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

NCT ID: NCT04241939

Last Updated: 2020-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-14

Study Completion Date

2020-09-14

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.

Conditions

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Obesity

Keywords

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Adolescent

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Numberless BDS

Intervention Type BEHAVIORAL

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.

Modified Motivational Interviewing

Intervention Type BEHAVIORAL

Modified motivational interviewing (clinic visits and weekly telephone calls), and the standard adolescent weight loss program.

Digital Scale

Use standard digital scale (number readout). Participants will weigh daily.

Group Type ACTIVE_COMPARATOR

Digital Scale

Intervention Type BEHAVIORAL

Participants perform daily weighing using a digital scale (number readout), in conjunction with standard adolescent weight loss program

Interventions

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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.

Intervention Type BEHAVIORAL

Digital Scale

Participants perform daily weighing using a digital scale (number readout), in conjunction with standard adolescent weight loss program

Intervention Type BEHAVIORAL

Modified Motivational Interviewing

Modified motivational interviewing (clinic visits and weekly telephone calls), and the standard adolescent weight loss program.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

The University of Texas Medical Branch, Galveston

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kanika Bowen-Jallow, MD, MMS

Role: PRINCIPAL_INVESTIGATOR

University of Texas

Locations

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UTMB

League City, Texas, United States

Site Status

UTMB

Webster, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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K12HD052023

Identifier Type: NIH

Identifier Source: secondary_id

View Link

19-0198

Identifier Type: -

Identifier Source: org_study_id