:

  • current or past participant in the NEW Keiki program
  • participating family member
  • able to understand English

Exclusion Criteria:

  • do not meet inclusion criteria

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Familiebaseret
  • Tidsperspektiver: Andet

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Composite measure of improvement in participant/family health to include change in Body Mass Index, Weight, Blood Pressure, Lab Values
Tidsramme: minimum 1 year
Change in body mass index (BMI),change in weight, change in blood pressure (BP), change in lab values
minimum 1 year
Composite measure of improvement in participant/family health to include change in lifestyle survey
Tidsramme: minimum 1 year
Change in lifestyle survey about diet/nutrition and behaviors
minimum 1 year
Composite measure of improvement in participant/family health to include change in fitness testing data
Tidsramme: minimum 1 year
Change in fitness testing data
minimum 1 year

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Ledende efterforsker: Malia Shimokawa, MD, Kapiolani Medical Center For Women & Children

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

1. marts 2014

Primær færdiggørelse (Faktiske)

1. december 2018

Studieafslutning (Faktiske)

1. december 2018

Datoer for studieregistrering

Først indsendt

25. marts 2014

Først indsendt, der opfyldte QC-kriterier

19. februar 2016

Først opslået (Skøn)

25. februar 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. marts 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. marts 2019

Sidst verificeret

1. marts 2019

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 2013-075

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

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 .

Abonner