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
2 other identifiers
interventional
20
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started Feb 2020
Shorter than P25 for not_applicable obesity
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 9, 2020
CompletedFirst Posted
Study publicly available on registry
January 27, 2020
CompletedStudy Start
First participant enrolled
February 14, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 14, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 14, 2020
CompletedNovember 9, 2020
January 1, 2020
7 months
January 9, 2020
November 6, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (6)
Anthropometrics
24 weeks
Bio-impedence measures
24 weeks
Anxiety
Change from 0 to 24 weeks
Depression
Change from 0 to 24 weeks
Bio-impedence measures
24 weeks
- +1 more secondary outcomes
Study Arms (2)
Numberless BDS and Modified-MI
EXPERIMENTALUse 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.
Digital Scale
ACTIVE COMPARATORUse standard digital scale (number readout). Participants will weigh daily.
Interventions
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.
Participants perform daily weighing using a digital scale (number readout), in conjunction with standard adolescent weight loss program
Modified motivational interviewing (clinic visits and weekly telephone calls), and the standard adolescent weight loss program.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
UTMB
League City, Texas, 77573, United States
UTMB
Webster, Texas, 77598, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kanika Bowen-Jallow, MD, MMS
University of Texas
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2020
First Posted
January 27, 2020
Study Start
February 14, 2020
Primary Completion
September 14, 2020
Study Completion
September 14, 2020
Last Updated
November 9, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data available upon request
- 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.
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.