NEW Keiki Family Based Intervention to Combat Childhood Obesity



Status:Completed
Conditions:Obesity Weight Loss
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:6 - Any
Updated:3/7/2019
Start Date:March 2014
End Date:December 2018

Use our guide to learn which trials are right for you!

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.

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.

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
We found this trial at
1
site
1319 Punahou St
Honolulu, Hawaii 96826
(808) 983-6000
Kapiolani Medical Center for Women and Children Hawai‘i Pacific Health is an integrated health care...
?
mi
from
Honolulu, HI
Click here to add this to my saved trials