Trial no.:	PACTR202409492459905	Date of Registration:	16/09/2024
Trial Status:	Registered in accordance with WHO and ICMJE standards

TRIAL DESCRIPTION

Public title

Diabetes Diagnosis and Remission: The Physical Activity, Cardiometabolic and Visual Outcomes Assessment Study II

Official scientific title

Efficacy of a physical activity regimen on cardiometabolic and visual outcomes among persons newly diagnosed with abnormal glucose tolerance: Study protocol for a pilot randomized controlled 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 body and eye and affects visual (visual acuity, contrast sensitivity, visual fields) and cardiometabolic [High-density lipoprotein (HDL), low-density lipoprotein (LDL), very low-density lipoprotein (VLDL), triglycerides, total cholesterol, albumin, indirect bilirubin, total bilirubin, direct bilirubin, Aspartate aminotransferase (AST), Alkaline phosphatase (ALP), Gamma-glutamyltransferase (GGT) and Alanine transaminase (ALT), total protein, creatinine, uric acid, urea and globulin] outcomes. Numerous health advantages of physical activity have been demonstrated, and thus, it is essential to understand the association between physical activity and cardiometabolic 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 cardiometabolic diseases and 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. Therefore, it is important to investigate the effect of physical activity on cardiometabolic and visual outcomes in an African population with AGT. Understanding the impact of physical activity on diabetes-related health outcomes will enable the development of relevant, culturally sensitive interventions for patients with AGT. This study seeks to build on a previous trial conducted by the same laboratory. It will be a randomized control trial (RCT) among people newly diagnosed with AGT.

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

01/10/2024

Actual trial start date

04/11/2024

Anticipated date of last follow up

24/12/2024

Actual Last follow-up date

07/02/2025

Anticipated target sample size (number of participants)

100

Actual target sample size (number of participants)

28

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	Structured 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	50
Control Group	Health Education	Once every month	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.	50	Uncontrolled

ELIGIBILITY CRITERIA
List inclusion criteria	List exclusion criteria	Age Category	Minimum age	Maximum age	Gender
1. People who have not participated in a previous clinical trial assessing similar outcomes. 2. People who have not been previously diagnosed with prediabetes or diabetes and are willing to participate in the study. 3. People between the ages of 25 years and 70 years. 4. 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: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s)	25 Year(s)	75 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

