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Purpose

In this pilot study, we will test the hypothesis that a POPOP for currently ineligible UAMS orthopedic surgery patients wanting hip or knee replacement improves markers of preoperative health, ability to reach a BMI threshold <40 kg/m2 required for surgical eligibility, and postoperative outcomes versus SOC.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • End-stage knee or hip osteoarthritis, avascular necrosis, or rheumatoid arthritis with recommended primary, unilateral total joint arthroplasty by orthopaedic surgeons at the University of Arkansas for Medical Sciences (Jeffrey Stambough, Dr. C. Lowry Barnes, Dr. Simon Mears, and Dr. Benjamin Stronach) - BMI between 41.00-48.00 kg/m2 at time of enrollment - Over the age of 18 years - Would consider undergoing a total joint arthroplasty if eligible - Owns a smartphone or tablet with Bluetooth capability, cell signal or WIFI connection - Willing to comply with the requirements of the study and provide informed consent prior to enrollment.

Exclusion Criteria

  • Patients with a BMI less than 41.00 or greater than 48.00 - Pregnancy - Breastfeeding - History of a major organ transplant or other health issue requiring immunosuppressant drugs - Strict vegetarian diet - Diagnosis of and/or are taking medication for psychiatric conditions including schizophrenia, bipolar disorder or manic depression - Patients scheduled for, or those who have previously undergone, bariatric surgery - Patients unable to understand and speak English - Patients requiring a revision or bilateral TJA - Patients unwilling or unable to use a bluetooth-enabled smartphone with cell service or home internet access - Incarceration

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Two group randomized control trial comparing the intervention (POPOP) and standard of care (SOC).
Primary Purpose
Treatment
Masking
None (Open Label)
Masking Description
Due to the nature of the interventions, masking or blinded participation is not possible.

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Standard of Care 		The first arm consists of UAMS standard of care (SOC), including providing a brochure with information (contact information, brief educational information) for the patient to consult with a nutritionist to help with self-directed weight loss.
  • Other: SOC (standard of care)
    Referral to a dietician for two months of self-directed weight loss
Experimental
Intervention (POPOP) 		The second arm is a specified 2-month POPOP focused on weight loss administered by the external partner, 20Lighter. The program includes customized meal plans; vitamin, mineral and nutritional supplementation; and daily engagement via a smartphone app with a 20Lighter health care provider. Video conferencing appointments will occur approximately every 3 weeks. The program does not require any exercise or physical engagement but does necessitate that patients have a smartphone or tablet with Bluetooth capability, cell signal or WIFI connection. During the first 40 days the customized meal plans are adhered to, then from days 41-60 patients will transition back to a normal dietary lifestyle via a customized plan based on considerations including, food preferences, physical engagement and height. Patients who achieve a BMI below 40.0 before the end of the 60 day program may be seen sooner than 90d for follow-up appointment in the UAMS clinic.
  • Other: POPOP (preoperative patient optimization program)
    A 2 month structured program focused on reduction of BMI, body weight, visceral fat, body fat and improvement of lean body mass and intracellular fluid.
    Other names:
    • 20Lighter

Recruiting Locations

More Details

NCT ID
NCT04910048
Status
Active, not recruiting
Sponsor
University of Arkansas

Detailed Description

After being informed about the study and potential risks, all patients giving written informed consent will be screened to determine eligibility for study entry. Patients who meet eligibility criteria will be randomized into one of two groups: Standard of Care or the POPOP (20Lighter).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.