ObesityNCT06206954
Supporting Decisions on Lifestyle Change
A study testing MyHealthPath Tool and MyHealthPath Guide in people with Obesity, run by University of Florida at 1 site in United States.
Trial summary
This study will test the effects of a brief, individually tailored intervention aiming to increase initiation of comprehensive behavioral weight loss treatment on weight. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- MyHealthPath Tool and MyHealthPath Guide
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 864 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2024to 30 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Body Mass Index (BMI) ≥ 30 kg/m2 based on self-report body weight and height, or BMI ≥ 27-29.9 kg/m2 with a weight related comorbidity of hypertension, type 2 diabetes, pre-diabetes, dyslipidemia, or obstructive sleep apnea, gastroesophageal reflux disease, or coronary artery disease.
- Self-report weight ≤ 375 lbs (the maximum weight that BodyTrace scales can accurately detect is 397 lbs, thus 375 lbs provides a buffer to allow detection of at least 20 lbs weight gain).
- Has a desire to weigh less
- Has valid email address in Electronic Health Record
- Has an appointment scheduled with enrolled PCP about 21-28 days after electronic data pull
- Speaks and reads English
- Has either WiFi internet access at home or a phone or tablet with a data plan.
Who cannot join
- Currently enrolled in evidence-based comprehensive weight loss treatment
- Pregnant or planning to become pregnant in the next 6 months
- Currently breastfeeding (or pumping breastmilk) more than 3 times per day.
- Currently undergoing treatment for cancer
- Had cardiovascular event in the past 60 days
- Severe depression symptoms on PHQ-8 (total score ≥20)
Show all 15Show fewer
- Inpatient psychiatric treatment in the past 6 months
- Eating disorder in past 5 years
- Congestive heart failure resulting in recent (past 6 months) hospitalization or contributing to difficulty breathing or difficulty doing daily activities.
- Dementia diagnosis
- Bariatric surgery in the past year or currently undergoing evaluation for bariatric surgery
- Currently taking doctor-prescribed medication for weight loss
- Inability to stand on body weight scale independently
- Impaired hearing
- Unable to read content on websites without assistance
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Increasing Initiation of Evidence-based Weight Loss Treatment
This study will test the effects of a brief, individually tailored intervention aiming to increase initiation of comprehensive behavioral weight loss treatment on weight.
- Conditions
- Obesity
- Being tested
- MyHealthPath Tool, MyHealthPath Guide
- Keywords
- initiation, recruitment, engagement, behavioral intervention
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyHealthPath ToolBehavioural
Tailored, brief online tool to help patients learn about weight treatment options
MyHealthPath GuideBehavioural
Informational material to help patients learn about weight treatment options
| Study group | Role | What they receive |
|---|---|---|
| MyHealthPath Tool | Experimental | Receive MyHealthPath Tool intervention. Receives: Behavioral: MyHealthPath Tool |
| MyHealthPath Guide | Active comparator | Receive MyHealthPath Guide intervention Receives: Behavioral: MyHealthPath Guide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion initiating treatment
Attend at least one intervention session of comprehensive behavioral weight loss intervention. Documented by interventionist/program.
Measured: Within 2 months of PCP appointment date
Secondary outcomes (4)
Number of treatment sessions attended
Total number of attended intervention session of comprehensive behavioral weight loss intervention. Documented by interventionist/program.
Measured: 6 months
Proportion discussing weight-related topic with PCP
Per patient self-report, discussed weight, diet, or physical activity with PCP at index PCP visit.
Measured: at completion of PCP visit (occuring up to 4 weeks after enrollment)
Proportion achieving 5% weight loss
Proportion of participants losing 5% of their baseline weight between baseline and 6 months
Measured: 6 months
Percent weight loss
Percent weight loss from baseline to 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start24 Jan 2024
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel cluster randomized
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 864 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Megan A McVay, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06206954
- Sponsor's protocol ID
- IRB202300516
- Other IDs
- R01DK134409
- Status last verified
- Jul 2026
- First submitted
- 2 Jan 2024
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual data will be shared with other researchers. Researchers may need to complete a data use authorization agreement.
