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.: PACTR202403582838150 Date of Approval: 12/03/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Impacts of Nutrition Education on Cardiometabolic Parameters of Newly Diagnosed Persons with Abnormal Glucose Tolerance in Cape Coast Metropolis, Ghana
Official scientific title Diabetes Diagnosis and Remission: A Nutrition Education and Cardiometabolic Health Outcomes Assessment Trial (NECHOA Trial)
Brief summary describing the background and objectives of the trial Cardiometabolic disorders, encompassing cardiovascular disease, type 2 diabetes mellitus, and obesity, persist as a global health dilemma, exerting an influence on individuals, communities, and healthcare systems. The escalating prevalence of abnormal glucose tolerance, a precursor to several cardiometabolic disorders, is of particular concern. In Ghana, like numerous other nations, the burden of abnormal glucose tolerance has been steadily mounting, thereby presenting significant implications for public health. Considering this, there is an imperative need for effective strategies to tackle this issue. Nutrition education has emerged as a crucial tool for empowering individuals with abnormal glucose tolerance to make well-informed dietary choices and enhance cardiometabolic health outcomes. However, the success of nutrition education interventions hinges on the way messages are framed and conveyed to the target population. The operation of communication framing, comprising the content and delivery of data, plays a key role in shaping individuals' perceptions, attitudes, and behaviors regarding their well-being. The present study sought to delve into the interaction between nutrition education and message framing on the cardiometabolic health outcomes of individuals newly diagnosed with abnormal glucose tolerance between the ages of 25 and 70 in the Cape Coast Metropolis of Ghana using a randomized control trial (RCT). It is a study that steered the convergence of health communication, behavioral psychology, and public health in an effort to expound on how tailored nutrition education message framing can influence the decision-making and health behaviors of this particular group. The objectives are to determine if nutrition education message framing will have a significant effect on cardiometabolic health outcomes and if sociodemographic characteristics will moderate the effect of nutrition education compliance on cardiometabolic health outcomes.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) CarMeR Study
Disease(s) or condition(s) being studied Circulatory System,Digestive System,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 12/09/2022
Actual trial start date 06/03/2023
Anticipated date of last follow up 05/12/2022
Actual Last follow-up date 29/05/2023
Anticipated target sample size (number of participants) 46
Actual target sample size (number of participants) 51
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 Nutrition Education with Message Framing Intervention Participants will receive in person nutrition education each month for the length of the intervention. Concurrently, they will be receiving text messages via WhatsApp and SMS every week and they will be called on their cell phones every fortnight with the same message given to them during the face to face intervention to serve as reminders and cues for action. 12 weeks During the intervention phase, positive and negative message framing were designed for the participants after recruitment (diagnosed with abnormal glucose tolerance) which was incorporated with the nutrition education after being assigned to their various groups. The first experimental group received individualized nutrition education pertaining to foods frequently consumed combined with negative message framing where the loss or harm people will experience when they fail to adopt these healthy dietary practices were accentuated. For instance: "The consequences of poor dietary choices with diabetes can be challenging. Make the right decisions to avoid unnecessary complications like eye problems (retinopathy), Diabetes foot problems are serious and can lead to amputation if untreated, Heart attack and stroke, Kidney problems (nephropathy), Nerve damage (neuropathy), Gum disease and other mouth problems and other related conditions, like cancer, sexual weakness and female in reproductive age will have negative maternal and child outcomes. "Remember that your food choices directly impact your glucose levels. Don't let unhealthy habits jeopardize your health." "Preventing negative outcomes starts with your diet. Take control today to safeguard your future." '' Diabetes kills, eat right and healthy'' As part of the nutrition education, participants were encouraged to: Eat three (3) regular meals per day, eat fiber rich foods, cut down on fried and fatty foods, avoid absolute fasting, pastries, fatty meats, very oily foods, salty or sodium rich foods, refined carbohydrates, sugary foods and beverages and processed foods Again, individualized meal plan was designed for each participant based on their diet history and food preferences taking into account, portion sizes and frequency. 17
Experimental Group Nutrition Education with Message Framing Intervention Participants will receive in-person nutrition education each month for the length of the intervention. Concurrently, they will be receiving text messages via WhatsApp and SMS every week and they will be called on their cell phones every fortnight with the same message given to them during the face-to-face intervention to serve as reminders and cues for action. 12 Weeks The second experimental group received individualized nutrition education pertaining to foods frequently consumed combined with positive message framing where the benefits people will experience when they adopt these healthy dietary practices were accentuated. Messages like: '' Eating three (3) regular meals per day, eating more high fiber foods such as but not limited to fruits, vegetables, whole grain bread and cereals, cutting down on fried and fatty foods, avoiding absolute fasting, pastries, fatty meats, very oily foods, salty or sodium rich foods, refined carbohydrates, sugary foods and beverages, processed foods helps to reduce blood glucose by helping keep your blood sugar levels in your target range as much as possible to help prevent or delay long-term, serious health problems, such as heart disease, vision loss, and kidney disease.'' ''Staying in your target range can also help improve your energy and mood and it also helps to manage your weight and reverse insulin resistance thereby improving your quality of life were some of the benefits included whiles giving the education'' As part of the education, individualized meal plans were designed for participants based on their diet history and food preferences. A sample meal plan was used for all the three groups to help tailor meal plans to meet individual needs. 17
