Telephone Counseling and Numberless Scales to Overcome Barriers to Adolescent Weight Loss

Study Overview
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Brief Summary
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This study tests the feasibility and acceptability of a numberless behavioral digital scale (BDS) intervention combined with motivational interviewing (MI) to affect lifestyle changes to promote weight loss in adolescents who are obese. Half of the participants will receive this intervention, while the other half will use a digital scale along with the standard adolescent weight loss program.

Detailed Description
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The proposed pilot project seeks to enhance motivation for lifestyle change in adolescents who are obese. It will test a novel intervention that combines modified MI-based counseling and BDS. We will test the feasibility of the intervention over a 12-week period, with 24-week follow-up compared to use of standard digital scale. All participants will undergo the standard adolescent weight loss program, which includes monthly clinic visits with dietary and physical activity counseling. The MI intervention will include modified MI, brief weekly telephone reinforcement, and use of a BDS. The BDS with its mobile app offers daily feedback through colors, daily missions to promote healthy habits, and weekly healthy tips from nutritionists. In addition to the primary outcome of feasibility (daily weighing) investigators will also explore the intervention's effect on motivation, psychological outcomes and various aspects of feasibility and acceptability.

Official Title
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Brief Telephone Counseling and Numberless Scales to Overcome Weight Loss Barriers in Underserved Adolescents

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Numberless BDS
* Behavioral: Digital Scale
* Behavioral: Modified Motivational Interviewing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 12 and 18 years BMI greater than or equal to 95th percentile for age and sex group or BMI greater than or equal to 35 kg/m^2 Participant (not parent) is able to read and understand English (app is in English) Smartphone device with Wi-Fi and app capability Willingness to be randomized to any condition Exclusion Criteria: Age 19 years or older Developmental delay Inability to provide informed consent Any medical condition that, in the opinion of the PI, would place the participant at increased risk Use of an investigational agent in the 30 days prior to signing informed consent History of prior non-compliance or the presence or history of psychiatric condition (including drug or alcohol addiction) that would , in the opinion of the PI, make it difficult for the participant to comply with study procedures or follow instructions Females who are pregnant or lactating, by verbal report Pre-existing conditions (i.e paralysis, heart failure, severe autism or mental retardation, psychosis, etc.) Prisoners Lack of transportation

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Numberless BDS and Modified-MI<br>Use of numberless BDS (color coded), app, and motivational interviewing. Participants will weigh daily and receive weekly motivational interviewing at clinic visits and via a weekly phone call. | Behavioral: Numberless BDS<br>* Participants perform daily weighing using a numberless BDS with feedback from app (color codes, challenges), in conjunction with modified motivational interviewing (clinic visits and weekly telephone calls), and the standard adolescent weight loss program.<br>Behavioral: Modified Motivational Interviewing<br>* Modified motivational interviewing (clinic visits and weekly telephone calls), and the standard adolescent weight loss program.<br>|
| Active Comparator: Digital Scale<br>Use standard digital scale (number readout). Participants will weigh daily. | Behavioral: Digital Scale<br>* Participants perform daily weighing using a digital scale (number readout), in conjunction with standard adolescent weight loss program<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of Modified MI and BDS | Attendance at in-clinic visits, completion of weekly phone calls, and daily weighing based on BDS app data collected at 24 week assessment. | 24 weeks | 
| Acceptability of Modified MI and BDS | Number of participants in each group who are lost to follow-up | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anthropometrics | Body Mass Index (BMI) | 24 weeks | 
| Bio-impedence measures | Measures body fat (%) | 24 weeks | 
| Anxiety | Self-reported anxiety on a scale from 0 (not at all) to 3 (severely) using the Beck Anxiety Inventory | Change from 0 to 24 weeks | 
| Depression | Self-reported depression screening on a scale from 0 (not at all) to 3 (nearly every day) using the PHQ-9: Modified for Teens | Change from 0 to 24 weeks | 
| Bio-impedence measures | Measures muscle mass (%) | 24 weeks | 
| Bio-impedence measures | Measures visceral fat (%) | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adolescent