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Enrolling by invitationNCT06928571Updated May 11, 2026

Using Online Tools to Increase Weight Loss in Primary Care

An interventional study of Connect4Health Engage and Connect4Health Discover in Obesity, sponsored by University of Florida. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-11.

Sponsored by University of Florida · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
473
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Obesity

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Keywords

  • obesity
03

In context

Obesity

6,297 studies on the registry are indexed under Obesity; 1,693 are open to participants now.

This study's planned enrollment of 473 is above the median of 78 across 4,879 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

University of Florida is the lead sponsor of 1,254 studies on the registry; 201 are open to participants now.

Of its 170 completed or terminated interventional studies of FDA-regulated products, 136 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
473 participants (estimated)

Study arms

  • Experimental
    Connect4Health Engage

    Receive Connect4Health Engage

    Behavioral: Connect4Health Engage

  • Active comparator
    Connect4Health Discover

    Receive Connect4Health Discover

    Behavioral: Connect4Health Discover

Interventions

  • BehavioralConnect4Health Engage

    Intervention focused on motivating and guiding patients to use empirically supported, freely available online tools for weight loss.

  • BehavioralConnect4Health Discover

    Educational control - information about healthy eating and physical activity

06

What researchers measure

Primary outcomes

  1. Proportion achieving ≥ 3% weight loss

    Proportion of patients achieving ≥3% weight loss

    Time frame: 52 weeks

Secondary outcomes

  1. Weight stability at 78 weeks

    Proportion of individuals who do not exceed 3% weight gain from baseline.

    Time frame: 78 weeks

  2. Weight change at 52 weeks (continuous)

    Weight change from baseline to week 52 in kgs (continuous)

    Time frame: 52 weeks

  3. Weight change at 78 weeks (continuous)

    Weight change from baseline to week 78 in kgs (continuous)

    Time frame: 78 week

  4. Weight stability at 52 weeks

    Proportion of individuals who do not exceed 3% weight gain from baseline at 52 weeks.

    Time frame: 52 weeks

  5. 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)

    Time frame: 52 week

  6. 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)

    Time frame: 78 weeks

  7. 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.

    Time frame: 52 weeks

  8. 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.

    Time frame: 78 weeks

  9. Percentage of energy from fat (52 weeks)

    Percent of energy from fat measured using NCI Percentage Energy from Fat Screener measure

    Time frame: 52 weeks

  10. Percentage of energy from fat (78 weeks)

    Percent of energy from fat measured using NCI Percentage Energy from Fat Screener measure

    Time frame: 78 weeks

07

Study locations

1 site
  • University of Florida
    Gainesville, Florida 32611, United States
08

References and documents

Individual participant data

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

Supporting information: Study protocol, Sap, Icf, Analytic code

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06928571
Lead sponsor
University of Florida
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Responsible party
Sponsor
First posted
Apr 15, 2025
Start date
Apr 15, 2025
Primary completion
Jun 2029 (estimated)
Completion
Jun 2029 (estimated)
Last update
May 11, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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