Progress 10/01/18 to 09/30/21
Outputs
Target Audience:
Nothing Reported
Changes/Problems:In Year 2, the COVID-19 pandemic presented a significant challenge to the research project. In accordance with the Cornell University campus closure, all human research was halted from March 13th until July 15th, resulting in missed study visits. During the research closure, we obtained electronic parent-report survey data from the mothers at the times when they would have been scheduled to attend their in-person laboratory visit. In compliance with New York State and Cornell University COVID-19 guidelines, we designed a thorough COVID-19 Standard Operating Procedure, which required minor adjustments to our testing protocol in order to successfully adhere to social distancing guidelines. The only substantive change to our protocol was the removal of the deferred imitation task, which was previously conducted at the 13-month visit. Because this task requires that the tester be within six feet of the mother and the infant for longer than ten minutes, we were unable to safely conduct it under COVID-19 restrictions. The only other changes to the protocols were minor adjustments to the placement of the tester relative to the participants in order to adhere to social distancing guidelines--these changes did not impact the quality or validity of the data collected. Upon reopening, we were able to make up some of the missed visits within a reasonable developmental window for the infants. What opportunities for training and professional development has the project provided?This project has provided significant opportunities for training and personal development for graduate students. For example, graduate students Kara Beckman and Jesse Brinkman have received extensive training in research methods, study management, and mentorship. This experiential training has included learning how to communicate with mothers with newborn infants, administer cognitive assessments to infants and structured interviews and questionnaires to parents, how to balance the scientific and managerial demands of research, how to communicate study tasks successfully to undergraduate research assistants in the lab, and how to appropriately manage, clean and analyze data. The graduate students have also had opportunities for professional development as a result of this project. For example, Jesse Brinkman recently presented preliminary findings at the Cornell Dietetics Research Symposium and presented a poster of her findings at the New York State Academy of Nutrition and Dietetics Annual Meeting and Expo on April 15, 2020. This project has given 21 undergraduates the opportunity to receive scientific training by Drs. Strupp and Canfield and the graduate students. These undergraduate students have gained experience in a variety of research activities including developing scoring and task-administration guides, analysis of physiological data, reading relevant scientific literature, conducting descriptive statistics, and preparing journal-club style paper presentations. Further, with the mentorship of Dr. Strupp and Kara Beckman, one of our undergraduate research assistants applied for and received a Hatch Supplement grant to support her work on the behavior coding of the Lab-TAB task. How have the results been disseminated to communities of interest?During Year 2, Jesse Brinkman, one of the graduate students working on this project, developed and delivered an hour-long presentation about the importance of maternal choline intake at an in-service training for 100 Food and Nutrition Education in Communities (FNEC) employees. The audience of this presentation included the Cornell Cooperative Extension director and numerous research associates, executive directors, and regional coordinators. Notably, more than half of the audience were trained paraprofessional staff who lead nutrition education sessions that reach 12,621 diverse, low-income adults and youth throughout New York State annually. In Year 3, Jesse Brinkman presented our findings concerning the lasting benefits of maternal choline supplementation on infant information processing speed (a predictor of child IQ) at the 2021 New York State Academy of Nutrition and Dietetics Annual Meeting and Exposition Poster Session. Here, she engaged with numerous clinicians throughout New York State to emphasize the role of adequate prenatal choline intake for optimal fetal neurodevelopment and discussed strategies to address various socio-ecological factors driving inadequate maternal choline intake. Manuscripts describing the effects of maternal choline supplementation on infant information processing speed, attention, memory, and emotion regulation are currently in preparation and will be submitted to leading journals in the fields of medicine and nutritional sciences within the next 6 months. The first of these will be submitted in January 2022. What do you plan to do during the next reporting period to accomplish the goals?
Nothing Reported
Impacts
What was accomplished under these goals?
