Pilot Sugar Reduction Intervention in Kiritimati Teenagers

NCT04319003 | Completed

• 1 other identifier: HS-18-00505
• Study Type: interventional
• Target: 63
• Locations: 2 countries
• Sites: 2

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.

Conditions

Type 2 Diabetes; Obesity

Outcome Measures

Primary Outcomes (23)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

Study Arms (2)

Control School

NO INTERVENTION

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

Intervention School

EXPERIMENTAL

This school received a one-week sugar-reduction intervention

Behavioral: Sugar-reduction intervention

Interventions

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

Intervention School

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Enrolled in one of the two high schools on Kiritimati

You may not qualify if:

• \> 18 years of age

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (2)

University of Southern California

Los Angeles, California, 90033, United States

Location

Kiritimati

London, Kiribati

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Elizabeth Beale, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 26, 2020
• First Posted: March 24, 2020
• Study Start: August 3, 2018
• Primary Completion: September 19, 2018
• Study Completion: September 19, 2018
• Last Updated: March 26, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); KI (1)