Clinical trial NCT02691039: NEW Keiki Family Based Intervention to Combat Childhood Obesity
Official title: N.E.W. Keiki - Nutrition + Exercise + Weight Management Programs: Family-based Intervention to Combat Childhood Obesity in Hawai'i
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Overweight
Lead sponsor: Hawaii Pacific Health
Sponsor class: OTHER
First posted: 2016-02-25
Enrollment: 213
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be participants or family members of participants in the NEW Keiki program.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Composite measure of improvement in participant/family health to include change in Body Mass Index, Weight, Blood Pressure, Lab Values
timeFrame: minimum 1 year
measure: Composite measure of improvement in participant/family health to include change in lifestyle survey
timeFrame: minimum 1 year
measure: Composite measure of improvement in participant/family health to include change in fitness testing data
timeFrame: minimum 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: Kapiolani Medical Center for Women and Children
state: Hawaii
Study officials:
affiliation: Kapiolani Medical Center For Women & Children
name: Malia Shimokawa, MD
role: PRINCIPAL_INVESTIGATOR
References: