An Addiction-Based Mobile Health Weight Loss Intervention With Coaching

NCT03500835 | Completed Results DMC

• 1 other identifier: CHLA-18-00134
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Pediatric Obesity; Mobile Technology; Addiction

Outcome Measures

Primary Outcomes (1)

• %BMIp95

  Mean change in excess BMI percent over the 95th percentile (%BMIp95) over the study period compared at 6 months to baseline. value at 6 months minus value at baseline

  6 months

Secondary Outcomes (2)

• Cost Analysis

  6 months

• Yale Food Addiction Scale

  6 months

Study Arms (3)

App Plus Coaching (AC)

EXPERIMENTAL

6 month addiction model based weight loss intervention in the form of an iPhone app coupled with personalized coaching.

Behavioral: App; Behavioral: Coaching

App Alone (AA)

EXPERIMENTAL

6 month addiction model based weight loss intervention in the form of an iPhone app.

Behavioral: App

Clinic

EXPERIMENTAL

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

Interventions

App BEHAVIORAL

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.

App Alone (AA); App Plus Coaching (AC)

Coaching BEHAVIORAL

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

App Plus Coaching (AC)

Clinic: Modified KidsNFitness BEHAVIORAL

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.

Clinic

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Los Angeles: lead
• Cedars-Sinai Medical Center: collaborator
• University of California, Los Angeles: collaborator
• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center: collaborator

Study Sites (1)

Children's Hospital of Los Angeles

Los Angeles, California, 90027, United States

Location

Related Publications (9)

• 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

• Tompkins CL, Laurent J, Brock DW. Food Addiction: A Barrier for Effective Weight Management for Obese Adolescents. Child Obes. 2017 Dec;13(6):462-469. doi: 10.1089/chi.2017.0003. Epub 2017 Jul 20.

  PMID: 28727935 BACKGROUND

• Majeed-Ariss R, Baildam E, Campbell M, Chieng A, Fallon D, Hall A, McDonagh JE, Stones SR, Thomson W, Swallow V. Apps and Adolescents: A Systematic Review of Adolescents' Use of Mobile Phone and Tablet Apps That Support Personal Management of Their Chronic or Long-Term Physical Conditions. J Med Internet Res. 2015 Dec 23;17(12):e287. doi: 10.2196/jmir.5043.

  PMID: 26701961 BACKGROUND

• Schulte EM, Gearhardt AN. Development of the Modified Yale Food Addiction Scale Version 2.0. Eur Eat Disord Rev. 2017 Jul;25(4):302-308. doi: 10.1002/erv.2515. Epub 2017 Mar 29.

  PMID: 28370722 BACKGROUND

• Metzendorf MI, Wieland LS, Richter B. Mobile health (m-health) smartphone interventions for adolescents and adults with overweight or obesity. Cochrane Database Syst Rev. 2024 Feb 20;2(2):CD013591. doi: 10.1002/14651858.CD013591.pub2.

  PMID: 38375882 DERIVED

• Pretlow R, Glasner S. Reconceptualization of eating addiction and obesity as displacement behavior and a possible treatment. Eat Weight Disord. 2022 Oct;27(7):2897-2903. doi: 10.1007/s40519-022-01427-1. Epub 2022 Jun 22.

  PMID: 35731464 DERIVED

• Vidmar AP, Yamashita N, Fox DS, Hegedus E, Wee CP, Salvy SJ. Can a Behavioral Weight-Loss Intervention Change Adolescents' Food Addiction Severity? Child Obes. 2022 Apr;18(3):206-212. doi: 10.1089/chi.2021.0271. Epub 2022 Jan 7.

  PMID: 35006001 DERIVED

• Lopez KE, Salvy SJ, Fink C, Werner J, Wee CP, Hegedus E, Gonzalez J, Fox DS, Vidmar AP. Executive Functioning, Depressive Symptoms, and Intervention Engagement in a Sample of Adolescents Enrolled in a Weight Management Program. Child Obes. 2021 Jun;17(4):281-290. doi: 10.1089/chi.2020.0334. Epub 2021 Apr 7.

  PMID: 33826861 DERIVED

• Vidmar AP, Salvy SJ, Pretlow R, Mittelman SD, Wee CP, Fink C, Steven Fox D, Raymond JK. An addiction-based mobile health weight loss intervention: protocol of a randomized controlled trial. Contemp Clin Trials. 2019 Mar;78:11-19. doi: 10.1016/j.cct.2019.01.008. Epub 2019 Jan 14.

  PMID: 30654026 DERIVED

MeSH Terms

Conditions

Pediatric Obesity; Behavior, Addictive

Interventions

Amyloid

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Compulsive Behavior; Impulsive Behavior; Behavior

Intervention Hierarchy (Ancestors)

Multiprotein Complexes; Macromolecular Substances; Proteins; Amino Acids, Peptides, and Proteins

Results Point of Contact

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

avidmar@chla.usc.edu

323-361-4606

Study Officials

• Alaina Vidmar

  Children's Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Department of Pediatric Endocrinology

Model Details: 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).

Study Record Dates

• First Submitted: April 10, 2018
• First Posted: April 18, 2018
• Study Start: January 1, 2019
• Primary Completion: December 1, 2022
• Study Completion: December 19, 2023
• Last Updated: December 6, 2024
• Results First Posted: December 6, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)