Trial Outcomes & Findings for A Home-based Intervention to Improve the Diet Quality of Preschoolers (NCT NCT03923491)
NCT ID: NCT03923491
Last Updated: 2023-12-18
Results Overview
HEI-2015 scores will be calculated from twenty four hour recall data (two of them which are combined and scored per 1000 kcal or as a % of intake per NCI scoring guidelines). HEI was designed to measure diet quality in terms of how well diets conform to the 2015 Dietary Guidelines for Americans. The total HEI score represents the sum of 12 components scores (minimum component can be 0 and maximum component score shown in parentheses for each), including total fruit (5), whole fruit (5), total vegetables (5), green and beans (includes dark green vegetables and cooked, dried beans and peas because intakes of these types of vegetables are furthest from the amounts recommended in the USDA Food Patterns) (5), whole grain (10), dairy (10), total protein food (5), seafood and plant proteins (5), fatty acids (10), refined grains (10), sodium (10) added sugar (10), saturated fat (10). Higher scores reflect better outcomes.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
63 participants
Primary outcome timeframe
Healthy Eating Index Scores at study completion (6 months)
Results posted on
2023-12-18
Participant Flow
Participants were recruited through a variety of active and passive strategies. For active recruitment, Special Supplemental Nutrition Program for Women, Infants and Children (WIC) nutritionists collected contact information of interested participants, which was then passed to research staff for follow-up. Study staff members also recruited caregivers in WIC waiting rooms or child welfare organizations.
Participant milestones
| Measure |
Healthy Feeding, Healthy Eating
The experimental arm will receive three home visits over the first three months of the intervention.Visits will be conducted by a community health worker (CHW) trained in Motivational Interviewing. The home visits will include video-feedback on a meal; in-home cooking demonstrations; tailored text-messages, and mailed materials. During the last three months of the intervention, CHW will conduct monthly phone calls, together with mailed materials and text messages. The intervention will be tailored for families based on the child's appetitive traits and eating behaviors.
Healthy Feeding, Healthy Eating: Home Based Motivational Interviewing to Improve Diet Quality of Preschoolers
|
Reading and Readiness
The Reading and Readiness group will receive information on school readiness promotion. Materials will be adapted and delivered by the community health worker (CHW) with a similar dose and schedule as the intervention group (three home visits and three phone calls). During the home visits, the CHW will show a video that models early childhood caregiver-child activities and demonstrates simple methods to interact with their children. They will also send a video of themselves reading with a child, receive text-messages based on these materials as well as the print materials during the last three months of the intervention.
Reading Readiness: Active Control that uses Motivational Interviewing to improve Reading Readiness of Preschool Children
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
30
|
|
Overall Study
COMPLETED
|
24
|
16
|
|
Overall Study
NOT COMPLETED
|
9
|
14
|
Reasons for withdrawal
| Measure |
Healthy Feeding, Healthy Eating
The experimental arm will receive three home visits over the first three months of the intervention.Visits will be conducted by a community health worker (CHW) trained in Motivational Interviewing. The home visits will include video-feedback on a meal; in-home cooking demonstrations; tailored text-messages, and mailed materials. During the last three months of the intervention, CHW will conduct monthly phone calls, together with mailed materials and text messages. The intervention will be tailored for families based on the child's appetitive traits and eating behaviors.
Healthy Feeding, Healthy Eating: Home Based Motivational Interviewing to Improve Diet Quality of Preschoolers
|
Reading and Readiness
The Reading and Readiness group will receive information on school readiness promotion. Materials will be adapted and delivered by the community health worker (CHW) with a similar dose and schedule as the intervention group (three home visits and three phone calls). During the home visits, the CHW will show a video that models early childhood caregiver-child activities and demonstrates simple methods to interact with their children. They will also send a video of themselves reading with a child, receive text-messages based on these materials as well as the print materials during the last three months of the intervention.
Reading Readiness: Active Control that uses Motivational Interviewing to improve Reading Readiness of Preschool Children
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
8
|
|
Overall Study
Withdrawal by Subject
|
4
|
6
|
Baseline Characteristics
A Home-based Intervention to Improve the Diet Quality of Preschoolers
Baseline characteristics by cohort
| Measure |
Healthy Feeding, Healthy Eating
n=33 Participants
The experimental arm will receive three home over the first three months of the intervention.Visits will be conducted by a community health worker (CHW) trained in Motivational Interviewing. The home visits will include video-feedback on a meal; in-home cooking demonstrations; tailored text-messages, and mailed materials. During the last three months of the intervention, CHW will conduct monthly phone calls, together with mailed materials and text messages. The intervention will be tailored for families based on the child's appetitive traits and eating behaviors.
