Trial Outcomes & Findings for Impact of Warnings on Sugar-Sweetened Beverages (NCT NCT04223687)

NCT ID: NCT04223687

Last Updated: 2021-09-01

Results Overview

The primary outcome is the percent of participants who selected at least one sugar-sweetened beverage for their child during the shopping task. Purchases will be recorded by the experimenter when they complete the shopping task.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 326 participants
• Primary outcome timeframe: At completion of ~10 minute shopping task, during 1-time study visit
• Results posted on: 2021-09-01

Participant Flow

Participant milestones

Measure	Neutral Label Neutral label: Neutral labels will be applied to the front-of-package of all sugar-sweetened beverage containers in the mock store. Investigators developed the design of these labels.	Sugar-Sweetened Beverage Warning Label Sugar-Sweetened Beverage Warning Label: Labels with a pictorial warning will be applied to the front-of-package of all sugar-sweetened beverage containers in the mock store. Investigators developed the text and design of these labels based on previous research.
Overall Study STARTED	163	163
Overall Study COMPLETED	162	163
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Neutral Label Neutral label: Neutral labels will be applied to the front-of-package of all sugar-sweetened beverage containers in the mock store. Investigators developed the design of these labels.	Sugar-Sweetened Beverage Warning Label Sugar-Sweetened Beverage Warning Label: Labels with a pictorial warning will be applied to the front-of-package of all sugar-sweetened beverage containers in the mock store. Investigators developed the text and design of these labels based on previous research.
Overall Study Missing primary outcome	1	0

Baseline Characteristics

Impact of Warnings on Sugar-Sweetened Beverages

Baseline characteristics by cohort

Measure	Neutral Label n=162 Participants Neutral label: Neutral labels will be applied to the front-of-package of all sugar-sweetened beverage containers in the mock store. Investigators developed the design of these labels.	Sugar-Sweetened Beverage Warning Label n=163 Participants Sugar-Sweetened Beverage Warning Label: Labels with a pictorial warning will be applied to the front-of-package of all sugar-sweetened beverage containers in the mock store. Investigators developed the text and design of these labels based on previous research.	Total n=325 Participants Total of all reporting groups
Age, Customized 18-29	24 Participants n=5 Participants	21 Participants n=7 Participants	45 Participants n=5 Participants
Age, Customized 30-39	65 Participants n=5 Participants	74 Participants n=7 Participants	139 Participants n=5 Participants
Age, Customized 40-49	53 Participants n=5 Participants	54 Participants n=7 Participants	107 Participants n=5 Participants
Age, Customized 50+	20 Participants n=5 Participants	14 Participants n=7 Participants	34 Participants n=5 Participants
Sex/Gender, Customized Man	41 Participants n=5 Participants	32 Participants n=7 Participants	73 Participants n=5 Participants
Sex/Gender, Customized Woman	120 Participants n=5 Participants	130 Participants n=7 Participants	250 Participants n=5 Participants
Sex/Gender, Customized Another gender identity	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic white	72 Participants n=5 Participants	70 Participants n=7 Participants	142 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic white	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic, no race reported	14 Participants n=5 Participants	15 Participants n=7 Participants	29 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic, other race(s)	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic Black or African American	46 Participants n=5 Participants	34 Participants n=7 Participants	80 Participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic Asian	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic, more than one race	3 Participants n=5 Participants	13 Participants n=7 Participants	16 Participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic, other race	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Data Not Reported	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment United States	162 Participants n=5 Participants	163 Participants n=7 Participants	325 Participants n=5 Participants
Time of participation Pre-pandemic	64 Participants n=5 Participants	65 Participants n=7 Participants	129 Participants n=5 Participants
Time of participation During pandemic	98 Participants n=5 Participants	98 Participants n=7 Participants	196 Participants n=5 Participants

PRIMARY outcome

Timeframe: At completion of ~10 minute shopping task, during 1-time study visit

The primary outcome is the percent of participants who selected at least one sugar-sweetened beverage for their child during the shopping task. Purchases will be recorded by the experimenter when they complete the shopping task.

