Poor Fetal GrowthNCT02745249
Assessing the Feasibility of Integrating Maternal Nutrition Interventions Into an Existing MNCH Platform in Bangladesh
A study testing Maternal Nutrition Behavior change in people with Poor Fetal Growth and Small-for-gestational Age, run by International Food Policy Research Institute at 1 site in United States.
Trial summary
Inadequate maternal nutrition is likely to undermine the potential impact of infant and young child feeding (IYCF) improvements made in the Alive \& Thrive (A\&T) first phase because it is linked to poor fetal growth leading to small-for-gestational age and pre-term newborns. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Poor Fetal Growth, Small-for-gestational Age, Premature Birth
- What is being tested?
- Maternal Nutrition Behavior change
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,500 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Oct 2016
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Recently delivered women with children <6 months of age
- Pregnant women in second and third trimester and her husbands
- Frontline health workers in the areas
Who cannot join
- Age <18
- Mental disorders that cannot understand and answer the questions
Trial locations and contacts
1 site in 1 country.
United States1 site
International Food Policy Research Institute
Washington D.C., District of Columbia, 20006
About this study
Official title: Assessing the Feasibility of Integrating Maternal Nutrition Interventions Into an Existing Maternal, Newborn, and Child Health Platform in Bangladesh: A Cluster-randomized Operational Evaluation
Inadequate maternal nutrition is likely to undermine the potential impact of infant and young child feeding (IYCF) improvements made in the Alive \& Thrive (A\&T) first phase because it is linked to poor fetal growth leading to small-for-gestational age and pre-term newborns. These babies do not respond to growth promoting feeding practices as well as normal newborns do. In Phase 2, Alive \& Thrive decided to focus on integrating a package of maternal nutrition interventions in a large-scale maternal, newborn and child health program (MNCH). This proposed evaluation aims to assess the feasibility of integrating maternal nutrition interventions into an existing MNCH platform in Bangladesh, using a cluster-randomized evaluation design.
Read the detailed description
Inadequate maternal nutrition is likely to undermine the potential impact of IYCF improvements made in the Alive \& Thrive (A\&T) first phase because it is linked to poor fetal growth leading to small-for-gestational age and pre-term newborns. These babies do not respond to growth promoting feeding practices as well as normal newborns do (WHO Healthy Growth project). In a study of 16,290 singleton infants born in rural Bangladesh from 2004 to 2007, more than 50% were born with low birth-weight. Low birth-weight is a risk factor for neonatal deaths, estimated to be 37 per 1,000 live births in Bangladesh. Factors associated with low birth-weight include young maternal age, poor pre-pregnant nutritional status, short birth intervals, poor maternal dietary intake (quality, quantity, and diversity), and inadequate pregnancy weight gain. Better maternal nutrition will improve maternal and newborn outcomes and facilitate achievement of a continuum of good nutrition.
In setting its country program goal for Bangladesh in phase 2, Alive \& Thrive decided to focus on demonstrating the feasibility of integrating a package of maternal nutrition interventions in a large-scale MNCH program. Maternal nutrition should receive equal priority as child nutrition and the A\&T program of BRAC already has developed an effective strategy though improving IYCF practices. MNCH programs offer the best opportunity for achieving large scale and sustainability. The GOB also promotes mainstreaming of nutrition intervention in health services. Considering the behavior change focus of the Alive \& Thrive strategy, efforts will concentrate on improving dietary practices, specifically, improved diversity of foods and energy intakes of pregnant women, and improve the intake of calcium and iron/folic acid supplements. BRAC's supply system will be used to ensure access to calcium and iron/folic acid supplements. The current Government of Bangladesh guidelines of supplementing pregnant women with iron and folic acid and calcium, taken with food (to minimize adverse effects) would be a focus of behavior change interventions.
The primary objectives of the proposed evaluation are to answer the following questions using a cluster-randomized evaluation design:
- Can the coverage and utilization of key maternal nutrition interventions be improved equitably by integrating nutrition-focused BCC and community mobilization into BRAC's rural MNCH program?
- What factors affect high quality integration of nutrition interventions into a well-established MNCH program platform?
Secondary objectives are to examine the following question:
- Can an intensive, formative-research based BCC intervention for maternal nutrition improve the quality of diets of pregnant women in rural Bangladesh and facilitate better early breastfeeding practices than via routine MNCH services?
