Growth DisordersNCT03024710
Promotion of Complimentary Feeding Practices in Bangladesh
A study testing Intervention cluster in people with Growth Disorders, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
Trial summary
Infant feeding practices and nutritional status among children is interrelated and link is well established. Incidence of malnutrition sharply rises during 6-9 months of age in most of the developing countries which coincide with the period of complimentary feeding (CF). Read more about this study
- Who is it for?
- Ages 6 to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Growth Disorders
- What is being tested?
- Intervention cluster
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteBangladesh
- Study dates
- Jan 2011to Jun 2013
- 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 6 to 12 months
- Healthy volunteers accepted
- Child
Who may be able to join
- The infant who has completed his/her 6 month of age from the date of birth along with their mother
Who cannot join
- Children with severe illnesses or handicaps affecting development, feeding, or activity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Promotion of Complimentary Feeding Practices Through Health Messages: a Community-based Clustered Randomized Trial in Rural Bangladesh
Infant feeding practices and nutritional status among children is interrelated and link is well established. Incidence of malnutrition sharply rises during 6-9 months of age in most of the developing countries which coincide with the period of complimentary feeding (CF). This prospective randomized trial will be implemented in ongoing health and demographic surveillance system of Matlab, ICDDR,B and will be nested into an ongoing maternal and child health services area. Area of community health workers (four blocks) will be divided into two pairs and each pair will be randomly assigned into intervention or control groups. The eligible and consented mother-infant newborn will be recruited either into an intervention or control groups based on the areas of the paired block. The mothers and family members of the intervention area will receive intensive counseling on complementary feeding practices through community health workers. In total about 360 mother-infant pair will be recruited in the study for each site. Data on children's anthropometry (weight and lengths), information on complementary feeding practices and related covariates will be collected through trained research staffs. Data will be evaluated on reduction of burden of malnutrition (stunting, underweight, wasting) and complimentary feeding index between intervention and control groups.
Read the detailed description
Back ground:
Link between infant feeding practices and nutritional status among children has been well established. Incidence of malnutrition sharply rises during 6-9 months of age which coincide with the period of complimentary feeding (CF). It is reported that poor nutrition increases the risk of illness, and is responsible, directly or indirectly, for one third of the estimated 9.5 million deaths in children less than 5 years of age. Early nutritional deficits are also linked to long-term impairment in growth and health. There is evidence that adults who were malnourished in early childhood have impaired intellectual performance. They may also have reduced capacity for physical work. High proportion of childhood malnutrition has negative impact for national development. Based on evidence of the effectiveness of interventions, achievement of universal coverage of exclusive breastfeeding (EBF) could prevent 13% of deaths occurring in children less than 5 years of age globally, while appropriate complementary feeding practices would result in an additional 6% reduction in under five mortality. Although there is huge potential for EBF till 6 months of age, the CF practices is also important to maintain the increase demand and growth after the period of EBF to maintain the optimal growth and development during infancy and early child hood period. However, there are lacks of efforts observed to increase the knowledge of good complementary feeding practices at population level. Under five child mortality is still high for Bangladesh. Among these deaths prematurity of the newborn/LBW and malnutrition together contribute to about 45% of all deaths. Despite the progress achieved, child malnutrition in Bangladesh remains among the highest in the world, and more severe than that of most other developing countries. This suggests that children in Bangladesh suffer from short-term acute shortfall in food intake as well as longer-term under-nutrition. Exclusive breast feeding is quiet static (43%-46%) for last few years in Bangladesh and around one fourth infant from 6-9 months ages start complementary feeding either too early or too late. Inappropriate practices of CF reflect the knowledge gap at the population level. Mother and family members are usually unaware about the nutrition need immediately after the completion of exclusive breast feeding practices. It was reported that Bangladesh scored 91.5/150 for Young Infant and Child Feeding (YICF) practices which was done by International Baby Food Action Network (IBFAN), Asia Pacific where community outreach and information support warranted much improvement. To reduce malnutrition: Comprehensive programme of integrated actions on many fronts has been addressed which includes "Promoting improved infant feeding practices, including breast feeding practices". Mothers and families need support to initiate and sustain appropriate infant and young child feeding practices through support person or peer group is recommended at the community level. Educational intervention on CF practices shows improvement in several studies in India, china and Brazil. Indian study observed feasibility of CF practices promotion through existing system and found limited improvement of infant length (difference in means 0.32 cm, 95% CI, 0.03, 0.61) between groups. Brazilian study assessed impact on child growth of the nutrition counseling component of the Integrated Management of Childhood Illnesses strategy and found children 12 month of age or older had improved weight gain (changes of +.25 and -.06 Z-score, respectively) and a positive but non-significant improvement in length (0.40 vs. 0.12). In this study medical doctors were used for counseling which is not applicable in poor resource settings. The China study was to improve infant growth by improving infant feeding practices. The education group infants were significantly heavier and longer, but only at 12 month (weight-for-age -1.17 vs. -1.93; P=5 0.004; height-for-age -1.32 vs. 1.96; P =0.022). But this study differ from exclusive breast feeding (EBF) duration and starting of complimentary feeding practices as recommended by WHO (EBF is practice 4-6 month and weaning starts at 4 months). None of the above studies evaluated feeding practices through CF index. In early 90's Bangladesh Rural Advancement Committee evaluated educational messages on CF practices other than WHO recommendation, Population level study on CF practice promotion is poor in Bangladesh. Given the above background, with lack of knowledge on CF practices in the community level and high burden of childhood malnutrition, we plan to improve complementary feeding practices in Matlab.
Hypothesis to be tested:
The proposed study hypothesized that an appropriate delivery of CF messages at the community level will improve the CF practices and subsequently decrease the burden of malnutrition during infancy.
Specific objectives:
The objectives of the project are to evaluate the effect of CF practice messages through community health workers to mothers and family members in comparison to mothers and family member who do not receive CF practice messages on the following outcomes:
Reducing the burden of stunting, underweight and wasting Evaluate complementary feeding index
Research Design and Methods:
Study site:
The study will be implemented in a rural community of Matlab under a sub-district of Bangladesh. Matlab is located 56 kilometer southeast of the capital Dhaka, where ICDDR,B has been running a health and demographic surveillance system (HDSS) in a population of about 220,000 since 1966. In HDSS, the community health research workers (CHRWs) collect all the demographic events and selected morbidities in the area by monthly household visits. The study area is divided into two parts. One is the ICDDR,B service area, where an extensive Maternal, Child Health and Family Planning Programme has been operating to strengthen the government's services since 1978. The other is the Government service area, where the population receives services from government facilities as in areas all over Bangladesh. The ICDDR,B service area is again divided by four blocks and each one is comprised of an approximate 27,000 population. Each block has a sub-centre that provides 24-hour services by midwifery staff. All the sub-centre and field activities are supported by the hospital at Matlab Township. Sub-centres are comparable with the union level health structure of government facilities. The study will be implemented in the ICDDR,B service area.
Currently at Matlab a comprehensive maternal, neonatal \& child health (MNCH) programme has been ongoing since March 2007. Under this programme pregnancies are identified by CHRWs during their routine bimonthly household visits. Once pregnancy is identified by urine test, CHRWs visit each woman at their home twice during pregnancy (12-14 weeks \& 33-34 weeks of pregnancy) and counsel them about facility-based delivery, antenatal care, and birth preparedness. After delivery, the CHRWs visit women on Days 0, 3, 7, and 28, 45, 75,105 and 180 to provide additional counseling, immediate newborn care, anthropometry measurements, \& collect morbidity information (Diarrhoea, Respiratory Tract infections \& other illness as well as also breast feeding \& other feeding status). The women also visit CHRWs houses for immunization, family planning and also for Home based Life Saving Skill (HBLSS) training along with their child and family members.
Study Design:
This randomized community intervention will be conducted on mother-infant pairs of two randomly selected areas from four blocks: intervention and control.
Implementation:
The study participants (the infant who has completed his/her 6 month of age from the date of birth along with their mother) will be enrolled from MNCH database according to criteria for the intervention group and same number of control will be selected as above mentioned procedure for each selected CHRW. At the beginning, baseline information will be collected for each participant after informed consent. All the mothers of the selected infants along with family member/s will receive training on standard complementary feeding practices at respective CHRWs houses. A Training manual will be developed according to WHO and Bangladesh Breast Feeding Foundation guideline. Refresher training will be arranged 3 months after the first training at the CHRWs houses with the same participants. The CHRW will visit each infant house till he/she reaches at 12 month of age at every two month interval.
Data collection:
During each visit CHRWs will record anthropometrical measurement, details feeding information both intervention and comparison group. CHRWs and Field Research Assistant (FRA) will also receive training on study questionnaire. Field Research Supervisors (FRS) will be included also in the training programme to include them in supervision process. The socio-demographic information will be collected from HDSS database. The recruited FRA will work with FRS and will be responsible for all trainings, supervision and monitoring the data collection. Monitoring will be done by a standard check list. CHRWs will bring the questionnaires in each subcenter meeting and FRA will receive and will send it to the computer room at Matlab after reviewing each questionnaire. Any inconsistency or quarries will be checked by FRA with the help of respective subcenter supervisor.
Sample Size:
The number of woman-infant pairs required was calculated based on the studies conducted earlier with peer counselors. We determined the sample size based on 20% difference (based on previously conducted same study) in the prevalence of height-for-age, and weight-for-age (40%) between intervention and control groups, with 5% significance level and 80% power. With a maximum of 30% lost to follow up a total of 120 pairs will be needed for each study arm (intervention and control). With design effect of 1.5, we need 180 woman-infant pairs from each arm.
Data Analysis:
The total observations will be categorized into two groups by using baseline status and after. Data will be presented as mean ± SD for continuous variables and proportion for categorical variables. Unadjusted odds ratio between exposure variables and complementary feeding will be determined by using univariate analysis. Multivariate logistic regression analysis will be done to evaluate the simultaneous effects of various exposure variables after adjusting for any confounding variables. A p-value <0.05 will be considered for significance.
- Conditions
- Growth Disorders
- Being tested
- Intervention cluster
- Keywords
- Stunting, complementary feeding Index, Bangladesh
- Medical subject headings
- Growth Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention clusterBehavioural
The mother- infant pairs (the infant who has completed his/her 6 month of age from the date of birth along with their mother) of intervention clusters will receive the CF practice counselling in groups as soon as enrolment is completed by CHRW at fixed site clinic and refreshers will be arranged 3 months apart from first training in groups at same place and by same person. However CHRWs will also counsel each participant during her bimonthly household visit.
| Study group | Role | What they receive |
|---|---|---|
| Intervention cluster | Experimental | The study participants (the infant who has completed his/her 6 month of age from the date of birth along with their mother) will be enrolled from MNCH database according to criteria for the intervention group.All the mothers of the selected infants along with family member/s will receive training on standard complementary feeding practices . Refresher training will be arranged 3 months after the first training.
The CHRW will visit each infant house till the infant reaches at 12 month of age at every two month interval. During the visit CHRWs will measure weight through standard SECA digital weighing scale in nearest 100 gm (precision 20 gram) and length in nearest 0.1 cm by local made standard length board with movable foot board. Receives: Behavioral: Intervention cluster |
| Controlled cluster | No intervention | The participants for control clusters will be (the infant who has completed his/her 6 month of age from the date of birth along with their mother) will be enrolled from MNCH database according to criteria. The mother-infant pairs from control cluster will receive the usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length for age of the infant between two areas ( less than -2SD according National intervention group) will be measured
Stunting will be calculated as length for age of the infant less than -2SD according National Center for Heath Statics.
Measured: 6 months
weight for length of the infant between two areas ( less than -2SD according National intervention group) will be measured
Wasting will be calculated as weight for length of the infant less than -2SD according National Center for Heath Statics.
Measured: 6 months
weight for age of the infant between two areas ( less than -2SD according National intervention group) will be measured
Underweight will be calculated as weight for age of the infant less than -2SD according National Center for Heath Statics.
Measured: 6 months
Secondary outcomes (1)
Difference in complementary feeding index among the intervention and control group
Variables in complementary feeding index: Continued breastfeeding, Bottle-feeding, Timely initiation of complementary feeding,Dietary diversity (past 24 hours), Food-frequency (past 7 days),Meal-frequency (past 24 hours)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2017 (estimated)
- Study startJan 2011
- Primary completionDec 2012
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Growth DisordersStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aminur Rahman, MBBS, MSc, Principal investigator, ICDDR,B, Dhaka, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03024710
- Sponsor's protocol ID
- PR-10079
- Status last verified
- Jan 2017
- First submitted
- 6 Sep 2016
- Last updated
- 20 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: As per icddr,b data policy study data will be shared with research administration for use future by others after following legal permission
Publications
Physical status: the use and interpretation of anthropometry. Report of a WHO Expert Committee. World Health Organ Tech Rep Ser. 1995;854:1-452.
PubMed 8594834Brown K, Dewey KG, Allen H. Complementary feeding of young children in developing countries: a review of current scientific knowledge. Geneva: World Health Organization, 1998:1544. (WHO/NUT/98.1)
World Health Organization. Complementary feeding: report of global consultation, 10-13 December 2001 and summary of guiding principles. Geneva: World Health Organization, 2001:920
Black RE, Allen LH, Bhutta ZA, Caulfield LE, de Onis M, Ezzati M, Mathers C, Rivera J; Maternal and Child Undernutrition Study Group. Maternal and child undernutrition: global and regional exposures and health consequences. Lancet. 2008 Jan 19;371(9608):243-60. doi: 10.1016/S0140-6736(07)61690-0. No abstract available.
PubMed 18207566Pollitt E, Gorman KS, Engle PL, Rivera JA, Martorell R. Nutrition in early life and the fulfillment of intellectual potential. J Nutr. 1995 Apr;125(4 Suppl):1111S-1118S. doi: 10.1093/jn/125.suppl_4.1111S.
PubMed 7536831Grantham-McGregor SM, Cumper G. Jamaican studies in nutrition and child development, and their implications for national development. Proc Nutr Soc. 1992 May;51(1):71-9. doi: 10.1079/pns19920012.
PubMed 1380717Haas JD, Murdoch S, Rivera J, Martorell R. Early nutrition and later physical work capacity. Nutr Rev. 1996 Feb;54(2 Pt 2):S41-8. doi: 10.1111/j.1753-4887.1996.tb03869.x.
PubMed 8710235Jones G, Steketee RW, Black RE, Bhutta ZA, Morris SS; Bellagio Child Survival Study Group. How many child deaths can we prevent this year? Lancet. 2003 Jul 5;362(9377):65-71. doi: 10.1016/S0140-6736(03)13811-1.
PubMed 12853204Mitra SN, Ahmed Al Sabir, Anne RC, Kanta J. Bangladesh Demography And Health Survey 2007. Dhaka And Calverton, Maryland: National Institute Of Population Research And Training (NIPORT), Mitra & Associates, And Macro International Inc., 2007.
Millennium Development Goals: Bangladesh Progress Report. February 2005. Jointly prepared by the Government of Bangladesh and the United Nations Country Team in Bangladesh
National Institute of Population Research and Training. Bangladesh demographic and health survey 2004. Dhaka: National Institute of Population Research and Training, 2005. 339 p.
The State of the World's Breastfeeding: Bangladesh report card:2005 International Baby Food Action Network (IBFAN), Asia Pacific.
Bhandari N, Mazumder S, Bahl R, Martines J, Black RE, Bhan MK; Infant Feeding Study Group. An educational intervention to promote appropriate complementary feeding practices and physical growth in infants and young children in rural Haryana, India. J Nutr. 2004 Sep;134(9):2342-8. doi: 10.1093/jn/134.9.2342.
PubMed 15333726Guldan GS, Fan HC, Ma X, Ni ZZ, Xiang X, Tang MZ. Culturally appropriate nutrition education improves infant feeding and growth in rural Sichuan, China. J Nutr. 2000 May;130(5):1204-11. doi: 10.1093/jn/130.5.1204.
PubMed 10801920Santos I, Victora CG, Martines J, Goncalves H, Gigante DP, Valle NJ, Pelto G. Nutrition counseling increases weight gain among Brazilian children. J Nutr. 2001 Nov;131(11):2866-73. doi: 10.1093/jn/131.11.2866.
PubMed 11694610
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promotion of Complimentary Feeding Practices Through Health Messages: a Community-based Clustered Randomized Trial in Rural Bangladesh
- ClinicalTrials.gov ID
- NCT03024710
- Acronym / sponsor ID
- PR-10079
- Conditions
- Growth Disorders
- Keywords
- Stunting, complementary feeding Index, Bangladesh
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, BangladeshUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 19 Jan 2017 (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.
Infant feeding practices and nutritional status among children is interrelated and link is well established. Incidence of malnutrition sharply rises during 6-9 months of age in most of the developing countries which coincide with the period of complimentary feeding (CF). This prospective randomized trial will be implemented in ongoing health and demographic surveillance system of Matlab, ICDDR,B and will be nested into an ongoing maternal and child health services area. Area of community health workers (four blocks) will be divided into two pairs and each pair will be randomly assigned into intervention or control groups. The eligible and consented mother-infant newborn will be recruited either into an intervention or control groups based on the areas of the paired block. The mothers and family members of the intervention area will receive intensive counseling on complementary feeding practices through community health workers. In total about 360 mother-infant pair will be recruited in the study for each site. Data on children's anthropometry (weight and lengths), information on complementary feeding practices and related covariates will be collected through trained research staffs. Data will be evaluated on reduction of burden of malnutrition (stunting, underweight, wasting) and complimentary feeding index between intervention and control groups.
Detailed description
Back ground:
Link between infant feeding practices and nutritional status among children has been well established. Incidence of malnutrition sharply rises during 6-9 months of age which coincide with the period of complimentary feeding (CF). It is reported that poor nutrition increases the risk of illness, and is responsible, directly or indirectly, for one third of the estimated 9.5 million deaths in children less than 5 years of age. Early nutritional deficits are also linked to long-term impairment in growth and health. There is evidence that adults who were malnourished in early childhood have impaired intellectual performance. They may also have reduced capacity for physical work. High proportion of childhood malnutrition has negative impact for national development. Based on evidence of the effectiveness of interventions, achievement of universal coverage of exclusive breastfeeding (EBF) could prevent 13% of deaths occurring in children less than 5 years of age globally, while appropriate complementary feeding practices would result in an additional 6% reduction in under five mortality. Although there is huge potential for EBF till 6 months of age, the CF practices is also important to maintain the increase demand and growth after the period of EBF to maintain the optimal growth and development during infancy and early child hood period. However, there are lacks of efforts observed to increase the knowledge of good complementary feeding practices at population level. Under five child mortality is still high for Bangladesh. Among these deaths prematurity of the newborn/LBW and malnutrition together contribute to about 45% of all deaths. Despite the progress achieved, child malnutrition in Bangladesh remains among the highest in the world, and more severe than that of most other developing countries. This suggests that children in Bangladesh suffer from short-term acute shortfall in food intake as well as longer-term under-nutrition. Exclusive breast feeding is quiet static (43%-46%) for last few years in Bangladesh and around one fourth infant from 6-9 months ages start complementary feeding either too early or too late. Inappropriate practices of CF reflect the knowledge gap at the population level. Mother and family members are usually unaware about the nutrition need immediately after the completion of exclusive breast feeding practices. It was reported that Bangladesh scored 91.5/150 for Young Infant and Child Feeding (YICF) practices which was done by International Baby Food Action Network (IBFAN), Asia Pacific where community outreach and information support warranted much improvement. To reduce malnutrition: Comprehensive programme of integrated actions on many fronts has been addressed which includes "Promoting improved infant feeding practices, including breast feeding practices". Mothers and families need support to initiate and sustain appropriate infant and young child feeding practices through support person or peer group is recommended at the community level. Educational intervention on CF practices shows improvement in several studies in India, china and Brazil. Indian study observed feasibility of CF practices promotion through existing system and found limited improvement of infant length (difference in means 0.32 cm, 95% CI, 0.03, 0.61) between groups. Brazilian study assessed impact on child growth of the nutrition counseling component of the Integrated Management of Childhood Illnesses strategy and found children 12 month of age or older had improved weight gain (changes of +.25 and -.06 Z-score, respectively) and a positive but non-significant improvement in length (0.40 vs. 0.12). In this study medical doctors were used for counseling which is not applicable in poor resource settings. The China study was to improve infant growth by improving infant feeding practices. The education group infants were significantly heavier and longer, but only at 12 month (weight-for-age -1.17 vs. -1.93; P=5 0.004; height-for-age -1.32 vs. 1.96; P =0.022). But this study differ from exclusive breast feeding (EBF) duration and starting of complimentary feeding practices as recommended by WHO (EBF is practice 4-6 month and weaning starts at 4 months). None of the above studies evaluated feeding practices through CF index. In early 90's Bangladesh Rural Advancement Committee evaluated educational messages on CF practices other than WHO recommendation, Population level study on CF practice promotion is poor in Bangladesh. Given the above background, with lack of knowledge on CF practices in the community level and high burden of childhood malnutrition, we plan to improve complementary feeding practices in Matlab.
Hypothesis to be tested:
The proposed study hypothesized that an appropriate delivery of CF messages at the community level will improve the CF practices and subsequently decrease the burden of malnutrition during infancy.
Specific objectives:
The objectives of the project are to evaluate the effect of CF practice messages through community health workers to mothers and family members in comparison to mothers and family member who do not receive CF practice messages on the following outcomes:
Reducing the burden of stunting, underweight and wasting Evaluate complementary feeding index
Research Design and Methods:
Study site:
The study will be implemented in a rural community of Matlab under a sub-district of Bangladesh. Matlab is located 56 kilometer southeast of the capital Dhaka, where ICDDR,B has been running a health and demographic surveillance system (HDSS) in a population of about 220,000 since 1966. In HDSS, the community health research workers (CHRWs) collect all the demographic events and selected morbidities in the area by monthly household visits. The study area is divided into two parts. One is the ICDDR,B service area, where an extensive Maternal, Child Health and Family Planning Programme has been operating to strengthen the government's services since 1978. The other is the Government service area, where the population receives services from government facilities as in areas all over Bangladesh. The ICDDR,B service area is again divided by four blocks and each one is comprised of an approximate 27,000 population. Each block has a sub-centre that provides 24-hour services by midwifery staff. All the sub-centre and field activities are supported by the hospital at Matlab Township. Sub-centres are comparable with the union level health structure of government facilities. The study will be implemented in the ICDDR,B service area.
Currently at Matlab a comprehensive maternal, neonatal \& child health (MNCH) programme has been ongoing since March 2007. Under this programme pregnancies are identified by CHRWs during their routine bimonthly household visits. Once pregnancy is identified by urine test, CHRWs visit each woman at their home twice during pregnancy (12-14 weeks \& 33-34 weeks of pregnancy) and counsel them about facility-based delivery, antenatal care, and birth preparedness. After delivery, the CHRWs visit women on Days 0, 3, 7, and 28, 45, 75,105 and 180 to provide additional counseling, immediate newborn care, anthropometry measurements, \& collect morbidity information (Diarrhoea, Respiratory Tract infections \& other illness as well as also breast feeding \& other feeding status). The women also visit CHRWs houses for immunization, family planning and also for Home based Life Saving Skill (HBLSS) training along with their child and family members.