Outcome measures

Measure	Neutral Label n=162 Participants Neutral label: Neutral labels will be applied to the front-of-package of all sugar-sweetened beverage containers in the mock store. Investigators developed the design of these labels.	Sugar-Sweetened Beverage Warning Label n=163 Participants Sugar-Sweetened Beverage Warning Label: Labels with a pictorial warning will be applied to the front-of-package of all sugar-sweetened beverage containers in the mock store. Investigators developed the text and design of these labels based on previous research.
Percentage of Participants Who Purchase at Least 1 Sugar-sweetened Beverage for Their Child	45 percentage of participants	28 percentage of participants

SECONDARY outcome

Timeframe: At completion of ~10 minute shopping task, during 1-time study visit

Total calories purchased from sugar-sweetened beverages is defined as the total number of calories of sugar-sweetened beverages in the participant's basket when they complete the shopping task.

Outcome measures

Measure	Neutral Label n=162 Participants Neutral label: Neutral labels will be applied to the front-of-package of all sugar-sweetened beverage containers in the mock store. Investigators developed the design of these labels.	Sugar-Sweetened Beverage Warning Label n=163 Participants Sugar-Sweetened Beverage Warning Label: Labels with a pictorial warning will be applied to the front-of-package of all sugar-sweetened beverage containers in the mock store. Investigators developed the text and design of these labels based on previous research.
Mean Total Calories Purchased From Sugar-sweetened Beverages	82.1 calories Standard Deviation 97.22	51.72 calories Standard Deviation 86.82

SECONDARY outcome

Timeframe: Post-test computer survey within 30 minutes following completion of ~10 minute shopping task

Population: Assessed for participants who provided response.

Intention to give sugar-sweetened beverages to child will be measured at post-test by survey. Response options are on a 1 to 7 scale, with higher scores representing a higher intention to give sugar-sweetened beverages to the participant's child.

Outcome measures

Measure	Neutral Label n=160 Participants Neutral label: Neutral labels will be applied to the front-of-package of all sugar-sweetened beverage containers in the mock store. Investigators developed the design of these labels.	Sugar-Sweetened Beverage Warning Label n=160 Participants Sugar-Sweetened Beverage Warning Label: Labels with a pictorial warning will be applied to the front-of-package of all sugar-sweetened beverage containers in the mock store. Investigators developed the text and design of these labels based on previous research.
Mean Intention to Give Sugar-sweetened Beverages to Child	1.85 score on a scale Standard Deviation 0.8	1.65 score on a scale Standard Deviation 0.6

SECONDARY outcome

Timeframe: Post-test computer survey within 30 minutes following completion of ~10 minute shopping task

Population: Assessed for participants who provided response.

Percent of participants who noticed the trial labels will be measured at post-test by survey.

Outcome measures

Measure	Neutral Label n=161 Participants Neutral label: Neutral labels will be applied to the front-of-package of all sugar-sweetened beverage containers in the mock store. Investigators developed the design of these labels.	Sugar-Sweetened Beverage Warning Label n=161 Participants Sugar-Sweetened Beverage Warning Label: Labels with a pictorial warning will be applied to the front-of-package of all sugar-sweetened beverage containers in the mock store. Investigators developed the text and design of these labels based on previous research.
Percentage of Participants Who Noticed Trial Label	47 percentage of participants	52 percentage of participants

SECONDARY outcome

Timeframe: Post-test computer survey within 30 minutes following completion of ~10 minute shopping task

Population: Assessed for participants who provided response.

How much the participant reports thinking about the health problems caused by drinking sugar-sweetened beverages will be measured at post-test by survey. Response options are on a 1 to 5 scale, with higher scores representing a higher amount of thinking about harms of drinking sugar-sweetened beverages.

Outcome measures

Measure	Neutral Label n=161 Participants Neutral label: Neutral labels will be applied to the front-of-package of all sugar-sweetened beverage containers in the mock store. Investigators developed the design of these labels.	Sugar-Sweetened Beverage Warning Label n=161 Participants Sugar-Sweetened Beverage Warning Label: Labels with a pictorial warning will be applied to the front-of-package of all sugar-sweetened beverage containers in the mock store. Investigators developed the text and design of these labels based on previous research.
Mean Thinking About Harms of Drinking Sugar-sweetened Beverages	1.90 score on a scale Standard Deviation 1.25	4.21 score on a scale Standard Deviation 0.95

SECONDARY outcome

Timeframe: Post-test computer survey within 30 minutes following completion of ~10 minute shopping task

Population: Assessed for participants who provided response.

Negative affect will be measured at post-test by survey. Response options are on a 1 to 5 scale, with higher scores representing a higher negative affect reaction.

Outcome measures

Measure	Neutral Label n=160 Participants Neutral label: Neutral labels will be applied to the front-of-package of all sugar-sweetened beverage containers in the mock store. Investigators developed the design of these labels.	Sugar-Sweetened Beverage Warning Label n=160 Participants Sugar-Sweetened Beverage Warning Label: Labels with a pictorial warning will be applied to the front-of-package of all sugar-sweetened beverage containers in the mock store. Investigators developed the text and design of these labels based on previous research.
Mean Negative Affective Reactions	1.51 score on a scale Standard Deviation 0.82	3.38 score on a scale Standard Deviation 1.12

SECONDARY outcome

Timeframe: Post-test computer survey within 30 minutes following completion of ~10 minute shopping task

Population: Assessed for participants who provided response.

Anticipated social interactions about the study labels will be measured at post-test by survey. Response options are on a 1 to 5 scale, with higher scores representing a higher likelihood of discussing the study labels with others.

Outcome measures

Measure	Neutral Label n=161 Participants Neutral label: Neutral labels will be applied to the front-of-package of all sugar-sweetened beverage containers in the mock store. Investigators developed the design of these labels.	Sugar-Sweetened Beverage Warning Label n=161 Participants Sugar-Sweetened Beverage Warning Label: Labels with a pictorial warning will be applied to the front-of-package of all sugar-sweetened beverage containers in the mock store. Investigators developed the text and design of these labels based on previous research.
Mean Anticipated Social Interactions	2.16 score on a scale Standard Deviation 1.32	3.89 score on a scale Standard Deviation 1.24

SECONDARY outcome

Timeframe: Post-test computer survey within 30 minutes following completion of ~10 minute shopping task

Population: Assessed for participants who provided response.

Percent of participants indicating they felt more in control of healthy eating decisions will be measured at post-test by survey.

Outcome measures

Measure	Neutral Label n=161 Participants Neutral label: Neutral labels will be applied to the front-of-package of all sugar-sweetened beverage containers in the mock store. Investigators developed the design of these labels.	Sugar-Sweetened Beverage Warning Label n=161 Participants Sugar-Sweetened Beverage Warning Label: Labels with a pictorial warning will be applied to the front-of-package of all sugar-sweetened beverage containers in the mock store. Investigators developed the text and design of these labels based on previous research.
Percentage of Participants Who Felt More in Control of Healthy Eating Decisions	30 percentage of participants	73 percentage of participants

SECONDARY outcome

Timeframe: Post-test computer survey within 30 minutes following completion of ~10 minute shopping task

Population: Assessed for participants who provided response.

Perceptions of added sugar content in sugar-sweetened beverages will be measured at post-test by survey. Response options are on a 1 to 5 scale, with higher scores representing a higher perceived amount of added sugar in sugar-sweetened beverages.

Outcome measures

Measure	Neutral Label n=160 Participants Neutral label: Neutral labels will be applied to the front-of-package of all sugar-sweetened beverage containers in the mock store. Investigators developed the design of these labels.	Sugar-Sweetened Beverage Warning Label n=161 Participants Sugar-Sweetened Beverage Warning Label: Labels with a pictorial warning will be applied to the front-of-package of all sugar-sweetened beverage containers in the mock store. Investigators developed the text and design of these labels based on previous research.
Mean Perceived Amount of Added Sugar in Sugar-sweetened Beverages	3.99 score on a scale Standard Deviation 0.67	4.08 score on a scale Standard Deviation 0.77

SECONDARY outcome

Timeframe: Post-test computer survey within 30 minutes following completion of ~10 minute shopping task

Population: Assessed for participants who provided response.

