Nutritional StuntingNCT05502978
Education Using WhatsApp and Face-to-Face Meetings on IYCF for the Nutritional Status of Infants
A study testing Blended education of Infant and Young Child Feeding in people with Nutritional Stunting, run by Gadjah Mada University at 3 sites in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Nutritional Stunting
- What is being tested?
- Blended education of Infant and Young Child Feeding
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 3 sitesIndonesia
- Study dates
- 7 Oct 2022to 15 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Participants who have multiple pregnancies
- After the baby was born has a congenital disease/congenital disorders
- Participants unwilling to continue with the study
Trial locations and contacts
3 sites in 1 country.
Indonesia3 sites
Sewon community health center
Bantul, Special Region of Yogyakarta, 55185
Pandak community health center
Bantul, Special Region of Yogyakarta, 55761
Bambanglipuro Health centre
Bantul, Special Region of Yogyakarta
About this study
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
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.
Read the 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
- Conditions
- Nutritional Stunting
- Being tested
- Blended education of Infant and Young Child Feeding
- Keywords
- blended education, Infant and Young Child Feeding, Nutritional status of Infant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blended education of Infant and Young Child FeedingBehavioural
Blended education is an intervention about IYCF consisting of 3 components: Education via WhatsApp group, counselling face to face, Consultation with nutritionist via WhatsApp call. In the intervention group, participants will get blended education about IYCF provided by trained cadres. Education via WhatsApp group. The implementation of this educational program was carried out for 3 meeting sessions, where previously trained cadres had distributed videos and digital booklets for IYCF material and opened a discussion session at the end of the meeting in WhatsApp group. Face to face Counselling (Home visit). The cadres conduct home visits every month when the participants have given birth until the child is 7 months old. Consultation with nutritionist via WhatsApp call. Consultations were carried out via WhatsApp calls about IYCF practice was for infants aged 1 month, 3 months, 6 and 7 months.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention group is third trimester pregnant women with 37 weeks of gestation who received blended education. Blended education is provided by cadres and nutritionists, both online and offline. Education consists of online assistance with digital booklets, videos via WhatsApp by cadres and consultation with nutritionists as well as home visits (offline/face-to-face) by cadres and the research team. One education is done during the third trimester at 37 weeks of gestation, second education is done at 38 weeks' gestation, the third education is done when the baby is 3 months old, all three of which are done online. Mother will be visited every month by cadres and the research team from birth to 7 month old. Consultation with a nutritionist is carried out via WhatsApp calls at critical times the failure rate in IYCF practice was for infants aged 1 month, 3 months, 6 and 7 months Receives: Behavioral: Blended education of Infant and Young Child Feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant Nutritional status
The baby's body condition is determined by the TB/U indicator (according to the WHO-MGRS standard book), nominal scale, body lenght measurement using Infantometer,1=stunting if TB/U <-2 SD 2= not stunting if TB/U -2 SD to < 3 SD, The higher scores mean a better nutritional status of infant
Measured: birth to 7 months
Infant and young child feeding practice (early initiation of breastfeeding practice)
The process of breastfeeding that begins as soon as possible, immediately after birth by allowing the baby to make skin-to-skin contact with the mother's skin for at least the first hour after birth, nominal scale, Measurement using a questionnaire
Measured: at birth to one hour
Infant and young child feeding practice (Exclusive breastfeeding practice)
The mother's behaviour is to give only breast milk without any additional food/drink, except for drugs or vitamins from birth to 6 months of age. nominal scale. Measurement using a questionnaire
Measured: at birth to 6 months
Infant and young child feeding practice (complementary feeding practice)
Complementary feeding activities are carried out by providing food at the right time and adequate in terms of quantity, ratio scale, measurement using a questionnaire,The higher scores mean a better practice complementary feeding.
