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.: PACTR202310582275172 Date of Registration: 10/10/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Post Harvest Losses Of Fruits And Vegetables along the Value Chain and its Relationship with Nutritional Status of Women And Children
Official scientific title Post Harvest Losses Of Fruits And Vegetables along the Value Chain and its Relationship with Nutritional Status of Women And Children
Brief summary describing the background and objectives of the trial According to studies, Sub-Saharan Africa yearly loses or wastes 50% of the fruits and vegetables that are produced there. About 30% to 50% of the fruits and vegetables in Ghana are wasted or lost throughout the value chain. In order to increase nutrition security, post-harvest losses of fruits and vegetables must be reduced. By doing so, nutrients that would otherwise be lost can be captured and channeled into the food system to produce healthy, lucrative, and affordable diets. This study therefore seeks to explore, among farmers, retailers, and households, the association between post-harvest loss of fruits and vegetables and nutritional status of women and children.
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 Education /Training
Anticipated trial start date 07/09/2022
Actual trial start date 06/09/2022
Anticipated date of last follow up 06/02/2023
Actual Last follow-up date 28/02/2023
Anticipated target sample size (number of participants) 240
Actual target sample size (number of participants) 210
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 by using procedures such as coin-tossing or dice-rolling Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group No intervention for 6 months There will be no intervention for the control group 70 Placebo
Experimental Group Nutrition education and counselling on food preservation methods twice weekly 6 months The intervention will be based on food preservation and storage methods in addition to nutrition education on fruits and vegetables consumption 70
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Fruits and vegetable farmers and retailers in the Ho west district. Women in their reproductive age and children aged 2- 5 years residing in the district. Farmers and retailers who do not deal in fruits and vegetables will be excluded and farmers and retailers who deal in fruits and vegetables outside the Ho west district Children with congenital disorders, disabilities and diseases (Malaria, HIV, TB, cancer, severe diarrhoae etc.) and / or requiring specialized care and hospitalization will be excluded from the study. Children with severe malnutrition (WHZ <-3SD or HAZ < -3SD) with complications that require inpatient care and tube fed children and children outside the preferred age range Pregnant women and women with diseases such Tuberculosis, malaria, HIV etc Adult: 19 Year-44 Year,Preschool Child: 2 Year-5 Year 19 Year(s) 44 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 01/08/2022 Committee of Human Research Publication and Ethics
Ethics Committee Address
Street address City Postal code Country
School of Medicine and Dentistry, KNUST Kumasi 23321 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Nutritional Status of women and children Baseline and Post intervention
Secondary Outcome Post-harvest loss along the value chain Baseline and Post Intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kpedze Community Health centre Kpedze Kpedze Ghana
Amedzofe Community Health centre Market street Amedzofe 23321 Ghana
Abutia Kissiflui Community Health Abutia Kissiflui Abutia Kissiflui Ghana
Dededo Community Health Centre Dededo Dededo 23321 Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
Personal P.O.Box AN 16798 Accra 23321 Ghana
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Benedicta Twum Dei Adenta Housing Down Accra Ghana Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Benedicta Twum Dei btd015a@hcuc.edu.gh 233242901719 Adenta housing down
City Postal code Country Position/Affiliation
Accra 23321 Ghana Doctoral Student
Role Name Email Phone Street address
Scientific Enquiries Reginald Annan reggie@imtf.org 233201237169 Private Mail Bag, University Post Office, Kumasi, Ghana
City Postal code Country Position/Affiliation
Kumasi 23321 Ghana Associate Professor
Role Name Email Phone Street address
Public Enquiries Hermann Erick Lutterodt paalutu@yahoo.com 233245972367 Private Mail Bag, University Post Office, Kumasi, Ghana
City Postal code Country Position/Affiliation
Kumasi 23321 Ghana Senior Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes In our commitment to fostering transparency, scientific collaboration, and advancing the understanding of post-harvest loss and its impact on nutritional status, we plan to share de-identified individual participant data (IPD) collected during the course of this research study. The sharing of IPD will be subject to rigorous ethical considerations, privacy safeguards, and responsible data access policies. Below, we outline the key elements of our IPD sharing plan: Data sharing access: • Access to the IPD will be granted to qualified researchers, institutions, or organizations upon formal request. • Requests for data access should be submitted to Benedicta Twum- Dei , KNUST, College of Sciences, Department of Biochemistry and Biotechnology , Kumasi . Tel 233242901719. Email: btd015a@hcuc.edu.gh and will undergo a thorough review by our KNUST Data Access Committee. • Data access will be authorized exclusively for the purpose of scientific research and will be subject to approval by the Data Access Committee. Data Protection and Privacy: • To ensure the utmost protection of the privacy and confidentiality of study participants, all IPD shared will be carefully de-identified or anonymized according to the most current data protection regulations and best practices. • Any potential risks of re-identification will be meticulously assessed and mitigated. • Researchers granted access to the data will be strictly bound by confidentiality and data usage guidelines. Informed Consent Form,Statistical Analysis Plan,Study Protocol Data sharing is anticipated to commence in December 2024, typically after the primary study outcomes have been publicly disseminated or at the conclusion of a predefined embargo period. The specific timeline is subject to potential revisions, which will be communicated promptly to interested parties. Data sharing access: • Access to the IPD will be granted to qualified researchers, institutions, or organizations upon formal request. • Requests for data access should be submitted to Benedicta Twum- Dei , KNUST, College of Sciences, Department of Biochemistry and Biotechnology , Kumasi . Tel 233242901719. Email: btd015a@hcuc.edu.gh and will undergo a thorough review by our KNUST Data Access Committee. • Data access will be authorized exclusively for the purpose of scientific research and will be subject to approval by the Data Access Committee.
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