Ignite Creation Date:
2025-12-24 @ 7:33 PM
Ignite Modification Date:
2026-01-01 @ 11:30 PM
Study NCT ID:
NCT04319003
Status:
COMPLETED
Last Update Posted:
2020-03-26
First Post:
2020-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Sugar Reduction Intervention in Kiritimati Teenagers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2018-09-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-24', 'studyFirstSubmitDate': '2020-02-26', 'studyFirstSubmitQcDate': '2020-03-20', 'lastUpdatePostDateStruct': {'date': '2020-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in mean blood glucose (mg/dL)', 'timeFrame': '2 weeks (1 week pre- and 1 week post-intervention)', 'description': '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.'}, {'measure': 'Change in mean amplitude of glycemic variability (MAGE) (mg/dL)', 'timeFrame': '2 weeks (1 week pre- and 1 week post-intervention)', 'description': '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.'}, {'measure': 'Change in standard deviation (mg/dL) of continuous glucose monitor data', 'timeFrame': '2 weeks (1 week pre- and 1 week post-intervention)', 'description': '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.'}, {'measure': 'Change in coefficient of variation (percent) of continuous glucose monitor data', 'timeFrame': '2 weeks (1 week pre- and 1 week post-intervention)', 'description': '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.'}, {'measure': 'Change in J-index of continuous glucose monitor data', 'timeFrame': '2 weeks (1 week pre- and 1 week post-intervention)', 'description': '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.'}, {'measure': 'Change in area under the curve of continuous glucose monitor data', 'timeFrame': '2 weeks (1 week pre- and 1 week post-intervention)', 'description': '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.'}, {'measure': 'Change in total sugar consumption (g/day) using 24-hour dietary recalls', 'timeFrame': '2 weeks (1 week pre- and 1 week post-intervention)', 'description': '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).'}, {'measure': 'Change in added sugar consumption (g/day) using 24-hour dietary recalls', 'timeFrame': '2 weeks (1 week pre- and 1 week post-intervention)', 'description': '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).'}, {'measure': 'Change in total water consumption (g/day) using 24-hour dietary recalls', 'timeFrame': '2 weeks (1 week pre- and 1 week post-intervention)', 'description': '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).'}, {'measure': 'Change in unsweetened water consumption (servings/day) using 24-hour dietary recalls', 'timeFrame': '2 weeks (1 week pre- and 1 week post-intervention)', 'description': '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).'}, {'measure': 'Change in energy (kcal/day) consumption using 24-hour dietary recalls', 'timeFrame': '2 weeks (1 week pre- and 1 week post-intervention)', 'description': '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).'}, {'measure': 'Change in total carbohydrate (g/day) consumption using 24-hour dietary recalls', 'timeFrame': '2 weeks (1 week pre- and 1 week post-intervention)', 'description': '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).'}, {'measure': 'Change in percent calories from carbohydrate consumption using 24-hour dietary recalls', 'timeFrame': '2 weeks (1 week pre- and 1 week post-intervention)', 'description': '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).'}, {'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)', 'description': '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).'}, {'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)', 'description': '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).'}, {'measure': 'Change in sugary beverage (tioka) consumption using beverage frequency questionnaires', 'timeFrame': '2 weeks (1 week pre- and 1 week post-intervention)', 'description': '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.'}, {'measure': 'Change in sugary beverage (tang) consumption using beverage frequency questionnaires', 'timeFrame': '2 weeks (1 week pre- and 1 week post-intervention)', 'description': '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.'}, {'measure': 'Change in sugary beverage (toddy) consumption using beverage frequency questionnaires', 'timeFrame': '2 weeks (1 week pre- and 1 week post-intervention)', 'description': '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.'}, {'measure': 'Change in sugary beverage (ice block) consumption using beverage frequency questionnaires', 'timeFrame': '2 weeks (1 week pre- and 1 week post-intervention)', 'description': '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.'}, {'measure': 'Change in sugary beverage (soda) consumption using beverage frequency questionnaires', 'timeFrame': '2 weeks (1 week pre- and 1 week post-intervention)', 'description': '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.'}, {'measure': 'Change in sugary beverage (juice) consumption using beverage frequency questionnaires', 'timeFrame': '2 weeks (1 week pre- and 1 week post-intervention)', 'description': '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.'}, {'measure': 'Change in sugary beverage (fruit drinks) consumption using beverage frequency questionnaires', 'timeFrame': '2 weeks (1 week pre- and 1 week post-intervention)', 'description': '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.'}, {'measure': 'Change in sugary beverage (coffee/tea) consumption using beverage frequency questionnaires', 'timeFrame': '2 weeks (1 week pre- and 1 week post-intervention)', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes', 'Obesity']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Enrolled in one of the two high schools on Kiritimati\n\nExclusion Criteria:\n\n* \\> 18 years of age'}, 'identificationModule': {'nctId': 'NCT04319003', 'briefTitle': 'Pilot Sugar Reduction Intervention in Kiritimati Teenagers', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern California'}, 'officialTitle': 'Surveillance of Obesity and Pre-Diabetes/Diabetes in Kiritimati School Children and Lifestyle Modifications to Reduce Risk', 'orgStudyIdInfo': {'id': 'HS-18-00505'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control School', 'description': 'This school did not receive intervention (until after the study was completed)'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention School', 'description': 'This school received a one-week sugar-reduction intervention', 'interventionNames': ['Behavioral: Sugar-reduction intervention']}], 'interventions': [{'name': 'Sugar-reduction intervention', 'type': 'BEHAVIORAL', 'description': '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', 'armGroupLabels': ['Intervention School']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'London', 'country': 'Kiribati', 'facility': 'Kiritimati', 'geoPoint': {'lat': 1.98487, 'lon': -157.47502}}], 'overallOfficials': [{'name': 'Elizabeth Beale, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Southern California'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern California', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Elizabeth Beale', 'investigatorAffiliation': 'University of Southern California'}}}}