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Enrolling by Invitation

NCT Number: NCT06928571

Using Online Tools to Increase Weight Loss in Primary Care

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida

Gainesville, Florida, 32611, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Connect4Health Engage

Behavioral

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

Connect4Health Discover

Behavioral

Educational control - information about healthy eating and physical activity

Primary outcomes

  1. Proportion achieving ≥ 3% weight loss

    Time frame: 52 weeks

    Proportion of patients achieving ≥3% weight loss

Secondary outcomes

  1. Weight stability at 78 weeks

    Time frame: 78 weeks

    Proportion of individuals who do not exceed 3% weight gain from baseline.

  2. Weight change at 52 weeks (continuous)

    Time frame: 52 weeks

    Weight change from baseline to week 52 in kgs (continuous)

  3. Weight change at 78 weeks (continuous)

    Time frame: 78 week

    Weight change from baseline to week 78 in kgs (continuous)

  4. Weight stability at 52 weeks

    Time frame: 52 weeks

    Proportion of individuals who do not exceed 3% weight gain from baseline at 52 weeks.

  5. 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 as measured using the International Physical Activity Questionnaire (IPAQ) (continuous measure MET minutes per week)

  6. Minutes of moderate-to-vigorous physical activity per week at 78 weeks

    Time frame: 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)

  7. Servings per day of fruits and vegetables (52 weeks)

    Time frame: 52 weeks

    Number of servings per day of fruits and vegetables measured by Eating at America's Table Study (EATS) fruit and vegetable screener.

  8. Servings per day of fruits and vegetables (78 weeks)

    Time frame: 78 weeks

    Number of servings per day of fruits and vegetables measured by Eating at America's Table Study (EATS) fruit and vegetable screener.

  9. Percentage of energy from fat (52 weeks)

    Time frame: 52 weeks

    Percent of energy from fat measured using NCI Percentage Energy from Fat Screener measure

  10. Percentage of energy from fat (78 weeks)

    Time frame: 78 weeks

    Percent of energy from fat measured using NCI Percentage Energy from Fat Screener measure

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Apr 15, 2025
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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