ObesityNCT04121312
Engaging Patients in Weight Loss Tools
A study testing Facilitation Intervention in people with Obesity, run by University of Florida at 2 sites in United States.
Trial summary
The overall aim of this study is to evaluate the acceptability and feasibility of a primary-care based approach to facilitating engagement in online behavior tracking and community support networks for weight loss ("facilitation condition") over 12 weeks among adults with obesity. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity
- What is being tested?
- Facilitation Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Oct 2019to 24 Jul 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PCPs:
- Employed as a PCP at a clinics in the UF health care system.
- Has practiced at current clinic for ≥1 year (self-report)
- Is employed ≥ 0.5 FTE (self-report)
- Has a patient panel that is majority adult (self-report)
- Patients: EHR-based criteria:
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- Age 18-75
- Last BMI in EHR ≥30 kg/m2
- Has an appointment scheduled ("index appointment") with an enrolled primary care PCP 7-30 days after electronic data pull.
- Is enrolled in MyChart or has an email address in the IDR system.
- Self-report criteria:
- Self-reported BMI > 29 kg/m2 (to account for under-reporting)
- Response yes to question: "Would you be interested in learning strategies to help you lose weight?"
- Ability to read and understand English without assistance.
- Has either (a) a phone or tablet with a data plan OR (b) reliable access to Wi-Fi (via computer, phone or tablet) in their home.
Who cannot join
- PCPs:
- 1. Planning to move out of the Gainesville or Jacksonville area in the next 12 months.
- Patients:
- Currently enrolled in formal weight loss program or a research study focused on changing diet, physical activity, or weight.
- In past month, has tracked the majority of their food intake on an app, website, or paper log an average of 3 or more days per week.
- Self-reported to be pregnant, breastfeeding, or planning to become pregnant in next 6 months.
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- Currently undergoing radiation or chemotherapy for cancer.
- Self-reported cardiac event in past 6 months.
- Self-reported Heart Failure (also known as chronic heart failure or CHF).
- Planning to move out of the Gainesville or Jacksonville area (depending on which clinic they are recruited from) in the next 6 months.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UF Health at the University of Florida
Gainesville, Florida, 32610
UF Health - Jacksonville
Jacksonville, Florida, 32008
About this study
Official title: Engaging Primary Care Patients in Online Weight Management Tools: A Pilot Study
The overall aim of this study is to evaluate the acceptability and feasibility of a primary-care based approach to facilitating engagement in online behavior tracking and community support networks for weight loss ("facilitation condition") over 12 weeks among adults with obesity.
- Conditions
- Obesity
- Being tested
- Facilitation Intervention
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facilitation InterventionBehavioural
See "arm" description
| Study group | Role | What they receive |
|---|---|---|
| Facilitation Intervention | Experimental | A brief, web-based facilitation guide (called "Weight Loss Your Way Kickoff Materials") that encourages initial and sustained engagement in online tracking and social network tools for weight loss.The intervention also includes 8 emails sent over 12 weeks to further motivate use of the online tools and weight loss. Receives: Behavioral: Facilitation Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient retention
Percent of enrolled patients completing the 12-week follow-up assessment. (NOTE: this is a feasibility pilot and is not conceptualized as having a single primary outcome)
Measured: 12 weeks
Secondary outcomes (9)
Provider retention
Percent of enrolled providers who complete telephone interview at end of study
Measured: 4-6 months (depends on patient recruitment rate)
Percent of contacted providers who enroll
Percent of PCPs offered the study who consent
Measured: NA (depends on period of recruitment, approx 1 month)
Percent of patients who enroll
Percent of patients contacted who are eligible and agree to participate.
Measured: NA (depends on period of recruitment, approx 2-4 months)
Rate of patient recruitment
Patients recruited per month during active recruitment periods
Measured: up to 16 weeks
Acceptability of intervention- provider
Response to 5 study specific questions asking about alignment with priorities, fit in workflow, feasibility, perception of patient benefit, and time. Also, response to open ended question about acceptability.
