LOVING (Learning About Our Behavior is Valuable for Increasing Nurturing Relationships and Healthy Growth) RCT (LOVING)

LOVING (Learning About Our Behavior is Valuable for Increasing Nurturing Relationships and Healthy Growth)

The LOVING study is a randomized controlled trial designed to determine whether adaptations to an internationally recognized parenting program that enhances sensitive caregiving likewise improves sensitive caregiving in Singapore and, in turn, downstream child outcomes in emotional, behavioral, and cognitive development during the early childhood years.

Research shows that sensitive caregiving is linked to secure relationships, decreased child mental health problems, better executive functioning, and potentially healthier body mass indices. The Video Feedback to Improve Positive Parenting and Sensitive Discipline (VIPP-SD) program is an internationally recognized home-based intervention designed to enhance sensitive caregiving. However, evidence demonstrating its efficacy in Asia remains extremely limited. Moreover, most previous evaluations have focused primarily on parenting or child mental health outcomes, with newer work only beginning to focus upon additional child outcomes.

In this study, families with young children from median-income and below households living in Singapore will be randomly assigned to one of three groups. Some families will participate in a locally adapted version of the home-based VIPP-SD program that includes additional health-related scenarios (VIPP-SD-SingH). Other families will be assigned to CARE-SD, which was developed within the context of proof-of-concept research. CARE-SD is a standardized, digitally delivered parenting program using vicarious pre-rendered video examples and comments derived from the VIPP-SD program and does not include personalized feedback during home visits. Furthermore, CARE-SD includes health related scenarios and language and settings familiar to families living in Singapore. A third group will receive developmental information about children's learning and development (i.e., NeuroEducation Active Control). The programs are brief and are designed to be practical and accessible for families.

Families participating in the study will take part in research visits that include questionnaires, observations of parent-child interaction, and activities designed to assess children's development. Laboratory visits will take place at IHDP (a collaborating institution) research facilities. Information collected in the study will help researchers better understand how parenting support programs influence children's emotional well-being, behavior, learning, and physical health.

The results of this research may help inform the development of effective programs to support families and promote healthy child development.

Study Overview

• Status: Recruiting
• Conditions: Child Development; Parent Child Relationship; Child Behavioral Problems
• Intervention / Treatment: Behavioral: VIPP-SD-SingH, "Video-Feedback Intervention to Promote Positive Parenting and Sensitive Discipline Adapted for the Singapore Context with a Health Component"; Behavioral: CARE-SD, "Caregiver Awareness of Relationships through E-learning for Sensitivity and Discipline"; Behavioral: NeuroEducation for Parents

Detailed Description

Early childhood is a critical developmental period during which caregiving relationships play an important role in shaping children's social, emotional, cognitive, and physical development. Sensitive caregiving occurs when a caregiver accurately perceives and responds to a child's signal in a timely and appropriate manner. It is associated with secure attachment relationships, fewer child behavioral and emotional difficulties, better executive functioning, and potentially healthier physical development.

Interventions that support sensitive caregiving have therefore been identified as promising approaches for promoting healthy child development and preventing later mental health and behavioral problems.

One of the most widely studied programs designed to enhance sensitive caregiving is the Video Feedback to Improve Positive Parenting and Sensitive Discipline (VIPP-SD) program. VIPP-SD is a brief, home-based intervention that uses video feedback to help caregivers recognize and respond sensitively to their child's cues and to support positive discipline practices. Numerous randomized trials conducted primarily in Europe and North America have demonstrated that the VIPP-SD can improve parental sensitivity and, in several cases, child behavioral outcomes. However, rigorous evaluations of these approaches in Asian contexts remain extremely limited. In addition, most existing studies have focused primarily on parenting and child mental health outcomes, with less attention to broader developmental domains such as executive functioning or physical health.

The LOVING study is a randomized controlled trial designed to evaluate whether an adapted version of the VIPP-SD program (i.e., VIPP-SD-SingH, Video-Feedback Intervention to Promote Positive Parenting and Sensitive Discipline Adapted for the Singapore Context with a Health Component), improves sensitive caregiving and downstream child externalizing (specifically conduct and oppositional defiant symptoms). The RCT will also examine additional child developmental outcomes among families in Singapore in a secondary (i.e., children's executive functioning and adiposity) and/or exploratory capacity.

