NCT03697317

Brief Summary

The improvement in morbidity and mortality observed with kidney transplantation is often curtailed by post-transplant weight gain, which is common among kidney transplant recipients (KTR). Post-transplant weight gain is associated with serious health issues such as cardiovascular disease, new onset diabetes after transplantation, and graft failure. Although these adverse effects of post-transplant weight gain are well recognized, interventions that target the modifiable risk factors of diet and physical activity to address post-transplantation weight gain are lacking. The purpose of this study is to test the feasibility of an in-home, televideo health coaching to increase the healthy behaviors of KTRs who are 6 months post-transplantation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 12, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 5, 2018

Completed
Last Updated

October 5, 2018

Status Verified

October 1, 2018

Enrollment Period

7 months

First QC Date

September 21, 2018

Last Update Submit

October 3, 2018

Conditions

Kidney Transplant RecipientDiet ModificationPhysical Activity

Outcome Measures

Primary Outcomes (3)

  • Recruitment of participants

    Achievement of 10 participants in 1 months

    1 month

  • Attendance to group sessions

    Maintain 80% attendance or better to program sessions

    3 months

  • Participant retention in study assessments

    85% or greater participant retention in study assessments

    6 months

Secondary Outcomes (2)

  • Change in diet quality assessed by Healthy Eating Index Scores

    Change from baseline to month 6

  • Change in weight

    Change from baseline to month 6

Other Outcomes (1)

  • Quality of Life-Kidney Transplant Questionnaire (KTQ)

    Baseline, 3 months, 6 months

Study Arms (2)

Televideo Lifestyle Coaching

EXPERIMENTAL
Behavioral: Televideo Lifestyle Coaching

Enhanced Usual Care

ACTIVE COMPARATOR
Behavioral: Enhanced Usual Care

Interventions

Televideo Lifestyle CoachingBEHAVIORAL

Six month total intervention: Three months of weekly 1-hour televideo healthy lifestyle coaching sessions involving 30 minutes of structured physical activity and 30 minutes of nutrition education and daily healthy lifestyle habit tracking. This is followed by 3 months of healthy lifestyle habit tracking only.

Televideo Lifestyle Coaching
Enhanced Usual CareBEHAVIORAL

Six months of healthy lifestyle habit tracking with access to written diet and physical activity materials.

Enhanced Usual Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years or older
  • Between 6 and 12 months post kidney transplantation
  • Kidney allograft only
  • Functioning allograft (not on dialysis)
  • BMI ≥ 22 kg/m2
  • Available to participate in assessments over 6 months
  • Ability to speak and understand English
  • Able to report data weekly by at least one of three alternative methods: telephone, email, or fax
  • Access to wireless internet

You may not qualify if:

  • Multi-organ transplant recipient
  • Uncontrolled diabetes (Hemoglobin A1c≥8%)
  • Currently pregnant or planning on becoming pregnant during the study
  • Participation in a formal weight management, nutrition, or physical activity program
  • Diagnosis of a major psychiatric illness
  • Major dietary restrictions
  • Inability to perform moderate to vigorous physical activity
  • Unwillingness to be randomized
  • Receiving supplemental nutrition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Related Publications (1)

  • Gibson CA, Gupta A, Greene JL, Lee J, Mount RR, Sullivan DK. Feasibility and acceptability of a televideo physical activity and nutrition program for recent kidney transplant recipients. Pilot Feasibility Stud. 2020 Sep 10;6:126. doi: 10.1186/s40814-020-00672-4. eCollection 2020.

    PMID: 32944274DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Cheryl A Gibson, PhD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 21, 2018

First Posted

October 5, 2018

Study Start

September 12, 2017

Primary Completion

March 30, 2018

Study Completion

March 30, 2018

Last Updated

October 5, 2018

Record last verified: 2018-10

Locations

US(1)