Trial Outcomes & Findings for Testing Digital Technologies to Help Families Build Healthy Habits (NCT NCT04845568)

Results Overview

The System Usability Scale (SUS) was used to measure usability of the intervention. The items were adapted so that the caregiver could report on their child's experience of usability. SUS consists of 10 items with five response options on a Likert scale: strongly disagree (0) to strongly agree (4). SUS yields a single number representing a composite measure of the overall usability of a system being studied, ranging from 1 to 100, with greater scores reflecting greater usability, and calculated as follows (Brooke, 1996): "Each item's score contribution will range from 0 to 4. For items 1,3,5,7,and 9 the score contribution is the scale position minus 1. For items 2,4,6,8 and 10, the contribution is 5 minus the scale position. Multiply the sum of the scores by 2.5 to obtain the overall score."

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

54 participants

Primary outcome timeframe

Assessed immediately after the 10-minute, single-session, in-person virtual reality or video intervention

Results posted on

2024-09-19

Participant Flow

Participant milestones

Participant milestones
Measure	Video This is the control condition, which views a short video and online interactive game with psychoeducational material on healthy eating and consideration of future consequences.	Virtual Reality This is the intervention condition, which participates in the virtual reality experience; the experience includes psychoeducational material on healthy eating and consideration of future consequences. Virtual Reality Experience: The virtual reality experience includes psychoeducation content about healthy eating and consideration of future consequences. It includes a game where participants are in a go kart and pick up healthy or unhealthy foods on the road. Participants play in the "present" and in the "future."
Overall Study STARTED	26	28
Overall Study COMPLETED	26	28
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Testing Digital Technologies to Help Families Build Healthy Habits

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Video (Children) n=13 Participants This is the control condition, which views a short video and online interactive game with psychoeducational material on healthy eating and consideration of future consequences.	Virtual Reality (Children) n=14 Participants This is the intervention condition, which participates in the virtual reality experience; the experience includes psychoeducational material on healthy eating and consideration of future consequences. Virtual Reality Experience: The virtual reality experience includes psychoeducation content about healthy eating and consideration of future consequences. It includes a game where participants are in a go kart and pick up healthy or unhealthy foods on the road. Participants play in the "present" and in the "future."	Video (Caregivers) n=13 Participants This is the control condition, which views a short video and online interactive game with psychoeducational material on healthy eating and consideration of future consequences.	Virtual Reality (Caregivers) n=14 Participants This is the intervention condition, which participates in the virtual reality experience; the experience includes psychoeducational material on healthy eating and consideration of future consequences. Virtual Reality Experience: The virtual reality experience includes psychoeducation content about healthy eating and consideration of future consequences. It includes a game where participants are in a go kart and pick up healthy or unhealthy foods on the road. Participants play in the "present" and in the "future."	Total n=54 Participants Total of all reporting groups
Age, Continuous	10.02 years STANDARD_DEVIATION 2.21 • n=5 Participants	10.66 years STANDARD_DEVIATION 1.51 • n=7 Participants	45.31 years STANDARD_DEVIATION 6.07 • n=5 Participants	43.71 years STANDARD_DEVIATION 8.29 • n=4 Participants	27.43 years STANDARD_DEVIATION 19.74 • n=21 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	8 Participants n=7 Participants	10 Participants n=5 Participants	12 Participants n=4 Participants	36 Participants n=21 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	18 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants	14 Participants n=7 Participants	11 Participants n=5 Participants	14 Participants n=4 Participants	50 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	5 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants	13 Participants n=21 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants	9 Participants n=4 Participants	35 Participants n=21 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment United States	13 Participants n=5 Participants	14 Participants n=7 Participants	13 Participants n=5 Participants	14 Participants n=4 Participants	54 Participants n=21 Participants

PRIMARY outcome

Timeframe: Assessed immediately after the 10-minute, single-session, in-person virtual reality or video intervention

Population: Data were reported by the caregivers, who reported for both the child and themselves. Only one score is reported for each child-caregiver dyad.