Healthy Feeding, Healthy Eating: Home Based Motivational Interviewing to Improve Diet Quality of Preschoolers
|
Reading and Readiness
n=30 Participants
The Reading and Readiness group will receive information on school readiness promotion. Materials will be adapted and delivered by the community health worker (CHW) with a similar dose and schedule as the intervention group (three home visits and three phone calls). During the home visits, the CHW will show a video that models early childhood caregiver-child activities and demonstrates simple methods to interact with their children. They will also send a video of themselves reading with a child, receive text-messages based on these materials as well as the print materials during the last three months of the intervention.
Reading Readiness: Active Control that uses Motivational Interviewing to improve Reading Readiness of Preschool Children
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.67 years
STANDARD_DEVIATION 6.94 • n=5 Participants
|
34.27 years
STANDARD_DEVIATION 8.36 • n=7 Participants
|
34.48 years
STANDARD_DEVIATION 7.59 • n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
29 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=5 Participants
|
30 participants
n=7 Participants
|
63 participants
n=5 Participants
|
|
Gender of target child
Female
|
18 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Gender of target child
Male
|
15 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Caregiver's relationship to child
Mother
|
30 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Caregiver's relationship to child
Father or other
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Country of birth
United States
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Country of birth
Other
|
22 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Language used at home
English
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Language used at home
Spanish
|
23 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Language used at home
Missing
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Annual Household Income
< $25,000
|
14 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Annual Household Income
$25,000-74,999
|
14 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Annual Household Income
>75,000
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Annual Household Income
Unknown
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Highest level of education
Less than 8th grade
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Highest level of education
High School
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Highest level of education
College
|
18 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Employment status
Employment full time
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Employment status
Employment part time
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Employment status
Other, includes employed seasonally, unemployed/looking for work, student, homemaker and disable. )
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Marital status
Married
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Marital status
Not married includes never married, separated, divorced, widowed.
|
15 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Marital status
Missing
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Currently living with a spouse/partner
Yes
|
23 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Currently living with a spouse/partner
No
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Currently living with a spouse/partner
Missing
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Number of other adults living in home
None
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Number of other adults living in home
One
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Number of other adults living in home
Two or more
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Number of other adults living in home
Missing
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Number of children (<18 y) living at home
One
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Number of children (<18 y) living at home
Two or more
|
25 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Currently pregnant
Yes
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Currently pregnant
No
|
27 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Currently pregnant
Missing
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Food Assistance
Yes
|
27 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Food Assistance
No
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Food Assistance
Missing
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Food insecurity
Yes, Includes any level of food insecurity
|
11 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Food insecurity
No
|
22 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Target child attends childcare
Yes
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Target child attends childcare
No
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Healthy Eating Index Scores at study completion (6 months)HEI-2015 scores will be calculated from twenty four hour recall data (two of them which are combined and scored per 1000 kcal or as a % of intake per NCI scoring guidelines). HEI was designed to measure diet quality in terms of how well diets conform to the 2015 Dietary Guidelines for Americans. The total HEI score represents the sum of 12 components scores (minimum component can be 0 and maximum component score shown in parentheses for each), including total fruit (5), whole fruit (5), total vegetables (5), green and beans (includes dark green vegetables and cooked, dried beans and peas because intakes of these types of vegetables are furthest from the amounts recommended in the USDA Food Patterns) (5), whole grain (10), dairy (10), total protein food (5), seafood and plant proteins (5), fatty acids (10), refined grains (10), sodium (10) added sugar (10), saturated fat (10). Higher scores reflect better outcomes.
Outcome measures
| Measure |
Healthy Feeding, Healthy Eating
n=24 Participants
The experimental arm will receive three home over the first three months of the intervention.Visits will be conducted by a community health worker (CHW) trained in Motivational Interviewing. The home visits will include video-feedback on a meal; in-home cooking demonstrations; tailored text-messages, and mailed materials. During the last three months of the intervention, CHW will conduct monthly phone calls, together with mailed materials and text messages. The intervention will be tailored for families based on the child's appetitive traits and eating behaviors.
Healthy Feeding, Healthy Eating: Home Based Motivational Interviewing to Improve Diet Quality of Preschoolers
|
Reading and Readiness
n=16 Participants
The Reading and Readiness group will receive information on school readiness promotion. Materials will be adapted and delivered by the community health worker (CHW) with a similar dose and schedule as the intervention group (three home visits and three phone calls). During the home visits, the CHW will show a video that models early childhood caregiver-child activities and demonstrates simple methods to interact with their children. They will also send a video of themselves reading with a child, receive text-messages based on these materials as well as the print materials during the last three months of the intervention.
