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Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834     Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za     Website: www.pactr.org

Trial no.: PACTR201301000452148 Date registered: 2012/11/07
TRIAL DESCRIPTION
Public title Lifestyle intervention to control high normal blood pressure and/or high normal blood glucose in church members
Official scientific title 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
Brief summary describing the background
and objectives of the trial
The aim of this study is to study the efficacy of a community (church)-based lifestyle intervention programme to control high normal blood pressure and/or high normal blood glucose in church members in a randomized controlled trial in Gauteng, South Africa. The objectives are to: (1) measure non-communicable diseases profile including hypertension and diabetes, health behaviours, weight management and psychological distress of church members; (2) measure reduction of reduce blood glucose and blood pressure levels after the intervention; (3) prevent the development of impaired glucose tolerance; (4) compare health behaviours, weight management and psychological distress, blood glucose and blood pressure levels between intervention and control groups, and within group during 6, 12, 24 and 36 months during and post intervention.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 2012-02-01
Actual trial start date
Anticipated date of last follow up 2017-01-05
Actual date of last follow up
Anticipated target sample size (number of participants) 600   
Actual target sample size (number of participants)   
Recruitment status Not yet recruiting
Secondary Ids Issuing authority/Trial register Links to Secondary ID

STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person
allocating the participants to the intervention arms
Masking If masking / blinding was used
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 Masking/blinding used

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control group Lifestyle education pamphlet once Provision of lifestyle education pamphlet on healthy diet and exercise benefits 300
Experimental group Lifestyle intervention 6 6-8 months The intervention programme goals are directed to diet and physical activity. The programme consists of 6 two hour sessions 300

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
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 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. 40 Years 65 Years Both

ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval
Name of the ethics committee
Yes 2012/10/12 Medunsa research & Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Ga-Rankuwa Pretoria 0204 South Africa

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Reducation in systolic blood pressure Baseline 12 months 24 months 36 months
Primary Outcome Reduction in blood glucose levels Baseline 12 months 24 months 36 months
Secondary Outcome BMI, waist-to-hip ratio, body composition Baseline 6 months 12 months 24 months 36 months
Secondary Outcome lipid levels: total cholesterol, LDL and HDL, triglycerides; blood lipid profiles Baseline 12 months 24 months 36 months
Secondary Outcome behavioural measures: diet, physical activity, tobacco, alcohol, weight, stress Baseline 6 months 12 months 24 months 36 months

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Limpopo Garankua Pretoria 0204 South Africa

FUNDING SOURCES
Name of source Street address City Postal code Country
VLIR Universitteitsplein 1 Antwerpen 2610 Belgium

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor VLIR Universiteitsplein 1 Antwerpen 2610 Belgium Funding Agency

COLLABORATORS
Name Street address City Postal code Country
Supa Penpid Garankuwa Pretoria 0204 South Africa
Karl Peltzer 134 Pretorius Street Pretoria 0204 South Africa
Prof P Mantla GaRankuwa Pretoria 0204 South Africa
Busi Ntuli-Ngcobo GaRankuwa Pretoria 0204 South Africa
Mashudu Manafe GaRankuwa Pretoria 0204 South Africa
Christophe De Block Universiteitsplein 1 Antwerpen 2610 Belgium
Marc Van Sprundel Universiteitsplein 1 Antwerpen 2610 Belgium

CONTACT PEOPLE
Role Name Email Phone Fax
Principal Investigator Prof Supa Pengpid supa_pengpid@embanet.com 012 5215036 0125214175
Street address City Postal code Country Position / Affiliation
Garankuwa Pretoria 0204 South Africa Professor/University of Limpopo
Role Name Email Phone Fax
Public Enquiries Prof Supa Pengpid supa_pengpid@embanet.com 012 521 5036 012 5214175
Street address City Postal code Country Position / Affiliation
Garankuwa Pretoria 0204 South Africa Professor/University of Limpopo
Role Name Email Phone Fax
Scientific Enquiries Prof Supa Pengpid supa_pengpid@embanet.com 012 521 5036 012 5214175
Street address City Postal code Country Position / Affiliation
Garankuwa Pretoria 0204 South Africa Professor/University of Limpopo