The System Usability Scale (SUS) was used to measure usability of the intervention. The items were adapted so that the caregiver could report on their child's experience of usability. SUS consists of 10 items with five response options on a Likert scale: strongly disagree (0) to strongly agree (4). SUS yields a single number representing a composite measure of the overall usability of a system being studied, ranging from 1 to 100, with greater scores reflecting greater usability, and calculated as follows (Brooke, 1996): "Each item's score contribution will range from 0 to 4. For items 1,3,5,7,and 9 the score contribution is the scale position minus 1. For items 2,4,6,8 and 10, the contribution is 5 minus the scale position. Multiply the sum of the scores by 2.5 to obtain the overall score."

Outcome measures

Outcome measures
Measure	Video n=13 Participants This is the control condition, which views a short video and online interactive game with psychoeducational material on healthy eating and consideration of future consequences.	Virtual Reality n=14 Participants This is the intervention condition, which participates in the virtual reality experience; the experience includes psychoeducational material on healthy eating and consideration of future consequences. Virtual Reality Experience: The virtual reality experience includes psychoeducation content about healthy eating and consideration of future consequences. It includes a game where participants are in a go kart and pick up healthy or unhealthy foods on the road. Participants play in the "present" and in the "future."
Acceptability as Measured by the System Usability Scale	80.63 scores on a scale Standard Deviation 10.72	76.54 scores on a scale Standard Deviation 17.66

PRIMARY outcome

Timeframe: Assessed immediately after the 10-minute, single-session, in-person virtual reality or video intervention

Population: Data were reported by the caregivers, who reported for both the child and themselves. Only one score is reported for each child-caregiver dyad.

The Usefulness, Satisfaction and Ease of Use Questionnaire was used to measure acceptability, specifically usefulness, ease of use, ease of learning, and satisfaction with an intervention or service. Items were adapted to have the caregivers report on their child's experience of usability. The shortened instrument used in this study (Lund, 2001) contains 19 items, and respondents indicate their agreement with each statement on a scale from 1 (strongly disagree) to 7 (strongly agree). Scores are summed to create an overall score of usability, ranging from 19 to 133, with greater scores indicating greater usability.

Outcome measures

Outcome measures
Measure	Video n=13 Participants This is the control condition, which views a short video and online interactive game with psychoeducational material on healthy eating and consideration of future consequences.	Virtual Reality n=14 Participants This is the intervention condition, which participates in the virtual reality experience; the experience includes psychoeducational material on healthy eating and consideration of future consequences. Virtual Reality Experience: The virtual reality experience includes psychoeducation content about healthy eating and consideration of future consequences. It includes a game where participants are in a go kart and pick up healthy or unhealthy foods on the road. Participants play in the "present" and in the "future."
Acceptability as Measured by the Usefulness, Satisfaction and Ease of Use Questionnaire	75.58 score on a scale Standard Deviation 12.67	79.31 score on a scale Standard Deviation 15.67

PRIMARY outcome

Timeframe: Assessed immediately after the 10-minute, single-session, in-person virtual reality intervention

Population: Data were collected in Virtual Reality condition only. Data were reported by the caregivers, who reported for both the child and themselves. Only one score is reported for each child-caregiver dyad.

Degree of Immersion in the virtual environment is assessed by parent self-report with the Presence Questionnaire (Witmer 2005). The Presence Questionnaire is a 24 item questionnaire that assesses involvement, auditory fidelity, adaption/immersion, interface quality, consistency with expectations, and haptic/visual fidelity. Given that sense of touch was not applicable to the present study, this item (23) was not included in the final score. Responses to the items are on a scale from 1 (not at all) to 7 (completely), and responses are summed to create an overall score. Potential scores range from 23 to 161, with greater scores indicating greater self-reported feelings of being immersed in the virtual environment.

