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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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20 September 2021 |
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Main ID: |
NCT04927871 |
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Date of registration:
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15/02/2021 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Hybridized Three Steps Intervention to Prevent Diabetes in Venezuela
HITS |
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Scientific title:
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Hybridized Three Steps (HITS) Intervention to Prevent Diabetes in Venezuela: HITS Diabetes With Prevention, An EVESCAM Lifestyle Intervention Study |
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Date of first enrolment:
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November 16, 2020 |
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Target sample size:
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156 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT04927871 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Venezuela
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Contacts
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Name:
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Maria M Infante, MD |
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Address:
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Telephone:
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+584125801131 |
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Email:
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mariainfante384@gmail.com |
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Affiliation:
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Name:
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Juan P Gonzalez-R, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Foundation for Public Health and Epidemiological Research of Venezuela |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Adults between 20 to 79 years years old
- No personal history of type 2 diabetes
- Body mass index = 25 kg/m2
- High risk for type 2 diabetes
Exclusion Criteria:
- Chronic ischemic heart disease: acute myocardial infarction, stable angina, unstable
angina.
- Stroke.
- Use of anticoagulants
- Severe renal failure
- Heart failure.
- Cannot do moderate-intensity physical activity
- Cannot attend most sessions
- Pregnancy or plans of having during the next sixth months
- Cancer or chemotherapy.
- Use of medications that affect weight (e.g. levothyroxine, pregabalin, orlistat)
Age minimum:
20 Years
Age maximum:
79 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Diabetes Mellitus, Type 2
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Obesity
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Overweight
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PreDiabetes
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Risk Factor, Cardiovascular
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Intervention(s)
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Behavioral: Diabetes Prevention Program
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Behavioral: Diabetes Prevention Program 4 months
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Behavioral: Medical Nutritional Therapy (MNT)
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Behavioral: Total Diet Replacement (TDR)
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Primary Outcome(s)
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Change of weight in kilograms
[Time Frame: 6 months]
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Secondary Outcome(s)
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Change in the points of Acceptance of the program assessed by a questionnaire using a Likert scale
[Time Frame: 6 months]
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Change in the points of Appropriateness of the core-curriculum assessed by a questionnaire using a Likert scale
[Time Frame: 6 months]
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Percentage of Attendance to the program
[Time Frame: 6 months]
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Percentage of Completion of the program.
[Time Frame: 6 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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