Progress 09/01/10 to 08/31/15
Outputs
Target Audience: The study findings have been reported only in a very limited way, given that the results of the study were only recently published online in the International Journal of Epidemiology (Christian P, Shaikh S, Shamim AA, Mehra S, Wu L, Mitra M, Ali A, Merrill RD, Choudhury N, Parveen M, Fuli R, Hossain MI, Islam MM, Klemm R, Schulze K, Labrique A, de Pee S, Ahmed T, West Jr KP. Effect of fortified complementary food supplementation on child growth in rural Bangladesh - a cluster-randomized trial. IJE Aug 2015, Epub). Target audience for the journal is the scientific and programming community. Experimental Biology Meetings: The results of this study were presented in April 2015 at teh Experimental Biology Meeting Dissemination of the study results and findings is being planned in Bangladesh, at USAID, USDA, the TOPS Program in the near future. Changes/Problems:There were no major changes made to the study. Civil unrest in the country was the major barrier and delays in the work resulted in us requesting two no-cost extensions for the study. Despite these major setbacks that happed during the study period, we were successfully able to complete the entire activity as originally planned. What opportunities for training and professional development has the project provided?As part of the study,two doctoral students were able to participate in the study to work on their thesis on nutriiton and child feeding and growth. Additionally, a junior faculty was able to get a small faculty innovation grant to add a responsive feeding questionnaire to the study as well as conduct dietary data analysis. Masters students from the Insititute of Nutrition Science, Dhaka University, Bangladesh did a 2 week field-rotation at our study site when the study was ongoing. How have the results been disseminated to communities of interest?The results of the study were presented at the 2015 Experimental Biology Meetings in Boston. In additon, the manuscript describing the findings of the study were published online in the Internatinal Journal of Epidemiology. A complementary foods interest group (called iLINS network) disseminated the paper to all the members of the network. Plans are underway for seminars and dissemination via the TOPS project as well as at USAID in Washington DC. Additionally, we are planning on a dissemination workshop in Bangaldesh and a policy brief in the coming few months. What do you plan to do during the next reporting period to accomplish the goals?
Nothing Reported
Impacts
What was accomplished under these goals?
From September 2012 until October 2014 we conducted a five-arm food supplementation trial in a rural 450 sq km study area in northwestern Bangladesh, delivering 4 different types of daily (1.1 millionsnacks in total)food supplements in the home to about 5500 children from 6 to 18 months of age, monitoring adherence, collecting daily morbidity data, conducting repeated (every 3 months) assessment of anthropometry and dietary intake and examining infant and child feeding practices, over and above providing rigorous nutrition counselingover 9 different contacts to all mothers(primary caretakers) of enrolled children in the study. Details of the study are published and the exciting findings of reduction in 4-6% stunting with supplementation published recently in the International Journal of Epidemiology. The entire project was carried out by JHU and Bangladeshi scientists working on the JiVitA projectwith about 800 field staff and data collectors. A data entry center operating under a JHU and local progammer and data managers with 8 data entry operators carried out the task of data managment, entry and cleaning, and handling of forms from the field. Ethical review boards in both USA and Bangladesh approved the study. A data safety and monitoring board monitored the conduct of the study and its implementation and reviewed the final results of the study on June 26, 2014. A 24 month follow-up in the study was completed in October 2014. Blood, urine and stool were collected at 18 months of age in a biochemical and gut health substudy. Data using these biospecimens were analyzed both at the Center for Human Nutrition's micronutrient laboratory as well as the laboratory at icddr,b. A NIH R-21 was written and awarded to carry out some of these additonallaboratory analysis, not funded by the USDA/NIFA project. We are analyzing serum samples for indicators of micronutrient status and inflammation and for growth factors. Stool biomarkers were analyzed for gut health, as well as the urine for the lactulose:mannitol test. We plan to disseminate the data of the study findings locally and nationally. Several additional manuscripts are under preparation to examine secondary outcomes in the study.
