Clinical trial NCT04319003: 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
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Obesity
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2020-03-24
Enrollment: 63
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* Enrolled in one of the two high schools on Kiritimati

Exclusion Criteria:

* \> 18 years of age

Primary outcomes:
measure: Change in mean blood glucose (mg/dL)
timeFrame: 2 weeks (1 week pre- and 1 week post-intervention)
measure: Change in mean amplitude of glycemic variability (MAGE) (mg/dL)
timeFrame: 2 weeks (1 week pre- and 1 week post-intervention)
measure: Change in standard deviation (mg/dL) of continuous glucose monitor data
timeFrame: 2 weeks (1 week pre- and 1 week post-intervention)
measure: Change in coefficient of variation (percent) of continuous glucose monitor data
timeFrame: 2 weeks (1 week pre- and 1 week post-intervention)
measure: Change in J-index of continuous glucose monitor data
timeFrame: 2 weeks (1 week pre- and 1 week post-intervention)
measure: Change in area under the curve of continuous glucose monitor data
timeFrame: 2 weeks (1 week pre- and 1 week post-intervention)
measure: Change in total sugar consumption (g/day) using 24-hour dietary recalls
timeFrame: 2 weeks (1 week pre- and 1 week post-intervention)
measure: Change in added sugar consumption (g/day) using 24-hour dietary recalls
timeFrame: 2 weeks (1 week pre- and 1 week post-intervention)
measure: Change in total water consumption (g/day) using 24-hour dietary recalls
timeFrame: 2 weeks (1 week pre- and 1 week post-intervention)
measure: Change in unsweetened water consumption (servings/day) using 24-hour dietary recalls
timeFrame: 2 weeks (1 week pre- and 1 week post-intervention)
measure: Change in energy (kcal/day) consumption using 24-hour dietary recalls
timeFrame: 2 weeks (1 week pre- and 1 week post-intervention)
measure: Change in total carbohydrate (g/day) consumption using 24-hour dietary recalls
timeFrame: 2 weeks (1 week pre- and 1 week post-intervention)
measure: Change in percent calories from carbohydrate consumption using 24-hour dietary recalls
timeFrame: 2 weeks (1 week pre- and 1 week post-intervention)
measure: Change in percent calories from total sugars consumption using 24-hour dietary recalls
timeFrame: 2 weeks (1 week pre- and 1 week post-intervention)
measure: Change in percent calories from added sugars consumption using 24-hour dietary recalls
timeFrame: 2 weeks (1 week pre- and 1 week post-intervention)
measure: Change in sugary beverage (tioka) consumption using beverage frequency questionnaires
timeFrame: 2 weeks (1 week pre- and 1 week post-intervention)
measure: Change in sugary beverage (tang) consumption using beverage frequency questionnaires
timeFrame: 2 weeks (1 week pre- and 1 week post-intervention)
measure: Change in sugary beverage (toddy) consumption using beverage frequency questionnaires
timeFrame: 2 weeks (1 week pre- and 1 week post-intervention)
measure: Change in sugary beverage (ice block) consumption using beverage frequency questionnaires
timeFrame: 2 weeks (1 week pre- and 1 week post-intervention)
measure: Change in sugary beverage (soda) consumption using beverage frequency questionnaires
timeFrame: 2 weeks (1 week pre- and 1 week post-intervention)
measure: Change in sugary beverage (juice) consumption using beverage frequency questionnaires
timeFrame: 2 weeks (1 week pre- and 1 week post-intervention)
measure: Change in sugary beverage (fruit drinks) consumption using beverage frequency questionnaires
timeFrame: 2 weeks (1 week pre- and 1 week post-intervention)
measure: Change in sugary beverage (coffee/tea) consumption using beverage frequency questionnaires
timeFrame: 2 weeks (1 week pre- and 1 week post-intervention)
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: London Village
country: Kiribati
facility: Kiritimati
Study officials:
affiliation: University of Southern California
name: Elizabeth Beale, MD
role: PRINCIPAL_INVESTIGATOR
References: