Birth WeightNCT05712629
The Effect of Functional Bread Dadih on Microbiota Profile of Weight Increase Pregnant Women and Infant Birth Weight
A study testing Bread and vla dadiah and Bread and vla without dadiah in people with Birth Weight and Pregnancy Weight Gain, run by Andalas University at 1 site in Indonesia.
Trial summary
The aims of study to determine the effect of giving functional bread and dadih's vla on weight gain of pregnant women and birth weight of babies. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Birth Weight, Pregnancy Weight Gain
- What is being tested?
- Bread and vla dadiah and Bread and vla without dadiah
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteIndonesia
- Study dates
- 12 Apr 2022to 20 Dec 2022
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Mothers with gestational 12 - 20 weeks
- Health Conditions
- Not moving home until delivery labour
- Not suffering from syndrome metabolic diseases
Who cannot join
- Not willing and signing an informed consent, and not willing to consume fungtional bread and dadih's vla or dadih sauce until delivery.
- Abortus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Functional Bread Dadih During Pregnancy and Health Outcomes
The aims of study to determine the effect of giving functional bread and dadih's vla on weight gain of pregnant women and birth weight of babies.
Read the detailed description
Dadih contains BAL 108 CFU/ml which is probiotic. Consumption of functional bread and dadih's vla during pregnancy can improve the composition of the gut microbiota so that it can increase maternal weight and provide adequate nutrition during pregnancy. Good nutrient absorption can support good nutritional status and weight in babies who are born. This study aims to determine the effect of giving functional bread and dadih's vla on weight gain of pregnant women and birth weight of babies.
This study used a randomized controlled trial (RCT) design with a population of all pregnant women in the Kuranji, Nanggalo and Andalas Health Centers. The sample consisted of 88 people and was divided into two groups, namely the intervention group and the control group. Each amounted to 44 samples. The sample selection used the double-blind method and randomized controlled trial (RCT) research design. The intervention started at about 12-20 weeks of gestation and continued until just before the time of delivery. In the third trimester, subjects received healthy food, breastfeeding practices, and child development education to support mothers in maintaining their nutritional status, preparing exclusive breastfeeding, and optimizing child development.
Healthy babies born to mothers will be the focus of this study and followed up until the age of three months to assess their growth. The information includes the baby's health history after birth, anthropometric measurements, nutritional intake, and breastfeeding practices which are measured repeatedly in the first, second, and third months.
Data quality assurance is carried out through training starting from the period of data collection and supervision during and after data collection, including the data analysis process. This included training for enumerators, subjects and using a validated questionnaire for a group of subjects representing similar characteristics for this study. Data input and cleaning process will use excel and SPSS while for food intake data using NutriSurvey 2007. Data entry will be carried out by data collection officers after data collection. The data cleaning process includes removing outliers and regrouping multiple results that have similar meanings. The data will be interpreted as mean ± standard deviation if the data is normally distributed and the median (min-max) if the data is not normally distributed. Statistical analysis using SPSS 25 and data will be analyzed using univariate and bivariate analysis. Univariate analysis is used to describe characteristics and socio-demographics, medical history, pregnancy, and obstetric profiles of pregnant women. Numerical variables between groups will be analyzed using an Independent sample t-test if the data has normal distribution or the Mann Whitney test if the data distribution is not normal. Categorical variables between groups will be analyzed using Chi-square or Fisher test. Differences between birth and 3 months old follow up will be analyzed using independent t-tests if the data distribution has normal distribution or Mann Whitney test if the data distribution is not normal.
- Conditions
- Birth Weight, Pregnancy Weight Gain
- Being tested
- Bread and vla dadiah, Bread and vla without dadiah
- Keywords
- Functional Bread, Weight Increase, Infant Weight
- Medical subject headings
- Birth Weight, Gestational Weight Gain, Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bread and vla dadiahOther
Consumption bread and vla dadiah to pregnant women 1 Pieces a day during 12 weeks.
Bread and vla without dadiahOther
Consumption bread and vla without dadiah to pregnant women 1 Pieces a day during 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Responden Intervention | Active comparator | Arm 1 (Interventional) : Respondent has given bread with composit flour and vla with dadiah. pregnant women received 1 pieces bread containing 50 gram provide total fat 4 gram, protein 5 gram, carbohydrate 23.8 gram, Fe 2 mg, 2150 kcal and vla dadiah containing 30 gram provide 308 kcal. Receives: Other: Bread and vla dadiah |
| Responden Placebo | Placebo comparator | Arm 2 (Placebo) : Respondent has given bread with original flour (wheat flour) and vla original without dadiah. pregnant women received 1 pieces bread containing 50 gram and vla containing 30 gram. Receives: Other: Bread and vla without dadiah |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Weight Pregnant Woman Measurement
Measuring Body Weight Pregnant Woman Baseline, 1St Measurement, 2nd Measurement, and 3rd Measurement (Weight in Kilograms)
Measured: 12 weeks
Body Height Pregnant Woman Measurement
Measuring Body Height Pregnant Woman Baseline, 1St Measurement, 2nd Measurement, and 3rd Measurement (Height in Meters or Centimeters)
Measured: 12 weeks
Body Mass Index Pregnant Woman Measurement
Measuring Body Height Pregnant Woman Baseline, 1St Measurement, 2nd Measurement, and 3rd Measurement (BMI in Kg/m^2)
Measured: 12 weeks
Birth Weight of Infant Measurement
Measuring weight of infant (Weight in Grams)
Measured: 9 months
Birth Length of Infant Measurement
Measuring Birth Length of infant (Length or height in Centimeters)
Measured: 9 months
Secondary outcomes (1)
Characteristic of Woman Pregnancy
Description of Characteristic respondent are Mother's tribe, mother's education, mother's job, mother's knowledge, family income, age, and gestational weeks
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2023
- Study start12 Apr 2022
- Primary completion20 Sep 2022
- Study completion20 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Birth WeightStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andalas University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
- Responsible party
- Principal investigator, Dr. Helmizar, SKM, M.Biomed, Andalas University
- Investigators
- Helmizar Helmizar, DR, Principal investigator, Nutrition Department Faculty of Universitas AndalasAzrimaidaliza Azrimaidaliza, DR, Study director, Department Nutrition Faculty of Universitas AndalasFerdinal Ferry, DR, Study director, Department Obstetry and Gynecology of Universitas AndalasFrima Elda, DR, Study director, Department Nutrition Faculty of Universitas AndalasAsrawati Asrawati, DR, Study director, Department Pediatric of Universitas Andalas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05712629
- Sponsor's protocol ID
- HL
- Status last verified
- Feb 2023
- First submitted
- 3 Jan 2023
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wijayanti, IA, Purwadi, P., & Thohari, I. (2017). The Effect of Adding Sago Flour to Yoghurt on the Physical Properties of Yoghurt Ice Cream. Journal of Animal Products Science and Technology (JITEK), 11(1), 38-45.
Wijayanti, MDS, Thohari, I., & Purwadi, P. 2017. Quality of curd in goat's milk incubated on various kinds of bamboo. Journal of Animal Products Science and Technology (JITEK), 11(1), 22-37.
Astuti, S.D., Andarwulan, N., Hariyadi, P. and Agustia, F.C., 2014. Formulasi dan karakterisasi cake berbasis tepung komposit organik kacang merah, kedelai, dan jagung. Jurnal Aplikasi Teknologi Pangan, 3(2).
Black, R.E. and Hopkins Bloomberg, J., 2008. The lancet series on maternal and child Undernutrition, executive summary. Lancet, 371, pp.1-10.
Brown KH, Peerson JM, Rivera J, Allen LH. Effect of supplemental zinc on the growth and serum zinc concentrations of prepubertal children: a meta-analysis of randomized controlled trials. Am J Clin Nutr. 2002 Jun;75(6):1062-71. doi: 10.1093/ajcn/75.6.1062.
PubMed 12036814Collado MC, Surono IS, Meriluoto J, Salminen S. Potential probiotic characteristics of Lactobacillus and Enterococcus strains isolated from traditional dadih fermented milk against pathogen intestinal colonization. J Food Prot. 2007 Mar;70(3):700-5. doi: 10.4315/0362-028x-70.3.700.
PubMed 17388062Caulfield, L.E., Huffman, S.L. and Piwoz, E.G., 1999. Interventions to improve intake of complementary foods by infants 6 to 12 months of age in developing countries: impact on growth and on the prevalence of malnutrition and potential contribution to child survival. Food and nutrition bulletin, 20(2), pp.183-200.
