Maternal MalnutritionWFNCT01883193
Women First: Preconception Maternal Nutrition
A study testing Comprehensive Maternal Nutrition Intervention in people with Maternal Malnutrition and Growth Failure, run by University of Colorado, Denver at 4 sites in 4 countries.
Trial summary
Multi-country three-arm, individually randomized, non-masked, controlled trial to ascertain the benefits of ensuring optimal maternal nutrition before conception and providing an evidence base for programmatic priority directed to minimizing the risk of malnutrition in all females of reproductive age. Read more about this study
- Who is it for?
- Ages 16 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal Malnutrition, Growth Failure, Mortality
- What is being tested?
- Comprehensive Maternal Nutrition Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,374 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Aug 2013to 30 Mar 2019
- 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 16 to 35 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 16-35 years of age;
- expectation to have first or further pregnancy without intent to utilize contraception
- Hb >8 g/dL
Who cannot join
- Nulliparous women who do not agree to hospital delivery (equipped for caesarian section) or/and do not have ready access to such a facility.
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
Democratic Republic of the Congo1 site
Kinshasa School of Public Health
Kinshasa
About this study
Multi-country three-arm, individually randomized, non-masked, controlled trial to ascertain the benefits of ensuring optimal maternal nutrition before conception and providing an evidence base for programmatic priority directed to minimizing the risk of malnutrition in all females of reproductive age.
Read the detailed description
The objective is to determine the benefits to the offspring of women in poor, food-insecure environments of commencing a daily comprehensive maternal nutrition supplement (with additional balanced calorie/protein supplement for underweight participants) ≥ 3 months prior to conception versus the benefits of commencing the same supplement at 12 weeks gestation and also to compare offspring outcomes with those of a control group which receives no supplement.
- Conditions
- Maternal Malnutrition, Growth Failure, Mortality, Morbidity, Stunting
- Being tested
- Comprehensive Maternal Nutrition Intervention
- Keywords
- preconception maternal nutrition, LBW, Length-for-age, maternal nutrition supplement, multi-micronutrient fortified lipid-based supplement, infant growth, low-resource settings
- Medical subject headings
- Failure to Thrive, Growth Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Maternal Nutrition InterventionDietary supplement
Also called multi micronutrient (MMN) fortified lipid-based supplement, lipid-based nutrient supplement, LNS
The nutrition intervention will be delivered before conception or at 12 weeks gestation and continued through delivery and compared with a control group. The supplement to be used is a multi-micronutrient (MMN) fortified lipid-based supplement composed of dried skimmed milk, soybean and peanut extract, sugar, maltodextrin stabilizers, and emulsifiers.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Preconception | Experimental | Arm 1 will commence the comprehensive maternal nutrition intervention at 3-7 months postpartum. Delivery of the intervention will be monitored biweekly by collection of empty and unused sachets of the lipid-based supplement (LNS), maternal report, and casual observation of household behavior. Arm 1 participants will be weighed monthly and Body Mass Index (BMI) calculated. If BMI <20 an additional energy supplement will be provided. Menstrual history will be obtained at each visit and a urine pregnancy test will be performed if menses is delayed. Receives: Dietary Supplement: Comprehensive Maternal Nutrition Intervention |
| Arm 2: Pregnancy | Experimental | Participants in Arm 2 will commence the same comprehensive maternal nutrition intervention at 12 weeks gestation. Receives: Dietary Supplement: Comprehensive Maternal Nutrition Intervention |
| Arm 3: Control | No intervention | Participants in Arm 3 will receive biweekly visits to monitor pregnancy status. No health advice will be given other than information about prenatal care, location of delivery, and breastfeeding education in the third trimester. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal linear growth
Research assistants will obtain neonatal length measurement at <24 hours of age.
Measured: <24 hours of age
Secondary outcomes (14)
Length-for-age Z-scores
Research assistants will obtain infant anthropometry measurements, which include length, head circumference, triceps skin folds, Mid Upper Arm Circumference (MUAC), and weight, at age 0.5, 1, 3, 6, 12, 18 and 24 months of age. Length-for-age Z-scores will be compared for offspring of mothers randomized to the three intervention arms.
