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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Massachusetts General Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
American Society of Transplantation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 28, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 22, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 8, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 8, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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