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

January 31, 2024 updated by: Leigh Anne Dageforde, Massachusetts General Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Massachusetts

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control group
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.
Device: Wrist activity tracker and scale
Wrist activity tracker used to evaluate number of steps, heart rate, and frequency of usage of the devices to monitor activity. Scale used to record a patient's weight value.
Other Names:
  • Fitbit Charge 4
Experimental: Group intervention group
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
Device: Wrist activity tracker and scale
Wrist activity tracker used to evaluate number of steps, heart rate, and frequency of usage of the devices to monitor activity. Scale used to record a patient's weight value.
Other Names:
  • Fitbit Charge 4
Behavioral: Nutritional Coaching group sessions
Nutritional coaching group sessions held via zoom and performed by a certified clinical nutritionist regarding nutrition, and physical activity specific for weight loss.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of intervention
Time Frame: 12 months (All study duration)
The Feasibility of Intervention Measurement (FIM) is a previously-validated survey tool used in implementation science, and answered by participants, that uses a Likert scale from 1 to 5 to evaluate feasibility of the proposed intervention. A score greater than or equal to 4 is considered acceptable feasibility.
12 months (All study duration)
Acceptability of intervention
Time Frame: 12 months (All study duration)
The Acceptability of Intervention Measurement (AIM) is a previously-validated survey tool used in implementation science, and answered by participants, that uses a Likert scale from 1 to 5 to evaluate acceptability of the proposed intervention. A score greater than or equal to 4 is considered adequate acceptability.
12 months (All study duration)
Rate of highly satisfied Patients
Time Frame: 12 months (All study duration)
Patient-completed satisfaction questionnaires will be evaluated using a Likert scale from 1 to 5 with five being very satisfied and one being very unsatisfied. Satisfaction surveys were asked separately for the use of devices (Fitbit and smart scale), every other month follow-up calls, and every other month group sessions. An additional overall satisfaction score was also obtained for the entire intervention. High satisfaction will be considered the proportion of "somewhat satisfied" and "very satisfied" answers.
12 months (All study duration)
Wrist activity tracker usage rate
Time Frame: 12 months (All study duration)
Usage rate will be calculated as the proportion of days in which steps are logged in relation to the number of days per month.
12 months (All study duration)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight change percentage
Time Frame: 12 months (All study duration)
Target Weight change percentage will be considered a greater than or equal to 2.5% loss at 6 months, and greater than or equal to 5% weight loss over the course of the 12-month period.
12 months (All study duration)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

American Society of Transplantation

Investigators

  • Principal Investigator: Leigh A Dageforde, MD, MPH, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2022

Primary Completion (Actual)

April 30, 2023

Study Completion (Actual)

May 30, 2023

Study Registration Dates

First Submitted

January 22, 2024

First Submitted That Met QC Criteria

January 31, 2024

First Posted (Actual)

February 8, 2024

Study Record Updates

Last Update Posted (Actual)

February 8, 2024

Last Update Submitted That Met QC Criteria

January 31, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021P003412

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to share individual participant data available to other researchers since all data analysis and publications that derive from the information collected through this trial will be handled and analyzed by the current research team. No additional analyses or data management other than the originally intended is planned or allowed.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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