Reading Readiness: Active Control that uses Motivational Interviewing to improve Reading Readiness of Preschool Children
|
|---|---|---|
|
HEI-2015 Total and Component Scores
HEI-2015 total
|
61.6 score on a scale
Standard Deviation 10.8
|
65.7 score on a scale
Standard Deviation 12.9
|
|
HEI-2015 Total and Component Scores
HEI-2015 Total Vegetable
|
2.1 score on a scale
Standard Deviation 1.5
|
2.3 score on a scale
Standard Deviation 1.5
|
|
HEI-2015 Total and Component Scores
HEI-2015 Greens & Beans
|
2.5 score on a scale
Standard Deviation 2.4
|
2.7 score on a scale
Standard Deviation 2.3
|
|
HEI-2015 Total and Component Scores
HEI-2015 Total Fruit
|
3.9 score on a scale
Standard Deviation 1.6
|
3.8 score on a scale
Standard Deviation 1.8
|
|
HEI-2015 Total and Component Scores
HEI-2015 Whole Fruit
|
4.1 score on a scale
Standard Deviation 1.7
|
2.8 score on a scale
Standard Deviation 2.4
|
|
HEI-2015 Total and Component Scores
HEI-2015 Whole Grain
|
4.6 score on a scale
Standard Deviation 3.4
|
4.0 score on a scale
Standard Deviation 3.9
|
|
HEI-2015 Total and Component Scores
HEI-2015 Total Dairy
|
8.3 score on a scale
Standard Deviation 2.7
|
8.7 score on a scale
Standard Deviation 2.0
|
|
HEI-2015 Total and Component Scores
HEI-2015 Total Protein
|
4.5 score on a scale
Standard Deviation 1.8
|
4.0 score on a scale
Standard Deviation 1.6
|
|
HEI-2015 Total and Component Scores
HEI-2015 Seafood Plant Protein
|
2.3 score on a scale
Standard Deviation 2.4
|
3.1 score on a scale
Standard Deviation 2.2
|
|
HEI-2015 Total and Component Scores
HEI-2015 Fatty Acid
|
3.5 score on a scale
Standard Deviation 3.1
|
5.2 score on a scale
Standard Deviation 3.1
|
|
HEI-2015 Total and Component Scores
HEI-2015 Sodium
|
4.8 score on a scale
Standard Deviation 3.2
|
7.0 score on a scale
Standard Deviation 2.7
|
|
HEI-2015 Total and Component Scores
HEI-2015 Refined Grain
|
6.6 score on a scale
Standard Deviation 2.9
|
7.0 score on a scale
Standard Deviation 2.9
|
|
HEI-2015 Total and Component Scores
HEI-2015 Added Sugar
|
7.4 score on a scale
Standard Deviation 2.7
|
7.5 score on a scale
Standard Deviation 3.2
|
|
HEI-2015 Total and Component Scores
HEI-2015 Saturated Fats
|
7.0 score on a scale
Standard Deviation 3.1
|
7.6 score on a scale
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: Food Parenting Practices at study completion (6 months)The intervention effects on 14 subscales of the Food Parenting Inventory were used as secondary outcome measures: Encourage try new foods (P), Encourage exploration of new foods (P), Urge child to eat new foods (P), Repeated Presentation of New foods (P), Family meals (P), Regular timing of meals and snacks (P), Inconsistent mealtimes (N), Indifferent feeding (N), Child involvement in food preparation (P), Pressure to Eat (N), Restriction (N), Food as a reward (N), Responsiveness to child's fullness cues (P), Monitoring (P). We also use one subscale of the Comprehensive Feeding Practices Questionnaire: Healthy Eating Guidance (P). All scales are rated on a 5-point Likert scale ranging from 1 (min) to 5 (max). Higher subscale scores indicate greater use of that child feeding practice. We have noted which practice has more positive/desirable practices with a (P) and more negative/not desired sub-scales have an (N) with higher scores.
Outcome measures
| Measure |
Healthy Feeding, Healthy Eating
n=24 Participants
The experimental arm will receive three home over the first three months of the intervention.Visits will be conducted by a community health worker (CHW) trained in Motivational Interviewing. The home visits will include video-feedback on a meal; in-home cooking demonstrations; tailored text-messages, and mailed materials. During the last three months of the intervention, CHW will conduct monthly phone calls, together with mailed materials and text messages. The intervention will be tailored for families based on the child's appetitive traits and eating behaviors.
