Weight Loss and Physical Activity Lifestyle Interventions In Post Liver And Kidney Transplants

Mass General Brigham

Status: Completed

Conditions: Weight Loss; Lifestyle Factors

Treatments: Behavioral: Nutritional Coaching group sessions; Device: Wrist activity tracker and scale

Study type: Interventional

Funder types: Other

Identifiers

NCT06249477

2021P003412

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Control group

Other group

Description:

Patients receive a wrist activity monitor and a scale. They are also followed with monthly calls ensuring adequate functioning of devices and receiving case-specific nutritional guidance.

Treatment:

Device: Wrist activity tracker and scale

Group intervention group

Experimental group

Description:

In addition to receiving a wrist activity monitor, scale, and being followed with monthly calls, patients in this arm received every other month nutritional coaching group sessions on topics related to nutrition and physical activity to promote education and lifestyle changes

Treatment:

Device: Wrist activity tracker and scale

Behavioral: Nutritional Coaching group sessions