The study will furthermore provide an exploratory proof of principle investigation of whether a standardized, digitally delivered parenting program using vicarious pre-rendered video examples and comments derived from the VIPP-SD program, which does not include personalized feedback during home visits, but like the VIPP-SD-SingH incorporates Singaporean experience and health related contexts, produces benefits relative to an active control. That is, this study's investigations involving CARE-SD (i.e.,Caregiver Awareness of Relationships through E-learning for Sensitivity and Discipline) will provide additional acceptability and feasibility information beyond that obtained in earlier LOVING research and preliminary proof-of-principle efficacy information.

Additional discovery analyses will compare VIPP-SD-SingH versus NeuroEducation Control and CARE-SD versus NeuroEducation Control on other outcomes, as well as mediating and moderating processes, including genetic moderators.

Six-hundred-twenty four parent-young-child pairs from median-income and below households will be recruited and randomly assigned to one of three study groups. Sample size was determined via G-power 3.1 in the following way. First, the minimal sample size needed for the primary confirmatory (VIPP-SD-SingH versus NeuroEducation) outcomes assessed with a repeated measures design and interaction term was calculated. With regards to parental sensitivity, an effect size of f = 0.18 was assumed based on prior meta-analytic data and f = 0.12 was chosen for ODD+CD symptoms in keeping with that reported with similar interview data within HSHS . Using an alpha of .05, correlations between pretest and posttest assessments of r = .30, and power .95, the required dyadic sample size is 72 per arm for parental sensitivity and 159 per arm for oppositional defiant and conduct problems. Assuming a 15 percent drop-out rate the necessary dyadic numbers become 83 and 183.

In addition, G-power 3.1 was also used to calculate the minimal sample size needed for the secondary confirmatory (VIPP-SD-SingH versus NeuroEducation) analyses. Given the comparatively limited literature base, rather than relying on past published effect sizes, f = 0.10 was chosen as a reasonable estimate for behavioral interventions. Using an alpha of .025 (i.e., corrected for the two secondary outcomes [i.e., MEFS performance & BMIz]), correlations between pretest and posttest assessments of r = .30, and power .80, the required dyadic sample size is 168 per arm, which becomes 194 after adjusting for a 15% drop-out rate.

Considering the parallel exploratory analyses requiring the additional CARE-SD arm, the total sample size should be minimally 249 (parental sensitivity), 548 (ODD and CD symptoms), and 582 (adiposity and executive functioning ). As such, even with the addition of covariates, the anticipated sample size of 624 dyads should be sufficient to detect primary and secondary confirmatory outcomes.

Participating families will complete research visits that include questionnaires, structured observations of parent-child interaction, hair samples for hormonal analyses, buccal cell swabs for genetic moderation, electrophysiology and assessments of children's development including executive functioning, emotional memory, and physical fitness. These assessments will allow for explorations of whether the interventions improve parenting sensitivity and child outcomes and whether changes in caregiving are associated with improvements in children's emotional, behavioral, cognitive, and physical outcomes.

Upon trial completion an exploratory cost effectiveness analysis of the VIPP-SD-SingH program versus NeuroEducation will be conducted. Findings from the LOVING trial will contribute to the limited evidence base on parenting interventions in Asian populations and will help inform the development of alternative approaches to support families and promote healthy child development in Singapore and similar contexts.

