Using Online Tools to Increase Weight Loss in Primary Care

NCT ID: NCT06928571

Last Updated: 2025-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

473 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-15

Study Completion Date

2029-05-31

Brief Summary

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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

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Statistician/analyst

Study Groups

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Connect4Health Engage

Receive Connect4Health Engage

Group Type EXPERIMENTAL

Connect4Health Engage

Intervention Type BEHAVIORAL

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

Connect4Health Discover

Receive Connect4Health Discover

Group Type ACTIVE_COMPARATOR

Connect4Health Discover

Intervention Type BEHAVIORAL

Educational control - information about healthy eating and physical activity

Interventions

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Connect4Health Engage

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

Intervention Type BEHAVIORAL

Connect4Health Discover

Educational control - information about healthy eating and physical activity

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Florida

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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R01DK137092

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB202400390

Identifier Type: -

Identifier Source: org_study_id

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