- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Hawaii
-
Honolulu, Hawaii, United States, 96826
- Kapiolani Medical Center for Women and Children
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Family-Based
- Time Perspectives: Other
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Composite measure of improvement in participant/family health to include change in Body Mass Index, Weight, Blood Pressure, Lab Values
Time Frame: 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
Time Frame: 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
Time Frame: minimum 1 year
|
Change in fitness testing data
|
minimum 1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Malia Shimokawa, MD, Kapiolani Medical Center for Women & Children
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013-075
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obesity
-
Central Hospital, Nancy, FranceNot yet recruiting
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
The Hospital for Sick ChildrenCompleted
-
Ihuoma EneliCompletedObesity, ChildhoodUnited States
-
Fundació Sant Joan de DéuRecruitingObesity, Childhood | Obesity, AdolescentSpain