ObesityNCT04241939
Telephone Counseling and Numberless Scales to Overcome Barriers to Adolescent Weight Loss
A study testing Numberless BDS, Digital Scale and Modified Motivational Interviewing in people with Obesity, run by The University of Texas Medical Branch, Galveston at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Numberless BDS, Digital Scale and Modified Motivational Interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Feb 2020to 14 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UTMB
League City, Texas, 77573
UTMB
Webster, Texas, 77598
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Numberless BDS, Digital Scale, Modified Motivational Interviewing
- Keywords
- Adolescent
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Numberless BDSBehavioural
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 ScaleBehavioural
Participants perform daily weighing using a digital scale (number readout), in conjunction with standard adolescent weight loss program
Modified Motivational InterviewingBehavioural
Modified motivational interviewing (clinic visits and weekly telephone calls), and the standard adolescent weight loss program.
| Study group | Role | What they receive |
|---|---|---|
| Numberless BDS and Modified-MI | Experimental | 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. Receives: Behavioral: Numberless BDS; Behavioral: Modified Motivational Interviewing |
| Digital Scale | Active comparator | Use standard digital scale (number readout). Participants will weigh daily. Receives: Behavioral: Digital Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks
Acceptability of Modified MI and BDS
Number of participants in each group who are lost to follow-up
Measured: 24 weeks
Secondary outcomes (6)
Anthropometrics
Body Mass Index (BMI)
Measured: 24 weeks
Bio-impedence measures
Measures body fat (%)
Measured: 24 weeks
Anxiety
Self-reported anxiety on a scale from 0 (not at all) to 3 (severely) using the Beck Anxiety Inventory
Measured: 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
Measured: Change from 0 to 24 weeks
Bio-impedence measures
Measures muscle mass (%)
Measured: 24 weeks
Bio-impedence measures
Measures visceral fat (%)
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start14 Feb 2020
- Primary completion14 Sep 2020
- Study completion14 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Kanika Bowen-Jallow, MD, MMS, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04241939
- Sponsor's protocol ID
- 19-0198
- Other IDs
- K12HD052023
- Status last verified
- Jan 2020
- First submitted
- 9 Jan 2020
- Last updated
- 9 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Telephone Counseling and Numberless Scales to Overcome Weight Loss Barriers in Underserved Adolescents
- ClinicalTrials.gov ID
- NCT04241939
- Acronym / sponsor ID
- 19-0198
- Conditions
- Obesity
- Keywords
- Adolescent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 14 Feb 2020 (actual)
- Primary completion
- 14 Sep 2020 (actual)
- Study completion
- 14 Sep 2020 (actual)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Numberless BDS and Modified-MI | Experimental | Behavioral: Numberless BDS, Behavioral: Modified Motivational InterviewingUse 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 comparator | Behavioral: Digital ScaleUse standard digital scale (number readout). Participants will weigh daily. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Numberless BDSParticipants 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. | Behavioural | Numberless BDS and Modified-MI |
| Digital ScaleParticipants perform daily weighing using a digital scale (number readout), in conjunction with standard adolescent weight loss program | Behavioural | Digital Scale |
| Modified Motivational InterviewingModified motivational interviewing (clinic visits and weekly telephone calls), and the standard adolescent weight loss program. | Behavioural | Numberless BDS and Modified-MI |
Primary outcome
Feasibility of Modified MI and BDS
Time frame: 24 weeks
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
Time frame: 24 weeks
Number of participants in each group who are lost to follow-up
6 secondary outcomes
Anthropometrics
Time frame: 24 weeks
Bio-impedence measures
Time frame: 24 weeks
Anxiety
Time frame: Change from 0 to 24 weeks
Depression
Time frame: Change from 0 to 24 weeks
Bio-impedence measures
Time frame: 24 weeks
Bio-impedence measures
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2020.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kanika Bowen-Jallow, MD, MMS principal investigator
University of Texas
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Numberless BDS, Digital Scale and Modified Motivational Interviewing in people with Obesity, run by The University of Texas Medical Branch, Galveston at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Modified MI and BDS (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2020.