Outcome measures

Outcome measures
Measure	Video This is the control condition, which views a short video and online interactive game with psychoeducational material on healthy eating and consideration of future consequences.	Virtual Reality n=14 Participants This is the intervention condition, which participates in the virtual reality experience; the experience includes psychoeducational material on healthy eating and consideration of future consequences. Virtual Reality Experience: The virtual reality experience includes psychoeducation content about healthy eating and consideration of future consequences. It includes a game where participants are in a go kart and pick up healthy or unhealthy foods on the road. Participants play in the "present" and in the "future."
Acceptability as Measured by Degree of Immersion (for Those in the Virtual Reality Condition)	—	116.92 score on a scale Standard Deviation 20.22

PRIMARY outcome

Timeframe: Assessed immediately after the 10-minute, single-session, in-person virtual reality or video intervention

Population: Data were reported by the child only. This item was not collected from caregivers.

Assessed with child interview questions created by the study team. Questions ask children to respond by indicating which smiley face on a 5 point analog scale best represents how they feel, from 1 (unhappy/not at all) to 5 (very happy/a lot). Acceptability was assessed by asking how much the child liked the intervention, and motivation was assessed by asking the child how motivated they are to eat healthier post-intervention. Greater numbers on each question represent greater acceptability and greater post-intervention motivation, respectively.

Outcome measures

Outcome measures
Measure	Video n=13 Participants This is the control condition, which views a short video and online interactive game with psychoeducational material on healthy eating and consideration of future consequences.	Virtual Reality n=14 Participants This is the intervention condition, which participates in the virtual reality experience; the experience includes psychoeducational material on healthy eating and consideration of future consequences. Virtual Reality Experience: The virtual reality experience includes psychoeducation content about healthy eating and consideration of future consequences. It includes a game where participants are in a go kart and pick up healthy or unhealthy foods on the road. Participants play in the "present" and in the "future."
Acceptability as Measured by Child Interview Questions Motivating (1 question)	4.08 score on a scale Standard Deviation 1.00	3.69 score on a scale Standard Deviation .86
Acceptability as Measured by Child Interview Questions Acceptability (1 question)	3.54 score on a scale Standard Deviation 0.84	4.31 score on a scale Standard Deviation 0.48

PRIMARY outcome

Timeframe: Assessed at baseline (before the intervention) and immediately after the 10-minute, single-session, in-person virtual reality or video intervention

Population: Data were reported by the child only. These data were not collected from caregivers.

Child self-report survey measure. The Self-Efficacy for Healthy Eating and Physical Activity (SE-HEPA) measure was developed by Steele, Bindler, Power, and Daratha (2008) and is based on Motl et al.'s (2000) unidimensional measure of self-efficacy for exercise. Based on Bandura's (1977) social cognitive theory, SE-HEPA was designed to evaluate a children's or adolescents' confidence in their ability to engage in healthy eating (8 items) and physical activity behaviors (8 items). Items are answered on 5 point Likert scales from strongly disagree (1) to strongly agree (5). Scores are summed to create two subscales: self-efficacy for healthy eating, and self-efficacy for physical activity. Possible scores for each subscale range from 8 to 40, with greater scores indicating greater self-efficacy.

