ObesityNCT02691039
NEW Keiki Family Based Intervention to Combat Childhood Obesity
An observational study of Obesity and Overweight, run by Malia Shimokawa, MD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Obesity, Overweight
- How many people
- 213 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects will be participants or family members of participants in the NEW Keiki program.
Who may be able to join
- current or past participant in the NEW Keiki program
- participating family member
- able to understand English
Who cannot join
- do not meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity, Overweight
- Medical subject headings
- Obesity, Overweight
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite measure of improvement in participant/family health to include change in Body Mass Index, Weight, Blood Pressure, Lab Values
Change in body mass index (BMI),change in weight, change in blood pressure (BP), change in lab values
Measured: minimum 1 year
Composite measure of improvement in participant/family health to include change in lifestyle survey
Change in lifestyle survey about diet/nutrition and behaviors
Measured: minimum 1 year
Composite measure of improvement in participant/family health to include change in fitness testing data
Change in fitness testing data
Measured: minimum 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2016 (estimated)
- Study startMar 2014
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Other
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- Malia Shimokawa, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Malia Shimokawa, MD, Hawaii Pacific Health
- Investigators
- Malia Shimokawa, MD, Principal investigator, Kapiolani Medical Center For Women & Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02691039
- Sponsor's protocol ID
- 2013-075
- Status last verified
- Mar 2019
- First submitted
- 25 Mar 2014
- Last updated
- 5 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- N.E.W. Keiki - Nutrition + Exercise + Weight Management Programs: Family-based Intervention to Combat Childhood Obesity in Hawai'i
- ClinicalTrials.gov ID
- NCT02691039
- Acronym / sponsor ID
- 2013-075
- Conditions
- Obesity, Overweight
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- Malia Shimokawa, MDUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 25 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Family based
- Time perspective
- Other
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects will be participants or family members of participants in the NEW Keiki program.
Key inclusion criteria (3 listed)
- current or past participant in the NEW Keiki program
- participating family member
- able to understand English
Key exclusion criteria (1 listed)
- do not meet inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Malia Shimokawa, MD principal investigator
Kapiolani Medical Center For Women & Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Overweight, run by Malia Shimokawa, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2019.