Measured: age 0.5, 1, 3, 6, 12, 18 and 24 months postnatal
Estimate fetal growth
Ultrasound measurements will be undertaken at 12 weeks gestation with the goals of confirming gestational age and estimating fetal growth.
Measured: 12 weeks gestation
Mean birth weight
As a dichotomous variable, the cutoff of 2500 g does not have the power of the continuum of birth length, but is included because of the long history of use in determining which newborns are severely underweight and this association with impaired neonatal and long-term prognosis. The design of this study will allow distinction between pre-term birth (PTB) and growth retardation of the term infant (mature IUGR).
Measured: at birth
Incidence of low birth weight (LBW) infants
As a dichotomous variable, the cutoff of 2500 g does not have the power of the continuum of birth length, but is included because of the long history of use in determining which newborns are severely underweight and this association with impaired neonatal and long-term prognosis. The design of this study will allow distinction between pre-term birth (PTB) and growth retardation of the term infant (mature IUGR).
Measured: at birth
Perinatal Mortality
The outcome is to determine, in poor food insecure communities if a daily comprehensive maternal nutrition supplement starting ≥ 3 months preconception and continuing throughout pregnancy will reduce the incidence of offspring perinatal mortality (including still births), compared with that for offspring of mothers who commence the same supplement starting at 12-16 weeks gestation.
Measured: From 20 weeks gestation through 1 month of age
Incidence of severe neonatal and infant infectious disease
Outcome measure is number of acute visits / admissions to health center/hospital for severe infectious disease. This secondary outcome will provide insight into the importance of maternal and fetal nutrition in the early prenatal development of host-defense mechanisms and, through comparison with the prenatal and control Arms, on the importance of maternal nutrition throughout pregnancy. It is further intended to collect minor morbidity data.
Measured: birth to 6 months of age
Epigenome (Maternal)
To compare longitudinal changes between groups in the maternal epigenome (including blood, buccal swabs, and possibly other readily obtainable samples) at baseline, 12 weeks pregnancy (prior to initiation of LNS in Arm 2), 34 weeks pregnancy, and at 3 months postpartum. Also will collect placental, fetal and cord blood epigenome at delivery by group and infant epigenome at 3 months with fingerstick blood and buccal swabs.
Measured: baseline, 12 and 34 weeks gestation, delivery, and 3 months postpartum (maternal); 2 weeks and 3 months of age (infant)
Epigenome (Infant)
To compare longitudinal changes between groups in the maternal epigenome (including blood, buccal swabs, and possibly other readily obtainable samples) at baseline, 12 weeks pregnancy (prior to initiation of LNS in Arm 2), 34 weeks pregnancy, and at 3 months postpartum. Also will collect placental, fetal and cord blood epigenome at delivery by group and infant epigenome at 3 months with fingerstick blood and buccal swabs.
Measured: 2 weeks and 3 months of age
Deep phenotyping of maternal metabolic and nutritional status
The outcome represents deep phenotyping by measuring in maternal tissues: hormones, metabolites, measures of inflammation, oxidant stress and immune function/status, and nutrient biomarkers as possible indices of fundamental metabolic alterations resulting from improved long-term maternal nutrition in food insecure populations. Longitudinal blood samples will be collected from maternal participants in Arms 1 and 2 at baseline, 12 weeks gestation (prior to initiation of LNS in Arm 2), 34 weeks gestation, delivery and 3 months postpartum. Samples will also be collected from participants in Arm 3 at 34 weeks gestation and at 3 months postpartum.
Measured: 12 and 34 weeks gestation, delivery, and 3 months postpartum
Microbiome (maternal)
Based on potential long-term effects on maternal nutritional and metabolic state from preconception intervention, we hypothesize that the gut microbiota will differ between the two intervention arms at the three proposed time points.
Measured: 12 & 34 weeks gestation and delivery (maternal)
Microbiome (infant)
Based on potential long-term effects on maternal nutritional and metabolic state from preconception intervention, we hypothesize that the gut microbiota will differ between the two intervention arms at the three proposed time points.
Measured: 14 days and 3 months of age (infant)
Composition of breast milk
We hypothesize that improved maternal nutrition at the time of greatest plasticity in early pregnancy will favorably influence maternal metabolic and nutritional status throughout pregnancy and thus potentially the composition of breast milk in terms of hormonal content, immune factors, cytokines, and gut growth factors.