Outcome measures

Outcome measures
Measure	Video n=13 Participants This is the control condition, which views a short video and online interactive game with psychoeducational material on healthy eating and consideration of future consequences.	Virtual Reality n=14 Participants This is the intervention condition, which participates in the virtual reality experience; the experience includes psychoeducational material on healthy eating and consideration of future consequences. Virtual Reality Experience: The virtual reality experience includes psychoeducation content about healthy eating and consideration of future consequences. It includes a game where participants are in a go kart and pick up healthy or unhealthy foods on the road. Participants play in the "present" and in the "future."
Change in Self-Efficacy for Healthy Eating and Physical Activity (SE-HEPA) Pre-intervention healthy eating	26.08 score on a scale Standard Deviation 9.68	26.64 score on a scale Standard Deviation 6.87
Change in Self-Efficacy for Healthy Eating and Physical Activity (SE-HEPA) Post-intervention healthy eating	28.69 score on a scale Standard Deviation 9.89	28.07 score on a scale Standard Deviation 7.89
Change in Self-Efficacy for Healthy Eating and Physical Activity (SE-HEPA) Pre-intervention Physical Activity	24.08 score on a scale Standard Deviation 7.32	23.64 score on a scale Standard Deviation 8.05
Change in Self-Efficacy for Healthy Eating and Physical Activity (SE-HEPA) Post-intervention Physical Activity	26.23 score on a scale Standard Deviation 9.37	26.93 score on a scale Standard Deviation 7.73

PRIMARY outcome

Timeframe: Items are assessed immediately pre intervention and at 2-weeks after intervention

Population: Data were reported by the caregivers only. Only one score is reported for each child-caregiver dyad. These measures were not collected from children.

The caregiver Readiness to Change Diet and Physical Activity items were adapted from previously used questions and designed to assess caregiver readiness to help their child change physical activity and eating behaviors. Parents self-report their intentions to help their children with healthy habits by answering "Do you intend to find ways to improve the way your child eats?" and "Do you intend to find ways to improve your child's physical activity level?" with responses from 1 ("No, and I'm not intending to make changes"), 2 ("Yes, I intend to make changes in the next 6 months"), 3 ("Yes, I intend to make changes in the next month"), to 4 ("I'm already helping my child improve their \[eating/activity\]"). Scores range from 1 to 4, with greater scores indicating greater caregiver readiness to help their child change. Items are not aggregated, and each item is analyzed separately.

Outcome measures

Outcome measures
Measure	Video n=13 Participants This is the control condition, which views a short video and online interactive game with psychoeducational material on healthy eating and consideration of future consequences.	Virtual Reality n=14 Participants This is the intervention condition, which participates in the virtual reality experience; the experience includes psychoeducational material on healthy eating and consideration of future consequences. Virtual Reality Experience: The virtual reality experience includes psychoeducation content about healthy eating and consideration of future consequences. It includes a game where participants are in a go kart and pick up healthy or unhealthy foods on the road. Participants play in the "present" and in the "future."
Change in Caregiver Readiness to Change Diet and Physical Activity Pre-intervention intend to help child change eating	3.15 score on a scale Standard Deviation .80	3.43 score on a scale Standard Deviation .51
Change in Caregiver Readiness to Change Diet and Physical Activity Two-week post-intervention intend to help child change eating	3.31 score on a scale Standard Deviation .86	3.86 score on a scale Standard Deviation .36
Change in Caregiver Readiness to Change Diet and Physical Activity Pre-intervention intend to help child change activity	3.08 score on a scale Standard Deviation .86	3.29 score on a scale Standard Deviation .73
Change in Caregiver Readiness to Change Diet and Physical Activity Two-week Post-intervention intend to help child change activity	3.31 score on a scale Standard Deviation .95	3.64 score on a scale Standard Deviation .63

PRIMARY outcome

Timeframe: At baseline and after the 10-minute, single-session, in-person intervention

Population: The outcome measures were analyzed separately for children and caregivers. Data below was collected by either the child only or the caregiver only, as indicated in the row title. Different measures were collected for children and caregivers, as indicated in the measure description.