Measured: 6 months to 7 months
Infant and young child feeding practice (continued breastfeeding >6 month practice)
Breastfeeding at the age of > 6 months as an additional consumption of complementary foods for breast milk, ordinal scale, measurement using a questionnaire, not good=given <10 times, good=given >10 times,The higher scores mean a better practice
Measured: 6 months to 7 months
Secondary outcomes (7)
Changes in knowledge breastfeeding
Ability to give precise answers to questions regarding breastfeeding, interval scale,measurement using a questionnaire totaling 15 items. The value is Poor knowledge (0-10), enough knowledge (11-20), Good knowledge (21-30). The higher scores mean a better knowledge about breastfeeding
Measured: 37 weeks gestation to the child is 4 months
Changes in attitude breastfeeding
Responses to breastfeeding in the cognitive, affective and psychomotor domains. All items are measured using a 4-point Likert scale, interval scale, measurement using a questionnaire
Measured: 37 weeks gestation to the child is 6 months
Changes in self-efficacy breastfeeding
Self-efficacy breastfeeding measurement is the score obtained by the research subjects through the responses given to the Breastfeeding Self Efficacy Scale Short Form (BSES-SF) scale, BSES consist of 14 items, ordinal scale, measurement using a questionnaire,The higher score of the the self-efficacy, the better the respondent's self-efficacy
Measured: 37 weeks gestation to the child is 6 months
Changes in knowledge complementary feeding
Ability to give correct answers to questions regarding complementary feeding, interval scale,measurement using a questionnaire totaling 20 items. The value is Poor knowledge (0-13), enough knowledge (14-27), Good knowledge (28-49). The higher scores mean a better knowledge about complementary feeding.
Measured: 37 weeks gestation to the child is 7 months
Changes in self-efficacy complementary feeding
Self-efficacy complementary feeding is mother's belief and confidence to carry out complementary feeding activities by providing food at the right and adequate time. ratio scale, measurement using a questionnaire,The higher score of the self-efficacy, the better the respondent's self-efficacy
Measured: 37 weeks gestation to the child is 7 months
Changes in knowledge of cadre
Knowledge measurement is ability to provide precise answers to questions regarding about infant and young child feeding,Interval scale, measurement using a questionnaire totalling 15 items.The value is Poor knowledge (1-5), enough knowledge (6-10), Good knowledge (11-15). The higher scores mean a better knowledge of cadres.
Measured: one week
Changes in practice counselling of cadre
Practice is the ability of cadres to provide counselling to participants, interval scale, measurement using a questionnaire totalling 26 items. The value is poor practice (0-8), enough practice (9-17), good practice (18-26). The higher scores mean a better practice counselling of cadres.
Measured: 37 weeks gestation to the child is 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start7 Oct 2022
- Primary completion15 Jul 2023
- Study completion15 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Nutritional StuntingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gadjah Mada University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eka Nurhayati, Gadjah Mada University
- Investigators
- Siti Helmyati, ph.D, Study director, Gadjah Mada University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05502978
- Sponsor's protocol ID
- 110289
- Status last verified
- Sep 2023
- First submitted
- 9 Aug 2022
- Last updated
- 15 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Epstein A, Moucheraud C, Sarma H, Rahman M, Tariqujjaman M, Ahmed T, Glenn J, Bossert T, Kruk ME. Does health worker performance affect clients' health behaviors? A multilevel analysis from Bangladesh. BMC Health Serv Res. 2019 Jul 24;19(1):516. doi: 10.1186/s12913-019-4205-z.
PubMed 31340809Mousavi SR, Amiri-Farahani L, Hasanpoor-Azghady SB, Saravi SO. Comparing the effect of in-person and virtual childbirth preparation trainings on the fear of childbirth (FOC) and pregnancy experience of pregnant women: protocol for a quasi-experimental feasibility study. Pilot Feasibility Stud. 2021 Nov 5;7(1):194. doi: 10.1186/s40814-021-00933-w.
PubMed 34740371Susiloretni KA, Hadi H, Prabandari YS, Soenarto YS, Wilopo SA. What works to improve duration of exclusive breastfeeding: lessons from the exclusive breastfeeding promotion program in rural Indonesia. Matern Child Health J. 2015 Jul;19(7):1515-25. doi: 10.1007/s10995-014-1656-z.
