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.: PACTR202010681941735 Date of Approval: 27/10/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title EFFECTS OF STRUCTURED AND UNSTRUCTURED PHYSICAL ACTIVITY ON COST OF CARE, SELECTED BIOCHEMICAL AND HEALTH RISK PROFILES OF ADULTS WITH OVERWEIGHT AND OBESITY
Official scientific title EFFECTS OF STRUCTURED AND UNSTRUCTURED PHYSICAL ACTIVITY ON COST OF CARE, SELECTED BIOCHEMICAL AND HEALTH RISK PROFILES OF ADULTS WITH OVERWEIGHT AND OBESITY
Brief summary describing the background and objectives of the trial Overweight and obesity are serious public health problems of the twenty first century. They are two of the leading preventable causes of death affecting an estimated 300 million people worldwide, with an increasing prevalence across population. Physical inactivity has been long reported as an important contributor to the high rates of overweight, obesity and other non-communicable diseases Health economics as the application of economic theories, models and empirical techniques to the analysis of decision-making in healthcare to ensure maximum value for any money spent on health services and not just the clinical effectiveness, but also the cost effectiveness of such service. Significant pressure is placed upon public and private sector organisations to ensure that money is spent wisely for health services provided. This has resulted in the need for providing evidence for cost effectiveness as justification for using, funding or continued funding of particular initiatives in public health. In Nigeria, there are no documented estimates from the available literature on the burden of overweight/obesity in terms of mortality and morbidity costs. However, it is possible that these costs may run into several billions of Naira in a year. A significant proportion of individuals usually adopt and readily participate in one form of unstructured physical activity or the other. Therefore, this study proposes to compare the effect of structured and unstructured physical activity on cost of care, biochemical and selected health risk profile among Nigerian adults with overweight and obesity. The objectives of this study are: (i) To compare the baseline, 6-week and 12-week cost of care, biochemical and health risk profiles following structured and unstructured physical activity among adults with overweight and obesity. (ii) To compare the 6-week and 12-week cost of care, biochemical and health risk profiles between the structured and unstructured physical activity groups.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Overweight and obesity
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 02/10/2019
Actual trial start date 02/03/2020
Anticipated date of last follow up 02/05/2020
Actual Last follow-up date 02/05/2020
Anticipated target sample size (number of participants) 44
Actual target sample size (number of participants) 40
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 Simple randomization using by using procedures such as coin-tossing or dice-rolling Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Structured Physical Activity group Exposure to aerobics exercises, flexibility exercises and resistance training for 45 minutes to 1 hour three times per week 45 minutes to 1 hour of moderate to vigorous intensity exercises. Participants will be exposed to a workout on the treadmill which will be determined using the Borg's rate of perceived exertion scale. They will then undergo some flexibility exercises of stretching of muscles of the upper limbs, lower limbs and trunks. The resistance exercise will consists of the participant's carrying dumbbells of varying weights determined using the maximum weight a participant can lift during full range of motion of the upper limb in one repetition. This will always be followed by a cool down exercise which consists of the flexibility exercises of the upper and lower limb muscles. They were also given pedometer to wear in their clothing to monitor the number of steps taken everyday. 22
Control Group Unstructured Physical activity group Every day using a pedometer(step counter) for walking. walking to reach a goal of a minimum of 10000 steps a day. The participants would be given a pedometer to wear on their clothing which counts the number of steps they made in a day. They were encouraged to make atleast 10000 steps in a day unsupervised. This is the minimum steps required in a day for health benefits. 22 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Only overweight and obese participants with BMI > 25kg/m2 were included in this study. 2. Participants, who understand, read and write in English language. Overweight or obese individuals who have been clinically diagnosed with any of the following conditions were excluded from this study; diabetes, lower limb amputation, spinal cord injury. Any other physical disabilities that could prevent them from participating in any physical activity. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 60 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 13/02/2020 University Of Ibadan and University College Hospital Joint Ethics review committee
Ethics Committee Address
Street address City Postal code Country
University College Hospital Ibadan Nigeria Ibadan 200212 Nigeria
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 30/06/2020 University Of Abuja Teaching Hospital ethical review committee
Ethics Committee Address
Street address City Postal code Country
Hospital Road Gwagwalada Abuja Abuja 900271 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Cost of care At baseline, 6 weeks and 12 weeks
Primary Outcome Lipid profiles At baseline, 6 weeks and 12 weeks
Primary Outcome Fasting blood sugar At baseline, 6 weeks and 12 weeks.
Primary Outcome Glycated Hemoglobin Hb1Ac At baseline and 12 weeks
Primary Outcome Aspartate Aminotransferase ASAT At baseline, 6 weeks and 12 weeks.
Primary Outcome Alanine transaminase ALAT At baseline, 6 weeks and 12 weeks.
Primary Outcome BMI At baseline, 6 weeks and 12 weeks.
Secondary Outcome Number of steps At baseline, 6 weeks and 12 weeks.
Secondary Outcome Waist circumference At baseline, 6 weeks and 12 weeks.
Secondary Outcome Blood pressure measurement At baseline, 6 weeks and 12 weeks.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Department of Physiotherapy University of Abuja Teaching Hospital Hospital Road Gwagwalada 900271 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Emmanuel Aliyu Hospital Road Gwagwalada Abuja 900271 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Emmanuel Aliyu Hospital Road Gwagwalada Abuja 900271 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Emmanuel Aliyu shalomemmy@gmail.com +2348036080677 Hospital Road
City Postal code Country Position/Affiliation
Gwagwalada Abuja 900271 Nigeria Chief Physiotherapist University of Abuja Teaching Hospital Abuja Nigeria
Role Name Email Phone Street address
Public Enquiries Emmanuel Aliyu shalomemmy@gmail.com +2348036080677 Hospital Road
City Postal code Country Position/Affiliation
Gwagwalada Abuja 900271 Nigeria Chief Physiotherapist University of Abuja Teaching Hospital
Role Name Email Phone Street address
Scientific Enquiries Emmanuel Aliyu shalomemmy@gmail.com +2348036080677 Hospital Road
City Postal code Country Position/Affiliation
Gwagwalada Abuja 900271 Nigeria Chief Physiotherapist University Of Abuja Teaching Hospital
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participants data that underlie the results reported in the article that will be published from the research after deidentification(text, tables, figures and appendices) will be made available to investigators whose proposed used of the data has been approved by an independent review committee identified for this purpose. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Beginning 9 months and ending 36 months following article publication. Will be provided later.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Will be provided later. 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