Purpose

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.

Condition

Eligibility

Eligible Ages
Between 12 Years and 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Other
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Numberless BDS and Modified-MI
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
    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.
  • Behavioral: Modified Motivational Interviewing
    Modified motivational interviewing (clinic visits and weekly telephone calls), and the standard adolescent weight loss program.
Active Comparator
Digital Scale
Use standard digital scale (number readout). Participants will weigh daily.
  • Behavioral: Digital Scale
    Participants perform daily weighing using a digital scale (number readout), in conjunction with standard adolescent weight loss program

More Details

Status
Completed
Sponsor
The University of Texas Medical Branch, Galveston

Study Contact

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.