Using Online Tools to Increase Weight Loss in Primary Care

Not Applicable

• Conditions: Obesity

• Registration Number: NCT06928571
• Lead Sponsor: University of Florida

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-07
• Study First Submitted QC: 2025-04-07
• Study Start: 2025-04-15
• Study First Posted: 2025-04-15
• Last Update Submitted: 2025-04-18
• Last Update Posted: 2025-04-22
• Primary Completion: 2028-11
• Study Completion: 2029-05

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 473

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Proportion achieving ≥ 3% weight loss	52 weeks	Proportion of patients achieving ≥3% weight loss

Secondary Outcome Measures

Name	Time	Method
Weight stability at 78 weeks	78 weeks	Proportion of individuals who do not exceed 3% weight gain from baseline.
Weight change at 52 weeks (continuous)	52 weeks	Weight change from baseline to week 52 in kgs (continuous)
Weight change at 78 weeks (continuous)	78 week	Weight change from baseline to week 78 in kgs (continuous)
Weight stability at 52 weeks	52 weeks	Proportion of individuals who do not exceed 3% weight gain from baseline at 52 weeks.
Minutes of moderate-to-vigorous physical activity per week at 52 weeks	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)
Servings per day of fruits and vegetables (78 weeks)	78 weeks	Number of servings per day of fruits and vegetables measured by Eating at America's Table Study (EATS) fruit and vegetable screener.
Percentage of energy from fat (52 weeks)	52 weeks	Percent of energy from fat measured using NCI Percentage Energy from Fat Screener measure
Percentage of energy from fat (78 weeks)	78 weeks	Percent of energy from fat measured using NCI Percentage Energy from Fat Screener measure
Minutes of moderate-to-vigorous physical activity per week at 78 weeks	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)
Servings per day of fruits and vegetables (52 weeks)	52 weeks	Number of servings per day of fruits and vegetables measured by Eating at America's Table Study (EATS) fruit and vegetable screener.

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States