Publications
- Type:
Journal Articles
Status:
Published
Year Published:
2015
Citation:
Christian P, Shaikh S, Shamim AA, Mehra S, Wu L, Mitra M, Ali A, Merrill RD, Choudhury N, Parveen M, Fuli R, Hossain MI, Islam MM, Klemm R, Schulze K, Labrique A, de Pee S, Ahmed T, West Jr KP. Effect of fortified complementary food supplementation on child growth in rural Bangladesh a cluster-randomized trial. Int J Epi Aug, 2015 (epub ahead of print).
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Progress 09/01/13 to 08/31/14
Outputs
Target Audience: Parents and children of rural northwestern Bangladesh who are participants in the study were reached for delivery of interventions and assessments as per the study protocol. Changes/Problems:
Nothing Reported
What opportunities for training and professional development has the project provided? Two doctoral students are undertaking their dissertation work nested within the larger study. How have the results been disseminated to communities of interest? Once the primary paper is published, plans for disseminating the results to various local, national, regional and international constituencies will be commenced in partnership with all the collaborators including the WFP and icddr,b. What do you plan to do during the next reporting period to accomplish the goals? Data analysis, manuscript preparation and biospecimen analysis will be undertaken during the next reporting period and prior to the close out of the study in March 2015.
Impacts
What was accomplished under these goals?
In this reporting period we completed all enrollments in the study as well as follow-up. The sample size attained per group was on target with the study design. In total, 5,449 eligible infants were enrolled, slightly over the proposed sample size (n=5,320); 37 children died, and 1,310 children were followed through 18 months of age or older in the nutrition education control group, 1,395 in the Plumpy'Doz group, 784 in the rice lentil group, 785 in the chickpea group and 789 in the WSB++ group for a 96% follow up rate. A full data safety and monitoring board meeting was held on June 26th, 2014. Study results and the review by the DSMB was completed at this meeting. Currently, the investigative team is analyzing the data to submit the primary manuscript for publication. Because of the initial delay in the study start-up, a no-cost extension for a year was requested and granted. In a substudy, venous blood was collected in children at 18 months of age at the end of the supplementation period. All biospecimens were shipped to JHU and serum specimens are now undergoing laboratory analysis for micronutrient status at the Center for Human Nutrition’s micronutrient laboratory at Johns Hopkins School of Public Health. This work will be conducted during the no-cost extension period. Once the primary paper is published, the study team plans to disseminate the results in Bangladesh as well as at international meetings. Papers reporting secondary outcomes such as cognition, morbidity and micronutrient status will also be developed, although this will like occur beyond the extension period for the study.
Publications
- Type:
Conference Papers and Presentations
Status:
Awaiting Publication
Year Published:
2014
Citation:
Shamim AA, Hanif AM, Merrill RD, Kramer RF, Kumkum MZ, Shaikh S, de Pee S, Ahmed T, Parveen M, Mehra S, Klemm R, Labrique A, West KP Jr. Christian P. Preferred delivery method and acceptability of Wheat Soy Blend (WSB++) as a daily complementary food supplement in northwest Bangladesh. Ecology of Food and Nutrition.
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Progress 09/01/12 to 08/31/13
Outputs
Target Audience: Children and parents in the rual northwestern Bangladeshi community who were participants in the trial. Consenting parents and their children were enrolled in the study, mothers received counseling on infant and young child feeding, and in 4 of the 5 groups, children received daily complementary foods as per the random allocation. Changes/Problems: The only significant barriers to meeting study objectives were related to the delay in the study start-up. Though it has continued to be a little difficult to maintain the pipeline of imported foods occasionally, this has not jeopardized the study since it began. Additionally, it has been difficult to run the study in a timely manner in 2013 on account of a hostile political climate within Bangladesh as general elections planned for January 2013 have lead to a great deal of unrest. This results in countrywide or regional "strikes" that shuts down all business in the country. Our team on the ground has been doing stellar work in managing the protocol, working longer hours on available work days (non-strike days) and compensating for missed work days on weekends to keep the study on track. There were no procedural changes or change in approach made. What opportunities for training and professional development has the project provided? Apart from previously reported opportunities, two JHU doctoral students became engaged in this research study to conduct their doctoral dissertation work. Both students are advisees of Dr. Parul Christian. How have the results been disseminated to communities of interest?
