Clinical trial NCT05502978: Education Using WhatsApp and Face-to-Face Meetings on IYCF for the Nutritional Status of Infants
Official title: Effect of Education Using WhatsApp and Face-to-Face Meetings Concerning Infant and Young Child Feeding in the COVID-19 Pandemic on the Nutritional Status of Infants: Protocol for a Prospective Interventional Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutritional Stunting
Keywords: blended education
Infant and Young Child Feeding
Nutritional status of Infant
Lead sponsor: Gadjah Mada University
Sponsor class: OTHER
First posted: 2022-08-16
Enrollment: 126
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The COVID-19 pandemic affects all activities, including stunting prevention. Almost all cities implement Internet-based learning can be used as an alternative to providing education and allows to exchange personal experiences and also establish interpersonal relationships. Education is one of the intervention efforts that aims to foster and improve the health status of the community, while counselling is a technical part of the educational process itself. blended counselling is the integration of online and offline counselling. Blended counselling is a strategy in the covid-19 pandemic condition and after pandemic. the virtual Education method has also been widely used around the world. The WhatsApp application ranks 2 among the most popular social media in Indonesia.

Blended education innovations are offered online in the form of digital booklets, videos, online discussions, and online consultations carried out via WhatsApp and offline visits according to health protocols. This blended education is expected to facilitate the work of cadres in providing Infant and young child feeding (IYCF) education, to improve IYCF practices for infant nutritional status.

Detailed description: The selection of the research group as the intervention and control group was done by random allocation. Respondents were recruited by self-selection conducted by the research team and the sampling method within the group (treatment group and control group) used was purposive sampling. Recruitment was carried out by means of respondent data obtained from community health center data. Mothers who met the criteria were then included as the research sample. The sample size in this study was determined based on the formula for hypothesis testing on the following two population averages (Lemeshow, et al, 1997). the minimum sample size for the intervention and control groups from previous studies (saleem, et al, 2014) with the results of each group the number of participants for each group of 57 participants plus 10% lost to follow-up, which is 6. the minimum number of samples is 63 samples so that the total number of a minimum sample of 126 respondents.

Participants were recruited by self-selection conducted by the research team and the sampling method within the group (intervention group and control group) used was purposive sampling. Recruitment was carried out by means of respondent data obtained from Primary health care data. Mothers who meet the criteria are then included as research samples. All eligible pregnant women who refer to primary health care for prenatal care at 36-40 weeks of gestation will be requested to participate in the study.

The study uses quantitative data collection methods to evaluate the process and outcome of blended education program. The IYCF assessment include questions regarding demographic data, including age, education, employment status, social economic status, and birth spacing for descriptive information.

The question pre-test post-test for cadres and IYCF education and counselling practice were drawn from IYCF counselling module ministry of health 2014. To assessed the quality of the trainers (research team, nutrition workers for IYCF counsellors and lactation counsellors), clarity of IYCF materials, presentations and training locations were drawn from the questionnaire developed by the researcher. The result effect education for participants by cadre assess using the questionnaire knowledge breastfeeding, responsive feeding and complementary feeding, attitude breastfeeding, self-efficacy breastfeeding and complementary-feeding. the validity and reliability of the questionnaire were tested.

The question pre-test post-test for participants using the questionnaire knowledge breastfeeding, responsive feeding and complementary feeding, attitude breastfeeding, self-efficacy breastfeeding and complementary-feeding. the validity and reliability of the questionnaire were tested. To assessed the quality of the cadre clarity of IYCF materials, presentations and WhatsApp media education were drawn from the questionnaire developed by the researcher. the research team and cadre will assess the respondent (using a questionnaire) about IYCF practice. The data taken at the time of observation were early initiation of breastfeeding, exclusive breastfeeding, breastfeeding \>6 months, complementary feeding and continued breastfeeding. Anthropometric measurements for infant nutritional status were carried out from birth to 7 months of age. Bodyweight, height, and head circumference were measured by cadres accompanied by research assistants. Measurement of weight and height using GAMAKIDS, while head circumference using a tape measure. Measurements were taken once a month at the same time, without wearing clothes.

Plan for missing data will be used regression imputation and last observation carried forward. In regression imputation, the existing variables are used to make a prediction, and then the predicted value is substituted as if an actual obtained value. This studies are performed with the longitudinal or time-series approach, in which the subjects are repeatedly measured over a series of time-points because the blended education intervention start from birth to 7 month old. This method replaces every missing value with the last observed value from the same subject. Whenever a value is missing, it is replaced with the last observed value.

Descriptive statistics will be used for baseline data. the collected data will be analyzed in the SPSS software (version 20) using descriptive statistics, such as frequency distribution tables. Also, T-test to see the difference in the average scores between the intervention group and the control group, as well as the pretest-posttest value, namely the influence of the blended education from antenatal period about IYCF on maternal knowledge, attitudes, and self-efficacy. A Chi-square test was also carried out to determine the relationship between two variables whose measurement parameters have been categorized.

One-way analysis of variance (ANOVA) will be used to the effect of blended education from antenatal period about IYCF on infant nutritional status together with knowledge, attitude, self-efficacy, and infection status. The confounding factors and the effect of modifier, stratification analysis was used mantel hanzel's test. The p value of less than 0.05 will be considered statistically significant

Eligibility criteria: Inclusion Criteria:

* Pregnant women who are currently pregnant for the first or second time
* Mother does not have chronic disease such as asthma, hypertension and coronary heart disease
* Planning to stay minimal for a year in the research area
* Having smartphone with access to internet and whatsApp messaging application

Exclusion Criteria:

* Participants who have multiple pregnancies
* After the baby was born has a congenital disease/congenital disorders
* Participants unwilling to continue with the study

Primary outcomes:
measure: Infant Nutritional status
timeFrame: birth to 7 months
measure: Infant and young child feeding practice (early initiation of breastfeeding practice)
timeFrame: at birth to one hour
measure: Infant and young child feeding practice (Exclusive breastfeeding practice)
timeFrame: at birth to 6 months
measure: Infant and young child feeding practice (complementary feeding practice)
timeFrame: 6 months to 7 months
measure: Infant and young child feeding practice (continued breastfeeding >6 month practice)
timeFrame: 6 months to 7 months
Secondary outcomes:
measure: Changes in knowledge breastfeeding
timeFrame: 37 weeks gestation to the child is 4 months
measure: Changes in attitude breastfeeding
timeFrame: 37 weeks gestation to the child is 6 months
measure: Changes in self-efficacy breastfeeding
timeFrame: 37 weeks gestation to the child is 6 months
measure: Changes in knowledge complementary feeding
timeFrame: 37 weeks gestation to the child is 7 months
measure: Changes in self-efficacy complementary feeding
timeFrame: 37 weeks gestation to the child is 7 months
measure: Changes in knowledge of cadre
timeFrame: one week
measure: Changes in practice counselling of cadre
timeFrame: 37 weeks gestation to the child is 7 months
Other outcomes:
Locations:
city: Bantul
country: Indonesia
facility: Sewon community health center
state: Yogyakarta
city: Bantul
country: Indonesia
facility: Pandak community health center
state: Yogyakarta
city: Bantul
country: Indonesia
facility: Bambanglipuro Health centre
state: Yogyakarta
Study officials:
affiliation: Gadjah Mada University
name: Siti Helmyati, ph.D
role: STUDY_DIRECTOR
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