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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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PACTR |
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Last refreshed on:
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29 May 2023 |
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Main ID: |
PACTR201301000452148 |
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Date of registration:
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07/11/2012 |
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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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Lifestyle intervention to control high normal blood pressure and/or high normal blood glucose in church members
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Scientific title:
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Efficacy of a church-based lifestyle intervention programme to control high normal blood pressure and/or high normal blood glucose in church members: a randomized controlled trial in Pretoria, South Africa |
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Date of first enrolment:
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01/02/2012 |
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Target sample size:
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600 |
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Recruitment status: |
Pending |
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URL:
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https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=452 |
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Study type:
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Interventional |
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Study design:
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Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously,Randomised,Simple randomiztion using a randomisation table created by a computer software program,Sealed opaque envelops
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Phase:
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Not Applicable
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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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Supa
Pengpid |
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Address:
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Garankuwa
0204
Pretoria
South Africa |
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Telephone:
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012 521 5036 |
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Email:
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supa_pengpid@embanet.com |
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Affiliation:
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Professor/University of Limpopo |
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Name:
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Supa
Pengpid |
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Address:
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Garankuwa
0204
Pretoria
South Africa |
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Telephone:
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012 521 5036 |
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Email:
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supa_pengpid@embanet.com |
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Affiliation:
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Professor/University of Limpopo |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1) age from 40-65 years,
2) willingness to participate in the screening programme
3) high normal blood pressure determined as a seating resting systolic blood pressure between 120 and 139 mmHg and/or a diastolic blood pressure of 80-89 mmHg, and/or a fasting glucose level between 6 and 6.9 mmol/l and
4) agree to participate over a 36-month period
Exclusion criteria: all previous diagnosis of heart diseases; previous diagnosis of hypertension and/or type 2 diabetes;
Unstable pulmonary disease;
History of alcoholism, drug abuse, or other psychiatric problems that are likely to limit compliance to the study;
Orthopedic or rheumatologic disease (i.e. severe rheumatoid arthritis);
Already enrolled in clinical research trial, and having kidney disease.
Age minimum:
40 Year(s)
Age maximum:
65 Year(s)
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Nutritional, Metabolic, Endocrine
high normal blood pressure and/or high normal blood glucose
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Nutritional, Metabolic, Endocrine
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high normal blood pressure and/or high normal blood glucose
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Intervention(s)
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Lifestyle intervention
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Lifestyle education pamphlet
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Primary Outcome(s)
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Reducation in systolic blood pressure
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Reduction in blood glucose levels
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Secondary Outcome(s)
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BMI, waist-to-hip ratio, body composition
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lipid levels: total cholesterol, LDL and HDL, triglycerides; blood lipid profiles
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behavioural measures: diet, physical activity, tobacco, alcohol, weight, stress
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Source(s) of Monetary Support
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VLIR
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Ethics review
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Status: Approved
Approval date: 12/10/2012
Contact:
Medunsa research & Ethics Committee
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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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