Encouraging Healthy and Sustainable Dietary Substitutions | NCT06175026

ID	Type	Description	Link
K01HL158608	U.S. NIH Grant/Contract		View source

Encouraging Healthy and Sustainable Dietary Substitutions | NCT06175026 | Trialant

Sponsor/Collaborators Module

Name	Class
National Heart, Lung, and Blood Institute (NHLBI)	NIH

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Health messages	Experimental	Messages shown will be related to the health impacts of making certain dietary substitutions (replacing beef with chicken and vegetarian entrees; replacing juice with whole fruit; replacing dairy milk with non-dairy milk; replacing sugar-sweetened beverages with water).	Behavioral: Health messages
Environment messages	Experimental	Messages shown will be related to the environmental impacts of making certain dietary substitutions (replacing beef with chicken and vegetarian entrees; replacing juice with whole fruit; replacing dairy milk with non-dairy milk; replacing sugar-sweetened beverages with water).	Behavioral: Environmental messages
Health and environment messages	Experimental	Messages shown will be related to the health and environmental impacts of making certain dietary substitutions (replacing beef with chicken and vegetarian entrees; replacing juice with whole fruit; replacing dairy milk with non-dairy milk; replacing sugar-sweetened beverages with water).	Behavioral: Health and environmental messages
Neutral messages	Active Comparator	Messages shown will be neutral and unrelated to the health or environmental impacts of making certain dietary substitutions (replacing beef with chicken and vegetarian entrees; replacing juice with whole fruit; replacing dairy milk with non-dairy milk; replacing sugar-sweetened beverages with water).

Name	Type	Description	Arm Group Labels	Other Names
Health messages	Behavioral	Participants view messages about the health impacts of certain dietary substitutions.	Health messages

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Perceived Message Effectiveness	Participants will rate each message on perceived message effectiveness (PME) for encouraging participants to make the target dietary substitution. PME will be assessed with 4 items [the text shown in brackets will be tailored to each substitution]: How much does this message discourage you from wanting to [eat beef and pork / drink juice / drink cow's milk / drink sugary drinks]? How much does this message make [eating beef and pork, etc.] seem unpleasant to you? How much does this message make you concerned about the effects of [eating beef and pork, etc.]? How much does this message make you want to [eat chicken or vegetarian options instead of beef and pork, etc.]? The response options for each item are: 1=Not at all, 2=Very little, 3=Somewhat, 4=Quite a bit, 5=A great deal. Investigators will average responses to these 4 items to create a perceived message effectiveness score. Higher scores indicated higher perceived message effectiveness.	Survey questions administered after participant viewed each message; overall survey took up to 20 minutes

Contacts/Locations Module

Name	Affiliation	Role
Anna Grummon, PhD	Assistant Professor	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Stanford School of Medicine		Palo Alto	California	94304	United States

Arm/Group Information

ID	Title	Description
FG000	Health Messages	Messages shown will be related to the health impacts of making certain dietary substitutions (replacing beef with chicken and vegetarian entrees; replacing juice with whole fruit; replacing dairy milk with non-dairy milk; replacing sugar-sweetened beverages with water). Health messages: Participants view messages about the health impacts of certain dietary substitutions.
FG001	Environment Messages	Messages shown will be related to the environmental impacts of making certain dietary substitutions (replacing beef with chicken and vegetarian entrees; replacing juice with whole fruit; replacing dairy milk with non-dairy milk; replacing sugar-sweetened beverages with water). Environmental messages: Participants view messages about the environmental impacts of certain dietary substitutions.
FG002	Health and Environment Messages	Messages shown will be related to the health and environmental impacts of making certain dietary substitutions (replacing beef with chicken and vegetarian entrees; replacing juice with whole fruit; replacing dairy milk with non-dairy milk; replacing sugar-sweetened beverages with water). Health and environmental messages: Participants view messages about the health and environmental impacts of certain dietary substitutions.
FG003	Neutral Messages	Messages shown will be neutral and unrelated to the health or environmental impacts of making certain dietary substitutions (replacing beef with chicken and vegetarian entrees; replacing juice with whole fruit; replacing dairy milk with non-dairy milk; replacing sugar-sweetened beverages with water). Neutral messages: Participants view neutral messages unrelated to the health and environmental impacts of certain dietary substitutions.

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG000441 subjects FG001446 subjects FG002431 subjects FG003435 subjects
COMPLETED		FG000441 subjects FG001446 subjects FG002431 subjects FG003435 subjects
NOT COMPLETED		FG0000 subjects FG0010 subjects FG0020 subjects FG0030 subjects

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Health Messages	Messages shown will be related to the health impacts of making certain dietary substitutions (replacing beef with chicken and vegetarian entrees; replacing juice with whole fruit; replacing dairy milk with non-dairy milk; replacing sugar-sweetened beverages with water). Health messages: Participants view messages about the health impacts of certain dietary substitutions.

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Perceived Message Effectiveness

Participants will rate each message on perceived message effectiveness (PME) for encouraging participants to make the target dietary substitution. PME will be assessed with 4 items [the text shown in brackets will be tailored to each substitution]:

How much does this message discourage you from wanting to [eat beef and pork / drink juice / drink cow's milk / drink sugary drinks]?
How much does this message make [eating beef and pork, etc.] seem unpleasant to you?
How much does this message make you concerned about the effects of [eating beef and pork, etc.]?
How much does this message make you want to [eat chicken or vegetarian options instead of beef and pork, etc.]?

