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Completed

NCT Number: NCT03697317

Televideo Exercise and Nutrition Program for Kidney Transplant Recipients

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.

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Key information

Conditions

Kidney Transplant Recipient Behavior Diet Modification Motor Activity Physical Activity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Televideo Lifestyle Coaching

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

Behavioral

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

Primary outcomes

  1. Recruitment of participants

    Time frame: 1 month

    Achievement of 10 participants in 1 months

  2. Attendance to group sessions

    Time frame: 3 months

    Maintain 80% attendance or better to program sessions

  3. Participant retention in study assessments

    Time frame: 6 months

    85% or greater participant retention in study assessments

Secondary outcomes

  1. Change in diet quality assessed by Healthy Eating Index Scores

    Time frame: Change from baseline to month 6

    Changes in dietary quality will be determined by calculating Healthy Eating Index- 2010 scores from 3 day food records. A total HEI-2010 score will be calculated, which is comprised of a summative score across 12 subscales, with higher scores indicative of a better diet quality (maximum score 100).

  2. Change in weight

    Time frame: Change from baseline to month 6

    Weight in kilograms will be measured with a digital scale

Other outcomes

  1. Quality of Life-Kidney Transplant Questionnaire (KTQ)

    Time frame: Baseline, 3 months, 6 months

    Quality of life will be assessed using the Kidney Transplant Questionnaire, a 25-question disease-specific questionnaire with 5 dimensions measured- physical symptoms, fatigue, uncertainty/fear, appearance, and emotions. A higher score indicates a greater quality of life. A change in score greater than 0.5 in each domain is clinically significant.

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 5, 2018
Registry last updated
Oct 5, 2018

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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