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Enrolling by invitation NCT06928571

Using Online Tools to Increase Weight Loss in Primary Care

No phase Interventional Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Connect4Health Engage, Connect4Health Discover.
Who it may be relevant to
Registry conditions: Obesity. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Hybrid Effectiveness/ Implementation Trial Using Online Tools to Increase Weight Loss Among Primary Care Patients

Overview

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.

Interventions

  • Behavioral Connect4Health Engage
    Intervention focused on motivating and guiding patients to use empirically supported, freely available online tools for weight loss.
  • Behavioral Connect4Health Discover
    Educational control - information about healthy eating and physical activity

Primary outcome measures

  • Proportion achieving ≥ 3% weight loss [Time frame: 52 weeks]
Secondary outcome measures (10)
  • Weight stability at 78 weeks [Time frame: 78 weeks]
  • Weight change at 52 weeks (continuous) [Time frame: 52 weeks]
  • Weight change at 78 weeks (continuous) [Time frame: 78 week]
  • Weight stability at 52 weeks [Time frame: 52 weeks]
  • Minutes of moderate-to-vigorous physical activity per week at 52 weeks [Time frame: 52 week]
  • Minutes of moderate-to-vigorous physical activity per week at 78 weeks [Time frame: 78 weeks]
  • Servings per day of fruits and vegetables (52 weeks) [Time frame: 52 weeks]
  • Servings per day of fruits and vegetables (78 weeks) [Time frame: 78 weeks]
  • Percentage of energy from fat (52 weeks) [Time frame: 52 weeks]
  • Percentage of energy from fat (78 weeks) [Time frame: 78 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Florida — Gainesville

Identifiers

NCT: NCT06928571 · IRB202400390 · R01DK137092

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