Measured: At end of intervention (about 4-6 months after start, depending on recruitment rate)
Acceptability of intervention- patient: 12 study specific questions
Response to 12 study specific questions asking about experience with "Weight Loss Your Way" kickoff materials; open ended response to questions about acceptability of intervention during qualitative interviews (of portion of enrollees)
Measured: 12 weeks
Initial engagement in Tracking tool and social network
Portion of patients who initially engage with tracking tool (i.e., log at least one food item or physical activity) and with social network (i.e., who report reading message board or posting at least once) (tracking and social network examined separately)
Measured: 12 weeks
Sustained engagement in Tracking tool and social network
Portion of patients who have used the tracking tool and social network at least once in past week at 12 week assessment (tracking and social network examined separately)
Measured: 12 week assessment (queried about prior week)
Weight change
Mean weight loss (kgs) and portion of participants achieving 3% body weight loss.
Measured: baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2019
- Study start28 Oct 2019
- Primary completion7 Jul 2020
- Study completion24 Jul 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 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Megan McVay, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04121312
- Sponsor's protocol ID
- IRB201902013
- Other IDs
- OCR26064
- Status last verified
- Jan 2024
- First submitted
- 3 Oct 2019
- Last updated
- 16 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engaging Primary Care Patients in Online Weight Management Tools: A Pilot Study
- ClinicalTrials.gov ID
- NCT04121312
- Acronym / sponsor ID
- IRB201902013
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 28 Oct 2019 (actual)
- Primary completion
- 7 Jul 2020 (actual)
- Study completion
- 24 Jul 2020 (actual)
- First posted
- 9 Oct 2019 (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.
The overall aim of this study is to evaluate the acceptability and feasibility of a primary-care based approach to facilitating engagement in online behavior tracking and community support networks for weight loss ("facilitation condition") over 12 weeks among adults with obesity.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Facilitation Intervention | Experimental | Behavioral: Facilitation InterventionA brief, web-based facilitation guide (called "Weight Loss Your Way Kickoff Materials") that encourages initial and sustained engagement in online tracking and social network tools for weight loss.The intervention also includes 8 emails sent over 12 weeks to further motivate use of the online tools and weight loss. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- PCPs:
- Patients: EHR-based criteria:
Key exclusion criteria (10 listed)
- PCPs:
- 1. Planning to move out of the Gainesville or Jacksonville area in the next 12 months.
- Patients:
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 |
|---|---|---|
| Facilitation InterventionSee "arm" description | Behavioural | Facilitation Intervention |
Primary outcome
Patient retention
Time frame: 12 weeks
Percent of enrolled patients completing the 12-week follow-up assessment. (NOTE: this is a feasibility pilot and is not conceptualized as having a single primary outcome)
9 secondary outcomes
Provider retention
Time frame: 4-6 months (depends on patient recruitment rate)
Percent of contacted providers who enroll
Time frame: NA (depends on period of recruitment, approx 1 month)
Percent of patients who enroll
Time frame: NA (depends on period of recruitment, approx 2-4 months)
Rate of patient recruitment
Time frame: up to 16 weeks
Acceptability of intervention- provider
Time frame: At end of intervention (about 4-6 months after start, depending on recruitment rate)
Acceptability of intervention- patient: 12 study specific questions
Time frame: 12 weeks
Initial engagement in Tracking tool and social network
Time frame: 12 weeks
Sustained engagement in Tracking tool and social network
Time frame: 12 week assessment (queried about prior week)
Weight change
Time frame: baseline to 12 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 16 Jan 2024.
- Individual participant dataSharing planned: No
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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.
Megan McVay, PhD principal investigator
University of Florida
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Facilitation Intervention in people with Obesity, run by University of Florida 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 15 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 16 Jan 2024. 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?
Patient retention (time frame: 12 weeks). 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 16 Jan 2024.