Trial Outcomes & Findings for Mobile Health Intervention to Support Healthful Diet (NCT NCT05236712)

NCT ID: NCT05236712

Last Updated: 2024-01-09

Results Overview

Alternative MED (aMED) score will be calculated using the Food Frequency Questionnaire (FFQ). aMED scores range from 0 (nonadherence) to 9 (perfect adherence)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 15 participants
• Primary outcome timeframe: baseline, 3 month
• Results posted on: 2024-01-09

Participant Flow

Participant milestones

Measure	Mobile Health Participants will receive access to a mobile app installed on their device and will be asked to use the app at least once a week Mobile app: The app sends reminder 'push' notifications to complete weekly surveys. The survey is a series of questions about foods and drinks participants had in the last week. Once the weekly survey is completed the app generates a personalized weekly report showing foods we encourage participants to eat more of, eat less of, or keep eating the same amount of. The app will also show menu recommendations for breakfast, lunch, dinner, and snacks that will help participants to eat healthier. Finally, the app also has a feature that allows chatting with the research team by sending and receiving in-app texts.	Usual Care Participants will receive information on public online resources
Overall Study STARTED	8	7
Overall Study COMPLETED	8	7
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Mobile Health Intervention to Support Healthful Diet

Baseline characteristics by cohort

Measure	Mobile Health n=8 Participants Participants will receive access to a mobile app installed on their device and will be asked to use the app at least once a week Mobile app: The app sends reminder 'push' notifications to complete weekly surveys. The survey is a series of questions about foods and drinks participants had in the last week. Once the weekly survey is completed the app generates a personalized weekly report showing foods we encourage participants to eat more of, eat less of, or keep eating the same amount of. The app will also show menu recommendations for breakfast, lunch, dinner, and snacks that will help participants to eat healthier. Finally, the app also has a feature that allows chatting with the research team by sending and receiving in-app texts.	Usual Care n=7 Participants Participants will receive information on public online resources	Total n=15 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Age, Continuous	72.4 years STANDARD_DEVIATION 4.8 • n=5 Participants	70.0 years STANDARD_DEVIATION 3.9 • n=7 Participants	71.27 years STANDARD_DEVIATION 4.43 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants	7 participants n=7 Participants	15 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline, 3 month

Alternative MED (aMED) score will be calculated using the Food Frequency Questionnaire (FFQ). aMED scores range from 0 (nonadherence) to 9 (perfect adherence)

Outcome measures

Measure	Mobile Health n=8 Participants Participants will receive access to a mobile app installed on their device and will be asked to use the app at least once a week Mobile app: The app sends reminder 'push' notifications to complete weekly surveys. The survey is a series of questions about foods and drinks participants had in the last week. Once the weekly survey is completed the app generates a personalized weekly report showing foods we encourage participants to eat more of, eat less of, or keep eating the same amount of. The app will also show menu recommendations for breakfast, lunch, dinner, and snacks that will help participants to eat healthier. Finally, the app also has a feature that allows chatting with the research team by sending and receiving in-app texts.	Usual Care n=7 Participants Participants will receive information on public online resources
Change From Baseline Mediterranean Diet (MED) Adherence Score at 3 Months	2.63 score on a scale Standard Deviation 2.0	-0.29 score on a scale Standard Deviation 1.38

PRIMARY outcome

Timeframe: baseline, 3 month

Insulin resistance scores, homeostatic model (HOMA-IR) was calculated with the following formula: fasting plasma glucose (in mmol/L) X fasting plasma insulin (in lU/mL) divided by 22.5. Higher score indicates worse insulin resistance. Typically, a HOMA-IR value of less than 1 is considered normal, indicating low insulin resistance.

Outcome measures

Measure	Mobile Health n=8 Participants Participants will receive access to a mobile app installed on their device and will be asked to use the app at least once a week Mobile app: The app sends reminder 'push' notifications to complete weekly surveys. The survey is a series of questions about foods and drinks participants had in the last week. Once the weekly survey is completed the app generates a personalized weekly report showing foods we encourage participants to eat more of, eat less of, or keep eating the same amount of. The app will also show menu recommendations for breakfast, lunch, dinner, and snacks that will help participants to eat healthier. Finally, the app also has a feature that allows chatting with the research team by sending and receiving in-app texts.	Usual Care n=7 Participants Participants will receive information on public online resources
Change From Baseline HOMA-IR Score at 3 Months	-0.18 score on a scale Standard Deviation 0.72	0.1 score on a scale Standard Deviation 0.74

SECONDARY outcome

Timeframe: baseline, 3 month

MedD knowledge will be assessed using the Mediterranean Diet Nutrition Knowledge (MDNK) Questionnaire. The total scores range from 0 to 30. Higher score higher knowledge

Outcome measures

Measure	Mobile Health n=8 Participants Participants will receive access to a mobile app installed on their device and will be asked to use the app at least once a week Mobile app: The app sends reminder 'push' notifications to complete weekly surveys. The survey is a series of questions about foods and drinks participants had in the last week. Once the weekly survey is completed the app generates a personalized weekly report showing foods we encourage participants to eat more of, eat less of, or keep eating the same amount of. The app will also show menu recommendations for breakfast, lunch, dinner, and snacks that will help participants to eat healthier. Finally, the app also has a feature that allows chatting with the research team by sending and receiving in-app texts.	Usual Care n=7 Participants Participants will receive information on public online resources
Change From Baseline Mediterranean Diet Knowledge Score at 3 Months	2.0 score on a scale Standard Deviation 2.33	-1.14 score on a scale Standard Deviation 1.95

SECONDARY outcome

Timeframe: baseline, 3 month

Questionnaire, 7 items rated on a 5-point scale (strongly agree 5; strongly disagree 1). Higher score more positive outcome expectations. The total scale ranges from 7 to 35

Outcome measures

Measure	Mobile Health n=8 Participants Participants will receive access to a mobile app installed on their device and will be asked to use the app at least once a week Mobile app: The app sends reminder 'push' notifications to complete weekly surveys. The survey is a series of questions about foods and drinks participants had in the last week. Once the weekly survey is completed the app generates a personalized weekly report showing foods we encourage participants to eat more of, eat less of, or keep eating the same amount of. The app will also show menu recommendations for breakfast, lunch, dinner, and snacks that will help participants to eat healthier. Finally, the app also has a feature that allows chatting with the research team by sending and receiving in-app texts.	Usual Care n=7 Participants Participants will receive information on public online resources
Change From Baseline Positive Outcome Expectations Score at 3 Months	1.5 score on a scale Standard Deviation 5.26	1.0 score on a scale Standard Deviation 3.74

SECONDARY outcome

Timeframe: baseline, 3 month

Questionnaire, 6 items rated on a 5-point scale (strongly agree 5; strongly disagree 1). Higher score more negative outcome expectations. The total score ranges from 30 to 6

Outcome measures

Measure	Mobile Health n=8 Participants Participants will receive access to a mobile app installed on their device and will be asked to use the app at least once a week Mobile app: The app sends reminder 'push' notifications to complete weekly surveys. The survey is a series of questions about foods and drinks participants had in the last week. Once the weekly survey is completed the app generates a personalized weekly report showing foods we encourage participants to eat more of, eat less of, or keep eating the same amount of. The app will also show menu recommendations for breakfast, lunch, dinner, and snacks that will help participants to eat healthier. Finally, the app also has a feature that allows chatting with the research team by sending and receiving in-app texts.	Usual Care n=7 Participants Participants will receive information on public online resources
Change From Baseline Negative Outcome Expectations Score at 3 Months	-3.25 score on a scale Standard Error 3.62	-0.43 score on a scale Standard Error 1.9

SECONDARY outcome

Timeframe: baseline, 3 month

Questionnaire, 2 items rated on a 5-point scale (strongly agree 5; strongly disagree 1). Higher score more self-regulation. The total scale ranges from 10 to 2

Outcome measures

Measure	Mobile Health n=8 Participants Participants will receive access to a mobile app installed on their device and will be asked to use the app at least once a week Mobile app: The app sends reminder 'push' notifications to complete weekly surveys. The survey is a series of questions about foods and drinks participants had in the last week. Once the weekly survey is completed the app generates a personalized weekly report showing foods we encourage participants to eat more of, eat less of, or keep eating the same amount of. The app will also show menu recommendations for breakfast, lunch, dinner, and snacks that will help participants to eat healthier. Finally, the app also has a feature that allows chatting with the research team by sending and receiving in-app texts.	Usual Care n=7 Participants Participants will receive information on public online resources
Change From Baseline Self-regulation Score at 3 Months	-0.13 score on a scale Standard Error 1.25	-1.86 score on a scale Standard Error 3.13

