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.: PACTR202401462338744 Date of Approval: 19/01/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Physical Activity on Visual Outcomes among People Newly Diagnosed with Abnormal Glucose Tolerance in the Cape Coast Metropolis, Ghana
Official scientific title Diabetes Diagnosis and Remission: A Physical Activity and Visual Outcomes Assessment Trial (PAVOA Trial)
Brief summary describing the background and objectives of the trial There is an increasing prevalence of abnormal glucose tolerance (AGT) in Ghana. Despite initiatives to control and prevent this, it remains a rapidly developing public health issue. Abnormal glucose tolerance has an effect on the eye and affects visual outcomes like visual acuity, contrast sensitivity, and visual fields. Numerous health advantages of physical activity have been demonstrated, and thus, it is essential to understand the association between physical activity and visual outcomes in patients with AGT. Without this, healthcare professionals, especially health promoters and eye-care professionals, may struggle to create patient-specific and culturally appropriate interventions to reduce the risk of visual impairment among people with AGT. Previous studies have attempted this, but they did not include people with prediabetes and focused only on people already diagnosed with diabetes, who are likely to be on other interventions prescribed upon diagnosis before the study. In addition, no study of this nature has been conducted in a typical African population. Therefore, it is important to investigate the effect of physical activity on visual outcomes in an African population with AGT. Understanding the impact of physical activity on diabetes-related visual outcomes will enable the development of relevant, culturally sensitive interventions for patients with AGT. This study is a randomized control trial (RCT) among people newly diagnosed with abnormal glucose tolerance between the ages of 25 and 70. The three main objectives are to ascertain if a physical activity intervention significantly reduces glycaemic levels, determine if a physical activity intervention significantly improves visual outcomes, and finally investigate if the effect of physical activity on visual outcomes varies significantly among subgroups within the population.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Eye Diseases,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 30/09/2022
Actual trial start date 20/05/2023
Anticipated date of last follow up 23/12/2022
Actual Last follow-up date 12/08/2023
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 50
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
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Central randomisation by phone/fax Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Physical Activity Regimen The participants in the experimental group will undergo moderate-intensity physical activity (150 minutes and above) or vigorous-intensity physical activity (75 minutes and above), or combine the two in an equivalent way, depending on their age, gender, and daily activity. Subsequently, for every four weeks during the intervention phase, the amount of time for physical activity will be increased by 75 minutes for moderate-intensity physical activity and 37.5 minutes for vigorous-intensity physical activity. 12 weeks The physical activity will be structured, meaning it will be planned, individualized, and tracked. The participants can perform this activity at home, at work, or at fitness facilities. The participant, based on their age, gender, and daily activity, will have the option to choose between moderate intensity (150 minutes and above) and vigorous intensity (75 minutes and above) or to combine them in an equivalent manner. The main moderate-intensity physical activity will be walking, and the main vigorous-intensity physical activity will be running. Subsequently, for every four weeks during the intervention phase, the amount of time for physical activity will be increased by 75 minutes for moderate-intensity physical activity and 37.5 minutes for vigorous-intensity physical activity. The participants, depending on preferences and the type of physical activity they choose, will be required to spread the target minutes over 3–5 sessions per week. There will be no more than two consecutive days without undertaking the exercise. The time of physical activity will be self-tracked using the accelerometer and GPS sensors of the participants’ smartphones. Mobile phone fitness and health applications will be used to document the patient’s physical activity history. The Apple Health App will be used by people who use iOS run mobile phones. The Google Fit app will be used for Android phones in cases where the brands of these mobile phones do not have in-built fitness and health applications. For participants with T2DM, the physical activity will not be performed after oral hypoglycemic administration without having a meal beforehand. 25
Control Group Health education Every four weeks 12 weeks Participants in the control group will receive comprehensive health education materials focusing on the importance of regular physical activity for overall health and well-being. The education will cover general recommendations for physical activity, potential benefits, and strategies for incorporating movement into daily life. Additionally, participants in the control group will be encouraged to engage in unstructured physical activity of their choice. Unlike the intervention group, there will be no prescribed duration, intensity, or frequency. Participants will be advised to follow their preferences and comfort levels. The goal is to promote a general understanding of the benefits of physical activity without providing a specific, planned regimen. As opposed to objective tracking using sensors in the experimental group, the control group participants will be asked to keep a simple log or diary of their physical activities. 25 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. People who have not been previously diagnosed with prediabetes or diabetes and are willing to participate in the study. 2. People between the ages of 25 years and 70 years. 3. People who consent to the study. 1. Pregnant women and breastfeeding mothers. 2. Individuals with pre-existing diabetes (either type 1 or type 2). 3. Individuals with a BMI below 18.5 kg/m². 4. Individuals with anemia. 5. People who do not consent to participate in the study. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 25 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 30/08/2022 University of Cape Coast Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
