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An Addiction-Based Mobile Health Weight Loss Intervention With Coaching

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ClinicalTrials.gov Identifier: NCT03500835
Recruitment Status : Recruiting
First Posted : April 17, 2018
Last Update Posted : April 29, 2019
Sponsor:
Collaborators:
Cedars-Sinai Medical Center
University of California, Los Angeles
Los Angeles Biomedical Research Institute
Information provided by (Responsible Party):
Alaina Vidmar, MD, Children's Hospital Los Angeles

Brief Summary:

New and creative approaches are needed to address childhood obesity. Current strategies result in suboptimal outcomes and are intensive and costly. It has been theorized that overeating, may have addictive qualities, although few weight management interventions have tested therapeutic techniques founded on addiction medicine principles, such as, withdrawal, tolerance and craving control1, 2. A pilot study utilizing an addiction model based mobile health (mHealth) weight-loss intervention in adolescents showed that the app intervention reduced BMI Z-score (zBMI) to a greater extent than youth participating in an in-clinic multidisciplinary weight management intervention, and appeared to be a cost-effective, labor efficient method for adolescent weight management.

The proposed multi-site randomized control trial (RCT) will test the effectiveness of an addiction-based weight loss intervention, embodied first as a smartphone app with telephone coaching and second as an identical approach phone-coaching alone intervention compared to age matched controls participating in an in-clinic weight management interventions in a larger sample of economically, racially and ethnically diverse adolescents (ages 14-18).

One hundred and eighty adolescents will be recruited from pediatric interdisciplinary weight management clinics operating out of five different hospital systems in Southern California and through targeted mailing to 40 ethnically, racially and economically diverse neighborhoods in Los Angeles County. The adolescents will be randomized 1:1 via stratified block randomization to either receive 1) interactive addiction model based mobile health (mHealth) weight-loss intervention with personalized phone-coaching (AppCoach), 2) interactive addiction model based mHealth weight-loss intervention alone (App) or 3) Multidisciplinary in-clinic weight management program (Clinic). Assessment of the intervention's effect on zBMI and percent over the 95th percentile (%BMIp95), fasting metabolic parameters, addictive eating habits, executive function, and motivation for change will be obtained at enrollment, 3, 6, 12 and 18 months (1 year post intervention follow up). In addition, a real-life economic analysis (cost, cost-saving and non-monetary benefits) analysis will be completed comparing AppCoach to 1) App and 2) Clinic. We will further explore whether primary and secondary outcomes differ by race and whether race moderates the relationship between initial intervention efficacy and prolonged weight maintenance.


Condition or disease Intervention/treatment Phase
Pediatric Obesity Mobile Technology Addiction Behavioral: App Behavioral: Coaching Behavioral: Clinic: Modified KidsNFitness Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The proposed multi-site randomized control trial (RCT) will test the effectiveness of an addiction-based weight loss intervention, embodied as a smartphone app with telephone coaching compared 1) an addiction-based weight loss intervention alone and 2) an in-clinic weight management intervention based on a traffic-light based approach in a larger sample of economically, racially and ethnically diverse adolescents (ages 14-18).
Masking: Single (Outcomes Assessor)
Masking Description: Blocked randomization will be utilized, to ensure the groups are balanced in terms of number of subjects and the distribution of potential confounding variables. Blocked randomization will be used to ensure the number of eligible subjects assigned to each group is equally distributed. Block size will be blinded from the primary investigator performing the study.
Primary Purpose: Supportive Care
Official Title: An Addiction Model Based Mobile Health Weight Loss Intervention With Coaching in Adolescents With Overweight and Obesity: Multi-Site Randomized Controlled Trial
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: App Plus Coaching (AC)
6 month addiction model based weight loss intervention in the form of an iPhone app coupled with personalized coaching.
Behavioral: App
  1. 6 month app intervention: Problem Food Withdrawal, Snacking Elimination and Food Amount Reduction
  2. Daily Weigh In
  3. App based reminders
  4. Follow Up: Face-to-face clinic visits at 3,6,12 and 18 months.

Behavioral: Coaching
  1. 6 month addiction based intervention: Problem Food Withdrawal, Snacking Elimination and Food Amount Reduction.
  2. Daily Weighing
  3. Daily Text messages from Coach
  4. Weekly 15 minute phone meetings with Coach
  5. Follow Up: Face-to-face clinic visits at 3,6,12 and 18 months post consent

Experimental: App Alone (AA)
6 month addiction model based weight loss intervention in the form of an iPhone app.
Behavioral: App
  1. 6 month app intervention: Problem Food Withdrawal, Snacking Elimination and Food Amount Reduction
  2. Daily Weigh In
  3. App based reminders
  4. Follow Up: Face-to-face clinic visits at 3,6,12 and 18 months.

Experimental: Clinic
In-Clinic Multi-disciplinary monthly weight management program. Curriculum adapted from the KidsNFitness Program and administered by an MD, RD, Psychologist and Health Educator over 90 minute sessions
Behavioral: Clinic: Modified KidsNFitness
  1. 6 month in-clinic, evidence-based, multi-disciplinary intervention
  2. 90 minute sessions, in clinic that occur every month for 6 months
  3. Follow Up: Face-to-face clinic visits Monthly x 6 months followed by face-to-face visit at12 and 18 months.




Primary Outcome Measures :
  1. zBMI and %BMIp95 [ Time Frame: 6 and 18 months ]
    Mean change in zBMI and excess BMI percent over the 95th percentile (%BMIp95)


Secondary Outcome Measures :
  1. Cost Analysis [ Time Frame: 6 months ]
    Real life economic analysis of the intervention arms compared to each other and in in-clinic intervention

  2. Yale Food Addiction Scale [ Time Frame: 6 and 18 months ]
    Evaluate effect of YFAS-c score as a co-variate of program success

  3. Behavior Rating Inventory of Executive Function [ Time Frame: 6 and 18 months ]
    Evaluate effect executive function as a co-variate of program success

  4. Adolescent Self Regulatory Inventory [ Time Frame: 6 and 18 months ]
    Evaluate effect ARI score as a co-variate of program success

  5. Food Cravings Questionnaire [ Time Frame: 6 and 18 months ]
    Evaluate effect of FCQ score as a co-variate of program success



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 14-18 years
  • Body mass index [BMI] ≥85th percentile for age and gender

Exclusion Criteria:

  • Concurrent participation in an alternative weight loss intervention
  • Blood pressure > 99th percentile for age, gender, and height
  • Known poorly controlled psychiatric illness and/or developmental delay
  • Participants Inability to read English

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): NCT03500835


Contacts
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Contact: Janelle Gonzalez 323-361-6446 jangonzalez@chla.usc.edu
Contact: Alaina Vidmar, MD 323-361-3385 avidmar@chla.usc.edu

Locations
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United States, California
Children's Hospital of Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Janelle Gonzalez    323-361-6446    jangonzalez@chla.usc.edu   
Sponsors and Collaborators
Children's Hospital Los Angeles
Cedars-Sinai Medical Center
University of California, Los Angeles
Los Angeles Biomedical Research Institute
Investigators
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Principal Investigator: Alaina Vidmar Children's Hospital Los Angeles

Publications:
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Responsible Party: Alaina Vidmar, MD, Assistant Professor Department of Pediatric Endocrinology, Children's Hospital Los Angeles
ClinicalTrials.gov Identifier: NCT03500835     History of Changes
Other Study ID Numbers: CHLA-18-00134
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Weight Loss
Behavior, Addictive
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes
Compulsive Behavior
Impulsive Behavior