Young Child Nutrition Working Group: Formulation Subgroup. Formulations for fortified complementary foods and supplements: review of successful products for improving the nutritional status of infants and young children. Food Nutr Bull. 2009 Jun;30(2 Suppl):S239-55. No abstract available.
PubMed 20496618Dijkhuizen MA, Wieringa FT, West CE, Martuti S, Muhilal. Effects of iron and zinc supplementation in Indonesian infants on micronutrient status and growth. J Nutr. 2001 Nov;131(11):2860-5. doi: 10.1093/jn/131.11.2860.
PubMed 11694609Fahmida U, Rumawas JS, Utomo B, Patmonodewo S, Schultink W. Zinc-iron, but not zinc-alone supplementation, increased linear growth of stunted infants with low haemoglobin. Asia Pac J Clin Nutr. 2007;16(2):301-9.
PubMed 17468087Helmizar H, Jalal F, Lipoeto NI, Achadi EL. Local food supplementation and psychosocial stimulation improve linear growth and cognitive development among Indonesian infants aged 6 to 9 months. Asia Pac J Clin Nutr. 2017 Jan;26(1):97-103. doi: 10.6133/apjcn.102015.10.
PubMed 28049268Hess SY, Lonnerdal B, Hotz C, Rivera JA, Brown KH. Recent advances in knowledge of zinc nutrition and human health. Food Nutr Bull. 2009 Mar;30(1 Suppl):S5-11. doi: 10.1177/15648265090301S102.
PubMed 19472599Hoj S, Fredholm M, Larsen NJ, Nielsen VH. Growth hormone gene polymorphism associated with selection for milk fat production in lines of cattle. Anim Genet. 1993 Apr;24(2):91-5. doi: 10.1111/j.1365-2052.1993.tb00246.x.
PubMed 7687103Khotimah, K. and Kusnadi, J., 2014. Antibacterial Activity of Probiotic Dates (Phoenix dactilyfera L.) Using Lacbobacillus plantarum and Lacbobacillus casei. J. Pangan Agroind, 2(3), pp.110-120.
Efendi F, Chen CM, Kurniati A, Berliana SM. Determinants of utilization of antenatal care services among adolescent girls and young women in Indonesia. Women Health. 2017 May-Jun;57(5):614-629. doi: 10.1080/03630242.2016.1181136. Epub 2016 May 26.
PubMed 27230132
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Functional Bread Dadih During Pregnancy and Health Outcomes
- ClinicalTrials.gov ID
- NCT05712629
- Acronym / sponsor ID
- HL
- Conditions
- Birth Weight, Pregnancy Weight Gain
- Keywords
- Functional Bread, Weight Increase, Infant Weight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Andalas UniversityUniversity, hospital or other
- Collaborators
- National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
- Study start
- 12 Apr 2022 (actual)
- Primary completion
- 20 Sep 2022 (actual)
- Study completion
- 20 Dec 2022 (actual)
- First posted
- 3 Feb 2023 (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 aims of study to determine the effect of giving functional bread and dadih's vla on weight gain of pregnant women and birth weight of babies.
Detailed description
Dadih contains BAL 108 CFU/ml which is probiotic. Consumption of functional bread and dadih's vla during pregnancy can improve the composition of the gut microbiota so that it can increase maternal weight and provide adequate nutrition during pregnancy. Good nutrient absorption can support good nutritional status and weight in babies who are born. This study aims to determine the effect of giving functional bread and dadih's vla on weight gain of pregnant women and birth weight of babies.
This study used a randomized controlled trial (RCT) design with a population of all pregnant women in the Kuranji, Nanggalo and Andalas Health Centers. The sample consisted of 88 people and was divided into two groups, namely the intervention group and the control group. Each amounted to 44 samples. The sample selection used the double-blind method and randomized controlled trial (RCT) research design. The intervention started at about 12-20 weeks of gestation and continued until just before the time of delivery. In the third trimester, subjects received healthy food, breastfeeding practices, and child development education to support mothers in maintaining their nutritional status, preparing exclusive breastfeeding, and optimizing child development.
Healthy babies born to mothers will be the focus of this study and followed up until the age of three months to assess their growth. The information includes the baby's health history after birth, anthropometric measurements, nutritional intake, and breastfeeding practices which are measured repeatedly in the first, second, and third months.
