An Addiction-Based Mobile Health Weight Loss Intervention With Coaching
NCT ID: NCT03500835
Last Updated: 2024-12-06
Study Results
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View full resultsBasic Information
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COMPLETED
NA
161 participants
INTERVENTIONAL
2019-01-01
2023-12-19
Brief Summary
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Detailed Description
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Hypothesis 1a: Participants who complete the six month AppCoach will have a greater decrease in their zBMI and %BMIp95 compared to baseline at completion of the 6 months intervention, than those receiving App or Clinic.
Hypothesis 1b: Participants who completed the six month AppCoach will have greater decrease in their zBMI and %BMIp95 compared to baseline at 6 and 12 months post intervention completion compared to App and Clinic.
Aim 2 (Secondary Outcomes): To compare the effects of AppCoach on addictive eating behaviors, motivation and self-regulatory behaviors at completion of the intervention and 6 and 12 months post intervention.
Hypothesis 2: Compared to App or Clinic, AppCoach will result in lower YFAS-c scores, higher motivation and improved self- regulatory behaviors scores when evaluated at completion of the intervention and 6 and 12 months post intervention.
Aim 3 (Mediators): To test whether baseline traits and behaviors mediate the effect of AppCoach compared to App and Clinic.
Hypothesis 3: Higher baseline YFAS-c scores lower executive function scores and previous history with mobile platforms will mediate the efficacy of AppCoach and App.
Aim 4: To conduct a real-life economic analysis (costs, cost-savings and non-monetary benefits) of delivering AppCoach compared to 1) App and 2) Clinic.
Hypothesis 4: An addiction-based weight loss mHealth intervention will be more cost-effective than weight-loss coaching alone and in-person delivery of multidisciplinary weight-loss intervention.
Research Design Methods:
Study Design:
Multi-center, randomized, controlled, trial of an addiction based mobile health (mHealth) weight loss intervention plus personalized coaching (AppCoach) compared to receive 1)interactive addiction model based mHealth weight-loss intervention alone (App) and 2) Multidisciplinary in-clinic weight management program (Clinic).
Recruitment and Eligibility:
Study procedures will be approved by the Children's Hospital Los Angeles (CHLA), the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Alta Med, UCLA, and Cedars Sinai Institutional Review Boards. Participants will be recruited for the intervention arms from newly referred patients of 5 interdisciplinary weight management clinics (CHLA, Alta Med, Los Angeles Biomedical Research Institute at Harbor-UCLA (LA Biomed), UCLA, and Cedars Sinai).
Patient Subjects:
Inclusion criteria include:
1\. Age 14-18 years 2. Body mass index \[BMI\] ≥85th percentile for age and gender
Exclusion criteria include:
1. Concurrent participation in an alternative weight loss intervention
2. Blood pressure \> 99th percentile for age, gender, and height
3. Known psychiatric illness and/or developmental delay
4. Participants Inability to read English
Parent Criteria:
1. Have an eligible child who meets the eligibility requirements listed above
2. Minimum age of 18 years old
Pre-Screening:
Clinic Recruitment:
Newly referred patients to the interdisciplinary clinics will be pre-screened for eligibility prior to their first clinic visit by an on-site clinical research coordinator (CRC). Those participants who meet eligibility criteria will be contacted via phone by the on-site CRC. The CRC will briefly introduce the study aims and intervention and request the youth and family to consider participation to be fully discussed at the first visit. The CRC will obtain the eligible participants' email address and send them a recruitment email.