University Close Cape Coast 00233 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Adherence to a physical activity intervention significantly improves visual outcomes in an African population with abnormal glucose tolerance. This outcome seeks to examine the difference in visual outcomes before and after the physical activity regimen has been completed by the participants. The dependent variables in this hypothesis are the visual outcomes (visual acuity, contrast sensitivity, and central visual field) of the participant, and the independent variable is the amount of physical activity done. This will be done using the mixed-design Analysis of Variance (ANOVA), with a within-subjects factor (pretest and posttest) and a between-subject factor (experimental and control), to find mean differences at a significance level of p < 0.05. At the end of the intervention
Secondary Outcome Adherence to a physical activity intervention significantly reduces glycaemic levels in an African population with abnormal glucose tolerance. This outcome seeks to assess the difference in glycaemic levels before and after the physical activity regimen has been completed by the participants. The dependent variable in this outcome is the glycaemic level of the participants, and the independent variable is the amount of physical activity done. This will be analysed using the intention-to-treat analysis. Between-group comparisons will be made using independent-samples t-tests to assess the effect of the physical activity regimen on glycaemic levels. At the end of the intervention
Secondary Outcome The impact of physical activity on visual outcomes varies significantly among subgroups in the population, including age category, gender, occupation, and level of education. This outcome seeks to examine the differences in the impact of physical activity on visual outcomes within the subgroups of the population, namely age category, gender, occupation, and level of education. The independent variables in this outcome are age category, gender, and occupation. The dependent variables in this outcome are the visual outcomes of visual acuity, contrast sensitivity, and central visual field. For this outcome, a Multiple Analysis of Variance (MANOVA) will be used to test the differences in the different visual outcomes based on the subgroups in the population (age category, gender, occupation). At the end of the intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cardiometabolic Epidemiology Research Laboratory Department of Health, Physical Education, and Recreation, University of Cape Coast Cape Coast Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
Cardiometabolic Epidemiology Research Laboratory Department of Health, Physical Education, and Recreation Cape Coast Ghana
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cardiometabolic Epidemiology Research Laboratory University of Cape Coast Close Cape Coast 00233 Ghana University
COLLABORATORS
Name Street address City Postal code Country
Prof. Stephen Ocansey Department of Optometry and Vision Sciences, University of Cape Coast Cape Coast Ghana
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ebenezer Oduro Antiri eo.antiri@klintapscohas.edu.gh +233209123749 Cardiometabolic Epidemiology Research Laboratory, Department of Health, Physical Education, and Recreation, University of Cape Coast
City Postal code Country Position/Affiliation
Cape Coast Ghana Research Associate
Role Name Email Phone Street address
Scientific Enquiries Thomas Hormenu thormenu@ucc.edu.gh +233244213465 Cardiometabolic Research Laboratory, Department of Health, Physical Education, and Recreation, University of Cape Coast
City Postal code Country Position/Affiliation
Cape Coast Ghana Senior Lecturer
Role Name Email Phone Street address
Public Enquiries Edward Wilson Ansah edward.ansah@ucc.edu.gh +233247703379 Department of Health, Physical Education, and Recreation, University of Cape Coast
City Postal code Country Position/Affiliation
Cape Coast Ghana Senior Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes In adherence to principles of transparency and scientific collaboration, the research team affirms its commitment to making individual participant data (IPD) available. This includes the sharing of all individual participant data collected throughout the course of the trial. The shared data will encompass a comprehensive dataset, and to ensure privacy and confidentiality, it will undergo a rigorous deidentification process. The shared IPD will include, but is not limited to, information gathered during participant enrollment, intervention or treatment details, and any relevant outcomes or measurements. Furthermore, the data dictionary corresponding to the shared IPD will be made available. This dictionary will provide a detailed guide to the variables, codes, and definitions used in the dataset, enhancing the usability and interpretability of the shared information. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol The IPD (Individual Participant Data) for the RCT (Randomized Controlled Trial) titled "Effect of Physical Activity on Visual Outcomes among People Newly Diagnosed with Abnormal Glucose Tolerance in the Cape Coast Metropolis, Ghana" will be shared within 6 months after the primary results of the study are published. The data will be made available to researchers and investigators for a period of 5 years following the specified sharing time frame. This allows for a reasonable duration for the primary research team to analyze and publish the initial findings while promoting transparency and facilitating additional analyses or verification by the broader scientific community. Access to the individual participant data (IPD) of the RCT titled "Effect of Physical Activity on Visual Outcomes among People Newly Diagnosed with Abnormal Glucose Tolerance in the Cape Coast Metropolis, Ghana" will be granted to researchers, investigators, and collaborating entities who meet the following key access criteria:
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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