Telephone Counseling and Numberless Scales to Overcome Barriers to Adolescent Weight Loss
- Conditions
- Obesity
- Interventions
- Behavioral: Digital ScaleBehavioral: Numberless BDSBehavioral: Modified Motivational Interviewing
- Registration Number
- NCT04241939
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- 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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Numberless BDS and Modified-MI Modified Motivational Interviewing 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. Digital Scale Digital Scale Use standard digital scale (number readout). Participants will weigh daily. Numberless BDS and Modified-MI Numberless BDS 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.
- Primary Outcome Measures
Name Time Method Feasibility of Modified MI and BDS 24 weeks Attendance at in-clinic visits, completion of weekly phone calls, and daily weighing based on BDS app data collected at 24 week assessment.
Acceptability of Modified MI and BDS 24 weeks Number of participants in each group who are lost to follow-up
- Secondary Outcome Measures
Name Time Method Anthropometrics 24 weeks Body Mass Index (BMI)
Anxiety Change from 0 to 24 weeks Self-reported anxiety on a scale from 0 (not at all) to 3 (severely) using the Beck Anxiety Inventory
Depression Change from 0 to 24 weeks Self-reported depression screening on a scale from 0 (not at all) to 3 (nearly every day) using the PHQ-9: Modified for Teens
Bio-impedence measures 24 weeks Measures visceral fat (%)
Trial Locations
- Locations (1)
UTMB
🇺🇸Webster, Texas, United States