- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04319003
Pilot Sugar Reduction Intervention in Kiritimati Teenagers
March 24, 2020 updated by: Elizabeth Beale, University of Southern California
Surveillance of Obesity and Pre-Diabetes/Diabetes in Kiritimati School Children and Lifestyle Modifications to Reduce Risk
Kiritimati is an isolated coral atoll in the Pacific Ocean, and is one of 32 islands that comprise the Republic of Kiribati.
Obesity and type 2 diabetes rates are high in Kiribati, but the causes and rates of childhood obesity/diabetes are unknown.
However, it has been hypothesized that high consumption of sugar-sweetened beverages on Kiritimati may be a contributing factor.
The investigators therefore conducted a study in Kiritimati in September 2018 with the aim of 1) quantifying obesity and diabetes rates amongst children on Kiritimati and 2) testing the feasibility of a sugar-reduction intervention in Kiritimati schools.
The investigators randomized the two high schools on the island to either the control group or the intervention group.
The investigators measured height/weight, continuous blood glucose (using flash glucose monitoring), and diet (using 24-hour diet recalls).
One week into the study, the intervention school received an intervention, which consisted of installation of a water filter at the school, the provision of water bottles to each student at the school, and a 30-minute educational presentation on the link between sugar consumption and type 2 diabetes.
The investigators then measured how blood glucose and diet changed the week following the intervention, and compared this to the control school.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
63
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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London Village, Kiribati
- Kiritimati
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California
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Los Angeles, California, United States, 90033
- University of Southern California
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Enrolled in one of the two high schools on Kiritimati
Exclusion Criteria:
- > 18 years of age
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control School
This school did not receive intervention (until after the study was completed)
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|
Experimental: Intervention School
This school received a one-week sugar-reduction intervention
|
The intervention consisted of a) installation of a water filter at the school.
b) each participant received a metal water bottle.
c) a registered dietitian gave a 30-minute presentation on sugar reduction for the purposes of type 2 diabetes prevention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in mean blood glucose (mg/dL)
Time Frame: 2 weeks (1 week pre- and 1 week post-intervention)
|
A continuous glucose monitor was attached to all participants, which collected data for 2 weeks.
Mean blood glucose was calculated for each participant using GlyCulator, an online tool for analyzing CGM data.
|
2 weeks (1 week pre- and 1 week post-intervention)
|
Change in mean amplitude of glycemic variability (MAGE) (mg/dL)
Time Frame: 2 weeks (1 week pre- and 1 week post-intervention)
|
A continuous glucose monitor was attached to all participants, which collected data for 2 weeks.
Glycemic variability (mean amplitude of glycemic excursions) was calculated for each participant using GlyCulator, an online tool for analyzing CGM data.
|
2 weeks (1 week pre- and 1 week post-intervention)
|
Change in standard deviation (mg/dL) of continuous glucose monitor data
Time Frame: 2 weeks (1 week pre- and 1 week post-intervention)
|
A continuous glucose monitor was attached to all participants, which collected data for 2 weeks.
Glycemic variability (standard deviation) was calculated for each participant using GlyCulator, an online tool for analyzing CGM data.
|
2 weeks (1 week pre- and 1 week post-intervention)
|
Change in coefficient of variation (percent) of continuous glucose monitor data
Time Frame: 2 weeks (1 week pre- and 1 week post-intervention)
|
A continuous glucose monitor was attached to all participants, which collected data for 2 weeks.
Glycemic variability (coefficient of variation (percent) was calculated for each participant using GlyCulator, an online tool for analyzing CGM data.
|
2 weeks (1 week pre- and 1 week post-intervention)
|
Change in J-index of continuous glucose monitor data
Time Frame: 2 weeks (1 week pre- and 1 week post-intervention)
|
A continuous glucose monitor was attached to all participants, which collected data for 2 weeks.
Glycemic variability (J-index) was calculated for each participant using GlyCulator, an online tool for analyzing CGM data.
|
2 weeks (1 week pre- and 1 week post-intervention)
|
Change in area under the curve of continuous glucose monitor data
Time Frame: 2 weeks (1 week pre- and 1 week post-intervention)
|
A continuous glucose monitor was attached to all participants, which collected data for 2 weeks.
Glycemic variability (area under the curve) was calculated for each participant using GlyCulator, an online tool for analyzing CGM data.
|
2 weeks (1 week pre- and 1 week post-intervention)
|
Change in total sugar consumption (g/day) using 24-hour dietary recalls
Time Frame: 2 weeks (1 week pre- and 1 week post-intervention)
|
The investigators conducted 24-hour diet recalls and entered data into the NDSR database for comparison of change in total sugar intake between the control and intervention schools (time x group interaction).
|
2 weeks (1 week pre- and 1 week post-intervention)
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Change in added sugar consumption (g/day) using 24-hour dietary recalls
Time Frame: 2 weeks (1 week pre- and 1 week post-intervention)
|
The investigators conducted 24-hour diet recalls and entered data into the NDSR database for comparison of change in added sugar intake between the control and intervention schools (time x group interaction).
|
2 weeks (1 week pre- and 1 week post-intervention)
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Change in total water consumption (g/day) using 24-hour dietary recalls
Time Frame: 2 weeks (1 week pre- and 1 week post-intervention)
|
The investigators conducted 24-hour diet recalls and entered data into the NDSR database for comparison of change in total water intake between the control and intervention schools (time x group interaction).
|
2 weeks (1 week pre- and 1 week post-intervention)
|
Change in unsweetened water consumption (servings/day) using 24-hour dietary recalls
Time Frame: 2 weeks (1 week pre- and 1 week post-intervention)
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The investigators conducted 24-hour diet recalls and entered data into the NDSR database for comparison of change in unsweetened water intake between the control and intervention schools (time x group interaction).
|
2 weeks (1 week pre- and 1 week post-intervention)
|
Change in energy (kcal/day) consumption using 24-hour dietary recalls
Time Frame: 2 weeks (1 week pre- and 1 week post-intervention)
|
The investigators conducted 24-hour diet recalls and entered data into the NDSR database for comparison of change in energy (kcal) intake between the control and intervention schools (time x group interaction).
|
2 weeks (1 week pre- and 1 week post-intervention)
|
Change in total carbohydrate (g/day) consumption using 24-hour dietary recalls
Time Frame: 2 weeks (1 week pre- and 1 week post-intervention)
|
The investigators conducted 24-hour diet recalls and entered data into the NDSR database for comparison of change in total carbohydrate intake between the control and intervention schools (time x group interaction).
|
2 weeks (1 week pre- and 1 week post-intervention)
|
Change in percent calories from carbohydrate consumption using 24-hour dietary recalls
Time Frame: 2 weeks (1 week pre- and 1 week post-intervention)
|
The investigators conducted 24-hour diet recalls and entered data into the NDSR database for comparison of change in % calories from carbohydrate intake between the control and intervention schools (time x group interaction).
|
2 weeks (1 week pre- and 1 week post-intervention)
|
Change in percent calories from total sugars consumption using 24-hour dietary recalls
Time Frame: 2 weeks (1 week pre- and 1 week post-intervention)
|
The investigators conducted 24-hour diet recalls and entered data into the NDSR database for comparison of change in % calories from total sugars intake between the control and intervention schools (time x group interaction).
|
2 weeks (1 week pre- and 1 week post-intervention)
|
Change in percent calories from added sugars consumption using 24-hour dietary recalls
Time Frame: 2 weeks (1 week pre- and 1 week post-intervention)
|
The investigators conducted 24-hour diet recalls and entered data into the NDSR database for comparison of change in % calories from added sugars intake between the control and intervention schools (time x group interaction).
|
2 weeks (1 week pre- and 1 week post-intervention)
|
Change in sugary beverage (tioka) consumption using beverage frequency questionnaires
Time Frame: 2 weeks (1 week pre- and 1 week post-intervention)
|
The investigators conducted beverage frequency questionnaires which asked about consumption of popular beverages on Kiritimati (specifically: "how many days per week do you typically drink this drink?"