The response options for each item are: 1=Not at all, 2=Very little, 3=Somewhat, 4=Quite a bit, 5=A great deal.

Investigators will average responses to these 4 items to create a perceived message effectiveness score. Higher scores indicated higher perceived message effectiveness.

Posted

Mean

Standard Deviation

score on a scale

Survey questions administered after participant viewed each message; overall survey took up to 20 minutes

ID	Title	Description

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Health Messages	Messages shown will be related to the health impacts of making certain dietary substitutions (replacing beef with chicken and vegetarian entrees; replacing juice with whole fruit; replacing dairy milk with non-dairy milk; replacing sugar-sweetened beverages with water). Health messages: Participants view messages about the health impacts of certain dietary substitutions.

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Dr. Anna H. Grummon, PhD	Stanford University	(650) 644-7366		agrummon@stanford.edu

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Sep 22, 2023	Jan 2, 2024	Prot_SAP_000.pdf
ICF	No	No	Yes	Informed Consent Form	Sep 22, 2023	Feb 15, 2024	ICF_001.pdf

ID	Term
D005518	Food Preferences

ID	Term
D005247	Feeding Behavior
D001519	Behavior

ID	Term
D006262	Health

ID	Term
D011154	Population Characteristics

Sex/Gender, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0006 BG0015 BG0027 BG00311 BG00429
Asian	BG00017 BG0019 BG00217 BG0039 BG004
Native Hawaiian or Other Pacific Islander	BG0002 BG0010 BG0023 BG0031 BG004
Black or African American	BG00055 BG00150 BG00258 BG00356 BG004
White	BG000319 BG001332 BG002302 BG003315 BG004
More than one race	BG00028 BG00130 BG00220 BG00323 BG004
Unknown or Not Reported	BG00010 BG00115 BG00217 BG00315 BG004

Group IDs	Group Description	Statistical Method	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type
OG000 OG003	The null hypothesis was that the health messages would not elicit different levels of perceived message effectiveness compared to the neutral messages.	Mixed Models Analysis	<0.001	The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.	Mean Difference (Final Values)	1.25	Standard Error of the Mean	.062	2-Sided	95	1.13	1.37	Superiority
OG001 OG003	The null hypothesis was that the environment messages would not elicit different perceived message effectiveness than the control messages.	Mixed Models Analysis	<.001	The p-value was not adjusted for multiple comparisons. The a prior threshold for statistical significance was 0.05.	Mean Difference (Final Values)	1.14	Standard Error of the Mean	.062	2-Sided	95	1.03	1.26	Superiority
OG002 OG003	The null hypothesis was that the health and environment messages would not elicit different perceived message effectiveness than the control messages.	Mixed Models Analysis	<0.001	The p-value was not adjusted for multiple comparisons. The a prior threshold for statistical significance was 0.05.	Mean Difference (Final Values)	1.29	Standard Error of the Mean	.062	2-Sided	95	1.17	1.41	Superiority
OG000 OG001		Mixed Models Analysis	.1892	This p-value was adjusted for multiple comparisons (considering 3 tests among intervention arms) using the Bonferroni Holm method.	Mean Difference (Final Values)	.10	Standard Error of the Mean	0.062	2-Sided	95	-0.018	.223	Superiority
OG000 OG002		Mixed Models Analysis	.47	This p-value was adjusted for multiple comparisons (considering 3 tests among intervention arms) using the Bonferroni Holm method.	Mean Difference (Final Values)	-.045	Standard Error of the Mean	0.62	2-Sided	95	-.17	.08	Superiority
OG001 OG002		Mixed Models Analysis	.051	This p-value was adjusted for multiple comparisons (considering 3 tests among intervention arms) using the Bonferroni Holm method.	Mean Difference (Final Values)	-.15	Standard Error of the Mean	.062	2-Sided	95	-.27	-.03	Superiority

OG000	Health Messages	Messages shown will be related to the health impacts of making certain dietary substitutions (replacing beef with chicken and vegetarian entrees; replacing juice with whole fruit; replacing dairy milk with non-dairy milk; replacing sugar-sweetened beverages with water). Health messages: Participants view messages about the health impacts of certain dietary substitutions.
OG001	Environment Messages	Messages shown will be related to the environmental impacts of making certain dietary substitutions (replacing beef with chicken and vegetarian entrees; replacing juice with whole fruit; replacing dairy milk with non-dairy milk; replacing sugar-sweetened beverages with water). Environmental messages: Participants view messages about the environmental impacts of certain dietary substitutions.
OG002	Health and Environment Messages	Messages shown will be related to the health and environmental impacts of making certain dietary substitutions (replacing beef with chicken and vegetarian entrees; replacing juice with whole fruit; replacing dairy milk with non-dairy milk; replacing sugar-sweetened beverages with water). Health and environmental messages: Participants view messages about the health and environmental impacts of certain dietary substitutions.
OG003	Neutral Messages	Messages shown will be neutral and unrelated to the health or environmental impacts of making certain dietary substitutions (replacing beef with chicken and vegetarian entrees; replacing juice with whole fruit; replacing dairy milk with non-dairy milk; replacing sugar-sweetened beverages with water). Neutral messages: Participants view neutral messages unrelated to the health and environmental impacts of certain dietary substitutions.