Nothing Reported
What do you plan to do during the next reporting period to accomplish the goals? Data collection and enrollment in the study and assessments will continue until the sample size is reached. The field and teams will continue to work hard to achieve a high level of followup.
Impacts
What was accomplished under these goals?
We conducted our first pre-trial DSMB on July 23, 2012 with the members of the DSMB reported to the IRB in the previous year’s annual report. The research proposal was shared with team members, an overview of the study presented to the board and questions taken from members of the DSMB. Additionally, a charter for the DSMB was developed. The approved DSMB report is enclosed. a. Study Enrollment and Feeding: We began enrollment of children in the study from September 2, 2012 and completed all the consents for the required sample size for the study, and enrollment is expected to end on May 16th, 2013. Because the consent for being enrolled is already obtained, and we know the exact date of enrollment (on the 6 month birthday) we have provided the end date of enrollment. Our anticipated enrollment will be 5451, < 2% higher than the previously approved sample size of 5320. Deciding when to stop enrollment is an inexact process across a study area of 596 sectors, with the stop date prepared in advance based on projections amidst rapid enrollment activities. With some losses to follow-up expected, we anticipate the final number of followed children to fall within our targeted sample size. Families of children are visited weekly to provide food, and to collect data on feeding and child morbidity. In addition, we provide counseling monthly for the first 6 months and then bi-monthly for the latter half of the year and interview the families of children at enrollment, at 9, 12, 15 and 18 months. We are presently conducting the 6, 9, and 12 month follow-up interviews in the overall study area as well as in the substudy area. We anticipate the 15 and 18 month interviews to begin soon in June and August, respectively of this year. b. Procurement and import of complementary food supplements (CFS): Two of the four foods for the trial, WSB++ and Plumpy’Doz are imported into the country solely for the study. The World Food Program (WFP) Country Office has been coordinating the import, customs’ clearance, transport to the study site and storage in mass quantities of these foods. Despite minor issues with the pipeline, and one defective batch of Plumpy’Doz, this has progressed well to keep the trial running. c. Production and testing of the two local CFS: The remaining two foods being tested (chickpea-based and rice-lentil based ) are manufactured in-country by Olympic Ltd. under the guidance and monitoring of food technologists from the World Food Program (WFP). Despite problems initially with the development of a method that could consistently produce batches of these foods free of microbial contamination (see our explanation in the likelihood of meeting timelines) that delayed the start of the study, production is now on time, consistent and uncontaminated so that enrolled children continue to be fed with no interruptions.
Publications
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Progress 09/01/11 to 08/31/12
Outputs
Target Audience: Data collection was not commenced until September 1, 2012. Participants in the study were contacted for obtaining informed consent during this period. The target audience were the parents of the children eligible for enrollment in the study. In a home-visit project workers read out an IRB approved consent statement to the parents of the eligible child and obtained written informed consent. All children who had turned 5 months of age were visited, as per the protocol. Changes/Problems: As explained ealier, although much progress has been made, there have also been a few delays in the first phase of the study involving product development. Our previous start-up date of enrollment of children into the trial of January 1, 2012 was pushed back by about 8 months, although we are hoping to shorten the enrollment to 6 months. What opportunities for training and professional development has the project provided? Training opportunities to project staff, faculty and student involved in implementing the study and collecting data for the study were provided which included technical skills such as conducting an interview, and assessment of anthropometry, cognitive function, and biochemical indicators. How have the results been disseminated to communities of interest?
Nothing Reported
What do you plan to do during the next reporting period to accomplish the goals? Enrollment in the study and the field trial will begin in the next reporting period. All preparatory work to begin this are ongoing.
Impacts
What was accomplished under these goals?
Significant progress was made over the past two years in the reporting period of 9/1/2010-8/31/2012 towards preparation for the study. This is described in detail by topic below. a) We sought and received ethical approval for the study by the IRBs at Johns Hopkins School of Public Health in the US and icddr,b in Bangladesh. b) Scopes of work, agreements and MoUs were generated and executed with collaborating organizations. c) A letter of approval from the Bangladesh Ministry of Health and Family Welfare (MoHFW) was obtained for importation of WSB++ and Plumpy'doz into the country. d) The two local CFS products (chickpea-based and rice-lentil based) were formulated and underwent stability, shelf life and acceptability testing. A company called Olympic Ltd was identified as the producer. An agreement for the production work was signed in March 2012 with the company. The packaging and labeling of the food products was also finalized and specifications provided to Olympic. e) A field based pretesting of the WSB++ which needs to be cooked prior to feeding was undertaken in the late fall of 2011. Cooking recipes were tested with mothers as well as trials of feeding were undertaken to see amounts consumed and wasted. Modalities of food delivery (cooked vs. uncooked) were tested and mother's preference was determined using focus groups. f) Forms development and pretesting: All forms were fully discussed, vetted, pretested and finalized for use in the trial. Standard operating procedures were developed and supplies have been procured and prepared for the study. As part of the development of the Child Feeding Counseling (CFC) intervention, a procedures and accompanying training manual were developed. g) Training of staff and standard operating procedures: 40 female interviewers were trained to conduct enrollment and period interviews for the study. These staff previously also trained as anthropometrists were provided systematic refresher training and standardized to perform anthropometry. 596 field distributors were trained to provide foods and monitor adherence and morbidity. A cadre of counselors were trained to provide infant /child feeding counseling to the mothers. h) A Data Safety and Monitoring Board for the study was formed. The first pre-trial meeting was held on Aug 1, 2012. i) Food production and testing was started in July by Olympic Ltd. However, SGS testing of the foods revealed higher than acceptable levels of mould and coliforms. Thus, the first production batch was rejected, and new hygiene standards and procedures discussed and implemented. Subsequently, a new batch was prepared and passed the test. Time-line: Although much progress has been made, there have also been a few delays in the first phase of the study involving product development. Our previous start-up date of enrollment of children into the trial of January 1, 2012 was pushed back by about 8 months, although we are hoping to shorten the enrollment to 6 months.
Publications
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Progress 09/01/10 to 08/31/11
Outputs
OUTPUTS: Significant progress was made over the past two years in the reporting period of 9/1/2010-8/31/2012 towards preparation for the study. This is described in detail by topic below. a) We sought and received ethical approval for the study by the IRBs at Johns Hopkins School of Public Health in the US and icddr,b in Bangladesh. b) Scopes of work, agreements and MoUs were generated and executed with collaborating organizations. c) A letter of approval from the Bangladesh Ministry of Health and Family Welfare (MoHFW) was obtained for importation of WSB++ and Plumpy'doz into the country. d) The two local CFS products (chickpea-based and rice-lentil based) were formulated and underwent stability, shelf life and acceptability testing. A company called Olympic Ltd was identified as the producer. An agreement for the production work was signed in March 2012 with the company. The packaging and labeling of the food products was also finalized and specifications provided to Olympic. e) A field based pretesting of the WSB++ which needs to be cooked prior to feeding was undertaken in the late fall of 2011. Cooking recipes were tested with mothers as well as trials of feeding were undertaken to see amounts consumed and wasted. Modalities of food delivery (cooked vs. uncooked) were tested and mother's preference was determined using focus groups. f) Forms development and pretesting: All forms were fully discussed, vetted, pretested and finalized for use in the trial. Standard operating procedures were developed and supplies have been procured and prepared for the study. As part of the development of the Child Feeding Counseling (CFC) intervention, a procedures and accompanying training manual were developed. g) Training of staff and standard operating procedures: 40 female interviewers were trained to conduct enrollment and period interviews for the study. These staff previously also trained as anthropometrists were provided systematic refresher training and standardized to perform anthropometry. 