Evaluating a Family-based Nutrition and Garden Intervention in Rural Guatemala

• Sponsor: Wuqu' Kawoq, Maya Health Alliance (Other)
• Overall Status: Completed
• CT.gov ID: NCT03689504
• Collaborator: Academy of Nutrition and Dietetics (Other)
• Enrollment: 140
• Location: 1
• Arms: 2
• Actual Duration (Months): 30.3
• Patients Per Site Per Month: 4.6

Study Details

Study Description

Brief Summary

This is a pilot quasi-experimental study to evaluate the impact of adding a family garden intervention to an existing wrap-around nutrition intervention for children with chronic malnutrition and their family. The existing nutrition intervention is provided by community health workers affiliated with Wuqu' Kawoq | Maya Health Alliance. A single community in rural Guatemala will participate in the intervention, with the goal to recruit approximately 70 families in the combined nutrition/garden intervention. A nearby community, also participating in the nutrition intervention, will serve as a nonrandom contemporaneous control.

Aims of the study include:

1. Evaluate the impact of the garden intervention on maternal and child dietary diversity, child growth and household food insecurity.

2. Use the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework to conduct a preliminary implementation analysis, to guide a future, well-controlled study.

Condition or Disease	Intervention/Treatment	Phase
Malnutrition; Dietary Modification	Dietary Supplement: Standard of care nutrition support; Behavioral: Home-based nutrition education; Behavioral: Home-based family gardening	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 140 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluating a Family-based Nutrition and Garden Intervention in Rural Guatemala
• Actual Study Start Date: Jan 20, 2018
• Actual Primary Completion Date: May 11, 2020
• Actual Study Completion Date: Jul 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard of Care The standard of care is an intensive individualized home-based nutrition education program, together with a home food ration and micronutrient supplement, delivered by frontline workers for 6 months.	Dietary Supplement: Standard of care nutrition support; Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter); Behavioral: Home-based nutrition education; Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.
Experimental: Home Garden Intervention This arm adds an 8 month individualized home-based family garden intervention to the existing standard of care (home-based nutrition education)	Dietary Supplement: Standard of care nutrition support; Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter); Behavioral: Home-based nutrition education; Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.; Behavioral: Home-based family gardening; Health promoters will facilitate the building and maintenance of a family home garden using a square foot or container gardening method.

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Mean Number of Food Groups Consumed Per Day at 6 Months - Child [Baseline, 6 months]

   Calculated from the World Health Organization Infant and Young Child Feeding Indicators 24 hour diet recall tool

2. Change From Baseline in Mean Number of Solid Meals Consumed Per Day at 6 Months - Child [Baseline, 6 months]

   Calculated from the World Health Organization Infant and Young Child Feeding Indicators 24 hour diet recall tool

3. Change From Baseline in Raw Household Food Insecurity Score at 6 Months [Baseline, 6 months]

   Standardized food insecurity score, using the Food and Agriculture Organization's Global Food Insecurity Experience Scale (possible score range 0-8), higher scores indicate more food insecurity

4. Change From Baseline in Mean Number of Food Groups Consumed Per Day at 6 Months - Female Head of Household [Baseline, 6 months]

   Calculated from the Food and Agriculture Organization's Minimum Dietary Diversity for Women dietary recall

Secondary Outcome Measures

1. Change in Height/Length for Age Z Score From Baseline to 6 Months [0 months (baseline), 6 months]

   These are differences from 0 to 6 months (baseline to 6 months of intervention) z-scores calculated against the World Health Organization pediatric growth reference population (https://www.who.int/tools/child-growth-standards/standards)

2. Change in Weight for Age Z Score From Baseline to 6 Months [0 months (Baseline), 6 months]

   These are differences from 0 to 6 months (baseline to 6 months of intervention) z-scores calculated against the World Health Organization pediatric growth reference population (https://www.who.int/tools/child-growth-standards/standards)

3. Change in Weight for Height/Length Z Score From Baseline to 6 Months [Baseline, 6 months]

   These are differences from 0 to 6 months (baseline to 6 months of intervention) z-scores calculated against the World Health Organization pediatric growth reference population (https://www.who.int/tools/child-growth-standards/standards)

