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Using Online Tools to Increase Weight Loss in Primary Care

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University of Florida

Status

Invitation-only

Conditions

Obesity

Treatments

Behavioral: Connect4Health Engage
Behavioral: Connect4Health Discover

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT06928571
IRB202400390
R01DK137092 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

473 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

473 participants in 2 patient groups

Connect4Health Engage
Experimental group
Description:
Receive Connect4Health Engage
Treatment:
Behavioral: Connect4Health Engage
Connect4Health Discover
Active Comparator group
Description:
Receive Connect4Health Discover
Treatment:
Behavioral: Connect4Health Discover

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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