Pilot Sugar Reduction Intervention in Kiritimati Teenagers

NCT ID: NCT04319003

Last Updated: 2020-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-03

Study Completion Date

2018-09-19

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control School

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention School

This school received a one-week sugar-reduction intervention

Group Type EXPERIMENTAL

Sugar-reduction intervention

Intervention Type 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

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Enrolled in one of the two high schools on Kiritimati

Exclusion Criteria

* \> 18 years of age
Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Southern California

OTHER

Sponsor Role lead

Responsible Party

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Elizabeth Beale

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elizabeth Beale, MD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

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University of Southern California

Los Angeles, California, United States

Site Status

Kiritimati

London, , Kiribati

Site Status

Countries

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United States Kiribati

Other Identifiers

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HS-18-00505

Identifier Type: -

Identifier Source: org_study_id

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