CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
Fitbit (Control) +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03191630
NCT03191630N/ACompleted

Increasing Activity Post-Kidney Transplant With SystemCHANGE

Ohio State University·interventional·Posted Jun 19, 2017·Updated Mar 23, 2021

In Brief

A clinical study evaluating Fitbit (Control) and SystemCHANGE and Fitbit (Intervention) for Kidney Transplant; Complications and 3 related conditions. Completed, enrolled 60 participants across 1 site.

Detailed Summary

Inactivity is a common problem among older kidney transplant recipients (KTRs) and is associated with their high incidence of obesity and cardiovascular problems which are the leading cause of death for KTRs. However, the combination of SystemCHANGE activity trackers holds promise for increasing physical activity of KTR patients post-surgery. This pilot study will incorporate Fitbit health trackers with an intervention of questions about influences to physical activity in a population of kidney transplant recipients who are at particularly high risk of cardiovascular disease and death.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedJun 19, 2017
Enrollment StartOct 1, 2017
Primary CompletionApr 30, 2020
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 9.0 years ago

Interventions

Fitbit (Control)behavioral

Study procedures include group sessions at the OSU Transplant Clinic with 10-12 participants for 6 months and a 6-month maintenance phase without contact from study personnel until month 12. Session 1 for the control group will be identical to the Intervention with the only exception being that participants in the control group will not be asked to increase their step goal. Throughout their participation, subjects will be asked questions only about their use of the Fitbit activity tracker. The research team will not be in contact with them for 6 months, after which time there will be a final group session.

SystemCHANGE and Fitbit (Intervention)behavioral

Study procedures include group sessions with 10-12 participants for 6 months and a 6-month maintenance phase without contact from study personnel until month 12. Study personnel will demonstrate proper Fitbit activity tracker use, and teach participants to sync to their smartphone and retrieve data from their Fitbit. Subjects will be called to encourage them to increase their step goal 5% each month. Fitbit activity tracker reports will be reviewed and participants will be asked to identify what people or things influence their physical activity. Subjects will be asked what they are learning about physical activity, their contentment level with current physical activity, and if they want to make changes. Participants will continue for months, after which time there will be a final group session.