Clinical trial NCT03500835: An Addiction-Based Mobile Health Weight Loss Intervention With Coaching
Official title: An Addiction Model Based Mobile Health Weight Loss Intervention With Coaching in Adolescents With Overweight and Obesity: Multi-Site Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Obesity
Mobile Technology
Addiction
Lead sponsor: Children's Hospital Los Angeles
Sponsor class: OTHER
Collaborators: name: Cedars-Sinai Medical Center
name: University of California, Los Angeles
name: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
First posted: 2018-04-18
Enrollment: 161
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: SUPPORTIVE_CARE

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).

Detailed description: Aim 1 (Primary Outcomes): To test the effectiveness of an addiction-based weight loss intervention, embodied first as a smartphone app with telephone coaching (AppCoach) compared to (1) addiction model based weight-loss app alone (App) and (2) multi-disciplinary in-clinic weight loss intervention (Clinic) on weight outcomes of overweight and obese adolescents at 3, 6, 12 and 18 months post enrollment.

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.

Eligibility 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

Primary outcomes:
measure: %BMIp95
timeFrame: 6 months
Secondary outcomes:
measure: Cost Analysis
timeFrame: 6 months
measure: Yale Food Addiction Scale
timeFrame: 6 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital of Los Angeles
state: California
Study officials:
affiliation: Children's Hospital Los Angeles
name: Alaina Vidmar
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.