ObesityNCT06928571
Using Online Tools to Increase Weight Loss in Primary Care
A study testing Connect4Health Engage and Connect4Health Discover in people with Obesity, run by University of Florida at 1 site in United States.
Trial summary
The goal of the proposed project is to test the effectiveness of an intervention (Connect4Health Engage) focused on motivating and guiding patients to use empirically supported, freely available online tools for weight loss. A randomized trial will be conducted in primary care clinics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Connect4Health Engage and Connect4Health Discover
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 473 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2025to Jun 2029
- 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
- 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 valid email address in EHR
- Has an appointment scheduled with enrolled PCP about 30-45 days after IDR query
- Speaks and reads English
- Has either WiFi internet access at home or a phone or tablet with a data plan.
Who cannot join
- BMI≥ 45 kg/m2.
- Currently enrolled in structured weight loss treatment
- In past month, has been actively participating in a weight loss focused online community (i.e., posting or reading content).
- Currently tracking food intake 3 days per week
- Pregnant or planning to become pregnant in the next 6 months
- Currently breastfeeding (or pumping breastmilk) 3 times per day or more.
Show all 19Show fewer
- Currently undergoing treatment for cancer or has active cancer
- Had cardiovascular event in the past 60 days
- 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
- Type 1 Diabetes
- Currently taking prescription medication for weight loss
- Inability to stand on body weight scale independently
- Impaired hearing
- Unable to read content on websites without assistance
- Planning to move out of the region in the next 12 months.
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: A Hybrid Effectiveness/ Implementation Trial Using Online Tools to Increase Weight Loss Among Primary Care Patients
The goal of the proposed project is to test the effectiveness of an intervention (Connect4Health Engage) focused on motivating and guiding patients to use empirically supported, freely available online tools for weight loss. A randomized trial will be conducted in primary care clinics. Fifteen to twenty PCPs will be recruited, followed by 453 patients. Patients will complete either the 52-week Connect4Health Engage intervention or Connect4Health Discover, an educational control.
- Conditions
- Obesity
- Being tested
- Connect4Health Engage, Connect4Health Discover
- Keywords
- obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connect4Health EngageBehavioural
Intervention focused on motivating and guiding patients to use empirically supported, freely available online tools for weight loss.
Connect4Health DiscoverBehavioural
Educational control - information about healthy eating and physical activity
| Study group | Role | What they receive |
|---|---|---|
| Connect4Health Engage | Experimental | Receive Connect4Health Engage Receives: Behavioral: Connect4Health Engage |
| Connect4Health Discover | Active comparator | Receive Connect4Health Discover Receives: Behavioral: Connect4Health Discover |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion achieving ≥ 3% weight loss
Proportion of patients achieving ≥3% weight loss
Measured: 52 weeks
Secondary outcomes (10)
Weight stability at 78 weeks
Proportion of individuals who do not exceed 3% weight gain from baseline.
Measured: 78 weeks
Weight change at 52 weeks (continuous)
Weight change from baseline to week 52 in kgs (continuous)
Measured: 52 weeks
Weight change at 78 weeks (continuous)
Weight change from baseline to week 78 in kgs (continuous)
Measured: 78 week
Weight stability at 52 weeks
Proportion of individuals who do not exceed 3% weight gain from baseline at 52 weeks.
Measured: 52 weeks
Minutes of moderate-to-vigorous physical activity per week at 52 weeks
Minutes of moderate-to-vigorous physical activity per week as measured using the International Physical Activity Questionnaire (IPAQ) (continuous measure MET minutes per week)
Measured: 52 week
Minutes of moderate-to-vigorous physical activity per week at 78 weeks
Description: Minutes of moderate-to-vigorous physical activity per week as measured using the International Physical Activity Questionnaire (IPAQ) (continuous measure MET minutes per week)
Measured: 78 weeks
Servings per day of fruits and vegetables (52 weeks)
Number of servings per day of fruits and vegetables measured by Eating at America's Table Study (EATS) fruit and vegetable screener.