Data quality assurance is carried out through training starting from the period of data collection and supervision during and after data collection, including the data analysis process. This included training for enumerators, subjects and using a validated questionnaire for a group of subjects representing similar characteristics for this study. Data input and cleaning process will use excel and SPSS while for food intake data using NutriSurvey 2007. Data entry will be carried out by data collection officers after data collection. The data cleaning process includes removing outliers and regrouping multiple results that have similar meanings. The data will be interpreted as mean ± standard deviation if the data is normally distributed and the median (min-max) if the data is not normally distributed. Statistical analysis using SPSS 25 and data will be analyzed using univariate and bivariate analysis. Univariate analysis is used to describe characteristics and socio-demographics, medical history, pregnancy, and obstetric profiles of pregnant women. Numerical variables between groups will be analyzed using an Independent sample t-test if the data has normal distribution or the Mann Whitney test if the data distribution is not normal. Categorical variables between groups will be analyzed using Chi-square or Fisher test. Differences between birth and 3 months old follow up will be analyzed using independent t-tests if the data distribution has normal distribution or Mann Whitney test if the data distribution is not normal.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Responden Intervention | Active comparator | Other: Bread and vla dadiahArm 1 (Interventional) : Respondent has given bread with composit flour and vla with dadiah. pregnant women received 1 pieces bread containing 50 gram provide total fat 4 gram, protein 5 gram, carbohydrate 23.8 gram, Fe 2 mg, 2150 kcal and vla dadiah containing 30 gram provide 308 kcal. |
| Responden Placebo | Placebo comparator | Other: Bread and vla without dadiahArm 2 (Placebo) : Respondent has given bread with original flour (wheat flour) and vla original without dadiah. pregnant women received 1 pieces bread containing 50 gram and vla containing 30 gram. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Mothers with gestational 12 - 20 weeks
- Health Conditions
- Not moving home until delivery labour
- Not suffering from syndrome metabolic diseases
Key exclusion criteria (2 listed)
- Not willing and signing an informed consent, and not willing to consume fungtional bread and dadih's vla or dadih sauce until delivery.
- Abortus
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 |
|---|---|---|
| Bread and vla dadiahConsumption bread and vla dadiah to pregnant women 1 Pieces a day during 12 weeks. | Other | Responden Intervention |
| Bread and vla without dadiahConsumption bread and vla without dadiah to pregnant women 1 Pieces a day during 12 weeks. | Other | Responden Placebo |
Primary outcome
Body Weight Pregnant Woman Measurement
Time frame: 12 weeks
Measuring Body Weight Pregnant Woman Baseline, 1St Measurement, 2nd Measurement, and 3rd Measurement (Weight in Kilograms)
Body Height Pregnant Woman Measurement
Time frame: 12 weeks
Measuring Body Height Pregnant Woman Baseline, 1St Measurement, 2nd Measurement, and 3rd Measurement (Height in Meters or Centimeters)
Body Mass Index Pregnant Woman Measurement
Time frame: 12 weeks
Measuring Body Height Pregnant Woman Baseline, 1St Measurement, 2nd Measurement, and 3rd Measurement (BMI in Kg/m^2)
Birth Weight of Infant Measurement
Time frame: 9 months
Measuring weight of infant (Weight in Grams)
Birth Length of Infant Measurement
Time frame: 9 months
Measuring Birth Length of infant (Length or height in Centimeters)
1 secondary outcome
Characteristic of Woman Pregnancy
Time frame: 4 weeks
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 8 Feb 2023.
- BackgroundWijayanti, IA, Purwadi, P., & Thohari, I. (2017). The Effect of Adding Sago Flour to Yoghurt on the Physical Properties of Yoghurt Ice Cream. Journal of Animal Products Science and Technology (JITEK), 11(1), 38-45.
- BackgroundWijayanti, MDS, Thohari, I., & Purwadi, P. 2017. Quality of curd in goat's milk incubated on various kinds of bamboo. Journal of Animal Products Science and Technology (JITEK), 11(1), 22-37.
- Results publicationAstuti, S.D., Andarwulan, N., Hariyadi, P. and Agustia, F.C., 2014. Formulasi dan karakterisasi cake berbasis tepung komposit organik kacang merah, kedelai, dan jagung. Jurnal Aplikasi Teknologi Pangan, 3(2).
- Results publicationBlack, R.E. and Hopkins Bloomberg, J., 2008. The lancet series on maternal and child Undernutrition, executive summary. Lancet, 371, pp.1-10.