Measured: 14 days postpartum
Neurodevelopment assessment
Offspring randomized to receive neurodevelopmental evaluation (BSID-III or InterNDA, 2:1 ratio) at 24 mo of age
Measured: 24 mo age
Gestational weight gain (GWG)
Describe GWG and its associations with fetal growth and birth outcomes within each country by baseline maternal nutritional status (BMI) and the receipt of nutrition interventions. Evaluate how GWG might mediate the effects of maternal nutrition interventions.
Measured: Enrollment to delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2013 (estimated)
- Study startAug 2013
- Primary completion30 Mar 2017
- Study completion30 Mar 2019
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 Maternal MalnutritionStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7,374 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Instituto de Nutricion de Centroamerica y Panama (INCAP), Kinshasa School of Public Health, Jawaharlal Nehru Medical College, Aga Khan University, RTI International
- Responsible party
- Sponsor
- Investigators
- Nancy Krebs, MD,MS, Principal investigator, University of Colorado, DenverMichael Hambidge, MD, SciD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01883193
- Sponsor's protocol ID
- 12-1672
- Other IDs
- OPP1055867, U10HD076474-01
- Acronym
- WF
- Status last verified
- Jul 2021
- First submitted
- 18 Jun 2013
- Last updated
- 8 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hambidge KM, Krebs NF, Westcott JE, Garces A, Goudar SS, Kodkany BS, Pasha O, Tshefu A, Bose CL, Figueroa L, Goldenberg RL, Derman RJ, Friedman JE, Frank DN, McClure EM, Stolka K, Das A, Koso-Thomas M, Sundberg S; Preconception Trial Group. Preconception maternal nutrition: a multi-site randomized controlled trial. BMC Pregnancy Childbirth. 2014 Mar 20;14:111. doi: 10.1186/1471-2393-14-111.
PubMed 24650219Hambidge KM, Westcott JE, Garces A, Figueroa L, Goudar SS, Dhaded SM, Pasha O, Ali SA, Tshefu A, Lokangaka A, Derman RJ, Goldenberg RL, Bose CL, Bauserman M, Koso-Thomas M, Thorsten VR, Sridhar A, Stolka K, Das A, McClure EM, Krebs NF; Women First Preconception Trial Study Group. A multicountry randomized controlled trial of comprehensive maternal nutrition supplementation initiated before conception: the Women First trial. Am J Clin Nutr. 2019 Feb 1;109(2):457-469. doi: 10.1093/ajcn/nqy228.
PubMed 30721941Hambidge KM, Bann CM, McClure EM, Westcott JE, Garces A, Figueroa L, Goudar SS, Dhaded SM, Pasha O, Ali SA, Derman RJ, Goldenberg RL, Koso-Thomas M, Somannavar MS, Herekar V, Khan U, Krebs NF. Maternal Characteristics Affect Fetal Growth Response in the Women First Preconception Nutrition Trial. Nutrients. 2019 Oct 21;11(10):2534. doi: 10.3390/nu11102534.
PubMed 31640153Gilley SP, Weaver NE, Sticca EL, Jambal P, Palacios A, Kerns ME, Anand P, Kemp JF, Westcott JE, Figueroa L, Garces AL, Ali SA, Pasha O, Saleem S, Hambidge KM, Hendricks AE, Krebs NF, Borengasser SJ. Longitudinal Changes of One-Carbon Metabolites and Amino Acid Concentrations during Pregnancy in the Women First Maternal Nutrition Trial. Curr Dev Nutr. 2019 Nov 18;4(1):nzz132. doi: 10.1093/cdn/nzz132. eCollection 2020 Jan.
PubMed 32175519Lander RL, Hambidge KM, Westcott JE, Tejeda G, Diba TS, Mastiholi SC, Khan US, Garces A, Figueroa L, Tshefu A, Lokangaka A, Goudar SS, Somannavar MS, Ali SA, Saleem S, McClure EM, Krebs NF, Group OBOTWFPNT. Pregnant Women in Four Low-Middle Income Countries Have a High Prevalence of Inadequate Dietary Intakes That Are Improved by Dietary Diversity. Nutrients. 2019 Jul 10;11(7):1560. doi: 10.3390/nu11071560.
PubMed 31295916Krebs NF, Hambidge KM. Response to Editorial: Balancing the benefits of maternal nutritional interventions; time to put women first! Am J Clin Nutr. 2019 Aug 1;110(2):521-522. doi: 10.1093/ajcn/nqz077. No abstract available.
PubMed 31367762Borengasser SJ, Baker PR 2nd, Kerns ME, Miller LV, Palacios AP, Kemp JF, Westcott JE, Morrison SD, Hernandez TL, Garces A, Figueroa L, Friedman JE, Hambidge KM, Krebs NF. Preconception Micronutrient Supplementation Reduced Circulating Branched Chain Amino Acids at 12 Weeks Gestation in an Open Trial of Guatemalan Women Who Are Overweight or Obese. Nutrients. 2018 Sep 11;10(9):1282. doi: 10.3390/nu10091282.
PubMed 30208589Aziz Ali S, Abbasi Z, Feroz A, Hambidge KM, Krebs NF, Westcott JE, Saleem S. Factors associated with anemia among women of the reproductive age group in Thatta district: study protocol. Reprod Health. 2019 Mar 18;16(1):34. doi: 10.1186/s12978-019-0688-7.
PubMed 30885226Tang M, Frank DN, Tshefu A, Lokangaka A, Goudar SS, Dhaded SM, Somannavar MS, Hendricks AE, Ir D, Robertson CE, Kemp JF, Lander RL, Westcott JE, Hambidge KM, Krebs NF. Different Gut Microbial Profiles in Sub-Saharan African and South Asian Women of Childbearing Age Are Primarily Associated With Dietary Intakes. Front Microbiol. 2019 Aug 14;10:1848. doi: 10.3389/fmicb.2019.01848. eCollection 2019.
PubMed 31474951Ali SA, Khan U, Abrejo F, Saleem S, Hambidge MK, Krebs NF, Westcott JE, Goldenberg RL, McClure EM, Pasha O. Challenges of Implementing an Individual Randomized Controlled Trial (Women First: Preconception Maternal Nutrition Study) in a Rural Study Site: A Case Study From Pakistan. Nutr Metab Insights. 2019 Jul 4;21:1178638819852059. doi: 10.1177/1178638819852059. eCollection 2019.
PubMed 31320804Dhaded SM, Hambidge KM, Ali SA, Somannavar M, Saleem S, Pasha O, Khan U, Herekar V, Vernekar S, Kumar S Y, Westcott JE, Thorsten VR, Sridhar A, Das A, McClure E, Derman RJ, Goldenberg RL, Koso-Thomas M, Goudar SS, Krebs NF. Preconception nutrition intervention improved birth length and reduced stunting and wasting in newborns in South Asia: The Women First Randomized Controlled Trial. PLoS One. 2020 Jan 29;15(1):e0218960. doi: 10.1371/journal.pone.0218960. eCollection 2020.
PubMed 31995570Hambidge KM, Krebs NF, Garces A, Westcott JE, Figueroa L, Goudar SS, Dhaded S, Pasha O, Aziz Ali S, Tshefu A, Lokangaka A, Thorsten VR, Das A, Stolka K, McClure EM, Lander RL, Bose CL, Derman RJ, Goldenberg RL, Bauserman M. Anthropometric indices for non-pregnant women of childbearing age differ widely among four low-middle income populations. BMC Public Health. 2017 Jul 24;18(1):45. doi: 10.1186/s12889-017-4509-z.
PubMed 28738791Lander RL, Hambidge KM, Krebs NF, Westcott JE, Garces A, Figueroa L, Tejeda G, Lokangaka A, Diba TS, Somannavar MS, Honnayya R, Ali SA, Khan US, McClure EM, Thorsten VR, Stolka KB; Women First Preconception Nutrition Trial Group. Repeat 24-hour recalls and locally developed food composition databases: a feasible method to estimate dietary adequacy in a multi-site preconception maternal nutrition RCT. Food Nutr Res. 2017 Apr 11;61(1):1311185. doi: 10.1080/16546628.2017.1311185. eCollection 2017.
