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.: PACTR202203696996305 Date of Approval: 16/03/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Nutrition Behavioral Change Communication intervention to Pregnant Adolescents.
Official scientific title Effects of Nutrition Behavioral Change Communication on Feto-Maternal Outcomes among Pregnant Adolescents in West Arsi Zone, Central Ethiopia: Cluster Randomized Controlled Trial.
Brief summary describing the background and objectives of the trial Background: When pregnancy occurs among Adolescents, competition for nutrients happens between the fetus and still growing girl. Pregnant adolescents remain an underserved population and therefore may benefit greatly from receiving prenatal health and nutrition behavioral change intervention. There is a gap in randomized control trials on the effects of nutrition behavioral change intervention on feto-maternal outcomes (Knowledge, Dietary practice, Gestational weight gain, and Birth Weight) among pregnant Adolescents in the community setting. Moreover, the research project will explore the health care providers' roles, barriers, and facilitators that may influence the nutrition behavioral change intervention provided for pregnant. Objective: To assess the effects of nutrition Education intervention packages on Feto-maternal Outcomes among Pregnant Adolescents of West Arsi Zone, Central Ethiopia, from October 2021– July 2022
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 Prevention
Anticipated trial start date 01/11/2022
Actual trial start date 01/12/2022
Anticipated date of last follow up 14/03/2022
Actual Last follow-up date 01/11/2023
Anticipated target sample size (number of participants) 900
Actual target sample size (number of participants) 488
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
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 Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Routine nutrition education from public health facility Four times, every two Month For 8 month Routine nutrition education 244 Active-Treatment of Control Group
Experimental Group Nutrition Behavioral Change Communication Intervention Four times every two month for 8 month Community-based guided counseling using the HBM will be the intervention package for this study. It is adapted from the recommendations by World Health Organization and Ministry of Health of Ethiopia [150, 151] and the training materials from the blended Training Module on Nutritional Counseling by EFDRE/MOH on 2018 ) [61]. The core contents of the counseling guide will be increasing meal frequency and portion size with increasing gestational age. Message on taking diversified meals, animal products, fruits, and vegetables will also be one component of the counseling guide. Messages on the consumption of iron/folic acid supplements and iodized salt will be included in the core contents of the counseling guide. Additional messages of the core contents will be reducing heavy workload, taking day rest, impregnated bed net use, and utilization of health care services. Moreover, the consequences of taking inadequate nutrients, susceptibility to and severity of the consequences of insufficient nutrient intakes will also be discussed during counseling. The demonstration will be made on local soup food preparation and techniques for better retention of nutrients. Moreover, Home gardening will be thought. The benefits of taking an adequate number of diversified meals and barriers that interfere with taking a balanced diet will also be included in the counseling guide. Participants' husbands and other relevant family members will be thought nutrition education and will be thought to support pregnant Adolescents. Counseling will be given based on the identified gaps and household income. Each pregnant woman will attend four counseling sessions throughout her entire pregnancy. Individual nutrition counseling will be given through a home visit on nonworking days (religious holidays and weekends). During counseling, counselors will use a client-centered approach to identify women’s dietary practices and their specific needs in terms of nutrition. Counselors will consider women’ 244
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The study will target pregnant Adolescents before 16 weeks of gestation. Pregnant Adolescents who have no intention of leaving the study area until delivery will be included in this study. Pregnant Adolescent with series sickness which will make data collection difficult Adolescent: 13 Year-18 Year 13 Year(s) 19 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
No 16/03/2022 Jimma University IRB
Ethics Committee Address
Street address City Postal code Country
02 jimma 378 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Gestational weight gain two times
Secondary Outcome Maternal nutritional status 2
Secondary Outcome Dietary practice 2
Secondary Outcome Knowlege and Attitude on healthy nutrition during pregnancy 2
Secondary Outcome Birth weight 2
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Shashemane 02 shashemane Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
jimma university 02 jimma Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Negele hospital and medical college 02 shashemane Ethiopia Hospital
COLLABORATORS
Name Street address City Postal code Country
Negele hospital and medical college 02 shashemane Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Adane Tesfaye adanetesfaye2006@gmail.com +251916857437 02
City Postal code Country Position/Affiliation
jimma Ethiopia Lecturer
Role Name Email Phone Street address
Public Enquiries Abinet Sadore abinetarege@gmail.com +25116100682 04
City Postal code Country Position/Affiliation
jimma Ethiopia lecturer
Role Name Email Phone Street address
Scientific Enquiries Tefera Belachew teferabelachew2@gmail.com +251917804072 06
City Postal code Country Position/Affiliation
jimma Ethiopia professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) Study Protocol Beginning 9 months and ending 36 months following article publication Request to PI
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