Perceived likelihood of child experiencing sugar-sweetened beverage related health outcomes will be measured at post-test by survey. Response options are on a 1 to 7 scale, with higher scores representing a higher perceived likelihood of child experiencing health problems due to sugar-sweetened beverages.

Outcome measures

Measure	Neutral Label n=152 Participants Neutral label: Neutral labels will be applied to the front-of-package of all sugar-sweetened beverage containers in the mock store. Investigators developed the design of these labels.	Sugar-Sweetened Beverage Warning Label n=157 Participants Sugar-Sweetened Beverage Warning Label: Labels with a pictorial warning will be applied to the front-of-package of all sugar-sweetened beverage containers in the mock store. Investigators developed the text and design of these labels based on previous research.
Mean Perceived Likelihood of Child Experiencing Health Problems Due to Sugar-sweetened Beverages	3.95 score on a scale Standard Deviation 0.99	4.07 score on a scale Standard Deviation 0.92

SECONDARY outcome

Timeframe: Post-test computer survey within 30 minutes following completion of ~10 minute shopping task

Population: Assessed for participants who provided response.

Parents' perceptions about sugar-sweetened beverages' healthfulness for their child will be measured at post-test by survey. Response options are on a 1 to 7 scale, with higher scores representing a higher perceived healthfulness of sugar-sweetened beverages for their child.

Outcome measures

Measure	Neutral Label n=161 Participants Neutral label: Neutral labels will be applied to the front-of-package of all sugar-sweetened beverage containers in the mock store. Investigators developed the design of these labels.	Sugar-Sweetened Beverage Warning Label n=160 Participants Sugar-Sweetened Beverage Warning Label: Labels with a pictorial warning will be applied to the front-of-package of all sugar-sweetened beverage containers in the mock store. Investigators developed the text and design of these labels based on previous research.
Mean Healthfulness of Sugar-sweetened Beverages for Child	2.24 score on a scale Standard Deviation 0.80	1.98 score on a scale Standard Deviation 0.82

SECONDARY outcome

Timeframe: Post-test computer survey within 30 minutes following completion of ~10 minute shopping task

Population: Assessed for participants who provided response.

Parents' perceptions about sugar-sweetened beverages appeal for their child will be measured at post-test by survey. Response options are on a 1 to 7 scale, with higher scores representing a higher perceived appeal of sugar-sweetened beverages for their child.

Outcome measures

Measure	Neutral Label n=161 Participants Neutral label: Neutral labels will be applied to the front-of-package of all sugar-sweetened beverage containers in the mock store. Investigators developed the design of these labels.	Sugar-Sweetened Beverage Warning Label n=161 Participants Sugar-Sweetened Beverage Warning Label: Labels with a pictorial warning will be applied to the front-of-package of all sugar-sweetened beverage containers in the mock store. Investigators developed the text and design of these labels based on previous research.
Mean Appeal of Sugar-sweetened Beverages for Child	3.32 score on a scale Standard Deviation 0.96	3.24 score on a scale Standard Deviation 0.98

SECONDARY outcome

Timeframe: Post-test computer survey within 30 minutes following completion of ~10 minute shopping task

Population: Assessed for participants who provided response.

Parents' perceptions of tastiness of sugar-sweetened beverages for their child will be measured at post-test by survey. Response options are on a 1 to 7 scale, with higher scores representing a higher perceived tastiness of sugar-sweetened beverages for their child.

Outcome measures

Measure	Neutral Label n=160 Participants Neutral label: Neutral labels will be applied to the front-of-package of all sugar-sweetened beverage containers in the mock store. Investigators developed the design of these labels.	Sugar-Sweetened Beverage Warning Label n=161 Participants Sugar-Sweetened Beverage Warning Label: Labels with a pictorial warning will be applied to the front-of-package of all sugar-sweetened beverage containers in the mock store. Investigators developed the text and design of these labels based on previous research.
Mean Tastiness of Sugar-sweetened Beverages for Child	3.47 score on a scale Standard Deviation 0.89	3.30 score on a scale Standard Deviation 0.95

SECONDARY outcome

Timeframe: Post-test computer survey within 30 minutes following completion of ~10 minute shopping task

Population: Assessed for participants who provided response.

