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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

Brief Summary:
The investigators will test a recent mobile technology based (mHealth) behavioral weight loss intervention (W8Loss2Go), which is designed for children and adolescents, and uses an addiction model to promote withdrawal from problem foods, snacking, and excessive amounts at meals. The investigators will test whether this intervention will reduce body mass index (BMI), help subjects identify and withdraw from "problem foods", eliminate snacking, and reduce the amounts of foods consumed at home meals.

Condition or disease Intervention/treatment Phase
Obesity Device: W8Loss2Go Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: W8Loss2Go: Behavioral Weight Loss Intervention Utilizing Mobile Health Technology in Pediatric Patients Referred to a Tertiary Care Center Weight Management Clinic
Study Start Date : April 2016
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Experimental: W8Loss2Go App
Subjects will complete all stages of W8Loss2Go mHealth intervention.
Device: 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.




Primary Outcome Measures :
  1. Body Mass Index (BMI) z -Score [ Time Frame: Baseline and 6 months ]
    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.


Secondary Outcome Measures :
  1. Number of Participants With Success in Withdrawing From Problem Foods [ Time Frame: 6 months ]
    The number of participants who were able to withdraw from 5 or more problem foods was evaluated.

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

  3. Number of Participants Able to Reduce Daily Meal Portion Size Utilizing Wireless Food Scale. [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 12-18 years
  2. Patients referred to EMPOWER
  3. Positive screen on the Yale Food Addiction Scale for Children
  4. Participant will not be leaving the country during the study duration.

Exclusion Criteria:

  1. Obesity comorbidities including impaired glucose tolerance, impaired fasting glucose, diabetes, fatty liver with ALT>40, BP > 99th percentile for age, gender, and height
  2. Psychiatric illness including depression and anxiety disorder
  3. Known developmental delay

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02689154


Locations
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United States, California
Children's Hospital of Los Angeles
Los Angeles, California, United States, 90027
Sponsors and Collaborators
Children's Hospital Los Angeles
Investigators
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Study Director: Steve D Mittelman, MD, PhD Children's Hospital Los Angeles
  Study Documents (Full-Text)

Documents provided by Alaina Vidmar, MD, Children's Hospital Los Angeles:
Informed Consent Form  [PDF] April 25, 2017

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Alaina Vidmar, MD, Pediatric Endocrinology Fellow Children's Hospital of Los Angeles, Children's Hospital Los Angeles
ClinicalTrials.gov Identifier: NCT02689154    
Other Study ID Numbers: CHLA-16-00007
First Posted: February 23, 2016    Key Record Dates
Results First Posted: April 12, 2019
Last Update Posted: April 12, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The individual participant data will be de-identified and coded. The sponsor of the study will have access to this data through the application download. The data will not be available to the public.
Keywords provided by Alaina Vidmar, MD, Children's Hospital Los Angeles:
Pediatric Obesity
Food Addiction
Mobile Health (mHealth)
Weight Management
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight