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Completed

NCT Number: NCT04319003

Pilot Sugar Reduction Intervention in Kiritimati Teenagers

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.

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Key information

Conditions

Type 2 Diabetes Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kiritimati, London, Kiribati

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Enrolled in one of the two high schools on Kiritimati

Exclusion criteria

  • > 18 years of age

Treatment and study plan

Sugar-reduction intervention

Behavioral

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 outcomes

  1. 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. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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).

  8. 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).

  9. 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).

  10. 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).

  11. 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).

  12. 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).

  13. 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).

  14. 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).

  15. 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).

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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.

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 24, 2020
Registry last updated
Mar 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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