Overall summary of progress: Substantial progress has been made on the Aims of the study; namely to test the hypotheses that supplementation of pregnant women with choline improves memory, attention, and emotion regulation of their infants (relative to offspring of women receiving a placebo). Thirty-three women successfully completed the clinical trial and 26 mother/infant pairs have been enrolled in the postnatal cognitive study. One mother/infant pair was lost to follow up after the 10-month visit, and therefore could not be included in the 13-month assessment. During the project, the COVID-19 pandemic resulted in the temporary suspension of in-person human subject research at Cornell from mid-March 2020 until mid-July 2020. Due to the suspension, some in-person assessments could not be conducted, but parent-report survey responses were collected (electronically) at all assessment ages. A summary of the total data collected at each age during the project is presented below. It should be noted that there was a loss of 4 in-person sessions for reasons other than COVID (moving out of state or no longer wanting to participate in the study). 5 Months: In-person assessments were completed for 25 of the 26 eligible infants. Survey responses were collected for all eligible 26 infants at this timepoint. 7 Months: In-person assessments were completed for 18 of the 26 eligible infants. Survey responses were collected for all eligible 26 infants at this timepoint. 10 Months: In-person assessments were completed for 23 of the 26 eligible infants. Survey responses were collected for 25 of 26 eligible infants at this timepoint. 13 Months: In-person assessments were completed for 15 of the 26 eligible infants at this timepoint. Additionally, seven infants were tested at a slightly later age (when testing could resume); we are currently determining whether these data are usable. Survey responses were collected for 25 of 26 eligible infants at this timepoint. Over the course of the study, 407 parent-report survey responses have been collected (4 for each infant age), 85 measures of maternal sensitivity and responsivity were recorded by study staff, and 317 tasks were administered. Physiological (heart rate) data have been collected for all infants for whom in-person visits were possible; these data are currently being cleaned and analyzed by trained data analysts. Important new findings regarding effects of maternal choline supplementation on infant information processing speed: One important goal of this project was to test the hypothesis that maternal choline supplementation during pregnancy has a beneficial effect on infant information processing speed, a predictor of child IQ. To achieve this goal, we measured saccadic eye movements during the Visual Expectations Task. To code these data, it was necessary to develop an observational coding system and then code the videotapes of the infants performing this task. During the past year, we completed this process and analyzed the data. The analyses revealed a significant beneficial effect of maternal choline supplementation on infant processing speed. Specifically, the mean reaction time for infants born to choline-supplemented mothers was 22.3 ms faster (P=0.047) than that of infants born to mothers in the control group. Notably, infant reaction time predicts IQ up through adolescence. This important finding corroborates the results from our controlled choline feeding study, in which infants of mothers consuming twice the choline adequate intake (AI) during the last trimester of pregnancy exhibited faster information processing than infants born to mothers consuming the AI (Caudill et al., 2017). However, the present study provides the first demonstration of a beneficial effect of maternal choline supplementation on infant information processing speed under conditions in which the women are consuming their usual diet with choline administered as a supplement. Progress on our assessments of attention and emotion regulation: Additional goals of this project were to test the hypotheses that maternal choline supplementation during pregnancy has lasting beneficial effects on infant attention and emotion regulation. During the past year, we finalized the development and implementation of coding systems needed to code the behavioral data for: (1) emotion expression during a frustration task and (2) quality of attentional focus during toy play. It is challenging to code these outcomes and a great deal of time and discussion were required to reach a high level of reliability. Coding of the video data for one of our three tasks assessing emotion regulation has been completed by teams of trained undergraduate students led by Drs. Strupp and Canfield and graduate students. In the next three months, we anticipate completing the coding of the other two tasks assessing emotion regulation. Data analysis will commence in January 2022. Coding of the task assessing attentional function (the Free Play task) has also been completed by teams of trained undergraduate students led by Drs. Strupp and Canfield and graduate students. Statistical analysis and interpretation of these data is underway and expected to be completed by December 2021. It is notable that for all tasks completed to date, interrater reliability analyses revealed excellent agreement among raters (ICC>0.9 for all codings), indicating high quality data. Progress on our assessment of memory function: An additional goal of this project was to test the hypothesis that maternal choline supplementation during pregnancy has a beneficial effect on infant memory. To achieve this goal, we administered a novelty preference tasks, a validated test of infant memory. To date, we have completed data collection for this task and have processed these data to produce the pre-specified dependent variables that will be used during statistical analyses. Descriptive and inferential analyses of these data are underway, and we anticipate data analysis will commence in October 2021. Progress on informing public health policy decisions regarding optimal choline intake requirements during pregnancy (one of our overarching goals): Significant progress has been made towards this goal. Manuscripts describing the effects of maternal choline supplementation on infant information processing speed, attention, memory, and emotion regulation are currently in preparation and will be submitted to leading journals in the fields of medicine and nutritional sciences within the next 6 months. The first of these will be submitted in January 2022. Second, preliminary results of the infant speed of processing data were already presented at the Cornell Dietetics Research Symposium and the New York State Academy of Nutrition and Dietetics Annual Meeting and Expo on April 15, 2020, and we have plans to present these and other findings at Nutrition 2022 (the annual meeting of the American Society for Nutrition).
