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.: PACTR202303505412195 Date of Registration: 20/03/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Impact of Dietary Counselling on Anthropometric Parameters, Antioxidant Nutrient Intake, and Glycemic Status in patients with Type 2 Diabetes Mellitus: A Prospective, Two-Arms Intervention Study
Official scientific title Impact of Dietary Counseling on Nutritional Status And Total Antioxidant Capacity of People Living With Type 2 Diabetes Attending Diet Therapy Clinic At A Municipal Hospital In Kumasi
Brief summary describing the background and objectives of the trial Oxidative stress is implicated in the progression of type 2 diabetes mellitus (T2DM) and its complications. Hyperglycemia, a key feature of T2DM causes a breakdown in the antioxidant defence system which has the sole duty of eliminating oxidative stress. Sufficient intake of dietary antioxidant nutrients supplements the endogenous antioxidant system arming the antioxidant defence system which eliminates oxidative stress, delaying the progression and complications of T2DM. This study aims to determine the impact that dietary counselling on anthropometric parameters, antioxidant nutrient intake, and glycemic status in patients with T2DM.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/10/2020
Actual trial start date 01/03/2021
Anticipated date of last follow up 01/01/2021
Actual Last follow-up date 01/06/2021
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants) 90
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 Dynamic (adaptive) random allocation such as minimization 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 Nutrition Education and Counselling Three Months Participants in the intervention group were taken from the Tafo Government Hospital due to the presence of a resident dietitian. Participants in the intervention group were offered face-to-face individualized dietary counselling by the resident dietitian per the standard protocols at the Diet Therapy Clinic of the Tafo Government Hospital (TGH). Each participant in the intervention group was counselled on lifestyle modifications such as dietary modification based on individualized calories, nutrient requirements, and physical activity to control weight, blood glucose, and blood pressure levels for at least 30 minutes. Food models of Ghanaian foods were used to explain recommended serving sizes of food based on the estimated individual calorie and macronutrient requirements. Diets rich in antioxidants such as fruits, vegetables, legumes, whole grains as well as fish, and nuts among others, were the integral components of the dietary counselling recommendations that were offered to the participants. Follow-up sections were made by phone call once a week by researchers and participants were to report for review sections in the dietitian's office once a month until the final re-assessment. The intervention took three (3) months and each participant was re-assessed three months after their first consultation with the dietitian. 45
Control Group No Intervention Three months It is unethical to take a patient off available treatment for research purposes; hence, the control group was taken from a hospital without a resident dietitian (Ejisu Government Hospital), where participants were not given dietetic counselling. Even though the participants did not receive dietetic counseling, they continued with their standard treatment at the wellness clinic. Participants were assessed within the same time frame as the intervention group; thus, a baseline assessment and an endline assessment which was performed three months from baseline. 45 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All adult males and females with DM, who showed willingness and satisfied the criteria below were involved in the study. 1. Patients who are 18 years and above and have been diagnosed with T2DM for at most a year prior to the beginning of data collection. 2. Patients who attend the diabetes clinic as outpatients. 3. Patients with T2DM who are receiving dietary counselling at Tafo Government Hospital (intervention group) and those not receiving dietary counselling but receiving the standard of care at the wellness clinic at Ejisu Government Hospital (control group). The exclusion criteria were as follows: 1. Patients with T2DM below 18 years. 2. Nonambulatory critically ill T2DM patients. 3. Patients with T2DM in the two selected hospitals who already had dietary counselling at other facilities. 4. Patients who, per their medical history, have conditions that contribute to oxidative stress, such as cancer, diabetic foot, various forms of ulcerations, kidney disease, and liver infection. 5. Patients with T2DM who had been consuming any antioxidant supplement at least one month prior to this study. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 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 24/02/2021 Committee on Human Research Publication and Ethics
Ethics Committee Address
Street address City Postal code Country
Kwame Nkrumah University of Science and Technology Kumasi KNUST Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The dietary counselling intervention was found to have led to a marginal improvement in nutrient intakes, blood pressure, anthropometric and biochemical parameters, and the physical activity levels of participants in the intervention group. Three months
Secondary Outcome Dietetic counselling led to a marginal reduction in hyperglycaemia, overweight, abdominal obesity, and high blood pressure in the intervention group compared to the control group at the endline. Three month
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tafo Government Hospital Tafo Hospital Road Kumasi Ghana
Ejisu Government Hospital Ejisu Hospital Road Kumasi Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
Harriet Wugah Department of Biochemistry and Biotechnology, Kwame Nkrumah University of Science and Technology Kumasi Ghana
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Harriet Wugah Department of Biochemistry and Biotechnology, Kwame Nkrumah University of Science and Teachnology Kumasi Ghana Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Harriet Wugah harrietwugah@gmail.com +233247245703 Department of Biochemistry and Biotechnology, Kwame Nkrumah University of Science and Technology
City Postal code Country Position/Affiliation
Kumasi Ghana Student
Role Name Email Phone Street address
Scientific Enquiries Collins Afriyie Appiah cappiahresearch@gmail.com +233249831437 Department of Biochemistry and Biotechnology, Kwame Nkrumah University of Science and Technology
City Postal code Country Position/Affiliation
Kumasi Ghana Supervisor
Role Name Email Phone Street address
Public Enquiries Micheal Akenteng Wiafe michael.wiafe@uds.edu.gh +233200905456 Department of Nutritional Sciences, University of Development Studies
City Postal code Country Position/Affiliation
Tamale Ghana Supervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes IPD shows data on participants' sociodemographic characteristics, physical activity, dietary intake, anthropometric and biochemical data, and nutrition status Informed Consent Form Data is available in this document Access criteria are controlled until the first publication, before then, the principal investigator should be contacted
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 19/03/2023
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 19/03/2023 Result - 19/03/2023
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information