Lifestyle Intervention for Kidney Transplant Recipients

(HEAL Trial)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Kansas Medical Center

Must not be taking: Anti-obesity, Anticoagulants, Antidepressants, others

Disqualifiers: Pregnancy, Diabetes, Heart failure, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to learn whether if it is feasible to implement a study of patients receiving kidney transplantation, to learn if these patients will complete selective outcomes measurements, and to examine if a lifestyle intervention may assist with preventing weight gain compared to standard medical care. The main questions it aims to answer are: * Is it feasible to recruit and retain patients who have undergone kidney transplantation into a study to compare standard medical care to standard medical care plus a lifestyle intervention focused on prevention of weight gain? * Will participants engage in the interventions and be compliant to the components of the interventions? * Will there be any difference between the interventions between the interventions for the occurrence of adverse events specific to kidney transplantation? * Will there be initial effectiveness for the standard medical care plus a lifestyle intervention to have a better effect on preventing weight gain compared to standard medical care alone? * Will there be initial effectiveness for the standard medical care plus a lifestyle intervention to have a better effect on body composition compared to standard medical care alone? * Will there be initial effectiveness for the standard medical care plus a lifestyle intervention to have a better effect on fasting glucose compared to standard medical care alone? * Will there be initial effectiveness for the standard medical care plus a lifestyle intervention to have a better effect on fasting insulin compared to standard medical care alone? * Will there be initial effectiveness for the standard medical care plus a lifestyle intervention to have a better effect on insulin sensitivity compared to standard medical care alone? * Will there be initial effectiveness for the standard medical care plus a lifestyle intervention to have a better effect on physical function compared to standard medical care alone? * Will there be initial effectiveness for the standard medical care plus a lifestyle intervention to have a better effect on health-related quality of life compared to standard medical care alone? * Will there be initial effectiveness for the standard medical care plus a lifestyle intervention to have a better effect on changes in dietary intake compared to standard medical care alone? * Will there be initial effectiveness for the standard medical care plus a lifestyle intervention to have a better effect on physical activity and sedentary behavior compared to standard medical care alone? Participants will: * Participants will continue with their standard medical care following kidney transplantation. * Participants only receiving standard medical care will also complete brief monitoring visits at week 6, 12, and 18. * Participants receiving the lifestyle intervention will attend weekly intervention sessions and will be recommended to modify their diet and physical activity behaviors in an effort to prevent weight gain. * Participants will complete outcome measurements as the start of the study and again after 6 months in the study. * After 6 months in the study, participants will also complete a brief intervention and answer other questions about their experience in the study.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must continue with your standard medical care following kidney transplantation.

What data supports the effectiveness of the treatment Lifestyle Intervention for Kidney Transplant Recipients?

Research shows that lifestyle interventions, including dietary and physical activity changes, are important in managing chronic kidney disease and have been recommended in clinical guidelines. Additionally, tailored lifestyle programs have been shown to improve nutrition and stress management in patients with early-stage kidney disease. ^{1 2 3 4 5}

Is lifestyle intervention safe for kidney transplant recipients?

Lifestyle interventions, including diet and exercise, have been studied in people with chronic kidney disease and are generally considered safe. These interventions are often recommended in clinical guidelines and have been tailored to individual needs, showing improvements in physical health indicators without reported safety concerns. ^{1 4 5 6 7}

How is the lifestyle intervention treatment for kidney transplant recipients different from other treatments?

This lifestyle intervention is unique because it focuses on helping kidney transplant recipients adhere to recommended lifestyle changes, such as diet and physical activity, which are crucial for the success of the transplant. Unlike standard drug treatments, this approach emphasizes behavior modification to improve long-term health outcomes. ^{1 8 9 10 11}

Research Team

Eligibility Criteria

This trial is for individuals who have received a kidney transplant and are dealing with obesity or need to control their blood sugar. They should be willing to participate in lifestyle changes, attend behavioral sessions, and follow up regularly. Those not able to commit to the study's requirements or at risk of non-compliance may not qualify.

Inclusion Criteria

I am eligible regardless of my gender or ethnicity.

I can walk for exercise.

Body mass index (BMI) >22 kg/m2. No maximal BMI provided weight does not exceed 350 pounds.

Exclusion Criteria

I am currently taking medication for weight loss.

My mental health medication has been stable for the last year and I haven't been hospitalized for depression in the last 5 years.

I have a health condition or am receiving treatment that affects my body weight.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard medical care or standard medical care plus a lifestyle intervention focused on dietary modification and physical activity for body weight regulation

6 months

Weekly intervention sessions for lifestyle group; monitoring visits at weeks 6, 12, and 18 for standard care group

Follow-up

Participants are monitored for safety and effectiveness after treatment, including outcome measurements and qualitative interviews

4 weeks

1 visit (in-person) for outcome measurements and interviews

Treatment Details

Interventions

• Lifestyle Intervention (Behavioural Intervention)

Trial Overview The study tests if adding a lifestyle intervention program (including diet and physical activity changes) to standard medical care can prevent weight gain better than standard care alone in kidney transplant recipients. It also looks at effects on body composition, glucose levels, insulin sensitivity, physical function, quality of life, dietary intake, and activity behaviors.