- Results publication: PubMed 12036814Brown KH, Peerson JM, Rivera J, Allen LH. Effect of supplemental zinc on the growth and serum zinc concentrations of prepubertal children: a meta-analysis of randomized controlled trials. Am J Clin Nutr. 2002 Jun;75(6):1062-71. doi: 10.1093/ajcn/75.6.1062.
- Results publication: PubMed 17388062Collado MC, Surono IS, Meriluoto J, Salminen S. Potential probiotic characteristics of Lactobacillus and Enterococcus strains isolated from traditional dadih fermented milk against pathogen intestinal colonization. J Food Prot. 2007 Mar;70(3):700-5. doi: 10.4315/0362-028x-70.3.700.
- Results publicationCaulfield, L.E., Huffman, S.L. and Piwoz, E.G., 1999. Interventions to improve intake of complementary foods by infants 6 to 12 months of age in developing countries: impact on growth and on the prevalence of malnutrition and potential contribution to child survival. Food and nutrition bulletin, 20(2), pp.183-200.
- Results publication: PubMed 20496618Young Child Nutrition Working Group: Formulation Subgroup. Formulations for fortified complementary foods and supplements: review of successful products for improving the nutritional status of infants and young children. Food Nutr Bull. 2009 Jun;30(2 Suppl):S239-55. No abstract available.
- Results publication: PubMed 11694609Dijkhuizen MA, Wieringa FT, West CE, Martuti S, Muhilal. Effects of iron and zinc supplementation in Indonesian infants on micronutrient status and growth. J Nutr. 2001 Nov;131(11):2860-5. doi: 10.1093/jn/131.11.2860.
- Results publication: PubMed 17468087Fahmida U, Rumawas JS, Utomo B, Patmonodewo S, Schultink W. Zinc-iron, but not zinc-alone supplementation, increased linear growth of stunted infants with low haemoglobin. Asia Pac J Clin Nutr. 2007;16(2):301-9.
- Results publication: PubMed 28049268Helmizar H, Jalal F, Lipoeto NI, Achadi EL. Local food supplementation and psychosocial stimulation improve linear growth and cognitive development among Indonesian infants aged 6 to 9 months. Asia Pac J Clin Nutr. 2017 Jan;26(1):97-103. doi: 10.6133/apjcn.102015.10.
- Results publication: PubMed 19472599Hess SY, Lonnerdal B, Hotz C, Rivera JA, Brown KH. Recent advances in knowledge of zinc nutrition and human health. Food Nutr Bull. 2009 Mar;30(1 Suppl):S5-11. doi: 10.1177/15648265090301S102.
- Zinc-iron, but not zinc-alone supplementation, increased linear growth of stunted infants with low haemoglobin. Asia Pacific Journal of Clinical Nutrition, 16(2), pp.301-309.Link provided by the sponsor.
- Antibacterial Activity of Probiotic Dates (Phoenix dactilyfera L.) Using Lacbobacillus plantarum and Lacbobacillus casei. J. Pangan Agroind, 2(3), pp.110-120.Link provided by the sponsor.
- Diversity, stability and resilience of the human gut microbiota. Nature, 489(7415), pp.220-230.Link provided by the sponsor.
- Use of Local Food Ingredients MOCAF (Modified Cassava Flour) and Rebon Planktonic Shrimp) in Cookies as an Alternative Supplementary Food for Children. InternationalLink provided by the sponsor.
- Effect of probiotic L. plantarum IS-10506 and zinc supplementation on humoral immune response and zinc status of Indonesian pre-school children. Journal of Trace Elements in MedicLink provided by the sponsor.
- Tracking progress on child and maternal nutrition: a survival and development priority. Unicef.Link 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.
Helmizar Helmizar, DR principal investigator
Nutrition Department Faculty of Universitas Andalas
Azrimaidaliza Azrimaidaliza, DR study director
Department Nutrition Faculty of Universitas Andalas
Ferdinal Ferry, DR study director
Department Obstetry and Gynecology of Universitas Andalas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bread and vla dadiah and Bread and vla without dadiah in people with Birth Weight and Pregnancy Weight Gain, run by Andalas University at 1 site 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 2 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 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
Body Weight Pregnant Woman Measurement (time frame: 12 weeks). 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 NCT05712629, which also lists 24 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 8 Feb 2023.