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Pilot Sugar Reduction Intervention in Kiritimati Teenagers

Primary Purpose

Type 2 Diabetes, Obesity

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Sugar-reduction intervention

About this trial

This is an interventional prevention trial for Type 2 Diabetes

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Enrolled in one of the two high schools on Kiritimati

Exclusion Criteria:

> 18 years of age

Sites / Locations

University of Southern California
Kiritimati

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control School

Intervention School

Arm Description

This school did not receive intervention (until after the study was completed)

This school received a one-week sugar-reduction intervention

Outcomes

Primary Outcome Measures

Change in mean blood glucose (mg/dL)

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.

Change in mean amplitude of glycemic variability (MAGE) (mg/dL)

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.

Change in standard deviation (mg/dL) of continuous glucose monitor data

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.

Change in coefficient of variation (percent) of continuous glucose monitor data

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.

Change in J-index of continuous glucose monitor data

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.

Change in area under the curve of continuous glucose monitor data

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.

Change in total sugar consumption (g/day) using 24-hour dietary recalls

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).

Change in added sugar consumption (g/day) using 24-hour dietary recalls

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).

Change in total water consumption (g/day) using 24-hour dietary recalls

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).

Change in unsweetened water consumption (servings/day) using 24-hour dietary recalls

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).

Change in energy (kcal/day) consumption using 24-hour dietary recalls

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).

Change in total carbohydrate (g/day) consumption using 24-hour dietary recalls

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).

Change in percent calories from carbohydrate consumption using 24-hour dietary recalls

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).

Change in percent calories from total sugars consumption using 24-hour dietary recalls

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).

Change in percent calories from added sugars consumption using 24-hour dietary recalls

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).

Change in sugary beverage (tioka) consumption using beverage frequency questionnaires

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.

Change in sugary beverage (tang) consumption using beverage frequency questionnaires

Change in sugary beverage (toddy) consumption using beverage frequency questionnaires

Change in sugary beverage (ice block) consumption using beverage frequency questionnaires

Change in sugary beverage (soda) consumption using beverage frequency questionnaires

Change in sugary beverage (juice) consumption using beverage frequency questionnaires

Change in sugary beverage (fruit drinks) consumption using beverage frequency questionnaires

Change in sugary beverage (coffee/tea) consumption using beverage frequency questionnaires

Secondary Outcome Measures

Full Information

NCT ID

NCT04319003

First Posted

February 26, 2020

Last Updated

March 24, 2020

Sponsor

University of Southern California

1. Study Identification

Unique Protocol Identification Number

NCT04319003

Brief Title

Pilot Sugar Reduction Intervention in Kiritimati Teenagers

Official Title

Surveillance of Obesity and Pre-Diabetes/Diabetes in Kiritimati School Children and Lifestyle Modifications to Reduce Risk

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Completed

Study Start Date

August 3, 2018 (Actual)

Primary Completion Date

September 19, 2018 (Actual)

Study Completion Date

September 19, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Southern California

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes, Obesity

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

63 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control School

Arm Type

No Intervention

Arm Description

This school did not receive intervention (until after the study was completed)

Arm Title

Intervention School

Arm Type

Experimental

Arm Description

This school received a one-week sugar-reduction intervention

Intervention Type

Behavioral

Intervention Name(s)

Sugar-reduction intervention

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in mean blood glucose (mg/dL)

Description

Time Frame