Ignite Creation Date:
2024-05-06 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06249477
Status:
COMPLETED
Last Update Posted:
2024-02-08
First Post:
2024-01-22
Brief Title:
Weight Loss and Physical Activity Lifestyle Interventions In Post Liver And Kidney Transplants
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Weight Loss and Physical Activity Lifestyle Interventions In Post Liver And Kidney Transplants
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 dont accomplish weight loss goal at 6 months will be invited to cross over to the nutritional coaching group sessions intervention arm
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None