Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2025-12-24 @ 4:36 PM
NCT ID:
NCT05190666
Eligibility Criteria:
Inclusion Criteria:
Participants must:
* have a body mass index between 25-45 kg/m2
* have had a knee replacement (including primary, staged or independent bilateral, or revision) \<6 months prior to baseline assessment
* have a computer, tablet, or smartphone with active internet access to self-monitor online and/or have a device or computer compatible with Fitbit
* completion of baseline assessment measures (height, weight, function tests, surveys, ≥4 days valid of activity monitoring, and 1 day of dietary recall)
* be English-speaking and able to read consent and study materials written in English
* be willing to attend 4 in-person assessments.
Exclusion Criteria:
* have any contraindications to diet or weight loss
* undergo simultaneous bilateral knee replacement or have a scheduled or anticipated knee replacement for the contralateral knee within the next 18 months
* have a mobility limiting comorbidity unrelated to knee replacement (e.g. spinal stenosis, fibromyalgia, peripheral vascular disease, stroke)
* are taking anti-obesity medications
* are enrolled in a formal weight loss program
* had or are planning to have bariatric/gastric/lap band surgery
* are planning to relocate out of the Columbia or Greenville, SC areas in the next 18 months.
Healthy Volunteers:
True
Sex:
ALL
Study:
NCT05190666
Study Brief:
Protocol Section:
NCT05190666