• Study Type: Interventional
• Enrollment (Estimated): 624
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christy Yifan Jiang, PhD; Phone Number: 80695639; Email: jyifan@nus.edu.sg
• Study Contact Backup: Name: Shamini Sanmugam, MA; Phone Number: 80695639; Email: shamini.sanmugam@nus.edu.sg

Study Locations

• Singapore
  • Singapore
    • Singapore, Singapore, Singapore, 117609
      • Recruiting
      • Insitute of Human Development and Potential, Agency for Science and Technology Research (A*STAR)
    • Singapore, Singapore, Singapore, 11907
      • Recruiting
      • National University of Singapore
    • Singapore, Singapore, Singapore, 229899
      • Recruiting
      • KK Women and Children's Hospital
    • Singapore, Singapore, Singapore, 637616
      • Recruiting
      • National Institute of Education, Nanyang Technological University
    • Singapore, Singapore, Singapore, 639798
      • Recruiting
      • Nanyang Technological University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Children must be 2 to 5.5 years of age at their pre-test visit. Children with a medical or developmental condition that makes it hard for them to see, hear, move, or communicate in typical ways (for example, autism spectrum disorder, down syndrome, spina bifida, or serious vision or hearing problems) will not be eligible to participate. This is because the study focuses on everyday patterns of parent-child interaction. Children with minor or symptom-free medical or genetic conditions (for example, traits that do not affect their day-to-day health or development) can take part.

Parents must be between 21 and 65 years old at the time of consent. Mothers and fathers who consider themselves to have a major caregiving role are eligible. Parents who have been hospitalized for more than two weeks (inclusive) within the past 6 months and/or have had any in-patient mental health treatment within the past 6 months may not participate, nor may parents with notable neurodegenerative diagnosis such as Alzheimer's, Parkinson's, or Huntington's disease.