Publications
|
Progress 10/01/19 to 09/30/20
Outputs
Target Audience:
Nothing Reported
Changes/Problems:In 2020, the COVID-19 pandemic presented a significant challenge to the research project. In accordance with the Cornell University campus closure, our laboratory space was closed from March 13th until July 15th, resulting in missed study visits. During the research closure, we obtained electronic parent-report survey data from the mothers at the times when they would have been scheduled to attend their in-person laboratory visit. In compliance with New York State and Cornell University COVID-19 guidelines, we designed a thorough COVID-19 Standard Operating Procedure, which required minor adjustments to our testing protocol in order to successfully adhere to social distancing guidelines. The only substantive change to our protocol was the deletion of the deferred imitation task, which was previously conducted at the 13-month visit. Because this task requires that the tester be within six feet of the mother and the infant for longer than ten minutes, we were unable to safely conduct it under COVID-19 restrictions. The only other changes to the protocols were minor adjustments to the placement of the tester relative to the participants in order to adhere to social distancing guidelines--these changes did not impact the quality or validity of the data collected. Upon reopening, we were able to make up some of the missed visits within a reasonable developmental window for the infants. In order to compensate for the missing data as a result of the COVID-19 research closure, we are now designing a protocol to bring the infants back for additional cognitive testing at age 30 months. During this visit, we will test declarative memory, as well as several domains of "executive functioning" (including working memory, attentional control, and delay of gratification). These tasks have been shown to predict later academic performance and behavioral adjustment. Finally, in order to increase the sample size (which was in some instances reduced by the COVID shut-down), we are currently recruiting a second cohort of women, whose infants will be tested on all of the same tasks. What opportunities for training and professional development has the project provided?This project has provided significant opportunities for training and personal development for graduate students. For example, graduate students Kara Beckman and Jesse Brinkman have received extensive training in research methods, study management, and mentorship. This experiential training has included learning how to communicate with mothers with newborn infants, administer cognitive assessments to infants and structured interviews and questionnaires to parents, how to balance the scientific and managerial demands of research, how to communicate study tasks successfully to undergraduate research assistants in the lab, and how to appropriately manage, clean and analyze data. The graduate students have also had opportunities for professional development as a result of this project. For example, Jesse Brinkman recently presented preliminary findings at the Cornell Dietetics Research Symposium and will also present a poster of her findings at the New York State Academy of Nutrition and Dietetics Annual Meeting and Expo on April 15. During the current reporting period, this study has given at least 10 undergraduates the opportunity to receive scientific training by Drs. Strupp and Canfield and the graduate students. These undergraduate students have gained experience in a variety of research activities including developing scoring and task-administration guides, analysis of physiological data, reading relevant scientific literature, conducting descriptive statistics, and preparing journal-club style paper presentations. Further, with the mentorship of Dr. Strupp and Kara Beckman, one of our undergraduate research assistants applied for and received a Hatch Supplement grant to support her work on the behavior coding of the Lab-Tab task. How have the results been disseminated to communities of interest?Jesse Brinkman, one of the graduate students working on this project, developed and delivered an hour-long presentation about the importance of maternal choline intake at an in-service training for 100 Food and Nutrition Education in Communities (FNEC) employees. The audience of this presentation included the Cornell Cooperative Extension director and numerous research associates, executive directors and regional coordinators. Notably, more than half of the audience were trained paraprofessional staff who led nutrition education sessions that reach 12,621 diverse, low-income adults and youth throughout New York State annually. What do you plan to do during the next reporting period to accomplish the goals? In Year 3, we will complete the four remaining 13-month assessments on the original cohort of participants; these have already been conducted. As discussed above, there was an unavoidable loss of data during the COVID-related halt of research during the spring. As a result, the sample size is reduced for some of the assessment ages. For that reason, we are now planning to bring the infants back for additional cognitive testing at age 30 months, when most participants can be included. During this visit, we will test declarative memory as well as several domains of "executive functioning" (including working memory, attentional control, and delay of gratification). These tasks have been shown to predict later academic performance and behavioral adjustment. In order to increase the sample size (which was in some instances reduced by the COVID-19 shut-down), we are currently recruiting a second cohort of pregnant women, whose infants will be tested on the same tasks at 5, 7, 10, 13, and 30 months. We will continue to develop, document, and validate our observational coding systems and conduct the scoring of the videos We will complete all data entry and data processing protocols and enter the data and validate the accuracy of all computerized data files. We will write statistical analysis programs for data cleaning and variable creation and we will finalize the statistical analysis plans appropriate for all our major endpoints. We also plan to begin preparing manuscripts for publication, but this must await the testing of infants in the second cohort, to be born in the coming year. Although this represents a slight delay, it is important that our findings be based on a sufficiently large sample size that they can inform recommendations for pregnant women.