Publications
McVay MA, Moore WS, Deceus D, Townsend SB, Rosenberg EI, Muenyi S, Lou X, Webb FJ, Diaz LD, Shankar MN, Ruiz J, Voils CI, Ross KM. A brief online tool to increase behavioral weight loss treatment initiation: Protocol for a cluster randomized trial. Contemp Clin Trials. 2025 Jul;154:107948. doi: 10.1016/j.cct.2025.107948. Epub 2025 May 15.
PubMed 40381908
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Initiation of Evidence-based Weight Loss Treatment
- ClinicalTrials.gov ID
- NCT06206954
- Acronym / sponsor ID
- IRB202300516
- Conditions
- Obesity
- Keywords
- initiation, recruitment, engagement, behavioral intervention
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 864 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 24 Jan 2024 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Jul 2028 (estimated)
- First posted
- 16 Jan 2024 (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 will test the effects of a brief, individually tailored intervention aiming to increase initiation of comprehensive behavioral weight loss treatment on weight.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel cluster randomized
| Arm | Type | Receives |
|---|---|---|
| MyHealthPath Tool | Experimental | Behavioral: MyHealthPath ToolReceive MyHealthPath Tool intervention. |
| MyHealthPath Guide | Active comparator | Behavioral: MyHealthPath GuideReceive MyHealthPath Guide intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 or older
- Body Mass Index (BMI) ≥ 30 kg/m2 based on self-report body weight and height, or BMI ≥ 27-29.9 kg/m2 with a weight related comorbidity of hypertension, type 2 diabetes, pre-diabetes, dyslipidemia, or obstructive sleep apnea, gastroesophageal reflux disease, or coronary artery disease.
- Self-report weight ≤ 375 lbs (the maximum weight that BodyTrace scales can accurately detect is 397 lbs, thus 375 lbs provides a buffer to allow detection of at least 20 lbs weight gain).
- Has a desire to weigh less
- Has valid email address in Electronic Health Record
Key exclusion criteria (15 listed)
- Currently enrolled in evidence-based comprehensive weight loss treatment
- Pregnant or planning to become pregnant in the next 6 months
- Currently breastfeeding (or pumping breastmilk) more than 3 times per day.
- Currently undergoing treatment for cancer
- Had cardiovascular event in the past 60 days
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 |
|---|---|---|
| MyHealthPath ToolTailored, brief online tool to help patients learn about weight treatment options | Behavioural | MyHealthPath Tool |
| MyHealthPath GuideInformational material to help patients learn about weight treatment options | Behavioural | MyHealthPath Guide |
Primary outcome
Proportion initiating treatment
Time frame: Within 2 months of PCP appointment date
Attend at least one intervention session of comprehensive behavioral weight loss intervention. Documented by interventionist/program.
4 secondary outcomes
Number of treatment sessions attended
Time frame: 6 months
Proportion discussing weight-related topic with PCP
Time frame: at completion of PCP visit (occuring up to 4 weeks after enrollment)
Proportion achieving 5% weight loss
Time frame: 6 months
Percent weight loss
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Derived from this study: PubMed 40381908McVay MA, Moore WS, Deceus D, Townsend SB, Rosenberg EI, Muenyi S, Lou X, Webb FJ, Diaz LD, Shankar MN, Ruiz J, Voils CI, Ross KM. A brief online tool to increase behavioral weight loss treatment initiation: Protocol for a cluster randomized trial. Contemp Clin Trials. 2025 Jul;154:107948. doi: 10.1016/j.cct.2025.107948. Epub 2025 May 15.
- Individual participant dataSharing planned: Yes. De-identified individual data will be shared with other researchers. Researchers may need to complete a data use authorization agreement.
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Obesity
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.
Megan A McVay, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyHealthPath Tool and MyHealthPath Guide in people with Obesity, run by University of Florida at 1 site 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 8 inclusion and 15 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: enrolling by invitation, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
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?
Proportion initiating treatment (time frame: Within 2 months of PCP appointment date). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06206954, which also lists 1 linked publication.
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 6 Aug 2026.