- Being tested
- Maternal Nutrition Behavior change
- Medical subject headings
- Fetal Growth Retardation, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maternal Nutrition Behavior changeBehavioural
| Study group | Role | What they receive |
|---|---|---|
| A&T- intensive | Experimental | A\&T-intensive arm receive standard MNCH services and intensified maternal nutrition behavior change intervention which focus on improving dietary practices, specifically improved diversity of foods and energy intakes of pregnant women, and improved intake of calcium and iron/folic acid (IFA) supplements. Receives: Behavioral: Maternal Nutrition Behavior change |
| A&T-non intensive | No intervention | A\&T-non intensive aim only receive MNCH services |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of iron-folic acid supplements
Recall the total number of IFA tablets consumed throughout the last pregnancy
Measured: IFA tablets used during 9 months of last pregnancy among recently delivered women with children <6 months of age by June 2016
Use of calcium supplements
Recall the total number of calcium tablets consumed throughout the last pregnancy
Measured: Calcium tablets used during 9 months of last pregnancy among recently delivered women with children <6 months of age by June 2016
Dietary diversity during pregnancy
Number of food groups women consumed
Measured: Pregnant women in second and third trimester of pregnancy (4-9 months) by June- August 2016
Dietary micronutrient intakes
Quantity of micronutrient intakes using 24-hour recall complemented by food weighing.
Measured: Pregnant women in second and third trimester of pregnancy (4-9 months) by June- August 2016
Coverage of maternal nutrition intervention
The proportion of pregnant and recently delivery women expose to and use of MNCH platform during the last 1 year
Measured: 1 year
Secondary outcomes (2)
Early initiation of breastfeeding
The proportion of newborns aged less than 6 months who were breastfed within 1 hour of birth
Measured: Infants up to 6 months in a cross-sectional endline survey scheduled for June- August 2016
Exclusive breastfeeding
The proportion of infants aged less than 6 months who were exclusively breastfed on the day preceding the interview.
Measured: Infants up to 6 months in a cross-sectional endline survey scheduled for June- August 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study startJul 2015
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Poor Fetal GrowthStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 3,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Food Policy Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02745249
- Sponsor's protocol ID
- 2015-32-PHND-M
- Status last verified
- Sep 2017
- First submitted
- 1 Apr 2016
- Last updated
- 27 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Nguyen PH, Martin-Prevel Y, Moursi M, Tran LM, Menon P, Ruel MT, Arimond M. Assessing Dietary Diversity in Pregnant Women: Relative Validity of the List-Based and Open Recall Methods. Curr Dev Nutr. 2019 Nov 18;4(1):nzz134. doi: 10.1093/cdn/nzz134. eCollection 2020 Jan.
PubMed 32258987Frongillo EA, Nguyen PH, Sanghvi T, Mahmud Z, Aktar B, Alayon S, Menon P. Nutrition Interventions Integrated into an Existing Maternal, Neonatal, and Child Health Program Reduce Food Insecurity Among Recently Delivered and Pregnant Women in Bangladesh. J Nutr. 2019 Jan 1;149(1):159-166. doi: 10.1093/jn/nxy249.
PubMed 30649523Nguyen PH, Frongillo EA, Sanghvi T, Wable G, Mahmud Z, Tran LM, Aktar B, Afsana K, Alayon S, Ruel MT, Menon P. Engagement of Husbands in a Maternal Nutrition Program Substantially Contributed to Greater Intake of Micronutrient Supplements and Dietary Diversity during Pregnancy: Results of a Cluster-Randomized Program Evaluation in Bangladesh. J Nutr. 2018 Aug 1;148(8):1352-1363. doi: 10.1093/jn/nxy090.
PubMed 29931108Nguyen PH, Kim SS, Sanghvi T, Mahmud Z, Tran LM, Shabnam S, Aktar B, Haque R, Afsana K, Frongillo EA, Ruel MT, Menon P. Integrating Nutrition Interventions into an Existing Maternal, Neonatal, and Child Health Program Increased Maternal Dietary Diversity, Micronutrient Intake, and Exclusive Breastfeeding Practices in Bangladesh: Results of a Cluster-Randomized Program Evaluation. J Nutr. 2017 Dec;147(12):2326-2337. doi: 10.3945/jn.117.257303. Epub 2017 Oct 11.
