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W8Loss2Go: mHealth Weight Management Strategy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
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
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
Hide 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
Arm/Group Title W8Loss2Go App
Hide 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
Hide 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.
1.Primary Outcome
Title Body Mass Index (BMI) z -Score
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
18 youth that completed the app intervention
Arm/Group Title W8Loss2Go App
Hide 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
Hide Description The number of participants who were able to withdraw from 5 or more problem foods was evaluated.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Withdrawal from Problem Food
Arm/Group Title W8Loss2Go App
Hide 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
Hide Description Success in these areas will be determined by data collected from within the application's database.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title W8Loss2Go App
Hide 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.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title W8Loss2Go App
Hide 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%
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
Hide 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%) 
Hide Serious Adverse Events
W8Loss2Go App
Affected / at Risk (%)
Total   0/18 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
W8Loss2Go App
Affected / at Risk (%)
Total   0/18 (0.00%) 
Although these results are encouraging, there are limitations to interpreting these results as they arise from a small, time limited, pilot study.
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
Layout table for Results Point of Contact information
Name/Title: Dr. Alaina Vidmar
Organization: Children's Hospital of Los Angeles
Phone: 323-361-3385
EMail: avidmar@chla.usc.edu
Publications:
Layout table for additonal information
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