PubMed 28469549Krebs NF, Hambidge KM, Westcott JL, Garces AL, Figueroa L, Tsefu AK, Lokangaka AL, Goudar SS, Dhaded SM, Saleem S, Ali SA, Bose CL, Derman RJ, Goldenberg RL, Thorsten VR, Sridhar A, Chowdhury D, Das A; Women First Preconception Maternal Nutrition Study Group. Growth from Birth Through Six Months for Infants of Mothers in the "Women First" Preconception Maternal Nutrition Trial. J Pediatr. 2021 Feb;229:199-206.e4. doi: 10.1016/j.jpeds.2020.09.032. Epub 2020 Sep 18.
PubMed 32956698Ali SA, Abbasi Z, Shahid B, Moin G, Hambidge KM, Krebs NF, Westcott JE, McClure EM, Goldenberg RL, Saleem S. Prevalence and determinants of anemia among women of reproductive age in Thatta Pakistan: Findings from a cross-sectional study. PLoS One. 2020 Sep 24;15(9):e0239320. doi: 10.1371/journal.pone.0239320. eCollection 2020.
PubMed 32970719
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Women First: Preconception Maternal Nutrition
- ClinicalTrials.gov ID
- NCT01883193
- Acronym / sponsor ID
- WF / 12-1672
- Conditions
- Maternal Malnutrition, Growth Failure, Mortality, Morbidity, Stunting
- Keywords
- preconception maternal nutrition, LBW, Length-for-age, maternal nutrition supplement, multi-micronutrient fortified lipid-based supplement, infant growth, low-resource settings
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,374 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Instituto de Nutricion de Centroamerica y Panama (INCAP), Kinshasa School of Public Health, Jawaharlal Nehru Medical College, Aga Khan University, RTI International
- Study start
- Aug 2013
- Primary completion
- 30 Mar 2017 (actual)
- Study completion
- 30 Mar 2019 (actual)
- First posted
- 21 Jun 2013 (estimated)
- 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.
Multi-country three-arm, individually randomized, non-masked, controlled trial to ascertain the benefits of ensuring optimal maternal nutrition before conception and providing an evidence base for programmatic priority directed to minimizing the risk of malnutrition in all females of reproductive age.
Detailed description
The objective is to determine the benefits to the offspring of women in poor, food-insecure environments of commencing a daily comprehensive maternal nutrition supplement (with additional balanced calorie/protein supplement for underweight participants) ≥ 3 months prior to conception versus the benefits of commencing the same supplement at 12 weeks gestation and also to compare offspring outcomes with those of a control group which receives no supplement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Preconception | Experimental | Dietary Supplement: Comprehensive Maternal Nutrition InterventionArm 1 will commence the comprehensive maternal nutrition intervention at 3-7 months postpartum. Delivery of the intervention will be monitored biweekly by collection of empty and unused sachets of the lipid-based supplement (LNS), maternal report, and casual observation of household behavior. Arm 1 participants will be weighed monthly and Body Mass Index (BMI) calculated. If BMI <20 an additional energy supplement will be provided. Menstrual history will be obtained at each visit and a urine pregnancy test will be performed if menses is delayed. |
| Arm 2: Pregnancy | Experimental | Dietary Supplement: Comprehensive Maternal Nutrition InterventionParticipants in Arm 2 will commence the same comprehensive maternal nutrition intervention at 12 weeks gestation. |
| Arm 3: Control | No intervention | –Participants in Arm 3 will receive biweekly visits to monitor pregnancy status. No health advice will be given other than information about prenatal care, location of delivery, and breastfeeding education in the third trimester. |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 16-35 years of age;
- expectation to have first or further pregnancy without intent to utilize contraception
- Hb >8 g/dL
Key exclusion criteria (1 listed)
- Nulliparous women who do not agree to hospital delivery (equipped for caesarian section) or/and do not have ready access to such a facility.
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 |
|---|---|---|
| Comprehensive Maternal Nutrition InterventionAlso: multi micronutrient (MMN) fortified lipid-based supplement, lipid-based nutrient supplement, LNSThe nutrition intervention will be delivered before conception or at 12 weeks gestation and continued through delivery and compared with a control group. The supplement to be used is a multi-micronutrient (MMN) fortified lipid-based supplement composed of dried skimmed milk, soybean and peanut extract, sugar, maltodextrin stabilizers, and emulsifiers. | Dietary supplement | Arm 1: Preconception, Arm 2: Pregnancy |
Primary outcome
Neonatal linear growth
Time frame: <24 hours of age
Research assistants will obtain neonatal length measurement at <24 hours of age.
