Trial Outcomes & Findings for Structured Mobile Technology Based Lifestyle Program vs Usual Care for Patients With Non-alcoholic Fatty Liver Disease (NCT NCT03839082)

Last Updated: 2022-05-03

Results Overview

CAP score is generated by a fibroscan. Scores are reported in dB/M ranging from 100-400, with lower scores indicating less hepatic steatosis (Liver fat). Percent change is calculated by (baseline CAP minus follow up CAP) divided by baseline CAP 12 month data, originally planned to assess values after crossover is not presented because no participants completed crossover participation.

Recruitment status

COMPLETED

Study phase

Target enrollment

75 participants

Primary outcome timeframe

Baseline, 6 months,

Results posted on

2022-05-03

Participant Flow

Five people withdrew prior to receiving fitbits or first surveys.

Participant milestones

Participant milestones
Measure	FitBit Then Usual Care Intervention includes education, physical activity, and a nutrition assessment. Usual Care then FitBit: Usual care is a visit (15-20 mins) every 6-12 months. Usual care includes a Fibroscan (FDA 510(k) device). FitBit then Usual Care: Intervention is tailored physical activity and nutritional counseling. Step counts are monitored by a FitBit Zip. A Fibroscan (FDA 510(k) device) is done.	Usual Care Then FitBit This is the waitlist control arm. Usual Care then FitBit: Usual care is a visit (15-20 mins) every 6-12 months. Usual care includes a Fibroscan (FDA 510(k) device). Once they start FitBit,, Intervention is tailored physical activity and nutritional counseling. Step counts are monitored by a FitBit Zip. A Fibroscan (FDA 510(k) device) is done.
Initial Randomization STARTED	33	37
Initial Randomization COMPLETED	7	12
Initial Randomization NOT COMPLETED	26	25
Crossover to Other Arm STARTED	7	12
Crossover to Other Arm COMPLETED	0	0
Crossover to Other Arm NOT COMPLETED	7	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Structured Mobile Technology Based Lifestyle Program vs Usual Care for Patients With Non-alcoholic Fatty Liver Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FitBit Then Usual Care n=33 Participants Intervention includes education, physical activity, and a nutrition assessment. FitBit then Usual Care: Intervention is tailored physical activity and nutritional counseling. Step counts are monitored by a FitBit Zip. A Fibroscan (FDA 510(k) device) is done. Usual Care then FitBit: Usual care is a visit (15-20 mins) every 6-12 months. Usual care includes a Fibroscan (FDA 510(k) device).	Usual Care Then FitBit n=37 Participants This is the waitlist control arm. Usual Care then FitBit: Usual care is a visit (15-20 mins) every 6-12 months. Usual care includes a Fibroscan (FDA 510(k) device). Once they start FitBit, intervention is tailored physical activity and nutritional counseling. Step counts are monitored by a FitBit Zip. A Fibroscan (FDA 510(k) device) is done.	Total n=70 Participants Total of all reporting groups
Age, Continuous	57 years n=5 Participants	50 years n=7 Participants	52.5 years n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	16 Participants n=7 Participants	37 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	21 Participants n=7 Participants	33 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	32 Participants n=5 Participants	29 Participants n=7 Participants	61 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized African-American	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized White	28 Participants n=5 Participants	30 Participants n=7 Participants	58 Participants n=5 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	33 participants n=5 Participants	37 participants n=7 Participants	70 participants n=5 Participants
Weight	204.78 pounds STANDARD_DEVIATION 58.62 • n=5 Participants	204.40 pounds STANDARD_DEVIATION 57.54 • n=7 Participants	204.49 pounds STANDARD_DEVIATION 57.95 • n=5 Participants
Body Mass Index	32.4 kg/m^2 n=5 Participants	32.02 kg/m^2 n=7 Participants	32.2 kg/m^2 n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 6 months,

Population: Due to the disruption caused by the COVID epidemic, follow up was dramatically lower than planned, and values were missing for some individuals in both arms.

Outcome measures

Outcome measures
Measure	FitBit n=1 Participants Intervention includes education, physical activity, and a nutrition assessment. FitBit: Intervention is tailored physical activity and nutritional counseling. Step counts are monitored by a FitBit Zip. A Fibroscan (FDA 510(k) device) is done.	Usual Care n=5 Participants This is the waitlist control arm. Usual Care: Usual care is a visit (15-20 mins) every 6-12 months. Usual care includes a Fibroscan (FDA 510(k) device).
Percent Change in Hepatic Steatosis as Measured by Controlled Attenuation Parameter (CAP) Score	-13.0 percent change	8.7 percent change Interval -3.3 to 16.2

SECONDARY outcome

Timeframe: Baseline, 6 months

Population: Weight data is only available for one individual at both times.

Percent change in body weight is measured by (body weight at 6 months minus body weight at baseline) divided by body weight at baseline

Outcome measures

Outcome measures
Measure	FitBit n=1 Participants Intervention includes education, physical activity, and a nutrition assessment. FitBit: Intervention is tailored physical activity and nutritional counseling. Step counts are monitored by a FitBit Zip. A Fibroscan (FDA 510(k) device) is done.	Usual Care This is the waitlist control arm. Usual Care: Usual care is a visit (15-20 mins) every 6-12 months. Usual care includes a Fibroscan (FDA 510(k) device).
Percent Change in Body Weight	NA percent change in weight Since weight data is only available for 1 individual at both times, it is not represented to honor privacy.	—

SECONDARY outcome

Timeframe: Baseline, 6 months

Population: Due to COVID 19's impact on participation, data for all participants is not available.

The IPAQ is a validated questionnaire that obtains information on days and minutes per week of different types of physical activity. Scores range from 0 - 500. Score at 6 months minus score at baseline determines change in IPAQ score. A negative change means less physcially active and a positive change means more physically active. Insufficient paired results existed to provide percent change measurements. Medians overall are provided.

Outcome measures

Outcome measures
Measure	FitBit n=10 Participants Intervention includes education, physical activity, and a nutrition assessment. FitBit: Intervention is tailored physical activity and nutritional counseling. Step counts are monitored by a FitBit Zip. A Fibroscan (FDA 510(k) device) is done.	Usual Care n=14 Participants This is the waitlist control arm. Usual Care: Usual care is a visit (15-20 mins) every 6-12 months. Usual care includes a Fibroscan (FDA 510(k) device).
Change in Physical Activity as Measured by International Physical Activity Questionnaire (IPAQ) Baseline	32.5 score on a scale Interval 20.0 to 60.0	42.5 score on a scale Interval 30.0 to 60.0
Change in Physical Activity as Measured by International Physical Activity Questionnaire (IPAQ) 6 months	45 score on a scale Interval 30.0 to 60.0	30 score on a scale Interval 10.0 to 50.0

Adverse Events

FitBit

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

Monica Tincopa

University of California Los Angeles

Phone: 310 825-2631

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place