Injunctive norms about limiting child's sugar-sweetened beverage consumption will be measured at post-test by survey. Injunctive norms refer to perceived approval from people important in the participant's life. Response options are on a 1 to 5 scale, with higher scores representing higher perceived approval about limiting their child's sugar-sweetened beverages.

Outcome measures

Measure	Neutral Label n=158 Participants Neutral label: Neutral labels will be applied to the front-of-package of all sugar-sweetened beverage containers in the mock store. Investigators developed the design of these labels.	Sugar-Sweetened Beverage Warning Label n=158 Participants Sugar-Sweetened Beverage Warning Label: Labels with a pictorial warning will be applied to the front-of-package of all sugar-sweetened beverage containers in the mock store. Investigators developed the text and design of these labels based on previous research.
Mean Injunctive Norms About Limiting Child's Sugar-sweetened Beverages	3.21 score on a scale Standard Deviation 1.33	3.60 score on a scale Standard Deviation 1.20

OTHER_PRE_SPECIFIED outcome

Timeframe: Post-test computer survey within 30 minutes following completion of ~10 minute shopping task

Population: Assessed for participants who provided response.

Avoidance of the study labels will be measured at post-test by survey. Response options are on a 1 to 5 scale, with higher scores representing a higher amount of avoidance of looking at the study labels.

Outcome measures

Measure	Neutral Label n=160 Participants Neutral label: Neutral labels will be applied to the front-of-package of all sugar-sweetened beverage containers in the mock store. Investigators developed the design of these labels.	Sugar-Sweetened Beverage Warning Label n=161 Participants Sugar-Sweetened Beverage Warning Label: Labels with a pictorial warning will be applied to the front-of-package of all sugar-sweetened beverage containers in the mock store. Investigators developed the text and design of these labels based on previous research.
Mean Anticipated Avoidance of Label	1.94 score on a scale Standard Deviation 1.2	3.43 score on a scale Standard Deviation 1.3

OTHER_PRE_SPECIFIED outcome

Timeframe: Post-test computer survey within 30 minutes following completion of ~10 minute shopping task

Population: Assessed for participants who provided response.

Perceived message effectiveness of the study labels will be measured at post-test by survey. Response options are on a 1 to 5 scale, with higher scores representing a higher perceived message effectiveness of the study labels.

Outcome measures

Measure	Neutral Label n=159 Participants Neutral label: Neutral labels will be applied to the front-of-package of all sugar-sweetened beverage containers in the mock store. Investigators developed the design of these labels.	Sugar-Sweetened Beverage Warning Label n=153 Participants Sugar-Sweetened Beverage Warning Label: Labels with a pictorial warning will be applied to the front-of-package of all sugar-sweetened beverage containers in the mock store. Investigators developed the text and design of these labels based on previous research.
Mean Perceived Message Effectiveness	2.0 score on a scale Standard Deviation 1.3	4.2 score on a scale Standard Deviation .9

OTHER_PRE_SPECIFIED outcome

Timeframe: Post-test computer survey within 30 minutes following completion of ~10 minute shopping task

Population: Assessed for people who provided response.

Support for sugar-sweetened beverage health warning labels will be measured at post-test by survey. Response options are on a 1 to 4 scale, with higher scores representing a higher amount of support for a sugar-sweetened beverage health warning label policy.

Outcome measures

Measure	Neutral Label n=161 Participants Neutral label: Neutral labels will be applied to the front-of-package of all sugar-sweetened beverage containers in the mock store. Investigators developed the design of these labels.	Sugar-Sweetened Beverage Warning Label n=161 Participants Sugar-Sweetened Beverage Warning Label: Labels with a pictorial warning will be applied to the front-of-package of all sugar-sweetened beverage containers in the mock store. Investigators developed the text and design of these labels based on previous research.
Mean Policy Support	3.00 score on a scale Standard Deviation 0.9	3.49 score on a scale Standard Deviation 0.8

Adverse Events

Sugar-Sweetened Beverage Warning Label

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Neutral Label

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

Marissa Hall, PhD

University of North Carolina at Chapel Hill

Phone: (919) 445-1310

Email: mghall@unc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place