14 secondary outcomes
Length-for-age Z-scores
Time frame: age 0.5, 1, 3, 6, 12, 18 and 24 months postnatal
Estimate fetal growth
Time frame: 12 weeks gestation
Mean birth weight
Time frame: at birth
Incidence of low birth weight (LBW) infants
Time frame: at birth
Perinatal Mortality
Time frame: From 20 weeks gestation through 1 month of age
Incidence of severe neonatal and infant infectious disease
Time frame: birth to 6 months of age
Epigenome (Maternal)
Time frame: baseline, 12 and 34 weeks gestation, delivery, and 3 months postpartum (maternal); 2 weeks and 3 months of age (infant)
Epigenome (Infant)
Time frame: 2 weeks and 3 months of age
Deep phenotyping of maternal metabolic and nutritional status
Time frame: 12 and 34 weeks gestation, delivery, and 3 months postpartum
Microbiome (maternal)
Time frame: 12 & 34 weeks gestation and delivery (maternal)
Microbiome (infant)
Time frame: 14 days and 3 months of age (infant)
Composition of breast milk
Time frame: 14 days postpartum
Neurodevelopment assessment
Time frame: 24 mo age
Gestational weight gain (GWG)
Time frame: Enrollment to delivery
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 Jul 2021.
- Background: PubMed 24650219Hambidge KM, Krebs NF, Westcott JE, Garces A, Goudar SS, Kodkany BS, Pasha O, Tshefu A, Bose CL, Figueroa L, Goldenberg RL, Derman RJ, Friedman JE, Frank DN, McClure EM, Stolka K, Das A, Koso-Thomas M, Sundberg S; Preconception Trial Group. Preconception maternal nutrition: a multi-site randomized controlled trial. BMC Pregnancy Childbirth. 2014 Mar 20;14:111. doi: 10.1186/1471-2393-14-111.
- Background: PubMed 30721941Hambidge KM, Westcott JE, Garces A, Figueroa L, Goudar SS, Dhaded SM, Pasha O, Ali SA, Tshefu A, Lokangaka A, Derman RJ, Goldenberg RL, Bose CL, Bauserman M, Koso-Thomas M, Thorsten VR, Sridhar A, Stolka K, Das A, McClure EM, Krebs NF; Women First Preconception Trial Study Group. A multicountry randomized controlled trial of comprehensive maternal nutrition supplementation initiated before conception: the Women First trial. Am J Clin Nutr. 2019 Feb 1;109(2):457-469. doi: 10.1093/ajcn/nqy228.
- Background: PubMed 31640153Hambidge KM, Bann CM, McClure EM, Westcott JE, Garces A, Figueroa L, Goudar SS, Dhaded SM, Pasha O, Ali SA, Derman RJ, Goldenberg RL, Koso-Thomas M, Somannavar MS, Herekar V, Khan U, Krebs NF. Maternal Characteristics Affect Fetal Growth Response in the Women First Preconception Nutrition Trial. Nutrients. 2019 Oct 21;11(10):2534. doi: 10.3390/nu11102534.
- Background: PubMed 32175519Gilley SP, Weaver NE, Sticca EL, Jambal P, Palacios A, Kerns ME, Anand P, Kemp JF, Westcott JE, Figueroa L, Garces AL, Ali SA, Pasha O, Saleem S, Hambidge KM, Hendricks AE, Krebs NF, Borengasser SJ. Longitudinal Changes of One-Carbon Metabolites and Amino Acid Concentrations during Pregnancy in the Women First Maternal Nutrition Trial. Curr Dev Nutr. 2019 Nov 18;4(1):nzz132. doi: 10.1093/cdn/nzz132. eCollection 2020 Jan.
- Background: PubMed 31295916Lander RL, Hambidge KM, Westcott JE, Tejeda G, Diba TS, Mastiholi SC, Khan US, Garces A, Figueroa L, Tshefu A, Lokangaka A, Goudar SS, Somannavar MS, Ali SA, Saleem S, McClure EM, Krebs NF, Group OBOTWFPNT. Pregnant Women in Four Low-Middle Income Countries Have a High Prevalence of Inadequate Dietary Intakes That Are Improved by Dietary Diversity. Nutrients. 2019 Jul 10;11(7):1560. doi: 10.3390/nu11071560.
