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.: PACTR202010667228786 Date of Approval: 27/10/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title EFFICACY OF CLINIC AND MOBILE PHONE-BASED WALK-TALK INTERVENTION ON SELECTED MATERNAL AND CHILD HEALTH OUTCOMES OF PREGNANT WOMEN IN IBADAN
Official scientific title EFFICACY OF CLINIC AND MOBILE PHONE-BASED WALK-TALK INTERVENTION ON SELECTED MATERNAL AND CHILD HEALTH OUTCOMES OF PREGNANT WOMEN IN IBADAN
Brief summary describing the background and objectives of the trial Physical inactivity is associated with adverse maternal and child outcomes. This study assessed the efficacy of a structured clinic and mobile phone-based six-minute walk-talk PA intervention on PA outcomes among pregnant women.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) RCT
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 11/09/2018
Actual trial start date 11/09/2018
Anticipated date of last follow up 07/01/2019
Actual Last follow-up date 07/01/2019
Anticipated target sample size (number of participants) 95
Actual target sample size (number of participants) 95
Recruitment status Completed
Publication URL None
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 Simple randomization using a randomization table created by a computer software program Numbered containers Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Clinic Based Six minute Walk Talk Physical Activity Three days per week Twelve weeks The six minute walk test was performed on a 20-meter level corridor course marked in 1-meter increments. Then, the participant was instructed to walk back and forth on the walkway at their self-selected pace for 6 minutes measured by a stopwatch. 36
Experimental Group Mobile Phone Based Six Minute Walk Talk Physical Activity Three times per week Twelve weeks The mobile application (App) that was used in this study was developed as a replica of the Clinic-Based PA Intervention and it ran on a smartphone or android phone with an OS of at least 3.5 31
Control Group Stereotype antenatal care intervention group Three times weekly Twelve weeks Participants in the control group received the usual Antenatal care only. There was no instruction on physical activity involvement for them in the course of the study 28 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Pregnant women who were not younger than 18 and not older than 40 years. Pregnant women in a 22 - 24-week gestational period, who have been medically screened and certified not to have any of the following medical conditions: pre-pregnancy diabetes mellitus, hypertension, heart Disease, and chronic Renal Disease. Pregnant women who were not on current medications that adversely influence glucose tolerance. Those with contraindications to participating in moderate PA based on information retrieved from the Physical Activity Readiness Medical Examination for Pregnancy (PARmed-X for Pregnancy). Those with previous or current participation in a PA program of >30 minutes of moderate-intensity or vigorous-intensity exercise. Those with more than two miscarriages, severe heart disease (including symptoms of angina, myocardial infarction or arrhythmias), persistent bleeding after 12 weeks of gestation, poorly controlled thyroid disease, pregnancy-induced hypertension or pre-eclampsia, and multiple pregnancies. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 18 Year(s) 40 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 11/09/2018 Institute for advanced Medical research and training
Ethics Committee Address
Street address City Postal code Country
University college hospital ethics committee, Ibadan Osogbo 200212 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pregnancy Physical Activity Questionnaire Baseline, 6th week, 12th week
Secondary Outcome Health History Questionnaire, PARmed-X for Pregnancy Baseline, 6th week, 12th week
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Obafemi Awolowo University Department of Medical rehabilitation, college of health sciences, Obafemi Awolowo University Osogbo 220232 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Akinwande Olabisi Aderonke Department of Medical rehabilitation, college of health sciences, Obafemi Awolowo University Osogbo 220232 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Akinwande Olabisi Aderonke Department of Medical rehabilitation, college of health sciences, Obafemi Awolowo University Osogbo 220232 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Olabisi Akinwande olabisiakinwande@yahoo.com +2348034550562 Department of Medical rehabilitation, college of health sciences, Obafemi Awolowo University
City Postal code Country Position/Affiliation
Osogbo 220232 Nigeria Researcher
Role Name Email Phone Street address
Public Enquiries Olabisi Akinwande olabisiakinwande@yahoo.com +2348034550562 Department of Medical rehabilitation, college of health sciences, Obafemi Awolowo University
City Postal code Country Position/Affiliation
Osogbo 220232 Nigeria Researcher
Role Name Email Phone Street address
Scientific Enquiries Olabisi Akinwande olabisiakinwande@yahoo.com +2348034550562 Department of Medical rehabilitation, college of health sciences, Obafemi Awolowo University
City Postal code Country Position/Affiliation
Osogbo 220232 Nigeria Researcher
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will be made available. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures and appendices) will be shared. Statistical Analysis Plan,Study Protocol Immediately following publication. No end date. Researchers who provide a methodological sound proposal to achieve aims in the research proposal.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
None No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information