Trial Outcomes & Findings for W8Loss2Go: mHealth Weight Management Strategy (NCT NCT02689154)

Last Updated: 2019-04-12

Results Overview

The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean. A negative change value reflects a decrease in BMI or a better outcome and a positive change value reflects an increase in BMI or a worsening in the outcome.

Recruitment status

COMPLETED

Study phase

Target enrollment

18 participants

Primary outcome timeframe

Baseline and 6 months

Results posted on

2019-04-12

Participant Flow

18 adolescents self-selected into the app intervention. During the intervention period the app participants did not attend the EMPOWER intervention. The app program did not require parental involvement.

Newly referred patients were pre-screened for eligibility prior to their first clinic visit. YFAS-c was utilized to screen for traits of food addiction. Inclusion criteria included age 12-18 years and positive YFAS-c. Exclusion criteria were: obesity co-morbidities known psychiatric illness or developmental delay, and the inability to read English.

Participant milestones

Participant milestones
Measure	W8Loss2Go App Subjects will complete all stages of W8Loss2Go mHealth intervention. W8Loss2Go: The participants will proceed through all parts of the app program (problem food withdrawal, snacking control and withdrawal from excessive portions) and receive weekly phone calls from the study coordinator, who will be monitoring app usage and providing motivation. Subjects will return to the EMPOWER clinic for a three month weight check and face-to-face meeting with their mentor. After the study period, participants will again complete the EBQ, and be offered continued enrollment in the EMPOWER clinic or continued home use of the mHealth technology.
Overall Study STARTED	18
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

W8Loss2Go: mHealth Weight Management Strategy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	W8Loss2Go App n=18 Participants Subjects will complete all stages of W8Loss2Go mHealth intervention. W8Loss2Go: The participants will proceed through all parts of the app program (problem food withdrawal, snacking control and withdrawal from excessive portions) and receive weekly phone calls from the study coordinator, who will be monitoring app usage and providing motivation. Subjects will return to the EMPOWER clinic for a three month weight check and face-to-face meeting with their mentor. After the study period, participants will again complete the EBQ, and be offered continued enrollment in the EMPOWER clinic or continued home use of the mHealth technology.
Age, Categorical <=18 years	18 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Age, Continuous	14.44 years STANDARD_DEVIATION 1.65 • n=99 Participants
Sex: Female, Male Female	13 Participants n=99 Participants
Sex: Female, Male Male	5 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	18 participants n=99 Participants
zBMI	2.21 z-score STANDARD_DEVIATION 0.45 • n=99 Participants

PRIMARY outcome

Timeframe: Baseline and 6 months

Population: 18 youth that completed the app intervention

Outcome measures

Outcome measures
Measure	W8Loss2Go App n=18 Participants Subjects will complete all stages of W8Loss2Go mHealth intervention. W8Loss2Go: The participants will proceed through all parts of the app program (problem food withdrawal, snacking control and withdrawal from excessive portions) and receive weekly phone calls from the study coordinator, who will be monitoring app usage and providing motivation. Subjects will return to the EMPOWER clinic for a three month weight check and face-to-face meeting with their mentor. After the study period, participants will again complete the EBQ, and be offered continued enrollment in the EMPOWER clinic or continued home use of the mHealth technology.
Body Mass Index (BMI) z -Score	-0.1 z-score Standard Deviation 0.04

SECONDARY outcome

Timeframe: 6 months

Population: Withdrawal from Problem Food

The number of participants who were able to withdraw from 5 or more problem foods was evaluated.

Outcome measures

Outcome measures
Measure	W8Loss2Go App n=18 Participants Subjects will complete all stages of W8Loss2Go mHealth intervention. W8Loss2Go: The participants will proceed through all parts of the app program (problem food withdrawal, snacking control and withdrawal from excessive portions) and receive weekly phone calls from the study coordinator, who will be monitoring app usage and providing motivation. Subjects will return to the EMPOWER clinic for a three month weight check and face-to-face meeting with their mentor. After the study period, participants will again complete the EBQ, and be offered continued enrollment in the EMPOWER clinic or continued home use of the mHealth technology.
Number of Participants With Success in Withdrawing From Problem Foods	18 Participants

SECONDARY outcome

Timeframe: 3 months

Success in these areas will be determined by data collected from within the application's database.

Outcome measures

Outcome measures
Measure	W8Loss2Go App n=18 Participants Subjects will complete all stages of W8Loss2Go mHealth intervention. W8Loss2Go: The participants will proceed through all parts of the app program (problem food withdrawal, snacking control and withdrawal from excessive portions) and receive weekly phone calls from the study coordinator, who will be monitoring app usage and providing motivation. Subjects will return to the EMPOWER clinic for a three month weight check and face-to-face meeting with their mentor. After the study period, participants will again complete the EBQ, and be offered continued enrollment in the EMPOWER clinic or continued home use of the mHealth technology.
Number of Participants Able to Eliminated Day Time Snacking	18 Participants

SECONDARY outcome

Timeframe: 1 month

Success in these areas will be determined by data collected from within the application's database. Participants will weight meals daily and the app will assist the participant in decrease the quantity of food consumed each day until they achieve age appropriate portion size.

Outcome measures

Outcome measures
Measure	W8Loss2Go App n=18 Participants Subjects will complete all stages of W8Loss2Go mHealth intervention. W8Loss2Go: The participants will proceed through all parts of the app program (problem food withdrawal, snacking control and withdrawal from excessive portions) and receive weekly phone calls from the study coordinator, who will be monitoring app usage and providing motivation. Subjects will return to the EMPOWER clinic for a three month weight check and face-to-face meeting with their mentor. After the study period, participants will again complete the EBQ, and be offered continued enrollment in the EMPOWER clinic or continued home use of the mHealth technology.
Number of Participants Able to Reduce Daily Meal Portion Size Utilizing Wireless Food Scale.	18 Participants

Adverse Events

W8Loss2Go App

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. Alaina Vidmar

Children's Hospital of Los Angeles

Phone: 323-361-3385

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place