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: pactr.samrc.ac.za
Trial no.: PACTR201612001036266 Date of Approval: 14/02/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Cameroon Fitness Study (CAMFITS)
Official scientific title Combination of Body Fat Monitoring and Awareness¿Raising to Promote Physical Activity and Combat Non-­Communicable Diseases in Cameroon-A pilot intervention
Brief summary describing the background and objectives of the trial Physical inactivity is a fast-growing public health problem which contributes to the incidence of a variety of chronic Non-Communicable Diseases (NCDs) and health complications, including obesity, diabetes and cancer. Most Cameroonians have limited awareness of indicators to quantify their fat mass and the relationship these have with their health. Motivation to sustain healthy exercise habits remains a major challenge in the fight against obesity and NCDs. The purpose of this project is to evaluate the effectiveness of using body fat monitoring and awareness-raising to motivate exercise adherence and control NCD risk factors among members of gyms and outdoor exercise groups in two Cameroonian cities.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) CAMFITS
Disease(s) or condition(s) being studied Non-Communicable disease, Obesity
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/09/2014
Actual trial start date 01/11/2014
Anticipated date of last follow up 30/09/2015
Actual Last follow-up date 30/09/2015
Anticipated target sample size (number of participants) 693
Actual target sample size (number of participants) 638
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
1032
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 Stratified allocation of fitness clubs by geographic location (region) Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Body fat tracking + Text messages Body fat tracking at every club visit; Weekly text messages 12 months Participants had access to body fat machines and also received text messages to motivate exercise adherence 178 Active-Treatment of Control Group
Experimental Group Body fat tracking only Body fat tracking at every club visit 12 months Participants had access to body fat machines and could take measurements at will 209 Active-Treatment of Control Group
Control Group Exercise as usual N/A 12 months No intervention 251 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-Registered member of exercise group -At least 18 years old -Consent to participate -Professional athletes -Pace-maker or other heart device present. -Plans to leave town before end of study 18 Year(s) 70 Year(s) 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 13/10/2014 The Ethics Review and Consultancy committee (ERCC), Cameroon Bioethics Initiative (CAMBIN)
Ethics Committee Address
Street address City Postal code Country
P. O. Box 31489, Biyem-Assi Yaounde 00237 Cameroon
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Exercise attendance rate of participants -Baseline -After 6 months -After 12 months
Secondary Outcome Anthropometric variables -Baseline -Post-intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
APSAC Yaounde Cameroon
Stefy Fitness Yaounde Cameroon
Cobra Fitness Yaounde Cameroon
Body Fitness Centre Yaounde Cameroon
CSSK Yaounde Cameroon
Yaounde Sports and fitness Yaounde Cameroon
Azam fitness Bamenda Cameroon
Marco Fitness Bamenda Cameroon
Sacred Heart Keep Fit Bamenda Cameroon
Mustard Seed Fitness Bamenda Cameroon
Nkem's Fitness Bamenda Cameroon
Up-Station Fitness Bamenda Cameroon
Elite Fitness Centre Yaounde Cameroon
Mateco Fitness Yaounde Cameroon
Buffalo Fitness Yaounde Cameroon
Lango'o Fitness Bamenda Cameroon
Jerize Fitness Bamenda Cameroon
Foyer du bien-etre Yaounde Cameroon
FUNDING SOURCES
Name of source Street address City Postal code Country
Grand Challenges Canada MaRS Centre, South Tower 101 College Street, Suite 406 Toronto M5G 1L7 Canada
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Health of Population in Transition Research Group P.O. Box 8046 Etougebe Yaounde 00237 Cameroon Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Health of Population in Transition Research Group P.O Box 8046 Yaounde 00237 Cameroon
Grand Challenges Canada MaRS Centre, South Tower 101 College Street, Suite 406 Toronto M5G 1L7 Canada
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Jude Saji judesaji@yahoo.com +237676048838 P.O. Box 13895
City Postal code Country Position/Affiliation
Yaounde 00237 Cameroon Research Officer/ Health of Populations in Transition Research Group
Role Name Email Phone Street address
Principal Investigator Felix Kembe Assah kembeassah@yahoo.com +237 674486342 P.O. Box 8046
City Postal code Country Position/Affiliation
Yaounde 00237 Cameroon Epidemiologist/ Faculty of Medicine and Biomedical Sciences University of Yaoundé I
Role Name Email Phone Street address
Public Enquiries Jude Saji judesaji@yahoo.com +237676048838 P.O. Box 13895
City Postal code Country Position/Affiliation
Yaounde 00237 Cameroon Research Officer/ Health of Population in Transition Research Group
Role Name Email Phone Street address
Scientific Enquiries Felix Kembe Assah kembeassah@yahoo.com +237 674486342 P.O. Box 8046
City Postal code Country Position/Affiliation
Yaounde 00237 Cameroon Epidemiologist/ Faculty of Medicine and Biomedical Sciences University of Yaoundé I
REPORTING
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