Feasibility and Plausible Effectiveness of a Lifestyle Intervention in Kidney Transplant Recipients (HEAL)

NARecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

December 17, 2024

Primary Completion Date

October 1, 2026

Study Completion Date

March 1, 2027

Conditions
Kidney TransplantOverweight or Obese AdultsGlucose Control
Interventions
OTHER

Standard medical care

Standard Care Intervention will continue to receive their regular standard clinical care during the 6-month intervention period of this study.

BEHAVIORAL

Monitoring Contacts

Participants will receive brief conducts (\<10 minutes) remotely (telephone or video platform) with the research staff at weeks 6, 12, and 18.

BEHAVIORAL

Behavioral Sessions

Participants will be provided weekly individual behavioral sessions during the 6-month intervention to assist in supporting recommended changes in energy intake (diet) and physical activity.

BEHAVIORAL

Diet

An energy balanced diet to meet energy needs that will allow for weight maintenance will be prescribed. This will be estimated using the Mifflin-St. Joer equation to estimate resting metabolic rate and for most participants we anticipate using a physical activity correction of 1.3 to account for energy needs for physical activity. This will provide the initial estimate of energy intake needs to maintain weight stability; however, the prescribed level of energy intake will be adjusted at 4-week intervals across the intervention based on the observed changes in weight, eating behaviors, and physical activity patterns in an effort to prevent excessive weight gain. Within the context of this level of energy intake, we will prescribe a diet that is consistent with the dietary recommendations of the National Kidney Foundation.

BEHAVIORAL

Physical Activity

Physical activity will be recommended in the form of aerobic types of activity such as brisk walking and will progress in 4-week intervals from an initial amount of 50 minutes per week to 150 minutes per week across the initial 6 months of the intervention. Moderate intensity will be prescribed, and will be anchored using RPE (rating of perceived exertion) to allow intensity to be self-regulated according to the participant's capacity. Physical activity will be prescribed in the form of walking; however, the participant will be permitted to engage in other forms of physical activity that meet the recommended dose and intensity.

Trial Locations (1)

66160

RECRUITING

University of Kansas Medical Center, Kansas City

All Listed Sponsors
collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

lead

University of Kansas Medical Center

OTHER