Participants must be from families earning near to Singapore's median household income or below, provided recruitment and enrollment difficulties have not triggered a pre-defined rule leading to the omission of this requirement. Parents and children must be able to communicate in English, Mandarin, Bahasu Melayu, and/or Tamil. Participants must also be willing to be audio-video recorded and amenable to random assignment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VIPP-SD-SingH; Participants assigned to this arm will receive the VIPP-SD-SingH program. Both adult and child participants will actively take part in at least some aspects of the VIPP-SD-SingH. Each VIPP-SD-SingH session is scheduled as close to 14 days after the prior home-visit as possible. Participants will not progress to the next VIPP-SD-SingH session if they have not completed the prior one. However, the maximum duration for the intervention will be 32 weeks.	Behavioral: VIPP-SD-SingH, "Video-Feedback Intervention to Promote Positive Parenting and Sensitive Discipline Adapted for the Singapore Context with a Health Component"; The VIPP-SD-SingH is an adaptation of the seven session home-visiting VIPP-SD program. During the first six VIPP-SD sessions the parent-child dyad will be asked to take part in certain activities together while being recorded. During sessions 2-7 the parent will watch the prior sessions's videos and receive frequent (e.g., 10-30 second) feedback ( e.g., focusing on children's perspectives, awareness of attachment and explorative child behavior, tips for sensitive discipline, and back-and-forth behavior). The VIPP-SD-SingH will include some adjustments for local language use and VIPP-SD compatible stimulation for reflections on tips and activities that allow greater generalization of the VIPP-SD principles to physical health contexts (e.g., waiting to eat a snack, using toys that encourage movement, or activities that may encourage relaxation).; Other Names: This was referred to as "O" or "Own" during earlier LOVING Development/Pilot research.
Other: CARE-SD; Participants assigned to this arm will receive the CARE-SD program for proof of principle, implying whatever the outcome further tests are indispensable for translation to policy or practice. Results will further inform feasibility/acceptability and preliminarily efficacy information. Parents will be asked to watch online CARE-SD sessions and then involve children in activities. After session videos have been opened, participants can mark a session as complete. Then, the completed session's materials will remain accessible for 14 days. Marking a session "complete" also triggers the next session to open 14 days later. User metrics and additional self-reported involvement data (e.g., How much did you watch? Did you do the activities?) will be collected, but will not influence the first-level assessment of completion (for Intent to Treat analyses) or session progression. Participants will not progress without completing prior sessions, though the maximum duration will be 32 weeks.	Behavioral: CARE-SD, "Caregiver Awareness of Relationships through E-learning for Sensitivity and Discipline"; CARE-SD, Caregiver Awareness of Relationships through E-learning for Sensitivity and Discipline was developed within the context of proof-of-concept research. CARE-SD is a standardized, digitally delivered parenting program using vicarious pre-rendered video examples and comments derived from the VIPP-SD program and does not include personalized feedback during home visits. Furthermore, CARE-SD includes health related scenarios and language and settings familiar to families living in Singapore. As with the VIPP-SD-SingH, CARE-SD's design includes seven sessions with scenarios and comments for generalizability to physical activity, feeding, and relaxation. After watching each of the videos in sessions 2-7, parents will be asked to try out the activities they've viewed with their own child. Instructions and suggestions for materials will be provided as will be questions for reflection.; Other Names: This was referred to as "V" or "Vicarious" in LOVING Developmental/Pilot research.
Other: NeuroEducation for Parents; This arm will serve as an Active Control for both VIPP-SD-SingH and CARE-SD. It is not expected to notably impact sensitive caregiving though it may impact caregiver knowledge about child development. After a sessions' videos have been opened, participants will have access to a form where they can mark a session as complete. Once they do so, the completed session's materials will remain accessible for 14 days. Marking a session as "complete" also triggers the next session to open 14 days later. Although user metrics and additional self-reported involvement data (e.g., How much did you watch? Did you read the additional material?) will be collected, those will not influence the first-level assessment of completion (for Intent to Treat analyses) or session progression. People will not progress to the next NeuroEducation session if they have not completed the prior one. However, the maximum duration for the intervention will be 32 weeks.	Behavioral: NeuroEducation for Parents; NeuroEducation for Parents was designed as a seven session online program for parents containing informational videos about young children's Brain Basics, Seven Senses, Learning and Memory, Emotion, Curiosity and Creativity, Thinking, and Friendships. Sensitive caregiving is not discussed explicitly. Each session will end with a short video quiz, complete with answers. Additional optional written material will be provided for parents who wish to learn more.; Other Names: This was referred to as "E" or "neuroEducation" in LOVING Developmental/Pilot research.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differential Change Pre-Post Parental Sensitivity Assessed via the Preschool MBQS (Parent Outcome) Confirmatory: VIPP-SD-SingH more favorable trajectory than NeuroEducation; Exploratory: CARE-SD more favorable trajectory than NeuroEducation	Change in parental sensitivity will be evaluated from video records of four dyadic interactions, totaling roughly 25 minutes of behavior per relevant lab visit. Trained coders will apply the Preschool MBQS (Pederson et al, 2013; Tarabulsy 2009), a 25-item forced q-sort to interactions. The interactions themselves will proceed in a set order beginning with a parent-child snack, obedience task, hopscotch-like game, and sticker-by-art activity. These will be included for relevance to obedience and the physical health related aspects in the VIPP-SD-SingH and CARE-SD programs (i.e., feeding/nutrition; physical activity/movement; rest/relaxation). Tasks are likely amenable to engaged interaction but also do not explicitly require it. Instructions will be delivered on notecards, to ensure consistency and also some divided attention. In principle, all tasks can be conducted in a developmentally appropriate manner. 20% will be independently coded.	Prior to revealing the Treatment Arm until One to Three Months Post Last Intervention Session
Differential Change in Pre-Post PAPA Assessed ODD/Conduct Symptom Count (Child Outcome) Confirmatory: VIPP-SD-SingH more favorable trajectory than NeuroEducation; Exploratory: CARE-SD more favorable trajectory than NeuroEducation	Parents will be interviewed by trained staff using modules from the "The Preschool Age Psychiatric Assessment (PAPA): A structured parent interview for diagnosing psychiatric disorders in preschool children" (see Egger et al., 2019). The outcome used in primary analyses will be the sum of the Oppositional Defiant Disorder (ODD) and Conduct Problems (CD) symptom counts (maximum score = 17). ODD symptoms will be assessed with regards to a "primary period" (e.g., 3 months) and require a minimal frequency to be met, which varies by symptom and is adjusted by age (as per the DSM5). CD symptom criteria are more varied, with some variables requiring only one occurrence, which in some cases can happen outside the primary period. In such cases, we will also collect occurrence within the last three months to better examine intervention effects. Note: The minimal time between Labs 1 and 3 will be 18 weeks, i.e., more than 3 months. 20% of interviews will contribute to fidelity checks.	Prior to revealing the Treatment Arm until One to Three Months Post Last Intervention Session