PubMed 29021370
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Feasibility of Integrating Maternal Nutrition Interventions Into an Existing Maternal, Newborn, and Child Health Platform in Bangladesh: A Cluster-randomized Operational Evaluation
- ClinicalTrials.gov ID
- NCT02745249
- Acronym / sponsor ID
- 2015-32-PHND-M
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,500 participants (actual)
- Lead sponsor
- International Food Policy Research InstituteUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 20 Apr 2016 (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.
Inadequate maternal nutrition is likely to undermine the potential impact of infant and young child feeding (IYCF) improvements made in the Alive \& Thrive (A\&T) first phase because it is linked to poor fetal growth leading to small-for-gestational age and pre-term newborns. These babies do not respond to growth promoting feeding practices as well as normal newborns do. In Phase 2, Alive \& Thrive decided to focus on integrating a package of maternal nutrition interventions in a large-scale maternal, newborn and child health program (MNCH). This proposed evaluation aims to assess the feasibility of integrating maternal nutrition interventions into an existing MNCH platform in Bangladesh, using a cluster-randomized evaluation design.
Detailed description
Inadequate maternal nutrition is likely to undermine the potential impact of IYCF improvements made in the Alive \& Thrive (A\&T) first phase because it is linked to poor fetal growth leading to small-for-gestational age and pre-term newborns. These babies do not respond to growth promoting feeding practices as well as normal newborns do (WHO Healthy Growth project). In a study of 16,290 singleton infants born in rural Bangladesh from 2004 to 2007, more than 50% were born with low birth-weight. Low birth-weight is a risk factor for neonatal deaths, estimated to be 37 per 1,000 live births in Bangladesh. Factors associated with low birth-weight include young maternal age, poor pre-pregnant nutritional status, short birth intervals, poor maternal dietary intake (quality, quantity, and diversity), and inadequate pregnancy weight gain. Better maternal nutrition will improve maternal and newborn outcomes and facilitate achievement of a continuum of good nutrition.
In setting its country program goal for Bangladesh in phase 2, Alive \& Thrive decided to focus on demonstrating the feasibility of integrating a package of maternal nutrition interventions in a large-scale MNCH program. Maternal nutrition should receive equal priority as child nutrition and the A\&T program of BRAC already has developed an effective strategy though improving IYCF practices. MNCH programs offer the best opportunity for achieving large scale and sustainability. The GOB also promotes mainstreaming of nutrition intervention in health services. Considering the behavior change focus of the Alive \& Thrive strategy, efforts will concentrate on improving dietary practices, specifically, improved diversity of foods and energy intakes of pregnant women, and improve the intake of calcium and iron/folic acid supplements. BRAC's supply system will be used to ensure access to calcium and iron/folic acid supplements. The current Government of Bangladesh guidelines of supplementing pregnant women with iron and folic acid and calcium, taken with food (to minimize adverse effects) would be a focus of behavior change interventions.
The primary objectives of the proposed evaluation are to answer the following questions using a cluster-randomized evaluation design:
- Can the coverage and utilization of key maternal nutrition interventions be improved equitably by integrating nutrition-focused BCC and community mobilization into BRAC's rural MNCH program?
- What factors affect high quality integration of nutrition interventions into a well-established MNCH program platform?
Secondary objectives are to examine the following question:
- Can an intensive, formative-research based BCC intervention for maternal nutrition improve the quality of diets of pregnant women in rural Bangladesh and facilitate better early breastfeeding practices than via routine MNCH services?
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A&T- intensive | Experimental | Behavioral: Maternal Nutrition Behavior changeA\&T-intensive arm receive standard MNCH services and intensified maternal nutrition behavior change intervention which focus on improving dietary practices, specifically improved diversity of foods and energy intakes of pregnant women, and improved intake of calcium and iron/folic acid (IFA) supplements. |
| A&T-non intensive | No intervention | –A\&T-non intensive aim only receive MNCH services |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Recently delivered women with children <6 months of age
- Pregnant women in second and third trimester and her husbands
- Frontline health workers in the areas
Key exclusion criteria (2 listed)
- Age <18
- Mental disorders that cannot understand and answer the questions
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 |
|---|---|---|
| Maternal Nutrition Behavior change | Behavioural | A&T- intensive |
Primary outcome
Use of iron-folic acid supplements
Time frame: IFA tablets used during 9 months of last pregnancy among recently delivered women with children <6 months of age by June 2016
Recall the total number of IFA tablets consumed throughout the last pregnancy
Use of calcium supplements
Time frame: Calcium tablets used during 9 months of last pregnancy among recently delivered women with children <6 months of age by June 2016
Recall the total number of calcium tablets consumed throughout the last pregnancy
Dietary diversity during pregnancy
Time frame: Pregnant women in second and third trimester of pregnancy (4-9 months) by June- August 2016
Number of food groups women consumed
Dietary micronutrient intakes
Time frame: Pregnant women in second and third trimester of pregnancy (4-9 months) by June- August 2016
Quantity of micronutrient intakes using 24-hour recall complemented by food weighing.