Measured: 52 weeks
Servings per day of fruits and vegetables (78 weeks)
Number of servings per day of fruits and vegetables measured by Eating at America's Table Study (EATS) fruit and vegetable screener.
Measured: 78 weeks
Percentage of energy from fat (52 weeks)
Percent of energy from fat measured using NCI Percentage Energy from Fat Screener measure
Measured: 52 weeks
Percentage of energy from fat (78 weeks)
Percent of energy from fat measured using NCI Percentage Energy from Fat Screener measure
Measured: 78 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start15 Apr 2025
- Primary completionJun 2029 (estimated)
- Study completionJun 2029 (estimated)
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 473 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06928571
- Sponsor's protocol ID
- IRB202400390
- Other IDs
- R01DK137092
- Status last verified
- May 2026
- First submitted
- 7 Apr 2025
- Last updated
- 11 May 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 will need to complete a Data Use Agreement.
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Hybrid Effectiveness/ Implementation Trial Using Online Tools to Increase Weight Loss Among Primary Care Patients
- ClinicalTrials.gov ID
- NCT06928571
- Acronym / sponsor ID
- IRB202400390
- Conditions
- Obesity
- Keywords
- obesity
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 473 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 15 Apr 2025 (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 goal of the proposed project is to test the effectiveness of an intervention (Connect4Health Engage) focused on motivating and guiding patients to use empirically supported, freely available online tools for weight loss. A randomized trial will be conducted in primary care clinics. Fifteen to twenty PCPs will be recruited, followed by 453 patients. Patients will complete either the 52-week Connect4Health Engage intervention or Connect4Health Discover, an educational control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Connect4Health Engage | Experimental | Behavioral: Connect4Health EngageReceive Connect4Health Engage |
| Connect4Health Discover | Active comparator | Behavioral: Connect4Health DiscoverReceive Connect4Health Discover |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 or older
- 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 valid email address in EHR
- Has an appointment scheduled with enrolled PCP about 30-45 days after IDR query
Key exclusion criteria (19 listed)
- BMI≥ 45 kg/m2.
- Currently enrolled in structured weight loss treatment
- In past month, has been actively participating in a weight loss focused online community (i.e., posting or reading content).
- Currently tracking food intake 3 days per week
- Pregnant or planning to become pregnant in the next 6 months
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 |
|---|---|---|
| Connect4Health EngageIntervention focused on motivating and guiding patients to use empirically supported, freely available online tools for weight loss. | Behavioural | Connect4Health Engage |
| Connect4Health DiscoverEducational control - information about healthy eating and physical activity | Behavioural | Connect4Health Discover |
Primary outcome
Proportion achieving ≥ 3% weight loss
Time frame: 52 weeks
Proportion of patients achieving ≥3% weight loss
10 secondary outcomes
Weight stability at 78 weeks
Time frame: 78 weeks
Weight change at 52 weeks (continuous)
Time frame: 52 weeks
Weight change at 78 weeks (continuous)
Time frame: 78 week
Weight stability at 52 weeks
Time frame: 52 weeks
Minutes of moderate-to-vigorous physical activity per week at 52 weeks
Time frame: 52 week
Minutes of moderate-to-vigorous physical activity per week at 78 weeks
Time frame: 78 weeks
Servings per day of fruits and vegetables (52 weeks)
Time frame: 52 weeks
Servings per day of fruits and vegetables (78 weeks)
Time frame: 78 weeks
Percentage of energy from fat (52 weeks)
Time frame: 52 weeks
Percentage of energy from fat (78 weeks)
Time frame: 78 weeks
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 11 May 2026.
- Individual participant dataSharing planned: Yes. De-identified individual data will be shared with other researchers. Researchers will need to complete a Data Use Agreement.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Connect4Health Engage and Connect4Health Discover 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 7 inclusion and 19 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 11 May 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 achieving ≥ 3% weight loss (time frame: 52 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 11 May 2026.