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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
63

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Kiribati
      • London Village, Kiribati
        • Kiritimati
  • United States
    • California
      • Los Angeles, California, United States, 90033
        • University of Southern California

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control School
This school did not receive intervention (until after the study was completed)
Experimental: Intervention School
This school received a one-week sugar-reduction intervention
Behavioral: 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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)
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)
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)
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)
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Southern California

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 3, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 19, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 19, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 26, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 24, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 26, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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