Behavioral beliefs (attitudes) and intentions toward health eating were measured with items adapted from previous literature based on the Theory of Planned Behavior. Where needed, language was adapted to lower the reading level for child participants. Items were answered on 7 point Likert scales from strongly disagree (1) to strongly agree (7). Scores were summed for child attitudes (beliefs), child intentions, and caregiver intentions, self-reported by children and caregivers pre- and post-intervention. Eight items measured child attitudes towards eating healthy, with total scores ranging from 8 to 56, and greater scores indicating more positive attitudes toward eating healthier. Six items measured child intentions toward healthy eating, with total scores ranging 6 to 42, and greater scores indicating greater intentions to engage in the behavior. Four items measured caregiver intentions to help child, with total scores ranging from 4 to 28, and greater scores indicating gre

Outcome measures

Outcome measures
Measure	Video n=13 Participants This is the control condition, which views a short video and online interactive game with psychoeducational material on healthy eating and consideration of future consequences.	Virtual Reality n=14 Participants This is the intervention condition, which participates in the virtual reality experience; the experience includes psychoeducational material on healthy eating and consideration of future consequences. Virtual Reality Experience: The virtual reality experience includes psychoeducation content about healthy eating and consideration of future consequences. It includes a game where participants are in a go kart and pick up healthy or unhealthy foods on the road. Participants play in the "present" and in the "future."
Change in Behavioral Beliefs (Attitudes) and Intentions Pre-Intervention Child Intentions toward healthy eating	27.62 score on a scale Standard Deviation 10.74	25.14 score on a scale Standard Deviation 9.45
Change in Behavioral Beliefs (Attitudes) and Intentions Post-Intervention Child Intentions toward healthy eating	31.46 score on a scale Standard Deviation 11.10	27 score on a scale Standard Deviation 8.8
Change in Behavioral Beliefs (Attitudes) and Intentions Pre-Intervention Child attitudes toward healthy eating	21.31 score on a scale Standard Deviation 7.18	19.36 score on a scale Standard Deviation 4.13
Change in Behavioral Beliefs (Attitudes) and Intentions Post-Intervention Child Healthy eating attitudes	21.85 score on a scale Standard Deviation 7.12	21.71 score on a scale Standard Deviation 5.01
Change in Behavioral Beliefs (Attitudes) and Intentions Pre-Intervention parent intentions toward healthy eating	24.54 score on a scale Standard Deviation 3.13	24.36 score on a scale Standard Deviation 6.28
Change in Behavioral Beliefs (Attitudes) and Intentions Post-Intervention parent intentions toward healthy eating	25 score on a scale Standard Deviation 3.14	26.93 score on a scale Standard Deviation 1.94

SECONDARY outcome

Timeframe: Immediately pre intervention/control and at 2 week follow-up

Population: Data were reported by the caregivers, who reported for on the child's behavior. Only one score is reported for each child-caregiver dyad.

Parents reported on their child's eating behavior of the previous week with three different items asking parents to report the number of servings per week the child ate of fruits, vegetables, and fast foods.

Outcome measures

Outcome measures
Measure	Video n=13 Participants This is the control condition, which views a short video and online interactive game with psychoeducational material on healthy eating and consideration of future consequences.	Virtual Reality n=14 Participants This is the intervention condition, which participates in the virtual reality experience; the experience includes psychoeducational material on healthy eating and consideration of future consequences. Virtual Reality Experience: The virtual reality experience includes psychoeducation content about healthy eating and consideration of future consequences. It includes a game where participants are in a go kart and pick up healthy or unhealthy foods on the road. Participants play in the "present" and in the "future."
Change in Child Diet Pre-intervention Weekly intake of fruits	3.23 servings per week Standard Deviation 1.42	3.50 servings per week Standard Deviation 1.09
Change in Child Diet Pre-intervention Weekly intake of vegetables	2.85 servings per week Standard Deviation .9	3.5 servings per week Standard Deviation .86
Change in Child Diet Pre-intervention Weekly intake of fast foods	2 servings per week Standard Deviation .58	2.14 servings per week Standard Deviation 1.1
Change in Child Diet Two-week Post-intervention Weekly intake of fruits	2.77 servings per week Standard Deviation 1.30	3.29 servings per week Standard Deviation 1.07
Change in Child Diet Two-week Post-intervention Weekly intake of vegetables	2.92 servings per week Standard Deviation 1.12	3.57 servings per week Standard Deviation 0.94
Change in Child Diet Two-week Post-intervention Weekly intake of fast food	1.85 servings per week Standard Deviation .56	1.79 servings per week Standard Deviation .7

SECONDARY outcome

Timeframe: Immediately pre intervention/control and at 2 week follow-up

Population: Data were reported by the caregivers, who reported for on the child's behavior. Only one score is reported for each child-caregiver dyad.

