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

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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202409492459905
Enrollment
100
Registered
2024-09-16
Start date
2024-10-01
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eye Diseases Nutritional, Metabolic, Endocrine

Interventions

Structured Physical Activity Regimen
Health Education

Sponsors

Cardiometabolic Epidemiology Research Laboratory
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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.;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.;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 as

Secondary

MeasureTime frame
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).;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.

Countries

Ghana

Contacts

Public ContactEdward Wilson Ansah

Senior Lecturer

edward.ansah@ucc.edu.gh+233247703379

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026