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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04241939
• Other study ID #: 19-0198
• Secondary ID: K12HD052023
• Status: Completed
• Phase: N/A
• Start date: February 14, 2020
• Est. completion date: September 14, 2020

Study information

• Verified date: January 2020
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 14, 2020
• Est. primary completion date: September 14, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

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.
• Digital Scale
Participants perform daily weighing using a digital scale (number readout), in conjunction with standard adolescent weight loss program
• Modified Motivational Interviewing
Modified motivational interviewing (clinic visits and weekly telephone calls), and the standard adolescent weight loss program.

Locations

Country	Name	City	State
United States	UTMB	League City	Texas
United States	UTMB	Webster	Texas

Sponsors (3)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Acceptability of Modified MI and BDS	Number of participants in each group who are lost to follow-up	24 weeks
Secondary	Anthropometrics	Body Mass Index (BMI)	24 weeks
Secondary	Bio-impedence measures	Measures body fat (%)	24 weeks
Secondary	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
Secondary	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
Secondary	Bio-impedence measures	Measures muscle mass (%)	24 weeks
Secondary	Bio-impedence measures	Measures visceral fat (%)	24 weeks