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.: PACTR201804003012418 Date of Approval: 25/01/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Randomized controlled trial to study the effect of nutritional intervention from farm to feeding on gestational weight gain, anemia and child nutritio
Official scientific title Effect of Locally Formulated Complementary Food and Enhanced Homestead Food Production Interventions on Maternal, Infant and Young Child Nutritional Status in the First 1000 Days in Rural Kebeles of Harari Region, Eastern Ethiopia: A Randomized Control Trial
Brief summary describing the background and objectives of the trial Background Maternal malnutrition is a major predisposing factor for morbidity and mortality especially among African women. The consequences of poor maternal nutritional status are reflected in low pregnancy weight gain and high infant and maternal morbidity and mortality. Suboptimal infant feeding practices, poor quality of complementary foods, frequent infections and micronutrient deficiencies have largely contributed to the high stunting rate, morbidities and mortality among infants and young children in the region. Nutritional interventions that consider the local scenario in the first 1000 days from pregnancy to 2 years of a child may be needed and tested to enhance maternal weight gain, reduce maternal anemia and nutritional status of the children. Specific objectives 1.To determine the effects of LFCF intervention on child stunting (Length for age) at 12month, 18month, 24month. 2.To find out the effects of LFCF intervention on mothers gestational period weight gain at 6, 12, 18, 24month after delivery. 3.To describe the effects of LFCF intervention on mothers anemia (hemoglobin level) at 6, 12, 18, 24month after delivery. 4.To compare and contrast the effect of EHFP intervention on maternal, infant and young child dietary diversification before and after intervention. 5.To determine the effect of EHFP intervention on child stunting at 12month, 18month, 24month. 6.To illustrate the effect of enhanced homestead food production (EHFP) intervention mothers gestational period weight gain at 6, 12, 18, 24month after delivery. 7.To illustrate the effect of EHFP intervention mothers anemia (hemoglobin level)at 6, 12, 18, 24month after delivery. 8.To find out the combined effect of the two randomized trials (LFCF and EHFP) on child stunting at intermediate ages (12month, 18month, 24month). 9.To determine the combined effect of the two randomized trials (LFCF and EHFP) on mothers¿ gestational weight gain and anemia at 6, 12, 18, 24 month after delivery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) LFCF and EHFP
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine,Nutritional: Gestational period weight gain, Anemia and Child Nutrional status,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 25/06/2018
Actual trial start date
Anticipated date of last follow up 02/11/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 400
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
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 randomisation using a random table created by a computer software program Allocation will be determined by the holder of sequence who will be off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Arm 2: Locally formulated complimentary food weekly 1000 days In addition to standard care, they will be offered complimentary food processing training, complimentary food processing inputs, Nutrition education (Feeding & dietary behaviour change intervention). 100
Experimental Group Arm 3: Enhanced homestead food production weekly 1000 days In addition to standard care, they will be provided with agricultural input, Gender sensitive agriculture training (home gardening), Nutrition education (Feeding & dietary behaviour change intervention) 100
Experimental Group Arm 4: Combined LFCF & EHFP intervention weekly 1000 days In addition to standard care, they will be on combined all LFCF & EHFP intervention 100
Control Group Arm 1: Standard care (Control group weekly 1000 days Exclusive breastfeeding promotion for all infants, birth to 6 months; Strengthening MCH, ANC, & PNC services; Strengthening village health worker system (HH water treatment and safe storage, sanitation, child faces management, hand washing at critical times, exploratory play time hygiene, solid waste disposal¿) 100 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All amenorrhic mothers for at least 3 months will be screened for pregnancy by HCG test by trained midwives with the help of health extension workers in their respective households. U/S will be used to estimate appropriate gestational age Then, pregnant mothers in their first trimester (the first three months) will be included for the study Pregnant mothers who are not planning to move in the next two years will be invited to participate in the study. High risk pregnancy according to the WHO (Age <16 or >40 years); Known medical and obstetrics conditions that can affect nutritional status which exist before pregnancy New-borns from the follow-up groups with prematurity, LBW, and congenital anomalies that can affect nutritional statu 16 Year(s) 55 Year(s) Female
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 22/01/2018 Institutional Health Research Ethics Revie Committee(IHRERC), Haramaya University
Ethics Committee Address
Street address City Postal code Country
Harar, CHMS Harar 235 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Gestational period weight gain 3rd month 6th month 9th month immediately after delivery
Primary Outcome Anemia status 3rd month 6th month 9th month
Primary Outcome stunting 12th month 18th month 24th month
Secondary Outcome Household food security baseline Mid-line end-line
Secondary Outcome dietary diversification baseline mid-line end-line
Secondary Outcome women empowerment baseline mid-line end-line
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Sukul Harari region Harar Not applicable Ethiopia
Sofi Harari region Harar not applicable Ethiopia
Gelma Shira Harari region Harar Not applicable Ethiopia
Qile Harari region Harar not applicable Ethiopia
Hasen-Gay Harari region Harar Not applicable Ethiopia
Erer Harari region Harar not applicable Ethiopia
Aboker Muti Harari region Harar not applicable Ethiopia
Harawe Harari region Harar Not applicable Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Haramaya University Harar 235 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Haramaya University Oromia region Harar 235 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
Nega Assefa Haramaya University, CHMS Harar 235 Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Aklilu Abrham akliltimnathserah@gmail.com +251923276062 HU-CHMS
City Postal code Country Position/Affiliation
Harar 235 Ethiopia Haramaya University
Role Name Email Phone Street address
Public Enquiries Firehiwot Mesfin mfirehiwotm@gmail.com +251910131250 HU-CHMS
City Postal code Country Position/Affiliation
Harar 235 Ethiopia Haramaya University; Head of Human Nutrition and Welfare Theme
Role Name Email Phone Street address
Scientific Enquiries Awgichew Teshome awge12@yahoo.com +251975307122 HU-CHMS
City Postal code Country Position/Affiliation
Harar 235 Ethiopia Haramaya University
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information