Using Online Tools to Increase Weight Loss in Primary Care

May 8, 2026 updated by: University of Florida

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
473

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32611
        • University of Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Connect4Health Engage
Receive Connect4Health Engage
Behavioral: Connect4Health Engage
Intervention focused on motivating and guiding patients to use empirically supported, freely available online tools for weight loss.
Active Comparator: Connect4Health Discover
Receive Connect4Health Discover
Behavioral: Connect4Health Discover
Educational control - information about healthy eating and physical activity

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion achieving ≥ 3% weight loss
Time Frame: 52 weeks
Proportion of patients achieving ≥3% weight loss
52 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Weight stability at 78 weeks
Time Frame: 78 weeks
Proportion of individuals who do not exceed 3% weight gain from baseline.
78 weeks
Weight change at 52 weeks (continuous)
Time Frame: 52 weeks
Weight change from baseline to week 52 in kgs (continuous)
52 weeks
Weight change at 78 weeks (continuous)
Time Frame: 78 week
Weight change from baseline to week 78 in kgs (continuous)
78 week
Weight stability at 52 weeks
Time Frame: 52 weeks
Proportion of individuals who do not exceed 3% weight gain from baseline at 52 weeks.
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 as measured using the International Physical Activity Questionnaire (IPAQ) (continuous measure MET minutes per week)
52 week
Minutes of moderate-to-vigorous physical activity per week at 78 weeks
Time Frame: 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)
78 weeks
Servings per day of fruits and vegetables (52 weeks)
Time Frame: 52 weeks
Number of servings per day of fruits and vegetables measured by Eating at America's Table Study (EATS) fruit and vegetable screener.
52 weeks
Servings per day of fruits and vegetables (78 weeks)
Time Frame: 78 weeks
Number of servings per day of fruits and vegetables measured by Eating at America's Table Study (EATS) fruit and vegetable screener.
78 weeks
Percentage of energy from fat (52 weeks)
Time Frame: 52 weeks
Percent of energy from fat measured using NCI Percentage Energy from Fat Screener measure
52 weeks
Percentage of energy from fat (78 weeks)
Time Frame: 78 weeks
Percent of energy from fat measured using NCI Percentage Energy from Fat Screener measure
78 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Florida

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 15, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 7, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 15, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB202400390
  • R01DK137092 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual data will be shared with other researchers. Researchers will need to complete a Data Use Agreement.

IPD Sharing Time Frame

Data will be made available within six months of completing data collection, or at the time of the first associated publication, whichever comes first.

IPD Sharing Access Criteria

The data and documentation will only be made available to users under a Data Use Agreement (DUA) that ensures commitments to using the data only for research purposes; to protecting identification of any individual subject; to securing the data using appropriate computer technology; and to destroying or returning the data to us after analyses are completed. To protect the privacy and confidentiality of participants and to ensure appropriate use of these data, the deidentified data will be shared in a restricted repository to be made available to qualified researchers who submit an application and execute a DUA with the appropriate participant protections. Consistent with our institution's IRB requirements, data will be available for up to five years following the study's completion.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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