4. Mean Change in Household Crop Species From Baseline to 6 Months Diversity Score [Baseline, 6 months]

   Raw count of total crop species cultivated in the home

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Months to 24 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Children who are already scheduled to be enrolled in Maya Health Alliance's intensive home-based nutrition program (non-investigational, standard of care) who are 6-24 months of age at the time of enrollment with a height-for-age Z scores of <= -2.5

• At least one caregiver willing to provide written informed consent

• Caregiver of a child enrolled in the study (for caregiver/head of household outcomes), including women who may be pregnant

• Planned residence in the study area for the next 18 months

Exclusion Criteria:

• Children with acute malnutrition (weight for length Z scores of <= -2.0)

• Children with a severe medical illness that affects growth (e.g., heart disease, kidney disease, genetic condition) as determined by a Maya Health Alliance staff physician.

• Caregivers with cognitive impairments that prevent them from being able to provide informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wuqu' Kawoq	Tecpán Guatemala	Chimaltenango	Guatemala

Sponsors and Collaborators

• Wuqu' Kawoq, Maya Health Alliance
• Academy of Nutrition and Dietetics

Investigators

• Principal Investigator: Peter Rohloff, MD PhD, Wuqu' Kawoq
• Principal Investigator: Beth Jimenez, RDN PhD, University of New Mexico
• Study Director: Andrea Guzman, RDN, Wuqu' Kawoq

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 20, 2018

More Information

Publications

None provided.

• Responsible Party: Wuqu' Kawoq, Maya Health Alliance
• ClinicalTrials.gov Identifier: NCT03689504
• Other Study ID Numbers: WK-2018-002
• First Posted: Sep 28, 2018
• Last Update Posted: Nov 9, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Wuqu' Kawoq, Maya Health Alliance: Guatemala; indigenous; dietary diversity; chronic malnutrition; Maya; agriculture; behavior change; food insecurity
• Additional relevant MeSH terms: Malnutrition

Study Results

Participant Flow

Arm/Group Title	Standard of Care	Home Garden Intervention
Arm/Group Description	The standard of care is an intensive individualized home-based nutrition education program, together with a home food ration and micronutrient supplement, delivered by frontline workers for 6 months. Standard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter) Home-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.	This arm adds an 8 month individualized home-based family garden intervention to the existing standard of care (home-based nutrition education) Standard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter) Home-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents. Home-based family gardening: Health promoters will facilitate the building and maintenance of a family home garden using a square foot or container gardening method.
Period Title: Overall Study
STARTED	70	70
COMPLETED	65	70
NOT COMPLETED	5	0

Baseline Characteristics

Arm/Group Title	Standard of Care	Home Garden Intervention	Total
Arm/Group Description	The standard of care is an intensive individualized home-based nutrition education program, together with a home food ration and micronutrient supplement, delivered by frontline workers for 6 months. Standard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter) Home-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.	This arm adds an 8 month individualized home-based family garden intervention to the existing standard of care (home-based nutrition education) Standard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter) Home-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents. Home-based family gardening: Health promoters will facilitate the building and maintenance of a family home garden using a square foot or container gardening method.	Total of all reporting groups
Overall Participants	70	70	140
Age (days) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [days]	376	343	353
Sex: Female, Male (Count of Participants)
Female	32 45.7%	29 41.4%	61 43.6%
Male	38 54.3%	41 58.6%	79 56.4%
Race/Ethnicity, Customized (Count of Participants)
Maya ethnicity/language preference	65 92.9%	68 97.1%	133 95%
Region of Enrollment (participants) [Number]
Guatemala	70 100%	70 100%	140 100%
Length for age Z score (Z score) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [Z score]	-3.05	-3.20	-3.15
Weight for age Z score (Z score) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [Z score]	-1.55	-1.58	-1.56
Weight for length Z score (Z score) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [Z score]	0.18	0.32	0.3
Minimum acceptable diet (Count of Participants)
Count of Participants [Participants]	34 48.6%	48 68.6%	82 58.6%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Mean Number of Food Groups Consumed Per Day at 6 Months - Child
Description	Calculated from the World Health Organization Infant and Young Child Feeding Indicators 24 hour diet recall tool
Time Frame	Baseline, 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard of Care	Home Garden Intervention
Arm/Group Description	The standard of care is an intensive individualized home-based nutrition education program, together with a home food ration and micronutrient supplement, delivered by frontline workers for 6 months. Standard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter) Home-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.	This arm adds an 8 month individualized home-based family garden intervention to the existing standard of care (home-based nutrition education) Standard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter) Home-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents. Home-based family gardening: Health promoters will facilitate the building and maintenance of a family home garden using a square foot or container gardening method.
Measure Participants	70	64
Mean (Standard Deviation) [food groups]	0.6 (1.84)	1.29 (1.59)

2. Primary Outcome

Title	Change From Baseline in Mean Number of Solid Meals Consumed Per Day at 6 Months - Child
Description	Calculated from the World Health Organization Infant and Young Child Feeding Indicators 24 hour diet recall tool
Time Frame	Baseline, 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard of Care	Home Garden Intervention
Arm/Group Description	The standard of care is an intensive individualized home-based nutrition education program, together with a home food ration and micronutrient supplement, delivered by frontline workers for 6 months. Standard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter) Home-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.	This arm adds an 8 month individualized home-based family garden intervention to the existing standard of care (home-based nutrition education) Standard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter) Home-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents. Home-based family gardening: Health promoters will facilitate the building and maintenance of a family home garden using a square foot or container gardening method.
Measure Participants	70	70
Mean (Standard Deviation) [solid meals]	0.81 (1.61)	1.11 (1.45)

3. Primary Outcome

Title	Change From Baseline in Raw Household Food Insecurity Score at 6 Months
Description	Standardized food insecurity score, using the Food and Agriculture Organization's Global Food Insecurity Experience Scale (possible score range 0-8), higher scores indicate more food insecurity
Time Frame	Baseline, 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard of Care	Home Garden Intervention
Arm/Group Description	The standard of care is an intensive individualized home-based nutrition education program, together with a home food ration and micronutrient supplement, delivered by frontline workers for 6 months. Standard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter) Home-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.	This arm adds an 8 month individualized home-based family garden intervention to the existing standard of care (home-based nutrition education) Standard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter) Home-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents. Home-based family gardening: Health promoters will facilitate the building and maintenance of a family home garden using a square foot or container gardening method.
Measure Participants	70	64
Mean (Standard Deviation) [score on a scale]	-0.55 (1.86)	-0.84 (2.1)

4. Primary Outcome

Title	Change From Baseline in Mean Number of Food Groups Consumed Per Day at 6 Months - Female Head of Household
Description	Calculated from the Food and Agriculture Organization's Minimum Dietary Diversity for Women dietary recall
Time Frame	Baseline, 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard of Care	Home Garden Intervention
Arm/Group Description	The standard of care is an intensive individualized home-based nutrition education program, together with a home food ration and micronutrient supplement, delivered by frontline workers for 6 months. Standard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter) Home-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.	This arm adds an 8 month individualized home-based family garden intervention to the existing standard of care (home-based nutrition education) Standard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter) Home-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents. Home-based family gardening: Health promoters will facilitate the building and maintenance of a family home garden using a square foot or container gardening method.
Measure Participants	70	64
Mean (Standard Deviation) [food groups]	-0.01 (1.88)	0.42 (1.75)

5. Secondary Outcome

Title	Change in Height/Length for Age Z Score From Baseline to 6 Months
Description	These are differences from 0 to 6 months (baseline to 6 months of intervention) z-scores calculated against the World Health Organization pediatric growth reference population (https://www.who.int/tools/child-growth-standards/standards)
Time Frame	0 months (baseline), 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard of Care	Home Garden Intervention
Arm/Group Description	The standard of care is an intensive individualized home-based nutrition education program, together with a home food ration and micronutrient supplement, delivered by frontline workers for 6 months. Standard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter) Home-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.	This arm adds an 8 month individualized home-based family garden intervention to the existing standard of care (home-based nutrition education) Standard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter) Home-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents. Home-based family gardening: Health promoters will facilitate the building and maintenance of a family home garden using a square foot or container gardening method.
Measure Participants	70	64
Mean (Standard Deviation) [change in Z score]	-0.21 (0.49)	-0.07 (0.51)

