Using Online Tools to Increase Weight Loss in Primary Care

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: Enrolling by invitation
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Connect4Health Engage; Behavioral: Connect4Health Discover

• Study Type: Interventional
• Enrollment (Estimated): 473
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Proportion achieving ≥ 3% weight loss	Proportion of patients achieving ≥3% weight loss	52 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight stability at 78 weeks	Proportion of individuals who do not exceed 3% weight gain from baseline.	78 weeks
Weight change at 52 weeks (continuous)	Weight change from baseline to week 52 in kgs (continuous)	52 weeks
Weight change at 78 weeks (continuous)	Weight change from baseline to week 78 in kgs (continuous)	78 week
Weight stability at 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	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	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)	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)	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)	Percent of energy from fat measured using NCI Percentage Energy from Fat Screener measure	52 weeks
Percentage of energy from fat (78 weeks)	Percent of energy from fat measured using NCI Percentage Energy from Fat Screener measure	78 weeks

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2025
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: April 7, 2025
• First Submitted That Met QC Criteria: April 7, 2025
• First Posted (Actual): April 15, 2025

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: obesity
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity
• Other Study ID 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