Pilot Sugar Reduction Intervention in Kiritimati Teenagers

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04319003
• Other study ID #: HS-18-00505
• Status: Completed
• Phase: N/A
• Start date: August 3, 2018
• Est. completion date: September 19, 2018

Study information

• Verified date: March 2020
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: September 19, 2018
• Est. primary completion date: September 19, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

Inclusion Criteria:

• Enrolled in one of the two high schools on Kiritimati

Exclusion Criteria:

• > 18 years of age

Related Conditions & MeSH terms

• Obesity
• Type 2 Diabetes

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

Locations

Country	Name	City	State
Kiribati	Kiritimati	London Village
United States	University of Southern California	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Countries where clinical trial is conducted

United States,  Kiribati, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 weeks (1 week pre- and 1 week post-intervention)
Primary	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.	2 weeks (1 week pre- and 1 week post-intervention)
Primary	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.	2 weeks (1 week pre- and 1 week post-intervention)
Primary	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.	2 weeks (1 week pre- and 1 week post-intervention)
Primary	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.	2 weeks (1 week pre- and 1 week post-intervention)
Primary	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.	2 weeks (1 week pre- and 1 week post-intervention)
Primary	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).	2 weeks (1 week pre- and 1 week post-intervention)
Primary	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).	2 weeks (1 week pre- and 1 week post-intervention)
Primary	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).	2 weeks (1 week pre- and 1 week post-intervention)
Primary	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).	2 weeks (1 week pre- and 1 week post-intervention)
Primary	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).	2 weeks (1 week pre- and 1 week post-intervention)
Primary	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).	2 weeks (1 week pre- and 1 week post-intervention)
Primary	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).	2 weeks (1 week pre- and 1 week post-intervention)
Primary	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).	2 weeks (1 week pre- and 1 week post-intervention)
Primary	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).	2 weeks (1 week pre- and 1 week post-intervention)
Primary	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.	2 weeks (1 week pre- and 1 week post-intervention)
Primary	Change in sugary beverage (tang) 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.	2 weeks (1 week pre- and 1 week post-intervention)
Primary	Change in sugary beverage (toddy) 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.	2 weeks (1 week pre- and 1 week post-intervention)
Primary	Change in sugary beverage (ice block) 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.	2 weeks (1 week pre- and 1 week post-intervention)
Primary	Change in sugary beverage (soda) 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.	2 weeks (1 week pre- and 1 week post-intervention)
Primary	Change in sugary beverage (juice) 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.	2 weeks (1 week pre- and 1 week post-intervention)
Primary	Change in sugary beverage (fruit drinks) 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.	2 weeks (1 week pre- and 1 week post-intervention)
Primary	Change in sugary beverage (coffee/tea) 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.	2 weeks (1 week pre- and 1 week post-intervention)