SECONDARY outcome

Timeframe: baseline, 3 month

Visual analog scale (VAS), 6 items using a 10-point scale. Higher values more self-efficacy. The total score ranges from O to 60

Outcome measures

Measure	Mobile Health n=8 Participants Participants will receive access to a mobile app installed on their device and will be asked to use the app at least once a week Mobile app: The app sends reminder 'push' notifications to complete weekly surveys. The survey is a series of questions about foods and drinks participants had in the last week. Once the weekly survey is completed the app generates a personalized weekly report showing foods we encourage participants to eat more of, eat less of, or keep eating the same amount of. The app will also show menu recommendations for breakfast, lunch, dinner, and snacks that will help participants to eat healthier. Finally, the app also has a feature that allows chatting with the research team by sending and receiving in-app texts.	Usual Care n=7 Participants Participants will receive information on public online resources
Change From Baseline Self-Efficacy Score at 3 Months	1.75 score on a scale Standard Deviation 10.59	-2.0 score on a scale Standard Deviation 10.21

SECONDARY outcome

Timeframe: baseline, 3 month

Questionnaire, 2 items rated on a 5-point scale (strongly agree 5; strongly disagree 1). Higher score more social support. The total score ranges from 10 to 2

Outcome measures

Measure	Mobile Health n=8 Participants Participants will receive access to a mobile app installed on their device and will be asked to use the app at least once a week Mobile app: The app sends reminder 'push' notifications to complete weekly surveys. The survey is a series of questions about foods and drinks participants had in the last week. Once the weekly survey is completed the app generates a personalized weekly report showing foods we encourage participants to eat more of, eat less of, or keep eating the same amount of. The app will also show menu recommendations for breakfast, lunch, dinner, and snacks that will help participants to eat healthier. Finally, the app also has a feature that allows chatting with the research team by sending and receiving in-app texts.	Usual Care n=7 Participants Participants will receive information on public online resources
Change From Baseline Social Support Score at 3 Months	1.5 score on a scale Standard Deviation 1.41	-0.14 score on a scale Standard Deviation 2.19

SECONDARY outcome

Timeframe: baseline, 3 month

Short Physical Performance Battery (SPPB) is a composite measure assessing walking speed, standing balance, and sit-to-stand performance. The three tests are summed to give a total score, with a maximum of 12 and minimum of 0. Higher score higher function

Outcome measures

Measure	Mobile Health n=8 Participants Participants will receive access to a mobile app installed on their device and will be asked to use the app at least once a week Mobile app: The app sends reminder 'push' notifications to complete weekly surveys. The survey is a series of questions about foods and drinks participants had in the last week. Once the weekly survey is completed the app generates a personalized weekly report showing foods we encourage participants to eat more of, eat less of, or keep eating the same amount of. The app will also show menu recommendations for breakfast, lunch, dinner, and snacks that will help participants to eat healthier. Finally, the app also has a feature that allows chatting with the research team by sending and receiving in-app texts.	Usual Care n=7 Participants Participants will receive information on public online resources
Change From Baseline Physical Performance Measure at 3 Months	1.5 score on a scale Standard Deviation 1.2	0.14 score on a scale Standard Deviation 0.9

SECONDARY outcome

Timeframe: baseline, 3 month

BMI in units

Outcome measures

Measure	Mobile Health n=8 Participants Participants will receive access to a mobile app installed on their device and will be asked to use the app at least once a week Mobile app: The app sends reminder 'push' notifications to complete weekly surveys. The survey is a series of questions about foods and drinks participants had in the last week. Once the weekly survey is completed the app generates a personalized weekly report showing foods we encourage participants to eat more of, eat less of, or keep eating the same amount of. The app will also show menu recommendations for breakfast, lunch, dinner, and snacks that will help participants to eat healthier. Finally, the app also has a feature that allows chatting with the research team by sending and receiving in-app texts.	Usual Care n=7 Participants Participants will receive information on public online resources
Change From Baseline BMI at 3 Months	-0.83 Kg/m^2 Standard Deviation 0.95	-0.16 Kg/m^2 Standard Deviation 0.65

Adverse Events

Mobile Health

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

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

Oleg Zaslavsky

Univcersity of Washington

Phone: 2068493301

Email: ozasl@uw.edu

Results disclosure agreements

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