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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Numberless BDS; Behavioral: Modified Motivational Interviewing; Behavioral: Digital Scale

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • League City, Texas, United States, 77573
      • UTMB
    • Webster, Texas, United States, 77598
      • UTMB

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The University of Texas Medical Branch, Galveston
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Kanika Bowen-Jallow, MD, MMS, University of Texas

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2020
• Primary Completion (Actual): September 14, 2020
• Study Completion (Actual): September 14, 2020

Study Registration Dates

• First Submitted: January 9, 2020
• First Submitted That Met QC Criteria: January 22, 2020
• First Posted (Actual): January 27, 2020

Study Record Updates

• Last Update Posted (Actual): November 9, 2020
• Last Update Submitted That Met QC Criteria: November 6, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Adolescent
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: 19-0198; K12HD052023 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The investigators will provide access to all data, regardless of publication, collected on this project. All external investigators must supply a written request identifying their research questions (s) and specifying the data they would like to analyze. The request must include a data security plan and explanation of how the data would be stored and who would have access.
• IPD Sharing Time Frame: Data available upon request
• IPD Sharing Access Criteria: All external investigators must supply a written request identifying their research questions (s) and specifying the data they would like to analyze. The request must include a data security plan and explanation of how the data would be stored and who would have access.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No