PubMed 25487415Susiloretni KA, Hadi H, Blakstad MM, Smith ER, Shankar AH. Does exclusive breastfeeding relate to the longer duration of breastfeeding? A prospective cohort study. Midwifery. 2019 Feb;69:163-171. doi: 10.1016/j.midw.2018.11.008. Epub 2018 Nov 19.
PubMed 30522038Kang H. The prevention and handling of the missing data. Korean J Anesthesiol. 2013 May;64(5):402-6. doi: 10.4097/kjae.2013.64.5.402. Epub 2013 May 24.
PubMed 23741561Saleem AF, Mahmud S, Baig-Ansari N, Zaidi AK. Impact of maternal education about complementary feeding on their infants' nutritional outcomes in low- and middle-income households: a community-based randomized interventional study in Karachi, Pakistan. J Health Popul Nutr. 2014 Dec;32(4):623-33.
PubMed 25895196Hosmer DW, Hosmer T, Le Cessie S, Lemeshow S. A comparison of goodness-of-fit tests for the logistic regression model. Stat Med. 1997 May 15;16(9):965-80. doi: 10.1002/(sici)1097-0258(19970515)16:93.0.co;2-o.
PubMed 9160492
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05502978
- Acronym / sponsor ID
- 110289
- Conditions
- Nutritional Stunting
- Keywords
- blended education, Infant and Young Child Feeding, Nutritional status of Infant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Gadjah Mada UniversityUniversity, hospital or other
- Study start
- 7 Oct 2022 (actual)
- Primary completion
- 15 Jul 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 16 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Blended education of Infant and Young Child FeedingThe intervention group is third trimester pregnant women with 37 weeks of gestation who received blended education. Blended education is provided by cadres and nutritionists, both online and offline. Education consists of online assistance with digital booklets, videos via WhatsApp by cadres and consultation with nutritionists as well as home visits (offline/face-to-face) by cadres and the research team. One education is done during the third trimester at 37 weeks of gestation, second education is done at 38 weeks' gestation, the third education is done when the baby is 3 months old, all three of which are done online. Mother will be visited every month by cadres and the research team from birth to 7 month old. Consultation with a nutritionist is carried out via WhatsApp calls at critical times the failure rate in IYCF practice was for infants aged 1 month, 3 months, 6 and 7 months |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Participants who have multiple pregnancies
- After the baby was born has a congenital disease/congenital disorders
- Participants unwilling to continue with the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blended education of Infant and Young Child FeedingBlended education is an intervention about IYCF consisting of 3 components: Education via WhatsApp group, counselling face to face, Consultation with nutritionist via WhatsApp call. In the intervention group, participants will get blended education about IYCF provided by trained cadres. Education via WhatsApp group. The implementation of this educational program was carried out for 3 meeting sessions, where previously trained cadres had distributed videos and digital booklets for IYCF material and opened a discussion session at the end of the meeting in WhatsApp group. Face to face Counselling (Home visit). The cadres conduct home visits every month when the participants have given birth until the child is 7 months old. Consultation with nutritionist via WhatsApp call. Consultations were carried out via WhatsApp calls about IYCF practice was for infants aged 1 month, 3 months, 6 and 7 months. | Behavioural | Intervention group |
Primary outcome
Infant Nutritional status
Time frame: birth to 7 months
The baby's body condition is determined by the TB/U indicator (according to the WHO-MGRS standard book), nominal scale, body lenght measurement using Infantometer,1=stunting if TB/U <-2 SD 2= not stunting if TB/U -2 SD to < 3 SD, The higher scores mean a better nutritional status of infant
Infant and young child feeding practice (early initiation of breastfeeding practice)
Time frame: at birth to one hour
The process of breastfeeding that begins as soon as possible, immediately after birth by allowing the baby to make skin-to-skin contact with the mother's skin for at least the first hour after birth, nominal scale, Measurement using a questionnaire
Infant and young child feeding practice (Exclusive breastfeeding practice)
Time frame: at birth to 6 months
The mother's behaviour is to give only breast milk without any additional food/drink, except for drugs or vitamins from birth to 6 months of age. nominal scale. Measurement using a questionnaire
Infant and young child feeding practice (complementary feeding practice)
Time frame: 6 months to 7 months
Complementary feeding activities are carried out by providing food at the right time and adequate in terms of quantity, ratio scale, measurement using a questionnaire,The higher scores mean a better practice complementary feeding.