Impacts
What was accomplished under these goals?
Substantial progress has been made on the Aims of the study - to assess the memory, attention, and emotion regulation of infants of supplemented women (v placebo). As of September 30, 2020, 33 women successfully completed the pregnancy clinical trial and 26 mother/infant pairs have been enrolled in the postnatal cognitive study. However, one mother/infant pair was lost to follow up after the 10-month visit, and therefore could not be included in the 13-month assessment. In the current reporting period, the COVID-19 pandemic resulted in the temporary suspension of in-person human subject research at Cornell from mid-March until mid-July. Due to the suspension, some in-person assessments could not be conducted, but parent-report survey responses were collected (electronically) at all assessment ages. In the section on Changes/Problems), we discuss some planned additions to the study to compensate for the lost data. Prior to this reporting period (Year 1), four infants had completed testing at all 4 assessment ages (5, 7, 10, and 13 months of age). During the current reporting period (Year 2), an additional 16 infants completed follow up at all four time points. A summary of the total data collected at each age during the previous and current reporting period is presented below. It should be noted that there was a loss of 4 in-person sessions for reasons other than COVID (moving out of state or no longer wanting to participate in the study). 5 Months: In-person assessments were completed for 25 of the 26 eligible infants. Survey responses were collected for all eligible 26 infants at this timepoint. 7 Months: In-person assessments were completed for 18 of the 26 eligible infants. Survey responses were collected for all eligible 26 infants at this timepoint. 10 Months: In-person assessments were completed for 23 of the 26 eligible infants. Survey responses were collected for 25 of 26 eligible infants at this timepoint. 13 Months: In-person assessments were completed for 11 of the 26 eligible infants. Survey responses were collected for 21 of 26 eligible infants at this timepoint. There were 7 infants tested at a slightly later age (when testing could resume); we are currently evaluating if this data is usable. Four additional 13-month assessments have already been completed in Year 3 but are not included in these totals. Prior to this reporting period, 32 in-person cognitive and behavioral assessments had been completed. During this reporting period we completed an additional 49 in-person assessments (as detailed above), for a total of 81 since the onset of the study. During this reporting period, 280 parent-report survey responses were collected (4 for each timepoint), 54 measures of maternal sensitivity and responsivity were recorded by study staff, and 200 tasks were administered. For the duration of this study (in total), 407 parent-report survey responses have been collected (4 for each timepoint), 85 measures of maternal sensitivity and responsivity were recorded by study staff, and 317 tasks were administered. Physiological (heart rate) data have been collected for all infants for whom in-person visits were possible and are being cleaned and analyzed by trained data analysts. We have exciting results to report for one of the tasks administered to the infants, called the Visual Expectations Task. During the past year, we developed an observational coding system to measure saccadic eye movements during this task, and used this system to code all video data from this task. The subsequent analyses revealed a significant effect of maternal choline supplementation on infant processing speed. Specifically, the mean reaction time for infants born to choline supplemented mothers was 22.3 ms faster (P=0.047) than that of infants born to mothers in the control group. Notably, infant reaction time predicts IQ up through adolescence. This important finding corroborates the results from our controlled choline feeding study, in which infants of mothers consuming twice the choline AI during the last trimester of pregnancy exhibited faster information processing than infants born to mothers consuming the AI (Caudill et al., 2017). However, the present study provides the first demonstration of a beneficial effect of maternal choline supplementation on infant information processing speed, under conditions in which the women are consuming their usual diet, with choline administered as a supplement. In addition, during the past year, we finalized our two most challenging observational coding systems (emotion expression during a frustration task and quality of attentional focus during toy play). Behavior coding of video data from the task assessing emotion regulation (the Lab-Tab) is almost complete, and analysis of data from this task is expected to commence in the spring of 2020. In addition, during the past year, recordings from the Free Play task have been coded by teams of trained undergraduate students led by Drs. Strupp and Canfield and graduate students; these will be analyzed during the coming year.
