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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT01095965 |
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Date of registration:
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29/03/2010 |
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Primary sponsor: |
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Public title:
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Nutrition Education Intervention in Adults With Type 2 Diabetes Mellitus in a Resource Poor Setting
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Scientific title:
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Implementation and Evaluation of a Nutrition Education Programme for Adults With Type 2 Diabetes Mellitus in a Resource Poor Setting of the Moretele Sub-District, North West Province, South Africa |
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Date of first enrolment:
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April 2010 |
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Target sample size:
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80 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01095965 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
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Countries of recruitment
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South Africa
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Contacts
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Name:
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Jane W Muchiri, Msc |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Pretoria |
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Name:
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Paul Rheeder, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Pretoria |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Type 2 diabetes mellitus
- 40 to 70 years
- At least one year living with diabetes
- Blood sugar levels of 10mmol/L or above in at least two occasions in the last six
months and consequent HbA1c levels of =8mmol/L
- Regular attendance of diabetic clinic
Exclusion Criteria:
- On insulin therapy
- Pregnant
- Full time employment
- Plans to move from study area during the study period
Age minimum:
40 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diabetes Mellitus, Type II [Non-insulin Dependent Type] [NIDDM Type] Uncontrolled
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Intervention(s)
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Behavioral: Nutrition education
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Primary Outcome(s)
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HbA1c as a measure of glycemic control
[Time Frame: 12 months]
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Secondary Outcome(s)
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Attitudes toward diabetes and its treatment
[Time Frame: 12 months]
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Blood pressure
[Time Frame: 12 months]
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Body mass index
[Time Frame: 12 months]
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Diabetes knowledge
[Time Frame: 12 months]
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Dietary intake
[Time Frame: 12 months]
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Lipid profile
[Time Frame: 12 months]
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Secondary ID(s)
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DOH-27-0310-3070
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MuchiriUP
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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