and "how much each day?") then compared change pre-and post-intervention between the two groups (time x group interaction) in servings/day.
|
2 weeks (1 week pre- and 1 week post-intervention)
|
Change in sugary beverage (tang) consumption using beverage frequency questionnaires
Time Frame: 2 weeks (1 week pre- and 1 week post-intervention)
|
The investigators conducted beverage frequency questionnaires which asked about consumption of popular beverages on Kiritimati (specifically: "how many days per week do you typically drink this drink?"
and "how much each day?") then compared change pre-and post-intervention between the two groups (time x group interaction) in servings/day.
|
2 weeks (1 week pre- and 1 week post-intervention)
|
Change in sugary beverage (toddy) consumption using beverage frequency questionnaires
Time Frame: 2 weeks (1 week pre- and 1 week post-intervention)
|
The investigators conducted beverage frequency questionnaires which asked about consumption of popular beverages on Kiritimati (specifically: "how many days per week do you typically drink this drink?"
and "how much each day?") then compared change pre-and post-intervention between the two groups (time x group interaction) in servings/day.
|
2 weeks (1 week pre- and 1 week post-intervention)
|
Change in sugary beverage (ice block) consumption using beverage frequency questionnaires
Time Frame: 2 weeks (1 week pre- and 1 week post-intervention)
|
The investigators conducted beverage frequency questionnaires which asked about consumption of popular beverages on Kiritimati (specifically: "how many days per week do you typically drink this drink?"
and "how much each day?") then compared change pre-and post-intervention between the two groups (time x group interaction) in servings/day.
|
2 weeks (1 week pre- and 1 week post-intervention)
|
Change in sugary beverage (soda) consumption using beverage frequency questionnaires
Time Frame: 2 weeks (1 week pre- and 1 week post-intervention)
|
The investigators conducted beverage frequency questionnaires which asked about consumption of popular beverages on Kiritimati (specifically: "how many days per week do you typically drink this drink?"
and "how much each day?") then compared change pre-and post-intervention between the two groups (time x group interaction) in servings/day.
|
2 weeks (1 week pre- and 1 week post-intervention)
|
Change in sugary beverage (juice) consumption using beverage frequency questionnaires
Time Frame: 2 weeks (1 week pre- and 1 week post-intervention)
|
The investigators conducted beverage frequency questionnaires which asked about consumption of popular beverages on Kiritimati (specifically: "how many days per week do you typically drink this drink?"
and "how much each day?") then compared change pre-and post-intervention between the two groups (time x group interaction) in servings/day.
|
2 weeks (1 week pre- and 1 week post-intervention)
|
Change in sugary beverage (fruit drinks) consumption using beverage frequency questionnaires
Time Frame: 2 weeks (1 week pre- and 1 week post-intervention)
|
The investigators conducted beverage frequency questionnaires which asked about consumption of popular beverages on Kiritimati (specifically: "how many days per week do you typically drink this drink?"
and "how much each day?") then compared change pre-and post-intervention between the two groups (time x group interaction) in servings/day.
|
2 weeks (1 week pre- and 1 week post-intervention)
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Change in sugary beverage (coffee/tea) consumption using beverage frequency questionnaires
Time Frame: 2 weeks (1 week pre- and 1 week post-intervention)
|
The investigators conducted beverage frequency questionnaires which asked about consumption of popular beverages on Kiritimati (specifically: "how many days per week do you typically drink this drink?"
and "how much each day?") then compared change pre-and post-intervention between the two groups (time x group interaction) in servings/day.
|
2 weeks (1 week pre- and 1 week post-intervention)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Elizabeth Beale, MD, University of Southern California
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 3, 2018
Primary Completion (Actual)
September 19, 2018
Study Completion (Actual)
September 19, 2018
Study Registration Dates
First Submitted
February 26, 2020
First Submitted That Met QC Criteria
March 20, 2020
First Posted (Actual)
March 24, 2020
Study Record Updates
Last Update Posted (Actual)
March 26, 2020
Last Update Submitted That Met QC Criteria
March 24, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HS-18-00505
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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