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differential Change in Pre-Post Adiposity Assessed by Body Mass Index z-score (BMIz) (Child Outcome) Confirmatory: VIPP-SD-SingH more favorable trajectory than NeuroEducation; Exploratory: CARE-SD more favorable trajectory than NeuroEducation	Change in child adiposity will be evaluated using body mass index z-score (BMIz). Weight and height measurements will be obtained by trained study staff using standardized anthropometric procedures. These measurements will be used to calculate BMI as weight (kg) divided by height (m²), which will then be converted to an age- and sex-specific BMI z-score (BMIz) using established reference standards. Weight and height will not be analyzed as separate outcome measures.	Prior to revealing the Treatment Arm until One to Three Months Post Last Intervention Session
Differential Change in Pre-Post Child Executive Functioning as Assessed via the MEFS. Confirmatory: VIPP-SD-SingH more favorable trajectory than NeuroEducation; Exploratory: CARE-SD more favorable trajectory than NeuroEducation	Child executive functioning (EF) will be assessed using the Minnesota Executive Function Scale (MEFS; Carlson & Zelazo, 2014, 2021). The MEFS will be administered individually by trained staff. The MEFS consists of an adaptive virtual sorting task that provides a brief composite measure of EF. The assessment was designed for use across a wide range of ability levels, with task difficulty adjusted across seven levels based on the child's performance. MEFS Total Scores will be used to summarize EF, with higher scores indicating better EF.	Prior to revealing the Treatment Arm until One to Three Months Post Last Intervention Session

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Additional Exploratory Outcomes, Mediators, and Moderators	The following are a) exploratory outcomes evaluated as pre-post differential change, favoring the intervention(s) over the Neuroeducation control; and/or b) exploratory mediators/moderators: Child Fitness: PreFit Tests (e.g., balance, 10m, long-jump); Child Diet Quality: Reported frequencies of food groups; Parent Reported Child Psychosocial Fn and/or Executive Control: CBCL Internalizing, CBCL Attentional Problems, BRIEF-P; Parent Reported Feeding and Activity: Feeding Practices, PREPAQ; Parent Self-Reported Parenting: IM-P (mindfulness); PSDQ (parenting styles); Parenting Growth Mindset; Parent Self Reported Mental Health (DASS-21) and Executive Functioning (ADEXI); Additional Measures of Observed Parenting; Cortisol from Hair; EEG Power/Asymmetry during resting and cognitive tasks; Emotional Memory; Genetic Moderation (e.g., SLC6A3 ePGS; ENVResp-ePGS); Child Development/Brain Knowledge (expected to favor the NeuroEducation Control group)	All laboratory pre-tests are prior to random assignment being revealed. Some measures are then also assessed whilst the treatments are ongoing, others 1-3 months after the last session, and others 6 or 12 months following the final treatment session.

Collaborators and Investigators

• Sponsor: National University of Singapore
• Collaborators: KK Women's and Children's Hospital; Nanyang Technological University; National Institute of Education, Singapore; Institute for Human Development and Potential (IHDP), Singapore
• Investigators: Principal Investigator: Anne E Rifkin-Graboi, PhD, National University of Singapore