Initial Visit:
1. On-site CRC will meet with eligible participants and provide details about the study procedures, obtain written consent from one parent/guardian and assent from each participant and answer any questions the participants and there parent may have.
a. In order to standardize the study description, the CRC will first play an introductory video clip describing the study, the participant responsibilities and follow-up requirements.
b. Upon obtaining verbal and written consent from one parent or guardian and verbal and written assent from each youth to participate in the study participants will be randomized to one of 3 intervention arms (AppCoach vs. App vs. Clinic)
2. All consenting participants will complete a battery of surveys (Refer to Measurements section).
Covariates/Moderators:
a. Yale Food Addiction Scale b. The Center for Epidemiologic Studies Depression scale c. The Perceived Stress Scale d. Behavior Rating Inventory of Executive function
Outcomes:
1. Intervention Satisfaction Survey
2. The Adolescent Self-Regulatory Inventory (ASRI)
3. Food Cravings Questionnaire
3. All consenting participants:
1. AppCoach and App Groups will receive:
1\. iPhones (as needed; participants will be required to have an iPhone). b. All Participants will receive: Wireless Bluetooth body weight scale (Wahoo Fitness Balance Scale; Wahoo fitness, Atlanta, GA) and a wireless Bluetooth digital food scale (Escali Smart Connect Kitchen Scale, Escali Corp., Burnsville, MN) both of which interfaced to the app.
c. Participants who require an iPhone will be loaned an iPhone 5S and accessories (including protective case), with an AT\&T service plan for the duration of the study that includes: unlimited texting, unlimited plan, unlimited voice calls to and from other cell telephones, 700 voice call minutes for calls to and from landlines, unlimited night and weekend calls to and from landlines, International calls or texts including Canada are NOT allowed and not covered.
d. Participants will return the loaned phones at the completion of the intervention (Visit 3).
e. The referring provider will receive a letter informing them that the youth they referred to the weight management clinic will be participating in this study for 6 months and then will be offered enrollment back into the initial referral program is desired.
4\. AppCoach Participants:
1. Each participant will register via a computer and then login with the app.
2. Participants will weigh-in on a scale in a private area and enter weight data on their iPhones.
3. On-site CRC will go through each section of app and have participants enter data.
4. Follow Up: Participants will schedule weekly 15 minute phone meetings with a coach and return for clinic visits at 3,6,12 and 18 months. The first phone visit will be via HIPAA secure video conferencing between the coach and the participant.
5\. App Participants:
a. Each participant will register via a computer and then login with the app. b. Participants will weigh-in on a scale in a private area and enter weight data on their iPhones.
c. On-site CRC will go through each section of app and have participants enter data.
d. Follow Up: Participants will schedule clinic visits at 3,6,12 and 18 months. 6. Clinic Participants:
1. Each participant will attend a multi-disciplinary in-clinic intervention that consists of 6 sessions (100 minutes for the first visit and 80 minutes for follow up visits).
2. They will travel to the local site of recruitment and attend 6 sessions in which they will meet with a provider team.
3. Participants will weigh-in on a scale in a private area and receive a wireless body and food scale
4. Follow Up: Participants will return clinic visits monthly for 6 months and then at 12 and 18 months post consent for maintenance follow-up.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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App Plus Coaching (AC)
6 month addiction model based weight loss intervention in the form of an iPhone app coupled with personalized coaching.
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.
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
App Alone (AA)
6 month addiction model based weight loss intervention in the form of an iPhone app.
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.
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
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.
Interventions
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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.
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
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.
Eligibility Criteria
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Inclusion Criteria
* Body mass index \[BMI\] ≥85th percentile for age and gender
Exclusion Criteria
* Blood pressure \> 99th percentile for age, gender, and height
* Known poorly controlled psychiatric illness and/or developmental delay
* Participants Inability to read English
14 Years
18 Years
ALL
No
Sponsors
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Cedars-Sinai Medical Center
OTHER
University of California, Los Angeles
OTHER
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
OTHER
Children's Hospital Los Angeles
OTHER
Responsible Party
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Alaina P. Vidmar, MD
Assistant Professor Department of Pediatric Endocrinology
Principal Investigators
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Alaina Vidmar
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Los Angeles
Locations
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Children's Hospital of Los Angeles
Los Angeles, California, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CHLA-18-00134
Identifier Type: -
Identifier Source: org_study_id