Pilot Sugar Reduction Intervention in Kiritimati Teenagers

Sponsor
University of Southern California (Other)
Overall Status
Completed
CT.gov ID
NCT04319003
Collaborator
(none)
63
2
2
1.5
31.5
20.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Sugar-reduction intervention
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
63 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Surveillance of Obesity and Pre-Diabetes/Diabetes in Kiritimati School Children and Lifestyle Modifications to Reduce Risk
Actual Study Start Date :
Aug 3, 2018
Actual Primary Completion Date :
Sep 19, 2018
Actual Study Completion Date :
Sep 19, 2018

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Change in mean blood glucose (mg/dL) [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) [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
10 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Enrolled in one of the two high schools on Kiritimati
Exclusion Criteria:
  • 18 years of age

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Southern California Los Angeles California United States 90033
2 Kiritimati London Village Kiribati

Sponsors and Collaborators

  • University of Southern California

Investigators

  • Principal Investigator: Elizabeth Beale, MD, University of Southern California

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Elizabeth Beale, Assistant Professor, University of Southern California
ClinicalTrials.gov Identifier:
NCT04319003
Other Study ID Numbers:
  • HS-18-00505
First Posted:
Mar 24, 2020
Last Update Posted:
Mar 26, 2020
Last Verified:
Mar 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 26, 2020