Publications and helpful links

General Publications

• Brown T, Moore TH, Hooper L, Gao Y, Zayegh A, Ijaz S, Elwenspoek M, Foxen SC, Magee L, O'Malley C, Waters E, Summerbell CD. Interventions for preventing obesity in children. Cochrane Database Syst Rev. 2019 Jul 23;7(7):CD001871. doi: 10.1002/14651858.CD001871.pub4.
• Carlson, S. M., & Zelazo, P. D. (2014). Minnesota Executive Function Scale: Test Manual. Reflection Sciences, Inc. St. Paul, MN.
• van IJzendoorn MH, Schuengel C, Wang Q, Bakermans-Kranenburg MJ. Improving parenting, child attachment, and externalizing behaviors: Meta-analysis of the first 25 randomized controlled trials on the effects of Video-feedback Intervention to promote Positive Parenting and Sensitive Discipline. Dev Psychopathol. 2023 Feb;35(1):241-256. doi: 10.1017/S0954579421001462. Epub 2022 Jan 17.
• Pederson, D. R., Moran, G., & Bento, S. (2013). The Maternal Behavior Q-sort: Assessing Maternal Sensitivity and the Quality of Mother-Infant Interaction [Unpublished Manual]. University of Western Ontario.
• Jiang, Y., Sun, S., Ji, X., Pang, A., Lim, S., Chin, W., Chong, M., Goodwill, A. M.,Khng, K., Chen, H., Setoh, P., Bakermans-Kranenburg, M. J., van IJzendoorn, M., & Rifkin-Graboi, A. (in preparation). Feasibility and acceptability of CARE-SD: A study of a digitally delivered parenting program in Singapore.
• Egger, H. L., Angold, A., Small, B., & Copeland, W. (2019). The Preschool Age Psychiatric Assessment: A structured parent interview for assessing psychiatric symptoms and disorders in preschool children. In The Oxford handbook of infant, toddler, and preschool mental health assessment, 2nd ed. (pp. 227-243). Oxford University Press. https://doi.org/10.1093/oxfordhb/9780199837182.013.9
• Carlson, S. M. (2021). Minnesota Executive Function Scale: Technical Report. Reflection Sciences, Inc. St. Paul, MN.
• Tarabulsy GM, Provost MA, Bordeleau S, Trudel-Fitzgerald C, Moran G, Pederson DR, Trabelsi M, Lemelin JP, Pierce T. Validation of a short version of the maternal behavior Q-set applied to a brief video record of mother-infant interaction. Infant Behav Dev. 2009 Jan;32(1):132-6. doi: 10.1016/j.infbeh.2008.09.006. Epub 2008 Nov 11.
• O'Farrelly C, Watt H, Babalis D, Bakermans-Kranenburg MJ, Barker B, Byford S, Ganguli P, Grimas E, Iles J, Mattock H, McGinley J, Phillips C, Ryan R, Scott S, Smith J, Stein A, Stevens E, van IJzendoorn MH, Warwick J, Ramchandani PG. A Brief Home-Based Parenting Intervention to Reduce Behavior Problems in Young Children: A Pragmatic Randomized Clinical Trial. JAMA Pediatr. 2021 Jun 1;175(6):567-576. doi: 10.1001/jamapediatrics.2020.6834.
• Nader PR, O'Brien M, Houts R, Bradley R, Belsky J, Crosnoe R, Friedman S, Mei Z, Susman EJ; National Institute of Child Health and Human Development Early Child Care Research Network. Identifying risk for obesity in early childhood. Pediatrics. 2006 Sep;118(3):e594-601. doi: 10.1542/peds.2005-2801.

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2026
• Primary Completion (Estimated): February 9, 2028
• Study Completion (Estimated): February 9, 2028

Study Registration Dates

• First Submitted: May 24, 2026
• First Submitted That Met QC Criteria: July 1, 2026
• First Posted (Actual): July 7, 2026

Study Record Updates

• Last Update Posted (Actual): July 7, 2026
• Last Update Submitted That Met QC Criteria: July 1, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Genetic; Physical fitness; Cortisol; EEG; Dopamine; BMI; Executive function; Asian; Preschool; Digital; Singapore; Home visiting; Externalizing problems; Theta; VIPP-SD; Sensitive caregiving; VIPP-SD-SingH; CARE-SD; NeuroEducation; Frontal Alpha Asymmetry; Emotional memory bias; Vicarious; Sensitive Discipline
• Additional Relevant MeSH Terms: Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Mathematical Concepts; Statistics as Topic; Sensitivity and Specificity
• Other Study ID Numbers: IRB: NUS-IRB-2025-92; H23P1M0007 (Other Grant/Funding Number: HHP, A*STAR)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Sharing will need to be evaluated on a case-by-case basis in order to comply with participants' informed consent choices as well as local and institutional policies.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No