- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02691039
NEW Keiki Family Based Intervention to Combat Childhood Obesity
N.E.W. Keiki - Nutrition + Exercise + Weight Management Programs: Family-based Intervention to Combat Childhood Obesity in Hawai'i
Studieoversigt
Status
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
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
Hawaii
-
Honolulu, Hawaii, Forenede Stater, 96826
- Kapiolani Medical Center for Women and Children
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
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
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
Sponsor
Efterforskere
- Ledende efterforsker: Malia Shimokawa, MD, Kapiolani Medical Center For Women & Children
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2013-075
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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