6. Secondary Outcome

Title	Change in Weight for Age Z Score From Baseline to 6 Months
Description	These are differences from 0 to 6 months (baseline to 6 months of intervention) z-scores calculated against the World Health Organization pediatric growth reference population (https://www.who.int/tools/child-growth-standards/standards)
Time Frame	0 months (Baseline), 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard of Care	Home Garden Intervention
Arm/Group Description	The standard of care is an intensive individualized home-based nutrition education program, together with a home food ration and micronutrient supplement, delivered by frontline workers for 6 months. Standard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter) Home-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.	This arm adds an 8 month individualized home-based family garden intervention to the existing standard of care (home-based nutrition education) Standard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter) Home-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents. Home-based family gardening: Health promoters will facilitate the building and maintenance of a family home garden using a square foot or container gardening method.
Measure Participants	70	64
Mean (Standard Deviation) [Change in Z score]	-0.22 (0.39)	-0.12 (0.29)

7. Secondary Outcome

Title	Change in Weight for Height/Length Z Score From Baseline to 6 Months
Description	These are differences from 0 to 6 months (baseline to 6 months of intervention) z-scores calculated against the World Health Organization pediatric growth reference population (https://www.who.int/tools/child-growth-standards/standards)
Time Frame	Baseline, 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard of Care	Home Garden Intervention
Arm/Group Description	The standard of care is an intensive individualized home-based nutrition education program, together with a home food ration and micronutrient supplement, delivered by frontline workers for 6 months. Standard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter) Home-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.	This arm adds an 8 month individualized home-based family garden intervention to the existing standard of care (home-based nutrition education) Standard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter) Home-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents. Home-based family gardening: Health promoters will facilitate the building and maintenance of a family home garden using a square foot or container gardening method.
Measure Participants	70	64
Mean (Standard Deviation) [Change in Z score]	-0.38 (0.64)	-0.24 (0.54)

8. Secondary Outcome

Title	Mean Change in Household Crop Species From Baseline to 6 Months Diversity Score
Description	Raw count of total crop species cultivated in the home
Time Frame	Baseline, 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard of Care	Home Garden Intervention
Arm/Group Description	The standard of care is an intensive individualized home-based nutrition education program, together with a home food ration and micronutrient supplement, delivered by frontline workers for 6 months. Standard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter) Home-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.	This arm adds an 8 month individualized home-based family garden intervention to the existing standard of care (home-based nutrition education) Standard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter) Home-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents. Home-based family gardening: Health promoters will facilitate the building and maintenance of a family home garden using a square foot or container gardening method.
Measure Participants	70	64
Mean (Standard Deviation) [crop species]	-1.1 (4.15)	4.62 (4.66)

Adverse Events

Time Frame	12 months
Arm/Group Title	Standard of Care		Home Garden Intervention
Arm/Group Description	The standard of care is an intensive individualized home-based nutrition education program, together with a home food ration and micronutrient supplement, delivered by frontline workers for 6 months. Standard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter) Home-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.		This arm adds an 8 month individualized home-based family garden intervention to the existing standard of care (home-based nutrition education) Standard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter) Home-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents. Home-based family gardening: Health promoters will facilitate the building and maintenance of a family home garden using a square foot or container gardening method.
All Cause Mortality
	Standard of Care		Home Garden Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/70 (0%)		0/70 (0%)
Serious Adverse Events
	Standard of Care		Home Garden Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/70 (0%)		0/70 (0%)
Other (Not Including Serious) Adverse Events
	Standard of Care		Home Garden Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/70 (0%)		0/70 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.