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Completed

NCT Number: NCT06249477

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

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.

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Key information

Conditions

Weight Loss Body Weight Body Weight Changes Lifestyle Factors Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Wrist activity tracker and scale

Device

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

Nutritional Coaching group sessions

Behavioral

Nutritional coaching group sessions held via zoom and performed by a certified clinical nutritionist regarding nutrition, and physical activity specific for weight loss.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • American Society of Transplantation

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 8, 2024
Registry last updated
Feb 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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