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.: PACTR202303722531066 Date of Approval: 31/03/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Impact of Dietary Counseling on Anthropometric Parameters, Antioxidant Nutrient Intake, and Metabolic Syndrome Parameters on Metabolic Syndrome Patients Attending Diet Therapy Clinic: A Pre-Post Non-Randomized Intervention Study.
Official scientific title Impact of Dietary Counseling on Nutritional Status, Antioxidant Nutrient Intake, and Metabolic Syndrome Parameters in People with Metabolic Syndrome Attending Diet Therapy Clinic at a Municipal Hospital In Kumasi, Ghana.
Brief summary describing the background and objectives of the trial Metabolic syndrome (MetS) has been associated with increased oxidative stress and its related complications. Studies suggest dietary approaches to increase antioxidant intake may help limit MetS-associated oxidative stress. Also, it has been suggested that nutritional status and MetS parameters can be improved by dietary counseling. In Ghana, people with MetS are routinely referred to hospital facilities for dietary counseling interventions for MetS management with a dietitian. However, there is limited data on the effect of dietary intervention on the antioxidant and oxidative stress status of people living with MetS in Ghana; thus, the purpose of this study was to explore the impact of dietary counseling on anthropometric parameters, antioxidant nutrient intakes, and MetS parameters in people living with MetS.
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 Physical activity and nutrition
Anticipated trial start date 17/03/2020
Actual trial start date 24/03/2021
Anticipated date of last follow up 30/06/2021
Actual Last follow-up date 06/07/2021
Anticipated target sample size (number of participants) 82
Actual target sample size (number of participants) 82
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 Non-randomised Central randomisation by phone/fax Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Nutrition education and counseling Three month Participants in the intervention group were offered face-to-face individualized dietary counseling by the resident dietitian per the standard protocols at the Diet Therapy Clinic. The researcher did not influence the intervention offered by the resident dietitian. Each participant was counseled on lifestyle modifications such as dietary modification based on based on individual dietary nutrients and caloric requirements, which aimed to control weight, hyperglycemia, hypertension, and dyslipidemia and increase antioxidant nutrient intake. For easy understanding and compliance, food models of Ghanaian foods were used to explain recommended serving sizes of food based on the estimated individual calorie and macronutrient requirements. A well-structured diet rich in fruits, vegetables, legumes, whole grains as well as fish, nuts, low sodium and low-fat dairy products, among others, were the integral components of the dietary counselling recommendations that were offered. In addition, participants were counseled to adopt a more physically active lifestyle to avoid excessive weight gain. The dietitian spent an average of 30-45 minutes on each participant per session. Each participant was re-assessed three months after their first consultation with the dietitians. 41
Control Group No intervention was given Three months It is unethical to take a patient off available treatment for research purposes; hence, the control group was selected from a hospital without a resident dietitian and participants were not given any dietetic counselling. Even though the participants did not receive dietetic counselling, they continued with their standard treatment at the diet clinic and a routine monthly follow-up visit. Participants were assessed within the same time frame as the intervention group; thus, at baseline and an endline assessment was performed three months from the baseline. 41 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Eligible subjects were 18–70-year-old adults. 2. Patients who had been diagnosed with MetS The diagnostic criteria were based on at least three or more of the following characteristics of the MetS by NCEP-ATP III: Below are the diagnostic criteria -Central obesity (waist circumference ≥102 cm for men and ≥88 cm for women). -Elevated triglycerides ≥1.7 mmol/l (or on pharmacological therapy). -Reduced HDL-cholesterol <1.0 mmol/l for men and <1.3 mmol/l for women - or on pharmacological therapy) -Raised BP ≥130/85 mmHg (or on pharmacological therapy). -Elevated fasting plasma glucose ≥5.6 mmol/l. (or on pharmacological therapy) 3. Patients who were receiving dietary counseling at Manhyia District Hospital (the intervention group) and those who were not receiving any dietary counseling but receiving their standard treatment at Ejisu Government Hospital (the control group). 4. Patients who gave their consent to be part of the study and were willing to follow a dietary counseling regimen for three months. Exclusion criteria included all those who; 1. Were below 18 years of age and did not meet the NCEP-ATP III criteria of MetS. 2. Were diagnosed with MetS less than a year ago and did not attend any of the hospitals under study. 3. Were non-ambulatory critically ill MetS patients whose conditions (from the patient hospital record book or folder) such as cancer, liver disease, asthma, and inflammatory disorders contribute immensely to oxidative stress. 4. MetS subjects with impaired memory or cognitive functions or the presence of mental illness causing an inability to give an appropriate or logical response to questions with the help of a psychiatrist. 5. Individuals with MetS who were on any antioxidant therapy or supplements one month prior to the study. 6. Refused to give their consent to be part of the study and refused to follow COVID-19 protocols. 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 03/03/2021 Committee on Human Research Publication and Ethics
Ethics Committee Address
Street address City Postal code Country
Room 7 Anatomy Block 3, School of Medical Sciences, Kwame Nkrumah University of Science and Technology, Kumasi Kumasi KNUST Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The provision of dietary counseling to participants in the intervention group resulted in reduced odds of high BP, hyperglycemia, hypercholesterolemia, and high low-density lipoprotein compared to participants in the control group. Dietary lifestyle change could be effective in improving the MetS parameters of patients. Moreover, the mean dietary intake of vitamins A and C significantly improved marginally among the intervention group. Adherence to dietary counseling by the participants in the intervention group was associated with increased dietary vitamin E intake at the end of the intervention. Three months
Secondary Outcome Dietary counseling intervention recipients experienced reductions in abdominal fat as evidenced by changes in their waist circumference. Also, they saw a reduction in blood pressure, and total cholesterol, and an improvement in the level of physical activity. Three months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Manhyia District Hospital Manhyia Palace Zongo road Kumasi 1906 Ghana
Ejisu Government Hospital Ejisu Market road Ejisu Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
Baba Suleman Aminu Tarkwa- Lighthouse RD Takoradi Ghana
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Baba Suleman Aminu Tarkwa RWQ Tarkoradi Ghana Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Baba Suleman Aminu aminusuleman930@gmail.com +233548043492 RWQ Tarkwa
City Postal code Country Position/Affiliation
Takoradi Ghana Student
Role Name Email Phone Street address
Scientific Enquiries Collins A. Appiah caappiah.cos@knust.edu.gh +233249831437 Department of Biochemistry and Biotechnology, KNUST, Ghana
City Postal code Country Position/Affiliation
Kumasi Ghana Supervisor
Role Name Email Phone Street address
Public Enquiries Michael Akenteng Wiafe michael.wiafe@uds.edu.gh +233200905456 Department of Nutritional Sciences School of Allied Health Sciences University for Development Studies, Tamale, Ghana
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, metabolic syndrome parameters, anthropometric and biochemical parameters, dietary intake, and nutrition status. Informed Consent Form Data available in this document and on request Until the first publication, key access criteria are controlled; before that, the principal investigator should be contacted first.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 23/03/2023
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 23/03/2023 Result - 23/03/2023
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information