Clinical trial NCT06928571: Using Online Tools to Increase Weight Loss in Primary Care
Official title: A Hybrid Effectiveness/ Implementation Trial Using Online Tools to Increase Weight Loss Among Primary Care Patients
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Obesity
Keywords: obesity
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2025-04-15
Enrollment: 473
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion achieving ≥ 3% weight loss
timeFrame: 52 weeks
Secondary outcomes:
measure: Weight stability at 78 weeks
timeFrame: 78 weeks
measure: Weight change at 52 weeks (continuous)
timeFrame: 52 weeks
measure: Weight change at 78 weeks (continuous)
timeFrame: 78 week
measure: Weight stability at 52 weeks
timeFrame: 52 weeks
measure: Minutes of moderate-to-vigorous physical activity per week at 52 weeks
timeFrame: 52 week
measure: Minutes of moderate-to-vigorous physical activity per week at 78 weeks
timeFrame: 78 weeks
measure: Servings per day of fruits and vegetables (52 weeks)
timeFrame: 52 weeks
measure: Servings per day of fruits and vegetables (78 weeks)
timeFrame: 78 weeks
measure: Percentage of energy from fat (52 weeks)
timeFrame: 52 weeks
measure: Percentage of energy from fat (78 weeks)
timeFrame: 78 weeks
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
References: