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

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Numberless BDS
Digital Scale
Modified Motivational Interviewing
Sponsored by
The University of Texas Medical Branch, Galveston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Obesity focused on measuring Adolescent

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UTMB
  • UTMB

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Numberless BDS and Modified-MI

Digital Scale

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.
Acceptability of Modified MI and BDS
Number of participants in each group who are lost to follow-up

Secondary Outcome Measures

Anthropometrics
Body Mass Index (BMI)
Bio-impedence measures
Measures body fat (%)
Anxiety
Self-reported anxiety on a scale from 0 (not at all) to 3 (severely) using the Beck Anxiety Inventory
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
Bio-impedence measures
Measures muscle mass (%)
Bio-impedence measures
Measures visceral fat (%)

Full Information

First Posted
January 9, 2020
Last Updated
November 6, 2020
Sponsor
The University of Texas Medical Branch, Galveston
Collaborators
National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT04241939
Brief Title
Telephone Counseling and Numberless Scales to Overcome Barriers to Adolescent Weight Loss
Official Title
Brief Telephone Counseling and Numberless Scales to Overcome Weight Loss Barriers in Underserved Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
February 14, 2020 (Actual)
Primary Completion Date
September 14, 2020 (Actual)
Study Completion Date
September 14, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Medical Branch, Galveston
Collaborators
National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Adolescent

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Numberless BDS and Modified-MI
Arm Type
Experimental
Arm Description
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.
Arm Title
Digital Scale
Arm Type
Active Comparator
Arm Description
Use standard digital scale (number readout). Participants will weigh daily.
Intervention Type
Behavioral
Intervention Name(s)
Numberless BDS
Intervention Description
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
Intervention Name(s)
Digital Scale
Intervention Description
Participants perform daily weighing using a digital scale (number readout), in conjunction with standard adolescent weight loss program
Intervention Type
Behavioral
Intervention Name(s)
Modified Motivational Interviewing
Intervention Description
Modified motivational interviewing (clinic visits and weekly telephone calls), and the standard adolescent weight loss program.
Primary Outcome Measure Information:
Title
Feasibility of Modified MI and BDS
Description
Attendance at in-clinic visits, completion of weekly phone calls, and daily weighing based on BDS app data collected at 24 week assessment.
Time Frame
24 weeks
Title
Acceptability of Modified MI and BDS
Description
Number of participants in each group who are lost to follow-up
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Anthropometrics
Description
Body Mass Index (BMI)
Time Frame
24 weeks
Title
Bio-impedence measures
Description
Measures body fat (%)
Time Frame
24 weeks
Title
Anxiety
Description
Self-reported anxiety on a scale from 0 (not at all) to 3 (severely) using the Beck Anxiety Inventory
Time Frame
Change from 0 to 24 weeks
Title
Depression
Description
Self-reported depression screening on a scale from 0 (not at all) to 3 (nearly every day) using the PHQ-9: Modified for Teens
Time Frame
Change from 0 to 24 weeks
Title
Bio-impedence measures
Description
Measures muscle mass (%)
Time Frame
24 weeks
Title
Bio-impedence measures
Description
Measures visceral fat (%)
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kanika Bowen-Jallow, MD, MMS
Organizational Affiliation
University of Texas
Official's Role
Principal Investigator
Facility Information:
Facility Name
UTMB
City
League City
State/Province
Texas
ZIP/Postal Code
77573
Country
United States
Facility Name
UTMB
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

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

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