Televideo Exercise and Nutrition Program for Kidney Transplant Recipients

NCT ID: NCT03697317

Last Updated: 2018-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-12

Study Completion Date

2018-03-30

Brief Summary

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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.

Detailed Description

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Conditions

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Kidney Transplant Recipient Diet Modification Physical Activity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Televideo Lifestyle Coaching

Group Type EXPERIMENTAL

Televideo Lifestyle Coaching

Intervention Type BEHAVIORAL

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.

Enhanced Usual Care

Group Type ACTIVE_COMPARATOR

Enhanced Usual Care

Intervention Type BEHAVIORAL

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

Interventions

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Televideo Lifestyle Coaching

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.

Intervention Type BEHAVIORAL

Enhanced Usual Care

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Kansas Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Cheryl Gibson

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cheryl A Gibson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

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University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 32944274 (View on PubMed)

Other Identifiers

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STUDY00140695

Identifier Type: -

Identifier Source: org_study_id

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