Publications
|
Progress 10/01/18 to 09/30/19
Outputs
Target Audience:
Nothing Reported
Changes/Problems:Changes: We have made no major changes to the study or procedures but have implemented one minor change. Specifically, the youngest infant testing age was changed from 4 months to 5 months. This was necessary because some 4-month old infants had insufficient postural control to sit upright in the highchair we purchased for the toy exploration task (to measure the quality of attentional focus). The simplest solution was to move to a slightly older testing age, a change that has no anticipated impact on any of our other infant assessments. Problems: Recruitment of subjects proved to be more difficult than anticipated, resulting in a slightly slower rate of recruitment than planned. Several factors contributed to this situation, including (1) women not wishing to donate placental material to the study (which was initially a requirement of the pregnancy phase of the study); (2) women not planning to deliver at the protocol-specified hospital; and (3) more women than expected did not meet our inclusion criteria, due to various conditions, including hypertension, obesity, diabetes, and autoimmune disorders. Despite these obstacles, we have been successful in recruiting the target number of women (30) into the study. What opportunities for training and professional development has the project provided?This project has provided significant opportunities for training and personal development for graduate students. For example, graduate students Kara Beckman and Jesse Brinkman have received extensive training in research methods, study management, and mentorship. This experiential training has included learning how to successfully recruit study participants, communicate with mothers of newborn infants, administer cognitive assessments to infants and structured interviews and questionnaires to parents, balance the scientific and managerial demands of research, and communicate study tasks successfully to undergraduate research assistants in the lab. The graduate students have also had opportunities for professional development as a result of this project. For example, Kara Beckman gave two seminar talks to the Maternal and Child Nutrition group. Additionally, Jesse Brinkman joined the lab as a graduate student in August and has already taken on an important role in mentoring undergraduate students. In the course of the reporting period, this study has given at least 8 undergraduates the opportunity to receive scientific training by Drs. Strupp and Canfield and the graduate students. These undergraduate students have gained experience in a variety of research activities including developing scoring and task-administration guides, reading relevant scientific literature, conducting descriptive statistics, and preparing journal-club style paper presentations. 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?During the second year of the project, we will continue to recruit mother/infant pairs into the study. As the infants reach testing age, we will continue to conduct the age-appropriate cognitive and behavioral infant assessments and gather parent-reported information in accordance with our protocols. We will continue to develop, document, and validate our observational coding systems and carry out the scoring of videos. We will complete all data entry and data processing protocols, enter the data, and validate the accuracy of all computerized data files. We will write statistical analysis programs for data cleaning and variable creation, and we will develop formal statistical analysis plans appropriate for all of our major endpoints.
Impacts
What was accomplished under these goals?
Substantial progress has been made on the two Specific Aims of the study--to assess the memory, attention, and emotion regulation of infants of choline supplemented women (v placebo). During this first year, we designed the behavioral and physiological data collection protocols, moved to new laboratory space and installed equipment and conducted troubleshooting and pilot testing, and completed 32 participant visits. We designed data processing and data management protocols for all of the questionnaire data originating from the pregnancy trial, entered all the data into spreadsheets, and wrote computer programs to process and summarize those data. We also designed and implemented data management protocols for all of the parent report questionnaire data collected during our postnatal follow-up visits, entered the data into computer files, and wrote programs to add these data to our mater database. In addition, we designed and implemented a process for cataloging, storing, editing, and backing up the large corpus of audio/video recordings we collect during the postnatal infant tests of memory, attention, and affect regulation. These recordings include infants' visual behavior while they view photographs of familiar and unfamiliar faces, their saccadic eye movements during a visual attention task, and infants' facial and bodily reactions to mildly stressful situations (e.g., removal of a toy; in order to assess the effect of maternal choline supplementation on emotion regulation). These video data are integral to the assessment of infant cognition and emotion but require the development and validation of systems of codes/rules for converting observations of key behaviors into measurements of cognitive or emotional constructs. A largely unique coding system must be developed for each task (e.g., attention during free play with a toy, attention while tracking a visual stimulus, attention during memory encoding, facial and bodily expressions of emotion during mild frustration). During the first year of this project, we have made steady progress developing our two most challenging observational coding systems (quality of attentional focus during toy play and emotion expression during frustration). Working with excellent teams of graduate and undergraduate students we spent dozens of hours carefully analyzing videos, produced an orderly sequence of drafts of increasingly sophisticated versions of coding manuals/scoring guides, and started the process of evaluating inter-rater reliability. We expect to be actively coding the audio/video data from most of our tasks during the second year of funding using well-documented coding systems for which we have validated excellent inter-rater reliability (κ >.85). Also during this reporting period, fourteen infants were assessed with our cognitive and behavioral tests at the 5-month time point, 7 infants were assessed at the 5 and 7-month time points, 7 infants were assessed at the 5, 7, and 10-month time points, and 4 infants completed all the planned postnatal testing (i.e. assessed at 5, 7, 10, and 13 months). In addition, infant physiological data were collected concurrently during each of the cognitive/behavioral assessments.
Publications
|