Study Design:
This randomized community intervention will be conducted on mother-infant pairs of two randomly selected areas from four blocks: intervention and control.
Implementation:
The study participants (the infant who has completed his/her 6 month of age from the date of birth along with their mother) will be enrolled from MNCH database according to criteria for the intervention group and same number of control will be selected as above mentioned procedure for each selected CHRW. At the beginning, baseline information will be collected for each participant after informed consent. All the mothers of the selected infants along with family member/s will receive training on standard complementary feeding practices at respective CHRWs houses. A Training manual will be developed according to WHO and Bangladesh Breast Feeding Foundation guideline. Refresher training will be arranged 3 months after the first training at the CHRWs houses with the same participants. The CHRW will visit each infant house till he/she reaches at 12 month of age at every two month interval.
Data collection:
During each visit CHRWs will record anthropometrical measurement, details feeding information both intervention and comparison group. CHRWs and Field Research Assistant (FRA) will also receive training on study questionnaire. Field Research Supervisors (FRS) will be included also in the training programme to include them in supervision process. The socio-demographic information will be collected from HDSS database. The recruited FRA will work with FRS and will be responsible for all trainings, supervision and monitoring the data collection. Monitoring will be done by a standard check list. CHRWs will bring the questionnaires in each subcenter meeting and FRA will receive and will send it to the computer room at Matlab after reviewing each questionnaire. Any inconsistency or quarries will be checked by FRA with the help of respective subcenter supervisor.
Sample Size:
The number of woman-infant pairs required was calculated based on the studies conducted earlier with peer counselors. We determined the sample size based on 20% difference (based on previously conducted same study) in the prevalence of height-for-age, and weight-for-age (40%) between intervention and control groups, with 5% significance level and 80% power. With a maximum of 30% lost to follow up a total of 120 pairs will be needed for each study arm (intervention and control). With design effect of 1.5, we need 180 woman-infant pairs from each arm.
Data Analysis:
The total observations will be categorized into two groups by using baseline status and after. Data will be presented as mean ± SD for continuous variables and proportion for categorical variables. Unadjusted odds ratio between exposure variables and complementary feeding will be determined by using univariate analysis. Multivariate logistic regression analysis will be done to evaluate the simultaneous effects of various exposure variables after adjusting for any confounding variables. A p-value <0.05 will be considered for significance.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention cluster | Experimental | Behavioral: Intervention clusterThe study participants (the infant who has completed his/her 6 month of age from the date of birth along with their mother) will be enrolled from MNCH database according to criteria for the intervention group.All the mothers of the selected infants along with family member/s will receive training on standard complementary feeding practices . Refresher training will be arranged 3 months after the first training. The CHRW will visit each infant house till the infant reaches at 12 month of age at every two month interval. During the visit CHRWs will measure weight through standard SECA digital weighing scale in nearest 100 gm (precision 20 gram) and length in nearest 0.1 cm by local made standard length board with movable foot board. |
| Controlled cluster | No intervention | –The participants for control clusters will be (the infant who has completed his/her 6 month of age from the date of birth along with their mother) will be enrolled from MNCH database according to criteria. The mother-infant pairs from control cluster will receive the usual care. |
Who may qualify
- Ages
- 6 to 12 months
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- The infant who has completed his/her 6 month of age from the date of birth along with their mother
Key exclusion criteria (1 listed)
- Children with severe illnesses or handicaps affecting development, feeding, or activity
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 |
|---|---|---|
| Intervention clusterThe mother- infant pairs (the infant who has completed his/her 6 month of age from the date of birth along with their mother) of intervention clusters will receive the CF practice counselling in groups as soon as enrolment is completed by CHRW at fixed site clinic and refreshers will be arranged 3 months apart from first training in groups at same place and by same person. However CHRWs will also counsel each participant during her bimonthly household visit. | Behavioural | Intervention cluster |
Primary outcome
Length for age of the infant between two areas ( less than -2SD according National intervention group) will be measured
Time frame: 6 months
Stunting will be calculated as length for age of the infant less than -2SD according National Center for Heath Statics.
weight for length of the infant between two areas ( less than -2SD according National intervention group) will be measured
Time frame: 6 months
Wasting will be calculated as weight for length of the infant less than -2SD according National Center for Heath Statics.
weight for age of the infant between two areas ( less than -2SD according National intervention group) will be measured
Time frame: 6 months
Underweight will be calculated as weight for age of the infant less than -2SD according National Center for Heath Statics.