Healthy Feeding, Healthy Eating: Home Based Motivational Interviewing to Improve Diet Quality of Preschoolers
|
Reading and Readiness
n=16 Participants
The Reading and Readiness group will receive information on school readiness promotion. Materials will be adapted and delivered by the community health worker (CHW) with a similar dose and schedule as the intervention group (three home visits and three phone calls). During the home visits, the CHW will show a video that models early childhood caregiver-child activities and demonstrates simple methods to interact with their children. They will also send a video of themselves reading with a child, receive text-messages based on these materials as well as the print materials during the last three months of the intervention.
Reading Readiness: Active Control that uses Motivational Interviewing to improve Reading Readiness of Preschool Children
|
|---|---|---|
|
Food Parenting Practices
Pressure to Eat (N)
|
3.3 units on a scale
Standard Deviation 1.1
|
3.4 units on a scale
Standard Deviation 1.1
|
|
Food Parenting Practices
Encourage try new foods (P)
|
4.1 units on a scale
Standard Deviation 0.5
|
4.1 units on a scale
Standard Deviation 0.6
|
|
Food Parenting Practices
Encourage exploration of new foods (P)
|
3.9 units on a scale
Standard Deviation 0.9
|
3.9 units on a scale
Standard Deviation 1.2
|
|
Food Parenting Practices
Urge child to eat new foods (P)
|
4.2 units on a scale
Standard Deviation 0.7
|
4.1 units on a scale
Standard Deviation 0.8
|
|
Food Parenting Practices
Repeated Presentation of New foods (P)
|
4.0 units on a scale
Standard Deviation 0.9
|
4.0 units on a scale
Standard Deviation 0.9
|
|
Food Parenting Practices
Family meals (P)
|
4.4 units on a scale
Standard Deviation 0.5
|
3.6 units on a scale
Standard Deviation 0.8
|
|
Food Parenting Practices
Regular timing of meals and snacks (P)
|
4.3 units on a scale
Standard Deviation 0.6
|
2.2 units on a scale
Standard Deviation 1.0
|
|
Food Parenting Practices
Inconsistent mealtimes (N)
|
2.1 units on a scale
Standard Deviation 0.9
|
2.2 units on a scale
Standard Deviation 1.0
|
|
Food Parenting Practices
Indifferent feeding (N)
|
2.5 units on a scale
Standard Deviation 1.2
|
2.7 units on a scale
Standard Deviation 1.1
|
|
Food Parenting Practices
Child involvement in food preparation (P)
|
3.0 units on a scale
Standard Deviation 0.8
|
2.8 units on a scale
Standard Deviation 1.2
|
|
Food Parenting Practices
Restriction (N)
|
4.0 units on a scale
Standard Deviation 1.2
|
4.1 units on a scale
Standard Deviation 1.1
|
|
Food Parenting Practices
Food as a reward (N)
|
3.0 units on a scale
Standard Deviation 1.0
|
3.5 units on a scale
Standard Deviation 0.9
|
|
Food Parenting Practices
Responsiveness to child's fullness cues (P)
|
4.2 units on a scale
Standard Deviation 0.8
|
3.6 units on a scale
Standard Deviation 1.2
|
|
Food Parenting Practices
Monitoring (P)
|
3.8 units on a scale
Standard Deviation 1.0
|
3.8 units on a scale
Standard Deviation 1.2
|
|
Food Parenting Practices
Healthy Eating Guidance (P
|
4.6 units on a scale
Standard Deviation 0.4
|
4.4 units on a scale
Standard Deviation 0.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Changes in Home Food Inventory Scores between baseline and study completion at 6 monthsHome Food Inventory Change Scores. Home food inventory (HFI) will be used to assess a wide range of commonly available foods in the home environment. A total healthy food availability score will be created from the following items (fruit- frozen, canned, fresh or dried, vegetables-frozen, fresh or canned, milk, water, whole grains, legumes) with a higher score representing more availability of healthy foods. Scores can range from 0-11. An unhealthy food score will also be created from the following items (Chips, Cakes/Cookies, Candy, Pastries, Juice, Soda, Sports drinks, Sweetened Beverages)- scores can range from 0-8 with higher scores representing availability of unhealthy foods.
Outcome measures
Outcome data not reported
Adverse Events
Healthy Feeding, Healthy Eating
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Reading and Readiness
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
Dr. Alison Tovar
Brown University School of Public Health
Phone: 401-863-7327
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place