Infant and young child feeding practice (continued breastfeeding >6 month practice)
Time frame: 6 months to 7 months
Breastfeeding at the age of > 6 months as an additional consumption of complementary foods for breast milk, ordinal scale, measurement using a questionnaire, not good=given <10 times, good=given >10 times,The higher scores mean a better practice
7 secondary outcomes
Changes in knowledge breastfeeding
Time frame: 37 weeks gestation to the child is 4 months
Changes in attitude breastfeeding
Time frame: 37 weeks gestation to the child is 6 months
Changes in self-efficacy breastfeeding
Time frame: 37 weeks gestation to the child is 6 months
Changes in knowledge complementary feeding
Time frame: 37 weeks gestation to the child is 7 months
Changes in self-efficacy complementary feeding
Time frame: 37 weeks gestation to the child is 7 months
Changes in knowledge of cadre
Time frame: one week
Changes in practice counselling of cadre
Time frame: 37 weeks gestation to the child is 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
- Results publication: PubMed 31340809Epstein A, Moucheraud C, Sarma H, Rahman M, Tariqujjaman M, Ahmed T, Glenn J, Bossert T, Kruk ME. Does health worker performance affect clients' health behaviors? A multilevel analysis from Bangladesh. BMC Health Serv Res. 2019 Jul 24;19(1):516. doi: 10.1186/s12913-019-4205-z.
- Results publication: PubMed 34740371Mousavi SR, Amiri-Farahani L, Hasanpoor-Azghady SB, Saravi SO. Comparing the effect of in-person and virtual childbirth preparation trainings on the fear of childbirth (FOC) and pregnancy experience of pregnant women: protocol for a quasi-experimental feasibility study. Pilot Feasibility Stud. 2021 Nov 5;7(1):194. doi: 10.1186/s40814-021-00933-w.
- Results publication: PubMed 25487415Susiloretni KA, Hadi H, Prabandari YS, Soenarto YS, Wilopo SA. What works to improve duration of exclusive breastfeeding: lessons from the exclusive breastfeeding promotion program in rural Indonesia. Matern Child Health J. 2015 Jul;19(7):1515-25. doi: 10.1007/s10995-014-1656-z.
- Results publication: PubMed 30522038Susiloretni KA, Hadi H, Blakstad MM, Smith ER, Shankar AH. Does exclusive breastfeeding relate to the longer duration of breastfeeding? A prospective cohort study. Midwifery. 2019 Feb;69:163-171. doi: 10.1016/j.midw.2018.11.008. Epub 2018 Nov 19.
- Results publication: PubMed 23741561Kang H. The prevention and handling of the missing data. Korean J Anesthesiol. 2013 May;64(5):402-6. doi: 10.4097/kjae.2013.64.5.402. Epub 2013 May 24.
- Results publication: PubMed 25895196Saleem AF, Mahmud S, Baig-Ansari N, Zaidi AK. Impact of maternal education about complementary feeding on their infants' nutritional outcomes in low- and middle-income households: a community-based randomized interventional study in Karachi, Pakistan. J Health Popul Nutr. 2014 Dec;32(4):623-33.
- Results publication: PubMed 9160492Hosmer DW, Hosmer T, Le Cessie S, Lemeshow S. A comparison of goodness-of-fit tests for the logistic regression model. Stat Med. 1997 May 15;16(9):965-80. doi: 10.1002/(sici)1097-0258(19970515)16:93.0.co;2-o.
- Blended counselling a means of supporting students University of Eastern FinlandLink provided by the sponsor.
- UNICEF/WHO/World Bank Group Joint Child Malnutrition EstimatesLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Siti Helmyati, ph.D study director
Gadjah Mada University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blended education of Infant and Young Child Feeding in people with Nutritional Stunting, run by Gadjah Mada University at 3 sites in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infant Nutritional status (time frame: birth to 7 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05502978, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2023.