1 secondary outcome
Difference in complementary feeding index among the intervention and control group
Time frame: 6 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 20 Jan 2017.
- Background: PubMed 8594834Physical status: the use and interpretation of anthropometry. Report of a WHO Expert Committee. World Health Organ Tech Rep Ser. 1995;854:1-452.
- BackgroundBrown K, Dewey KG, Allen H. Complementary feeding of young children in developing countries: a review of current scientific knowledge. Geneva: World Health Organization, 1998:1544. (WHO/NUT/98.1)
- BackgroundWorld Health Organization. Complementary feeding: report of global consultation, 10-13 December 2001 and summary of guiding principles. Geneva: World Health Organization, 2001:920
- Background: PubMed 18207566Black RE, Allen LH, Bhutta ZA, Caulfield LE, de Onis M, Ezzati M, Mathers C, Rivera J; Maternal and Child Undernutrition Study Group. Maternal and child undernutrition: global and regional exposures and health consequences. Lancet. 2008 Jan 19;371(9608):243-60. doi: 10.1016/S0140-6736(07)61690-0. No abstract available.
- Background: PubMed 7536831Pollitt E, Gorman KS, Engle PL, Rivera JA, Martorell R. Nutrition in early life and the fulfillment of intellectual potential. J Nutr. 1995 Apr;125(4 Suppl):1111S-1118S. doi: 10.1093/jn/125.suppl_4.1111S.
- Background: PubMed 1380717Grantham-McGregor SM, Cumper G. Jamaican studies in nutrition and child development, and their implications for national development. Proc Nutr Soc. 1992 May;51(1):71-9. doi: 10.1079/pns19920012.
- Background: PubMed 8710235Haas JD, Murdoch S, Rivera J, Martorell R. Early nutrition and later physical work capacity. Nutr Rev. 1996 Feb;54(2 Pt 2):S41-8. doi: 10.1111/j.1753-4887.1996.tb03869.x.
- Background: PubMed 12853204Jones G, Steketee RW, Black RE, Bhutta ZA, Morris SS; Bellagio Child Survival Study Group. How many child deaths can we prevent this year? Lancet. 2003 Jul 5;362(9377):65-71. doi: 10.1016/S0140-6736(03)13811-1.
- BackgroundMitra SN, Ahmed Al Sabir, Anne RC, Kanta J. Bangladesh Demography And Health Survey 2007. Dhaka And Calverton, Maryland: National Institute Of Population Research And Training (NIPORT), Mitra & Associates, And Macro International Inc., 2007.
- BackgroundMillennium Development Goals: Bangladesh Progress Report. February 2005. Jointly prepared by the Government of Bangladesh and the United Nations Country Team in Bangladesh
- BackgroundNational Institute of Population Research and Training. Bangladesh demographic and health survey 2004. Dhaka: National Institute of Population Research and Training, 2005. 339 p.
- BackgroundThe State of the World's Breastfeeding: Bangladesh report card:2005 International Baby Food Action Network (IBFAN), Asia Pacific.
- Individual participant dataSharing planned: Yes. As per icddr,b data policy study data will be shared with research administration for use future by others after following legal permission
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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.
Aminur Rahman, MBBS, MSc principal investigator
ICDDR,B, Dhaka, Bangladesh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention cluster in people with Growth Disorders, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
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 1 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 20 Jan 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 Bangladesh. 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?
Length for age of the infant between two areas ( less than -2SD according National intervention group) will be measured (time frame: 6 months). The study lists 3 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 NCT03024710, which also lists 20 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 20 Jan 2017.