Using Online Tools to Increase Weight Loss in Primary Care

NCT06928571 | Enrolling By Invitation

• 2 other identifiers: IRB202400390R01DK137092
• Study Type: interventional
• Target: 473
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

obesity

Outcome Measures

Primary Outcomes (1)

• Proportion achieving ≥ 3% weight loss

  Proportion of patients achieving ≥3% weight loss

  52 weeks

Secondary Outcomes (10)

• Weight stability at 78 weeks

  78 weeks

• Weight change at 52 weeks (continuous)

  52 weeks

• Weight change at 78 weeks (continuous)

  78 week

• Weight stability at 52 weeks

  52 weeks

• Minutes of moderate-to-vigorous physical activity per week at 52 weeks

  52 week

Study Arms (2)

Connect4Health Engage

EXPERIMENTAL

Receive Connect4Health Engage

Behavioral: Connect4Health Engage

Connect4Health Discover

ACTIVE COMPARATOR

Receive Connect4Health Discover

Behavioral: Connect4Health Discover

Interventions

Connect4Health Engage BEHAVIORAL

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

Connect4Health Engage

Connect4Health Discover BEHAVIORAL

Educational control - information about healthy eating and physical activity

Connect4Health Discover

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Statistician/analyst
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 15, 2025
• Study Start: April 15, 2025
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• 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.
• 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.

Locations

US (1)