W8Loss2Go: mHealth Weight Management Strategy

NCT02689154 | Completed Results

• 1 other identifier: CHLA-16-00007
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Pediatric Obesity; Food Addiction; Mobile Health (mHealth); Weight Management

Outcome Measures

Primary Outcomes (1)

• Body Mass Index (BMI) z -Score

  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.

  Baseline and 6 months

Secondary Outcomes (3)

• Number of Participants With Success in Withdrawing From Problem Foods

  6 months

• Number of Participants Able to Eliminated Day Time Snacking

  3 months

• Number of Participants Able to Reduce Daily Meal Portion Size Utilizing Wireless Food Scale.

  1 month

Study Arms (1)

W8Loss2Go App

EXPERIMENTAL

Subjects will complete all stages of W8Loss2Go mHealth intervention.

Device: W8Loss2Go

Interventions

W8Loss2Go DEVICE

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.

W8Loss2Go App

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Children's Hospital Los Angeles: lead

Study Sites (1)

Children's Hospital of Los Angeles

Los Angeles, California, 90027, United States

Location

Related Publications (8)

• 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.

  PMID: 26290954 BACKGROUND

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

  PMID: 25751444 BACKGROUND

• 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.

  PMID: 26229119 BACKGROUND

• 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.

  PMID: 25886009 BACKGROUND

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

  PMID: 21492090 BACKGROUND

• 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.

  PMID: 25705553 BACKGROUND

• 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.

  PMID: 25760813 BACKGROUND

• 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.

  PMID: 30117309 DERIVED

MeSH Terms

Conditions

Obesity; Pediatric Obesity; Food Addiction

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Addictive; Compulsive Behavior; Impulsive Behavior; Behavior; Feeding and Eating Disorders; Mental Disorders

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.

Results Point of Contact

• Title: Dr. Alaina Vidmar
• Organization: Children's Hospital of Los Angeles

avidmar@chla.usc.edu

323-361-3385

Study Officials

• Steve D Mittelman, MD, PhD

  Children's Hospital Los Angeles

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Endocrinology Fellow Children's Hospital of Los Angeles

Study Record Dates

• First Submitted: February 15, 2016
• First Posted: February 23, 2016
• Study Start: April 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: April 12, 2019
• Results First Posted: April 12, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)