A randomised controlled trial testing the effect of counselling via Zoom upon intake of iron and folic acid supplements, diets, and antenatal care in pregnancy in the rural plains of Nepal

INTERVENTION: Tailored virtual counselling will be conducted with pregnant women and their families by nutrition assistants (NAs) using zoom (or similar) video conferencing on tablets containing SIM cards that have prepaid mobile data packages. NAs are trained auxiliary nurse midwives (ANMs) employed by HERD International to provide counselling services to pregnant women. Using stories and inductive questioning to trigger dialogue and reflection, the NAs will encourage pregnant women and their families to think critically about the causes of anaemia in pregnancy in their households and community. Two virtual counselling sessions will be conducted with each pregnant woman, first at 12 to 28 weeks’ gestation (shortly after enrolment) and second at a minimum of 2 weeks after the first session (at around 14 to 32 weeks’ gestation). In each session, the NAs engage pregnant women and their families in a cycle of action and reflection in response to the stories and inductive questioning. Then, common issues and examples of actions that could be made will be discussed. These may include improving pregnant women’s uptake of iron and folic acid supplementation (IFA), deworming tablets, antenatal care, and improving diet, especially intake of iron‐rich foods and actions to enhance absorption of iron. Then, with the NA’s support, the pregnant women and families will make specific action plans to address the issues that are relevant for their family drawing upon examples provided by the NA where needed. In the second visit, these action plans will be reviewed and further discussed in order to support pregnant women and their families to address the issues. Then a second action plan will be drawn up for the remainder of the pregnancy. NAs will encourage pregnant w CONDITION: Prevention of iron deficiency anaemia during pregnancy ; Pregnancy and Childbirth PRIMARY OUTCOME: The proportion of pregnant women consuming IFA on at least 80% of the days (i.e. on 12 or more days out of 14 days recalled) at endline interview which will be at least two weeks after the second virtual counselling session (17‐36 weeks’ gestation). SECONDARY OUTCOME: ; All secondary outcomes will be recalled by trial participants during face‐to‐face or telephone interviews and recorded in electronic questionnaires collected at endline:; 1. Count of Antenatal (ANC) visits between enrolment and endline interview; 2. 24 hour Women’s Diet Diversity Score collected using the women’s dietary diversity score updated 2021 tool collected at endline (mean per arm); 3. Consumption of intervention‐promoted foods (green leafy veg with lemon, organ meat or and meat/fish) in the 24 hours preceding the endline interview.; 4. Practicing ways to enhance bioavailability in the 7 days preceding the at endline questionnaire. This will be scored as 1 if the pregnant woman reports having done any of the following in the previous 7 days and will otherwise be scored as 0:; ‐ using lemon or other vitamin C‐rich foods with meals,; ‐ eating sprouted grains or pulses,; ‐ avoiding tea/coffee 1 hr either side of meals,; ‐ spreading meat‐eating over two eating occasions rather than one.; 5. Knowledge of iron‐rich foods: a count of the number of iron‐rich food groups correctly recalled at the endline interview.; ; Exploratory outcomes on the impact pathway:; 1. Timing of first ANC (in completed months’ gestation) – collected at baseline if ANC has been initiated, otherwise collected at endline.; 2. Timing of first IFA (in completed weeks’ gestation) – collected at baseline if ANC has been initiated, otherwise collected at endline.; 3. Quality of Antenatal care received between baseline and endline. This will comprise a score constructed from recall of advice received, measurement of height/ weight/ blood pressure/ fetal heartbeat, tetanus vaccination, deworming tablet receipt/intake, blood and urine tests, checking position of the baby). Data will be collected at endline.; 4. Understanding of why blood tests are taken at antenatal check‐ups. Measured as the proportion of women who had a blood test at their ANC visits who could correctly explain one or more reason for having a blood test taken at the endline questionnaire.; ; Process evaluation outcomes:; 1. Acceptability and Appropriateness measured using:; 1.1 Qualitative and quantitative interviews with trial participants in the intervention arm after the intervention is complete; 1.2. Satisfaction (content, comfort, delivery, and credibility) with the antenatal virtual counselling Participation and engagement of the of the pregnant women (PW) and family members; 1.3. Focus group discussions with project staff, nutrition assistants (NAs) and data assistants (DAs), 2 times during trial implementation; 1.4. Satisfaction with the trainings/ orientation/ technical and monitoring support; 2. Effectiveness measured using quantitative interview at endline:; 2.1. Proportion of PW taking the required IFA doses in the 14 days preceding the endline interview; 2.2. Proportion of PW reporting eating diverse diet (diet diversity score) in the 24 hours preceding the endline; 2.3. Proportion of PW completing the required ANC visit for their gestation month; 2.4. Proportion of PW whose family member attended one or both of the virtual counselling sessions; 3. Feasibility; 3.1. Quantitative data extracted from trial implementation (monitoring) data filled by NAs; 3.1.1 Proportion of scheduled virtual counselling sessions not completed (cancelled/ not able to connect / not finished); 3.1.2 Number of attempts made to contact participant when intervention not possible; 3.1.3 Proportion of PW completing 2 virtual counselling sessions; 3.1.4 Reasons for cancellation of scheduled virtual counselling session (network, electricity, not charged, credit, difficulty in using tablets, not picking the phone); 3.2. Quantitative Interview at baseline; 3.2.1 Proportion of women approached with direct access to a phone/device that DA can contact them on; 3.3. Qualitative interviews with trial participants after intervention is complete; 3.3.1 Factors affecting participation in the intervention; 3.4. Focus group discussions with NAs (2 times during trial implementation) and monthly review meeting with intervention team; 3.4.1 Factors (barrier and facilitators) affecting the delivery of the intervention and corrective actions taken; 4. Fidelity measured using quantitative and qualitative observation of the virtual sessions:; 4.1. Proportion of NAs adhering to the virtual counselling manual guidance; 4.2. Proportion of NA’s delivering the session competently; 5. Implementation cost measured using quantitative data extracted from actual expenditure:; 5.1. Total intervention cost from program provider perspective (including start up and design/adaptation, and implementation costs); 5.2. Total intervention costs by line items/inputs (e.g. human resource, materials, capital, admin/joint) and activities (e.g. trainings, preparation/planning, delivering virtual counselling); 5.3. Cost of intervention per PW; 6. Coverage (reach and equity) measured using quantitative Interview with trial Participants at baseline/enrolment:; 6.1. Proportion of PW enrolled out of those approached; 6.2. Proportion of PW enrolled from different ethnic and socioeconomic groups out of those approached; 6.3. Proportion primiparous women enrolled of those approached; 6.4. Proportion of young (<18 years of age) enrolled of those approached; 7. Sustainability:; 7.1. Quantitative Interview with trial Participants at baseline/enrolment; 7.1.1 Availability of devices among pregnant women; 7.2. Quantitative post session forms filled by the attendees in the dissemination session; 7.2.1 Proportion of organizations (government and non‐governmental) attending the dissemination workshop willing to implement the intervention; INCLUSION CRITERIA: 1. Pregnant girl/woman aged between 13 to 49 years 2. Able to respond to questions 3. Resident of study cluster (whether at husband’s or parental home) 4. Less than or equal to 28 weeks’ gestation estimated from recall of last menstrual period (or expected date of delivery given by a health worker) 5. Plans not to leave the country during the follow‐up period 5 weeks since enrolment 6. Does not have another pregnant woman in her household already enrolled in the trial 7. Consents to participate in the trial