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.: PACTR202205582468458 Date of Approval: 11/05/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Nutrition/dietary intervention impact on health outcomes
Official scientific title Impact of guided nutrition and dietary intervention on nutritional/biochemical indices of non-communicable disease patients
Brief summary describing the background and objectives of the trial The study was aimed to evaluate the impact of dietary intervention on the nutritional and biochemical indices of non-communicable disease patients. There is a paucity of evidence on diet interventions in disease management/control in Sub-Saharan Africa. Interventions will comprise nutrition counselling, therapeutic menu planning/administration, monitoring/follow up.
Type of trial RCT
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 20/10/2021
Actual trial start date 24/11/2021
Anticipated date of last follow up 20/05/2022
Actual Last follow-up date 19/08/2022
Anticipated target sample size (number of participants) 300
Actual target sample size (number of participants) 150
Recruitment status Closed to recruitment,follow-up continuing
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Dietary intervention Therapeutic menu tailored to reduce complications risks of, and improve disease condition 6months to 1 year Dietary intervention which comprised two experimental groups i) nutrition counselling and therapeutic menu planning ii) nutrition counselling, therapeutic menu planning, preparation and administration 100
Control Group Nutrition counselling Nutrition/counselling/educated repeated twice throughout the intervention duration 6 months to 1 year Nutrition counselling on food practices/diets to consumed where given to the control group 50 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Non-communicable disease patients, Adults, Admitted to the hospital Willfully consent to participate Nutrition-related conditions that may contraindicate the positive impact of the diet No evidence of non-communicable disease Outpatients Do not consent to participate Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 35 Year(s) 80 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 05/05/2022 Health Research Ethics Committe Federal Medical Centre Abeokuta
Ethics Committee Address
Street address City Postal code Country
Bisi Onabanjo way, Idi-Aba Abeokuta 44010 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The normalization of nutrition and biochemical indicators Before the intervention, 2 months after and 6 months after intervention
Secondary Outcome Anthropometry - healthy weight status is attained, biochemical indices are controlled, quality of diet is improved Before the intervention, and twice more intermittently between the intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tertiary Health Care Institution in Nigeria OAUTH, LUTH, FMC ABEOKUTA, FMC UMUAHIA, UNIVERSITY OF ABUJA TEACHING HOSPITAL, FMC ASABA, JUTH Ile Ife Idi Araba Abeokuta Umuahia Abuja Asaba Jos Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Iheme Gideon O. Department of Human Nutrition and Dietetics, MOUAU Umuahia 44010 Nigeria Self-sponsored
COLLABORATORS
Name Street address City Postal code Country
Ifeoma Egechizuorom FMC Umuahia Umuahia 44010 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Gideon Iheme ihemegideon@gmail.com +2347062691795 Department of Human Nutrition and Dietetics, MOUAU
City Postal code Country Position/Affiliation
Umuahia 44010 Nigeria Lecturer
Role Name Email Phone Street address
Public Enquiries Gideon Iheme ihemegideon@gmail.com +2347062691795 MOUAU
City Postal code Country Position/Affiliation
Umuahia 44010 Nigeria Lecture
Role Name Email Phone Street address
Scientific Enquiries Gideon Iheme ihemegideon@gmail.com +2347062691795 Department of Human Nutrition and Dietetics, MOUAU
City Postal code Country Position/Affiliation
Umuahia 44010 Nigeria Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The study protocol, statistical analysis plan, informed consent form, analytic code and summary results will be shared upon completion of this study. Analytic Code,Informed Consent Form,Statistical Analysis Plan,Study Protocol 2 years time -2024 Controlled - raw dataset (IBM SPSS format) can be requested for, data will be made available upon reasonable request to the corresponding author.
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