20/05/2024

University of Cape Coast Institutional Review Board

Ethics Committee Address
Street address	City	Postal code	Country
University of Cape Coast	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 period
Primary 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 period
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, level of education, and more importantly, place of residence. 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 period
Primary 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 period
Secondary Outcome	Adherence to a physical activity intervention significantly improves cardiometabolic outcomes in an African population with abnormal glucose tolerance. This outcome seeks to examine the difference in cardiometabolic outcomes before and after the physical activity regimen has been completed by the participants. The dependent variables in this hypothesis are the cardiometabolic outcomes [High-density lipoprotein (HDL), low-density lipoprotein (LDL), very low-density lipoprotein (VLDL), triglycerides, total cholesterol, albumin, indirect bilirubin, total bilirubin, direct bilirubin, Aspartate aminotransferase (AST), Alkaline phosphatase (ALP), Gamma-glutamyltransferase (GGT) and Alanine transaminase (ALT), total protein, creatinine, uric acid, urea and globulin] 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.	Baseline and after the completion 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
University of Cape Coast Hospital	Directorate of Health Services	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	Department of Health, Physical Education, and Recreation	Cape Coast		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 "Efficacy of a physical activity regimen on cardiometabolic and visual outcomes among persons newly diagnosed with abnormal glucose tolerance: Study protocol for a pilot randomized controlled trial" 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 "Efficacy of a physical activity regimen on cardiometabolic and visual outcomes among persons newly diagnosed with abnormal glucose tolerance: Study protocol for a pilot randomized controlled trial" 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
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Trial Information	Public title	26/09/2024	The trial and it's objectives remain the same. However we have interchanged the public and scientific titles for technical and visibility purposes.	Efficacy of a physical activity regimen on visual outcomes among persons newly diagnosed with abnormal glucose tolerance.	Diabetes Diagnosis and Remission: The Physical Activity and Visual Outcomes Assessment Study II
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Trial Information	Public title	17/09/2025	This study has since been expanded to include cardiometabolic measures as post-trial measures. These were already included in the diagnostic screening, but upon review and ethics approval, they were included as outcomes for the experimental study as well.	Diabetes Diagnosis and Remission: The Physical Activity and Visual Outcomes Assessment Study II	Diabetes Diagnosis and Remission: The Physical Activity, Cardiometabolic and Visual Outcomes Assessment Study II
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Trial Information	Official scientific title	26/09/2024	The trial and it's objectives remain the same. However we have interchanged the public and scientific titles for technical and visibility purposes.	Diabetes Diagnosis and Remission: The Physical Activity and Visual Outcomes Assessment Study II	Efficacy of a physical activity regimen on visual outcomes among persons newly diagnosed with abnormal glucose tolerance.
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Trial Information	Official scientific title	30/09/2024	This change is recommended for effective dissemination and publication of the trial protocol.	Efficacy of a physical activity regimen on visual outcomes among persons newly diagnosed with abnormal glucose tolerance.	Efficacy of a physical activity regimen on visual outcomes among persons newly diagnosed with abnormal glucose tolerance: Study protocol for a pilot randomized controlled trial.
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Trial Information	Official scientific title	17/09/2025	The title has been updated to reflect the final nature of the trial.	Efficacy of a physical activity regimen on visual outcomes among persons newly diagnosed with abnormal glucose tolerance: Study protocol for a pilot randomized controlled trial.	Efficacy of a physical activity regimen on cardiometabolic and visual outcomes among persons newly diagnosed with abnormal glucose tolerance: Study protocol for a pilot randomized controlled trial.
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Trial Information	Trial description	17/09/2025	This reflects the broadening of the scope of the study that has been justified above.	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. 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 seeks to build on a previous trial conducted by the same laboratory. It will be 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 in a typical African population across urban, peri-urban and rural areas, 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.	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 body and eye and affects visual (visual acuity, contrast sensitivity, visual fields) and cardiometabolic [High-density lipoprotein (HDL), low-density lipoprotein (LDL), very low-density lipoprotein (VLDL), triglycerides, total cholesterol, albumin, indirect bilirubin, total bilirubin, direct bilirubin, Aspartate aminotransferase (AST), Alkaline phosphatase (ALP), Gamma-glutamyltransferase (GGT) and Alanine transaminase (ALT), total protein, creatinine, uric acid, urea and globulin] outcomes. Numerous health advantages of physical activity have been demonstrated, and thus, it is essential to understand the association between physical activity and cardiometabolic 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 cardiometabolic diseases and 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. Therefore, it is important to investigate the effect of physical activity on cardiometabolic and visual outcomes in an African population with AGT. Understanding the impact of physical activity on diabetes-related health outcomes will enable the development of relevant, culturally sensitive interventions for patients with AGT. This study seeks to build on a previous trial conducted by the same laboratory. It will be a randomized control trial (RCT) among people newly diagnosed with AGT.
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Trial Information	Actual trial start date	17/09/2025	The trial started a month after the anticipated date due to delays in eligible participants confirming their readiness to begin the intervention.		04 Nov 2024
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Trial Information	Completion date	17/09/2025	The study concluded 12 weeks after the start date, as originally intended.		07 Feb 2025
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Trial Information	Final no of participants	17/09/2025	The screening yielded 28 individuals who consented to participate in the study		28
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Trial Information	Recruitment status	17/09/2025	This RCT has been completed.	Recruiting	Completed
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Outcome	OutCome List	17/09/2025	This has been updated to a primary outcome as it forms a core part of the RCT and changes in this outcome will reflect in changes in the secondary outcomes	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 period	Primary 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 period
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Outcome	OutCome List	17/09/2025	This has been updated to a primary outcome as it forms a core part of the RCT and changes in this outcome will reflect in changes in the secondary outcomes		Secondary Outcome, Adherence to a physical activity intervention significantly improves cardiometabolic outcomes in an African population with abnormal glucose tolerance. This outcome seeks to examine the difference in cardiometabolic outcomes before and after the physical activity regimen has been completed by the participants. The dependent variables in this hypothesis are the cardiometabolic outcomes [High-density lipoprotein (HDL), low-density lipoprotein (LDL), very low-density lipoprotein (VLDL), triglycerides, total cholesterol, albumin, indirect bilirubin, total bilirubin, direct bilirubin, Aspartate aminotransferase (AST), Alkaline phosphatase (ALP), Gamma-glutamyltransferase (GGT) and Alanine transaminase (ALT), total protein, creatinine, uric acid, urea and globulin] 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., Baseline and after the completion of the intervention.
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Reporting	IPD-Sharing time frame	17/09/2025	This change has been made to reflect the current title of the study	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.	The IPD (Individual Participant Data) for the RCT (Randomized Controlled Trial) titled "Efficacy of a physical activity regimen on cardiometabolic and visual outcomes among persons newly diagnosed with abnormal glucose tolerance: Study protocol for a pilot randomized controlled trial" 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.
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Reporting	Key access criteria	17/09/2025	This change has been made to reflect the current title of the study	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:	Access to the individual participant data (IPD) of the RCT titled "Efficacy of a physical activity regimen on cardiometabolic and visual outcomes among persons newly diagnosed with abnormal glucose tolerance: Study protocol for a pilot randomized controlled trial" will be granted to researchers, investigators, and collaborating entities who meet the following key access criteria:

Pan African Clinical Trials Registry