Trial Outcomes & Findings for Digital Intervention To Improve Diet Quality (NCT NCT04098016)

NCT ID: NCT04098016

Last Updated: 2024-03-01

Results Overview

The average number of text messages completed over the 3-month intervention period. Text messages will be deployed three times a week throughout the 12-week intervention.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 54 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2024-03-01

Participant Flow

Participant milestones

Measure	Intervention Participants will receive: 1) tailored behavior change goals, 2) self-monitoring with tailored feedback, and 3) skills training. Digital Intervention: Participants will receive: 1) tailored behavior change goals, 2) self-monitoring with tailored feedback, 3) skills training.
Overall Study STARTED	54
Overall Study COMPLETED	48
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Digital Intervention To Improve Diet Quality

Baseline characteristics by cohort

Measure	Intervention n=54 Participants Participants will receive: 1) tailored behavior change goals, 2) self-monitoring with tailored feedback, and 3) skills training. Digital Intervention: Participants will receive: 1) tailored behavior change goals, 2) self-monitoring with tailored feedback, 3) skills training.
Age, Continuous	31.1 years STANDARD_DEVIATION 7.7 • n=5 Participants
Sex: Female, Male Female	54 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic White	34 Participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic Black	14 Participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic two or more races	2 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	2 Participants n=5 Participants
Race/Ethnicity, Customized Did not respond	2 Participants n=5 Participants
Region of Enrollment United States	54 Participants n=5 Participants
Healthy Eating Index-2015 score	49.7 units on a scale STANDARD_DEVIATION 12.4 • n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Only applicable to the intervention group.

The average number of text messages completed over the 3-month intervention period. Text messages will be deployed three times a week throughout the 12-week intervention.

Outcome measures

Measure	Intervention n=54 Participants Participants will receive: 1) tailored behavior change goals, 2) self-monitoring with tailored feedback, and 3) skills training. Digital Intervention: Participants will receive: 1) tailored behavior change goals, 2) self-monitoring with tailored feedback, 3) skills training.
Intervention Engagement- Number of Text Messages Completed	7.4 text messages Standard Deviation 4.6

SECONDARY outcome

Timeframe: Baseline to 3 months

The Healthy Eating Index (HEI) is a measure of diet quality used to assess how well a set of foods aligns with key recommendations of the Dietary Guidelines for Americans (DGA). The scores range from 0 to 100. A higher score reflects greater alignment with key dietary recommendations from the DGA.

Outcome measures

Measure	Intervention n=48 Participants Participants will receive: 1) tailored behavior change goals, 2) self-monitoring with tailored feedback, and 3) skills training. Digital Intervention: Participants will receive: 1) tailored behavior change goals, 2) self-monitoring with tailored feedback, 3) skills training.
Change in Healthy Eating Index Score	0.8 score on a scale Standard Deviation 12.9

Adverse Events

Intervention

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. Melissa Kay

Duke University

Phone: 7812493062

Email: melissa.kay@duke.edu

Results disclosure agreements

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