Control Group Nutrition Education with Message Framing Intervention Participants will receive in-person nutrition education each month for the length of the intervention. Concurrently, they will be receiving text messages via WhatsApp and SMS every week and they will be called on their cell phones every fortnight with the same education given to them during the face-to-face intervention to serve as reminders and cues for action. 12 Weeks Participants are given only the nutrition education without message framing. They are encouraged to: • Eat three (3) regular meals per day with reduced portion sizes • Eat more high fiber foods e.g. Vegetables, whole grain bread and cereals • Cut down on fried and fatty foods • Avoid absolute fasting • Avoid pastries, fatty meats, very oily foods, salty or sodium rich foods • Avoid refined carbohydrates, sugary foods and beverages • Avoid processed foods among others In addition to this, individualized meal plan were designed for participants based on their diet history and food preferences for all the three groups. Below is a sample of the meal plan that was tailored to meet the individual needs of the people: BREAKFAST (6:00 – 8:00 AM) Slices brown bread + unseived corn porridge/, Oats, Tom Brown, Wheat or Brown rice Porridge, Decaffeinated tea Any of above plus: Low fat milk, vegetable salad, sweetener Mid-Morning Snack: (9: 00 – 10: 00 AM) A serving of fresh fruit, 1 medium size orange or apple, small size mango or 1 local sz, ½ medium sz pawpaw/ ¼ medium sz. local pineapple / 1 big banana or 2 small fingers / 1 fresh soft coconut with its water / 6 normal sz. fresh grapes /1 glass (250 ml) of fresh fruit juice Lunch: (11:00 – 2:00) Rice (Brown or polished and wheat), Banku/kenkey (fante)/Tz, Fufu, Yam, Apem, Cocoyam, Beans with accompaniments Plus Soups: Light soup with cut vegetables, Okro or kontonmire soup, Palm nut / groundnut soup (once a week) or Vegetable stews (less oil) Plus Proteins: Fish – salmon/mackerel/cassava fish/herrings, Tilapia/red fish, Snail, Lean meat, Egg Afternoon Snack: (2:00 – 3:00 PM)........................ Same as 9AM Dinner: (3:00 – 6:00 PM) Same as lunch or breakfast Evening Snack (if needed) Note: Portion sizes must be reduced 17 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 have given informed 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. 6. People on high cholesterol medications. 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 Compliance to a nutrition education intervention significantly improves cardiometabolic outcomes specifically, blood glucose levels, lipid profiles, Body Mass Index BMI and blood pressure in an African population with abnormal glucose tolerance. This outcome seeks to assess the difference in cardiometabolic health parameters before and after the nutrition education has been completed by the participants and at the same time to ascertain which type of message framing among the three groups led to more improved cardiometabolic health outcomes. The dependent variable in this outcome is the cardiometabolic health outcomes of the participants, and the independent variable is the nutrition education message framing. To analyze this, multinomial regression analysis will be used on three cardiometabolic outcomes: BMI, blood glucose levels and blood pressure. Where the last cardiometabolic outcome, which is lipid profile, will be analyzed using linear regression. Nutrition education message framing which is the independent variable will be categorized at three levels (Positive-framed, Negative-framed and non-frame) respectively and dependent variables like BMI will be categorized into groups "Normal Weight," "Overweight," and "Obese." Blood glucose levels will be categorized into normal, prediabetes and diabetes, blood pressure will also be categorized into normal, prehypertension and hypertension. Linear regression will be used to analyze the impact of Nutrition Education Message Framing on lipid profile which will be measured on a continuous scale. At the end of the intervention
Secondary Outcome Sociodemographic characteristics will moderate the effect of nutrition education compliance on cardiometabolic health outcomes among African population with abnormal glucose tolerance. The purpose is to examine whether the combined influence of sociodemographic characteristics and nutrition education compliance has a significant impact on cardiometabolic health outcomes. This outcome suggests that considering both sociodemographic factors and adherence to nutrition education may provide a more comprehensive understanding of their collective effect on health. Analysis will be done using Multinomial Regression and linear regression. Where data on sociodemographic characteristics (educational level, wealth status and age), nutrition education compliance, and cardiometabolic health outcomes will be defined and operationalized. For nutrition education compliance, a binary variable indicating adherence or non-adherence will be most appropriate. And linear regression analysis will be done on the lipid profile which is on a continuous scale (LDL, HDL, Total cholesterol) against the independent variables. 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
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Juliet Elikem Paku juliet.paku001@stu.ucc.edu.gh +233558151229 School bus Road
City Postal code Country Position/Affiliation
Cape Coast 00233 Ghana Research Associate
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 00233 Ghana Senior Lecturer
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 0233 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 "Impacts of Nutrition Education on Cardiometabolic Parameters of Newly Diagnosed Persons with Abnormal Glucose Tolerance in 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 "Impacts of Nutrition Education on Cardiometabolic Parameters of Newly Diagnosed Persons with Abnormal Glucose Tolerance in Cape Coast Metropolis, Ghana" will be granted to researchers, investigators, and collaborating entities who meet the following key access criteria: 1. Acceptable Intent for Research Purpose: Access will be provided to individuals or groups with a clear and legitimate research intent. 2. Ethical Approval: Researchers seeking access must have obtained appropriate ethical approvals from their respective institutional review boards or ethics committees, ensuring that their research adheres to established ethical standards. 3. Transparency and Reproducibility: Access will be granted to those committed to transparency and reproducibility in research. 4. Compliance with Data Sharing Protocols: Researchers must agree to comply with the predefined data-sharing protocols and guidelines established by the primary research team. 5. Collaborative Engagement: Preference will be given to researchers who express a willingness to collaborate with the primary research team.
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