Coverage of maternal nutrition intervention
Time frame: 1 year
The proportion of pregnant and recently delivery women expose to and use of MNCH platform during the last 1 year
2 secondary outcomes
Early initiation of breastfeeding
Time frame: Infants up to 6 months in a cross-sectional endline survey scheduled for June- August 2016
Exclusive breastfeeding
Time frame: Infants up to 6 months in a cross-sectional endline survey scheduled for June- August 2016
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 27 Sep 2017.
- Derived from this study: PubMed 32258987Nguyen PH, Martin-Prevel Y, Moursi M, Tran LM, Menon P, Ruel MT, Arimond M. Assessing Dietary Diversity in Pregnant Women: Relative Validity of the List-Based and Open Recall Methods. Curr Dev Nutr. 2019 Nov 18;4(1):nzz134. doi: 10.1093/cdn/nzz134. eCollection 2020 Jan.
- Derived from this study: PubMed 30649523Frongillo EA, Nguyen PH, Sanghvi T, Mahmud Z, Aktar B, Alayon S, Menon P. Nutrition Interventions Integrated into an Existing Maternal, Neonatal, and Child Health Program Reduce Food Insecurity Among Recently Delivered and Pregnant Women in Bangladesh. J Nutr. 2019 Jan 1;149(1):159-166. doi: 10.1093/jn/nxy249.
- Derived from this study: PubMed 29931108Nguyen PH, Frongillo EA, Sanghvi T, Wable G, Mahmud Z, Tran LM, Aktar B, Afsana K, Alayon S, Ruel MT, Menon P. Engagement of Husbands in a Maternal Nutrition Program Substantially Contributed to Greater Intake of Micronutrient Supplements and Dietary Diversity during Pregnancy: Results of a Cluster-Randomized Program Evaluation in Bangladesh. J Nutr. 2018 Aug 1;148(8):1352-1363. doi: 10.1093/jn/nxy090.
- Derived from this study: PubMed 29021370Nguyen PH, Kim SS, Sanghvi T, Mahmud Z, Tran LM, Shabnam S, Aktar B, Haque R, Afsana K, Frongillo EA, Ruel MT, Menon P. Integrating Nutrition Interventions into an Existing Maternal, Neonatal, and Child Health Program Increased Maternal Dietary Diversity, Micronutrient Intake, and Exclusive Breastfeeding Practices in Bangladesh: Results of a Cluster-Randomized Program Evaluation. J Nutr. 2017 Dec;147(12):2326-2337. doi: 10.3945/jn.117.257303. Epub 2017 Oct 11.
- Individual participant dataSharing planned: Undecided
Related trials for Poor Fetal Growth
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
Recruiting
STV Analysis Versus Visual Evaluation of Cardiotocography in FGR
Fetal Growth Retardation
RecruitingPhase 2
Statin Intervention for Severe Early-Onset Placental Insufficiency. (STATIN-PRE Trial)
Preeclampsia (PE), Intrauterine Growth Restriction (IUGR)
RecruitingObservational study
Natural History of Craniofacial Anomalies and Developmental Growth Variants
Prognathism, Retrognathism
RecruitingObservational study
Primordial Dwarfism Registry
MOPDII, Meier-Gorlin Syndrome
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maternal Nutrition Behavior change in people with Poor Fetal Growth and Small-for-gestational Age, run by International Food Policy Research Institute at 1 site in United States.
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 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 27 Sep 2017. 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 United States. 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?
Use of iron-folic acid supplements (time frame: IFA tablets used during 9 months of last pregnancy among recently delivered women with children <6 months of age by June 2016). 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 NCT02745249, which also lists 4 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 27 Sep 2017.