Parents reported on their child's eating behavior of the previous week with two different items asking parents to report the number of days per week the child ate breakfast and family dinner.

Outcome measures

Outcome measures
Measure	Video n=13 Participants This is the control condition, which views a short video and online interactive game with psychoeducational material on healthy eating and consideration of future consequences.	Virtual Reality n=14 Participants This is the intervention condition, which participates in the virtual reality experience; the experience includes psychoeducational material on healthy eating and consideration of future consequences. Virtual Reality Experience: The virtual reality experience includes psychoeducation content about healthy eating and consideration of future consequences. It includes a game where participants are in a go kart and pick up healthy or unhealthy foods on the road. Participants play in the "present" and in the "future."
Change in Child Eating Behavior Two-week Post-intervention Weekly intake of breakfast	5.77 days per week Standard Deviation 1.64	5.93 days per week Standard Deviation .92
Change in Child Eating Behavior Pre-intervention family dinner	4.54 days per week Standard Deviation 2.11	4.93 days per week Standard Deviation 2.50
Change in Child Eating Behavior Pre-intervention intake of breakfast	5.54 days per week Standard Deviation 1.61	5.86 days per week Standard Deviation 1.66
Change in Child Eating Behavior Two-week Post-intervention Weekly intake of family dinner	4.85 days per week Standard Deviation 1.72	4.5 days per week Standard Deviation 2.03

SECONDARY outcome

Timeframe: Immediately pre intervention/control and at 2 week follow-up

Population: Data were reported by the caregivers, who reported for on the child's behavior. Only one score is reported for each child-caregiver dyad.

Parents reported on their child's activity behavior of the previous week with two different items asking parents to report the average number of hours per day the child engaged in screen time and physical activity, on a scale from 1 to 5, with 1 = none; 2 = less than 1 hour per day; 3 = 1 to 2 hours per day; 4 = 3 to 4 hours per day; 5 = more than 4 hours per day.

Outcome measures

Outcome measures
Measure	Video n=13 Participants This is the control condition, which views a short video and online interactive game with psychoeducational material on healthy eating and consideration of future consequences.	Virtual Reality n=14 Participants This is the intervention condition, which participates in the virtual reality experience; the experience includes psychoeducational material on healthy eating and consideration of future consequences. Virtual Reality Experience: The virtual reality experience includes psychoeducation content about healthy eating and consideration of future consequences. It includes a game where participants are in a go kart and pick up healthy or unhealthy foods on the road. Participants play in the "present" and in the "future."
Change in Screen Time and Activity Behavior Pre-intervention screen time	4.31 units on a scale Standard Deviation .88	4.11 units on a scale Standard Deviation 1.02
Change in Screen Time and Activity Behavior Pre-intervention active hours	2.35 units on a scale Standard Deviation .72	2.89 units on a scale Standard Deviation .66
Change in Screen Time and Activity Behavior Two-week Post-intervention screen time	3.35 units on a scale Standard Deviation 1.05	3.61 units on a scale Standard Deviation 1.20
Change in Screen Time and Activity Behavior Two-week Post-intervention active hours	2.54 units on a scale Standard Deviation .80	2.96 units on a scale Standard Deviation .46

Adverse Events

Video

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Virtual Reality

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ellen Fitzsimmons-Craft

Washington University

Phone: 3142862074

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place