596 field distributors were trained to provide foods and monitor adherence and morbidity. A cadre of counselors were trained to provide infant /child feeding counseling to the mothers. h) A Data Safety and Monitoring Board for the study was formed. The first pre-trial meeting was held on Aug 1, 2012. i) Food production and testing was started in July by Olympic Ltd. However, SGS testing of the foods revealed higher than acceptable levels of mould and coliforms. Thus, the first production batch was rejected, and new hygiene standards and procedures discussed and implemented. Subsequently, a new batch was prepared and passed the test. j) Start-up of the field trial. The field trial successfully commenced on Sept 2, 2012 and enrollment of children in the study has begun. The first few weeks of supplementation have been successful. Time-line: Although much progress has been made, there have also been a few delays in the first phase of the study involving product development. Our previous start-up date of enrollment of children into the trial of January 1, 2012 was pushed back by about 8 months, although we are hoping to shorten the enrollment to 6 months. PARTICIPANTS: Individuals who worked on the project: Parul Christian (PD);Tahmeed Ahmed (Co-PD);Saskia dePee (Co-PD); other JHU investigators: Keith P. West Jr., Rolf Klemm, Rebecca Merrill, Sucheta Mehra, Alain Labrique; Other icddr,b scientists: Nuzhat Choudhury, Munirul Islam; WFP-CO: although not supported under this grant have worked very hard on the project over the past 1.5 years. The Staff of the JiVitA Project in Bangladesh: Over 700 staff of the JiVitA project are involved in the implementation and conduct of the field trial. This project is a research project on the Johns Hopkins University registered as an international NGO in Bangladesh. Senior investigators (Dr. Hasmot Ali, Mr. Shamim Ahmed, and Dr. Saijuddin Shaikh with other senior staff) worked on all aspects of the field preparations for the study. Partner Organizations: icddr,b: The local premier research institute is a partner and has worked on the development and acceptability testing of two locally produced complementary food supplements (CFS. WFP: World Food Program both in Rome and country office has been a key partner in helping with food development support through their food technologists, as well as importation of the WSB++ and Plumpy'doz products and contracting a local company for production of the local CFSs. DSM, Basel: DSM is providing us both technical support, and in-kind support for the premixes being used in the two local food products. Nutriset, France: Is providing Plumpy'doz gratis for the trial. TARGET AUDIENCES: Nothing significant to report during this reporting period. PROJECT MODIFICATIONS: After careful vetting, it was agreed by the investigative group, that from a scientific, ethical and political perspective, testing the impact of complementary food supplements (CFSs) beyond nutrition education/counseling will place the trial in a better position to inform future policy and programs. Thus, instead of comparing nutrition education (provided alone) as a control group versus each of the CFS arms in the study, it was deemed better to provide nutrition education to all the study subjects. Thus, the research will address whether providing food supplements in addition to nutrition education can have an impact on child growth and stunting beyond that which can be achieved with nutrition education alone. Personnel time required to provide nutrition education across all randomized groups in the study will increase. We are using the materials on infant and young child feeding being developed and tested in country by other organizations, and are likely to be widely used. This change was discussed with the program officer during one of the updates via phone provided by the PD.
Impacts
Our study planned to develop two complementary foods supplements (CFS) using local products. This development and testing was undertaken by our collaborators at icddr,b in Bangladesh. After a year of work the two local products (chickpea-based and rice-lentil based) have been formulated and have undergone stability, shelf life and acceptability testing. WFP supported a food technologist from the Institute of Nutrition, Mahidol University in Thailand to help with the work on CFS development as well as help in identifying an appropriate in-country food manufacturer to produce the complementary foods at scale for the study. A company called Olympic Ltd was identified to manufacture these products at scale for the field trial. A lot of leveraging, especially from our WFP partner has made much of this work move forward. For example, the work of a food technologist, that we identified through one of our collaborating university in Thailand and was hired by WFP, and that of a DSM technical specialist on micronutrient powders and pre-mix have been key to advancing product development.
Publications
- No publications reported this period
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