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.: PACTR202301779437544 Date of Approval: 24/01/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of a culturally adapted exercise program on the anthropometrics and body composition of postmenopausal women with excess weight gain: A randomised controlled trial
Official scientific title Culturally adapted exercise program on the anthropometrics and body composition of postmenopausal women
Brief summary describing the background and objectives of the trial Physical activity (PA) is recommended as a component of weight management for the prevention of weight gain and weight regains after weight loss, yet no literature has adapted culturally appropriate PA on postmenopausal women’s health. Therefore, we aimed to investigate the effect of a developed culturally appropriate exercise program for Ghanaian postmenopausal women with excess weight gain on the anthropometrics and body composition. A single-blind randomized controlled trial in which participants randomly received 12 weeks of culturally-induced exercise program. A total of 226 postmenopausal Ghanaian postmenopausal women were randomized into exercise and control groups. (113 in the control and 113 in the exercise group). Anthropometrics (BMI, WHR, WHtR WC, HC and body weight) and body composition (body fat, visceral fat, muscle mass) were determined pre and post-the 12-week intervention. The study aimed to investigate the effect of a culturally appropriate exercise program developed for postmenopausal Ghanaian women with excess weight gain on the anthropometrics and body composition of postmenopausal women with excess weight gain
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 01/03/2022
Actual trial start date 01/06/2022
Anticipated date of last follow up 30/06/2022
Actual Last follow-up date 31/08/2022
Anticipated target sample size (number of participants) 301
Actual target sample size (number of participants) 226
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
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 Permuted block randomization Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group exercise group 12 weeks A 12-week culturally adapted exercise program combining cultural dance aerobic activity (Ampe) and resistance exercises 113
Control Group control group 12 weeks no intervention. Asked to maintained lifestyle 113 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Postmenopausal Ghanaian women over 45 who were not on any weight-loss therapy and had no physical or mental disabilities were included Women who are not Ghanaians and had not resided in Ghana for the previous three years before the study were not eligible Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 45 Year(s) 70 Year(s) Female
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 26/04/2019 The Human Research Ethics Committee at the University of the Witwatersrand
Ethics Committee Address
Street address City Postal code Country
Johannesburg Gauteng 2050 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome anthropometrics and body composition 12 weeks
Secondary Outcome anthropometric parameters 12 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
community Techiman Muncipality Techiman Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
Self funding Ayeduase- kumasi, Plt4 BK J Kumasi 233 Ghana
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor FRC Gauteng Johannesburg 2050 South Africa Grant
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Isaac Mensah Bonsu 1389584@students.wits.ac.zza +2330542546187 Ayeduase
City Postal code Country Position/Affiliation
Kumasi 233 Ghana KNUST
Role Name Email Phone Street address
Scientific Enquiries Hellen Myezwa hellen.myezwa@wits.ac.za +27834696249 Gauteng
City Postal code Country Position/Affiliation
Johannesburg South Africa University of the Witwatersrand
Role Name Email Phone Street address
Public Enquiries Corlia Brandt corlia.brandt@wits.ac.za +27832640189 Gauteng
City Postal code Country Position/Affiliation
Johannesburg South Africa University of the Witwatersrand
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Post-menopausal women were on average 58.70 ± 6.38 years old with more than half (52.1%) above 58 years. The exercise program did not significantly affect the waist-to-hip ratio (WHR). There were statistically significant differences in body weight, BMI, WHtR, visceral fat, and total body fat in the exercise group compared with the control group. Muscle mass increased significantly (+0.21 kg), whereas hip circumference (-2.46 cm) and waist circumference (-1.39 cm) decreased significantly compared with the control group Study Protocol for the period of 12 weeks on request
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 30/12/2022
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 17/01/2023 Result - 30/12/2022 Result - 30/12/2022 Result - 30/12/2022 Result - 30/12/2022
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information