- Background: PubMed 31367762Krebs NF, Hambidge KM. Response to Editorial: Balancing the benefits of maternal nutritional interventions; time to put women first! Am J Clin Nutr. 2019 Aug 1;110(2):521-522. doi: 10.1093/ajcn/nqz077. No abstract available.
- Background: PubMed 30208589Borengasser SJ, Baker PR 2nd, Kerns ME, Miller LV, Palacios AP, Kemp JF, Westcott JE, Morrison SD, Hernandez TL, Garces A, Figueroa L, Friedman JE, Hambidge KM, Krebs NF. Preconception Micronutrient Supplementation Reduced Circulating Branched Chain Amino Acids at 12 Weeks Gestation in an Open Trial of Guatemalan Women Who Are Overweight or Obese. Nutrients. 2018 Sep 11;10(9):1282. doi: 10.3390/nu10091282.
- Background: PubMed 30885226Aziz Ali S, Abbasi Z, Feroz A, Hambidge KM, Krebs NF, Westcott JE, Saleem S. Factors associated with anemia among women of the reproductive age group in Thatta district: study protocol. Reprod Health. 2019 Mar 18;16(1):34. doi: 10.1186/s12978-019-0688-7.
- Background: PubMed 31474951Tang M, Frank DN, Tshefu A, Lokangaka A, Goudar SS, Dhaded SM, Somannavar MS, Hendricks AE, Ir D, Robertson CE, Kemp JF, Lander RL, Westcott JE, Hambidge KM, Krebs NF. Different Gut Microbial Profiles in Sub-Saharan African and South Asian Women of Childbearing Age Are Primarily Associated With Dietary Intakes. Front Microbiol. 2019 Aug 14;10:1848. doi: 10.3389/fmicb.2019.01848. eCollection 2019.
- Background: PubMed 31320804Ali SA, Khan U, Abrejo F, Saleem S, Hambidge MK, Krebs NF, Westcott JE, Goldenberg RL, McClure EM, Pasha O. Challenges of Implementing an Individual Randomized Controlled Trial (Women First: Preconception Maternal Nutrition Study) in a Rural Study Site: A Case Study From Pakistan. Nutr Metab Insights. 2019 Jul 4;21:1178638819852059. doi: 10.1177/1178638819852059. eCollection 2019.
- Background: PubMed 31995570Dhaded SM, Hambidge KM, Ali SA, Somannavar M, Saleem S, Pasha O, Khan U, Herekar V, Vernekar S, Kumar S Y, Westcott JE, Thorsten VR, Sridhar A, Das A, McClure E, Derman RJ, Goldenberg RL, Koso-Thomas M, Goudar SS, Krebs NF. Preconception nutrition intervention improved birth length and reduced stunting and wasting in newborns in South Asia: The Women First Randomized Controlled Trial. PLoS One. 2020 Jan 29;15(1):e0218960. doi: 10.1371/journal.pone.0218960. eCollection 2020.
- Background: PubMed 28738791Hambidge KM, Krebs NF, Garces A, Westcott JE, Figueroa L, Goudar SS, Dhaded S, Pasha O, Aziz Ali S, Tshefu A, Lokangaka A, Thorsten VR, Das A, Stolka K, McClure EM, Lander RL, Bose CL, Derman RJ, Goldenberg RL, Bauserman M. Anthropometric indices for non-pregnant women of childbearing age differ widely among four low-middle income populations. BMC Public Health. 2017 Jul 24;18(1):45. doi: 10.1186/s12889-017-4509-z.
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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.
Nancy Krebs, MD,MS principal investigator
University of Colorado, Denver
Michael Hambidge, MD, SciD principal investigator
University of Colorado, Denver
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive Maternal Nutrition Intervention in people with Maternal Malnutrition and Growth Failure, run by University of Colorado, Denver at 4 sites in 4 countries.
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 3 inclusion and 1 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 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Democratic Republic of the Congo, Guatemala, India, Pakistan. 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?
Neonatal linear growth (time frame: <24 hours of age). 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 NCT01883193, 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 Jul 2021.