Clinical trial NCT06249477: Weight Loss and Physical Activity Lifestyle Interventions In Post Liver And Kidney Transplants
Official title: Weight Loss and Physical Activity Lifestyle Interventions In Post Liver And Kidney Transplants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Lifestyle Factors
Keywords: Transplant
Weight loss
Lifestyle intervention
Obesity management
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: American Society of Transplantation
First posted: 2024-02-08
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This research project seeks to learn more about how lifestyle interventions can help liver and kidney transplant recipients achieve weight loss goals. The investigators want to evaluate if an intervention using weight and activity wrist monitors, as well as nutritional coaching group sessions is acceptable and useful for post-transplant patients aiming for weight loss. All participants will be given a wrist activity monitor, and a scale. Half of participants will be invited to participate in the nutritional coaching group sessions. The research team will look at weight loss, devices' usage, and satisfaction, and see if there are any difference among the two groups.

Detailed description: This project aims to understand feasibility, acceptability, and appropriateness of using connected health services (use of Fitbit and Scale), and nutritional coaching group sessions as a lifestyle intervention for post-transplant patients seeking weight loss. Secondarily, the investigators aim to assess effectiveness of the intervention to generate weight loss. Enrolled patients will receive a wrist activity tracker (Fitbit Charge 4) and a scale, of which information synchronizes to the electronic health record. Steps, usage, and weight values will be recorded and analyzed from the devices. All patients will be followed with monthly calls to assess issues with devices, and address case-specific questions. Simultaneously, half of the patients will be randomized to receive every other month nutritional coaching group sessions on topics related to nutrition and physical activity. Patients will have an in-person follow-up appointment where laboratory values, body measurements, and physical and mental readiness for weight loss surveys and scales will be applied at 6 and 12-months. Patients that don't accomplish weight loss goal at 6 months will be invited to cross over to the nutritional coaching group sessions intervention arm.

Eligibility criteria: Inclusion Criteria:

* Prior liver or kidney transplant recipient
* BMI \>=30
* 6 months to 10 years post-transplant
* Stable immunosuppression as defined by no treatment for rejection in the past 3 months
* Access to Smartphone or computer
* Able to provide informed consent

Exclusion Criteria:

* Dual and/or simultaneous organ kidney and liver transplant
* Any type of other prior transplant
* Age \<= 18 years old
* Treatment for rejection within the last 3 months
* Major infection requiring hospitalization within the last 3 months
* Relisting for liver transplant or returned to dialysis for kidney transplant
* Physical inability to participate in lifestyle intervention activity recommendations
* Patients that are actively enrolled in a weight center program

Primary outcomes:
measure: Feasibility of intervention
timeFrame: 12 months (All study duration)
measure: Acceptability of intervention
timeFrame: 12 months (All study duration)
measure: Rate of highly satisfied Patients
timeFrame: 12 months (All study duration)
measure: Wrist activity tracker usage rate
timeFrame: 12 months (All study duration)
Secondary outcomes:
measure: Weight change percentage
timeFrame: 12 months (All study duration)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Leigh A Dageforde, MD, MPH
role: PRINCIPAL_INVESTIGATOR
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