Participant Groups

Group I: Standard Medical Care plus Lifestyle Intervention Experimental Treatment 4 Interventions

Standard Medical Care plus Lifestyle Intervention will continue to receive their regular standard clinical care and a behavioral intervention focused on dietary modification and physical activity for body weight regulation.

Group II: Standard Medical Care Active Control 2 Interventions

Standard Care Intervention will continue to receive their regular standard clinical care during the 6-month intervention period of this study and will also receive brief conducts (\<10 minutes) from the research staff at weeks 6, 12, and 18.

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

Dr. Steve Stites

University of Kansas Medical Center

Chief Executive Officer

MD from University of Kansas School of Medicine

Dr. Matthias Salathe

University of Kansas Medical Center

Chief Medical Officer

MD from University of Kansas School of Medicine

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Dr. Griffin P. Rodgers

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

Chief Executive Officer since 2007

MD, M.A.C.P.

Dr. Griffin P. Rodgers

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

Chief Medical Officer since 2007

MD, M.A.C.P.

Findings from Research

Early intensive dietary intervention and follow-up significantly reduced weight gain in renal transplant patients, with group A gaining an average of 5.5 kg compared to 11.8 kg in group B over one year.

Patients receiving dietary advice (group A) maintained a lower body mass index (BMI) at both 4 months and 1 year posttransplant compared to those who did not receive advice (group B), highlighting the importance of dietary management in posttransplant care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of dietary intervention on weight gains after renal transplantation. Patel, MG.[2019]

In a randomized controlled trial involving renal transplant recipients with abnormal glucose tolerance, those receiving regular dietary consultations showed significant reductions in total fat and saturated fat intake compared to standard care, indicating the effectiveness of dietitian involvement in improving dietary habits.

While the intervention group experienced a trend towards weight loss, simple exercise advice did not lead to improvements in physical activity levels or cardiorespiratory fitness, suggesting that more comprehensive strategies are needed to enhance fitness in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of dietetic advice for modification of cardiovascular disease risk factors in renal transplant recipients. Orazio, LK., Isbel, NM., Armstrong, KA., et al.[2016]

A study involving 120 patients with early stage chronic kidney disease (CKD) showed that tailored lifestyle interventions over 30 months led to significant improvements in waist circumference, nutrition, and stress management compared to usual care.

Despite these positive changes in physical indicators, there was no observed improvement in quality of life, highlighting the need for clinicians to consider patients' readiness to change when implementing lifestyle modifications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tailoring Health-promoting Programs for Patients with Chronic Kidney Disease: Randomized Controlled Trial. Teng, HL., Yen, M., Fetzer, S., et al.[2021]

This study aims to evaluate a culturally tailored diet and exercise intervention for kidney transplant recipients, focusing on feasibility and acceptability immediately after transplantation.

The intervention will be personalized by a registered dietitian and a physical rehabilitation therapist, using technology to enhance communication and retention, with outcomes including adherence and quality of life improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for the IMPACT Trial: Improving Healthcare Outcomes in American Transplant Recipients Using Culturally-Tailored Novel Technology. Rice, CM., Singh, PP., Judd, NS., et al.[2023]

The Healthy Hearts and Kidneys study is evaluating different mobile health (mHealth) interventions to help individuals with type 2 diabetes and chronic kidney disease make lifestyle changes, focusing on behavioral counseling and technology-based self-monitoring.

Participants are randomized into four groups to assess the effectiveness of these interventions on weight loss and urinary excretion of sodium and phosphorus, highlighting the importance of tailored approaches in managing complex chronic diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Healthy Hearts and Kidneys (HHK) study: Design of a 2×2 RCT of technology-supported self-monitoring and social cognitive theory-based counseling to engage overweight people with diabetes and chronic kidney disease in multiple lifestyle changes. Sevick, MA., Woolf, K., Mattoo, A., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Physical activity and nutrition in chronic kidney disease. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

The effect of dietary intervention on weight gains after renal transplantation. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Evaluation of dietetic advice for modification of cardiovascular disease risk factors in renal transplant recipients. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

Tailoring Health-promoting Programs for Patients with Chronic Kidney Disease: Randomized Controlled Trial. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Lifestyle change interventions for children and adolescents with diabetes or kidney disease. [2013]

6. United States pubmed.ncbi.nlm.nih.gov

Protocol for the IMPACT Trial: Improving Healthcare Outcomes in American Transplant Recipients Using Culturally-Tailored Novel Technology. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

The Healthy Hearts and Kidneys (HHK) study: Design of a 2×2 RCT of technology-supported self-monitoring and social cognitive theory-based counseling to engage overweight people with diabetes and chronic kidney disease in multiple lifestyle changes. [2021]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Medication compliance and lifestyle adherence in renal transplant recipients in Kuwait. [2022]

9. Iran pubmed.ncbi.nlm.nih.gov

Compliance with recommended life style behaviors in kidney transplant recipients: does it matter in living donor kidney transplant? [2010]

10. India pubmed.ncbi.nlm.nih.gov

Nonadherence Behaviors and Some Related Factors in Kidney Transplant Recipients. [2023]

11. Australia pubmed.ncbi.nlm.nih.gov

Compliance of kidney transplant patients to the recommended lifestyle behaviours: single centre experience. [2008]