W8Loss2Go: mHealth Weight Management Strategy

• ClinicalTrials.gov Identifier: NCT02689154
• Recruitment Status: Completed
• First Posted: February 23, 2016
• Results First Posted: April 12, 2019
• Last Update Posted: April 12, 2019
• Sponsor: Children's Hospital Los Angeles
• Information provided by (Responsible Party): Alaina Vidmar, MD, Children's Hospital Los Angeles

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Obesity
• Intervention: Device: W8Loss2Go
• Enrollment: 18

Participant Flow

Recruitment Details	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.
Pre-assignment Details	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.

Arm/Group Title	W8Loss2Go App
Arm/Group Description	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.
Period Title: Overall Study
Started	18
Completed	18
Not Completed	0

Baseline Characteristics

Arm/Group Title		W8Loss2Go App
Arm/Group Description		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 Number of Baseline Participants		18
Baseline Analysis Population Description		Of the 50 eligible adolescents approached, 18 elected to participate in the app intervention
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	18 participants
	<=18 years	18 100.0%
	Between 18 and 65 years	0 0.0%
	>=65 years	0 0.0%
Age, Continuous; Median (Standard Deviation); Unit of measure: Years
	Number Analyzed	18 participants
		14.44 (1.65)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	18 participants
	Female	13 72.2%
	Male	5 27.8%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	18 participants
	Hispanic or Latino	11 61.1%
	Not Hispanic or Latino	7 38.9%
	Unknown or Not Reported	0 0.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	18 participants
		18
zBMI [1]; Mean (Standard Deviation); Unit of measure: Z-score
	Number Analyzed	18 participants
		2.21 (0.45)
		[1] Measure Description: Measure Description: 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 higher number suggests high degree of obesity at baseline.

Outcome Measures

1. Primary Outcome

Title	Body Mass Index (BMI) z -Score
Description	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.
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

18 youth that completed the app intervention

Arm/Group Title	W8Loss2Go App
Arm/Group Description:	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 Number of Participants Analyzed	18
Mean (Standard Deviation); Unit of Measure: z-score
	-0.1 (0.04)

2. Secondary Outcome

Title	Number of Participants With Success in Withdrawing From Problem Foods
Description	The number of participants who were able to withdraw from 5 or more problem foods was evaluated.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Withdrawal from Problem Food

Arm/Group Title	W8Loss2Go App
Arm/Group Description:	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 Number of Participants Analyzed	18
Measure Type: Count of Participants; Unit of Measure: Participants
	18 100.0%

3. Secondary Outcome

Title	Number of Participants Able to Eliminated Day Time Snacking
Description	Success in these areas will be determined by data collected from within the application's database.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	W8Loss2Go App
Arm/Group Description:	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 Number of Participants Analyzed	18
Measure Type: Count of Participants; Unit of Measure: Participants
	18 100.0%

4. Secondary Outcome

Title	Number of Participants Able to Reduce Daily Meal Portion Size Utilizing Wireless Food Scale.
Description	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.
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	W8Loss2Go App
Arm/Group Description:	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 Number of Participants Analyzed	18
Measure Type: Count of Participants; Unit of Measure: Participants
	18 100.0%

Adverse Events

Time Frame	6 months
Adverse Event Reporting Description	Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Arm/Group Title	W8Loss2Go App
Arm/Group Description	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.
All-Cause Mortality
	W8Loss2Go App
	Affected / at Risk (%)
Total	0/18 (0.00%)
Serious Adverse Events
	W8Loss2Go App
	Affected / at Risk (%)
Total	0/18 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	W8Loss2Go App
	Affected / at Risk (%)
Total	0/18 (0.00%)

Limitations and Caveats

Although these results are encouraging, there are limitations to interpreting these results as they arise from a small, time limited, pilot study.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Dr. Alaina Vidmar
• Organization: Children's Hospital of Los Angeles
• Phone: 323-361-3385
• EMail: avidmar@chla.usc.edu

Publications:

Chaplais E, Naughton G, Thivel D, Courteix D, Greene D. Smartphone Interventions for Weight Treatment and Behavioral Change in Pediatric Obesity: A Systematic Review. Telemed J E Health. 2015 Oct;21(10):822-30. doi: 10.1089/tmj.2014.0197. Epub 2015 Aug 20.

Dimitrijevic I, Popovic N, Sabljak V, Skodric-Trifunovic V, Dimitrijevic N. Food addiction-diagnosis and treatment. Psychiatr Danub. 2015 Mar;27(1):101-6.

Lin PH, Intille S, Bennett G, Bosworth HB, Corsino L, Voils C, Grambow S, Lazenka T, Batch BC, Tyson C, Svetkey LP. Adaptive intervention design in mobile health: Intervention design and development in the Cell Phone Intervention for You trial. Clin Trials. 2015 Dec;12(6):634-45. doi: 10.1177/1740774515597222. Epub 2015 Jul 30.

Delisle C, Sandin S, Forsum E, Henriksson H, Trolle-Lagerros Y, Larsson C, Maddison R, Ortega FB, Ruiz JR, Silfvernagel K, Timpka T, Lof M. A web- and mobile phone-based intervention to prevent obesity in 4-year-olds (MINISTOP): a population-based randomized controlled trial. BMC Public Health. 2015 Feb 7;15:95. doi: 10.1186/s12889-015-1444-8.

Gearhardt AN, Corbin WR. The role of food addiction in clinical research. Curr Pharm Des. 2011;17(12):1140-2. doi: 10.2174/138161211795656800.

Jeon E, Park HA. Development of a smartphone application for clinical-guideline-based obesity management. Healthc Inform Res. 2015 Jan;21(1):10-20. doi: 10.4258/hir.2015.21.1.10. Epub 2015 Jan 31.

Pretlow RA, Stock CM, Allison S, Roeger L. Treatment of child/adolescent obesity using the addiction model: a smartphone app pilot study. Child Obes. 2015 Jun;11(3):248-59. doi: 10.1089/chi.2014.0124. Epub 2015 Mar 11.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Vidmar AP, Pretlow R, Borzutzky C, Wee CP, Fox DS, Fink C, Mittelman SD. An addiction model-based mobile health weight loss intervention in adolescents with obesity. Pediatr Obes. 2019 Feb;14(2):e12464. doi: 10.1111/ijpo.12464. Epub 2018 Aug 16.

• Responsible Party: Alaina Vidmar, MD, Children's Hospital Los Angeles
• ClinicalTrials.gov Identifier: NCT02689154
• Other Study ID Numbers: CHLA-16-00007
• First Submitted: February 15, 2016
• First Posted: February 23, 2016
• Results First Submitted: December 28, 2018
• Results First Posted: April 12, 2019
• Last Update Posted: April 12, 2019