Lifestyle Intervention for Kidney Transplant Recipients

(HEAL Trial)

Overseen By John M. Jakicic, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Kansas Medical Center

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

Disqualifiers: Pregnancy, Diabetes, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 6 months

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a lifestyle intervention, including dietary counseling and physical activity, can prevent weight gain in recent kidney transplant recipients. It compares the effects of standard medical care alone to standard care with additional support for diet and physical activity changes. The trial aims to determine if participants adhere to the program and if it improves health outcomes such as weight, body composition, and quality of life. Suitable candidates have received a kidney transplant within the last 3-5 months and can engage in diet and exercise changes. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance post-transplant care and improve quality of life.

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 prior data suggests that this lifestyle intervention is safe for kidney transplant recipients?

A previous study showed that lifestyle changes are safe and feasible for kidney transplant recipients. Research indicates that changes in diet and exercise can enhance physical health without causing harm. Another study found that combining exercise with dietary changes can improve sleep and reduce fatigue in these patients. Overall, these findings suggest that lifestyle changes are well-tolerated and do not lead to significant negative effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the lifestyle intervention for kidney transplant recipients because it offers a fresh approach to care by integrating behavioral changes focused on diet and physical activity. Unlike the standard medical care, which typically centers on medication management to prevent organ rejection and manage complications, this intervention targets lifestyle factors to help regulate body weight, potentially improving overall health and transplant outcomes. This novel focus on personal lifestyle adjustments could help reduce the risk of transplant-related complications and enhance the quality of life for recipients, making it a promising addition to conventional treatments.

What evidence suggests that this lifestyle intervention is effective for preventing weight gain in kidney transplant recipients?

Research has shown that lifestyle changes can help kidney transplant patients. In this trial, participants in the "Standard Medical Care plus Lifestyle Intervention" arm will receive a behavioral intervention focused on dietary modification and physical activity. Studies have found these changes safe and beneficial for improving physical health. For example, increased activity and a healthier diet can enhance heart and lung fitness and raise levels of good cholesterol. One study found that combining exercise with a better diet improved sleep and reduced tiredness. Overall, lifestyle changes can greatly support the health of kidney transplant patients. ^{1 2 3 4 6}

Who Is on the Research Team?

John M. Jakicic, PhD

Principal Investigator

University of Kansas Medical Center

Are You a Good Fit for This Trial?

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

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

Ability to provide informed consent.

I am eligible regardless of my gender or ethnicity.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Lifestyle 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.

How Is the Trial Designed?

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+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

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]

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]

Most kidney transplant recipients in Mansoura, Egypt showed good compliance with their immunosuppressive medications, which is crucial for preventing organ rejection.

However, compliance with other recommended lifestyle behaviors, such as diet, exercise, and regular medical checkups, was low, indicating a need for better patient education and support to improve overall health outcomes post-transplant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compliance with recommended life style behaviors in kidney transplant recipients: does it matter in living donor kidney transplant? Gheith, OA., El-Saadany, SA., Abuo Donia, SA., et al.[2010]

In a study of 120 kidney transplant patients in Kuwait, 60% showed compliance with their medications and lifestyle changes, which is crucial for preventing complications after transplantation.

Factors such as being a Kuwaiti citizen, being female, and having unrelated living donors were linked to poorer medication compliance, highlighting the need for targeted support to improve adherence and reduce complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medication compliance and lifestyle adherence in renal transplant recipients in Kuwait. Kenawy, AS., Gheith, O., Al-Otaibi, T., et al.[2022]

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]

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]

Recent studies show that lifestyle interventions, particularly increased physical activity and a healthy diet rich in fruits, vegetables, and whole grains, provide significant health benefits for patients with chronic kidney disease (CKD).

Higher dietary potassium intake, indicated by increased urine potassium excretion, is linked to lower blood pressure and better kidney outcomes in CKD patients, while the safety and benefits of using salt substitutes in this population need further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity and nutrition in chronic kidney disease. Wang, AY., March, DS., Burton, JO.[2023]

The review found that there is a lack of effective evidence-based lifestyle interventions for obese children and adolescents with diabetes, and no effective interventions for those with kidney diseases, highlighting a significant gap in treatment options.

The research emphasizes the urgent need for further studies to develop targeted interventions that can promote lifestyle changes in these vulnerable populations, as current options are insufficient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

Most kidney transplant patients adhered to their medication regimens, but many struggled with lifestyle recommendations, which are crucial for long-term health after transplantation.

Factors such as time since transplantation, family support, and educational level significantly influenced adherence, highlighting the need for targeted educational programs to improve adherence and quality of life for at-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonadherence Behaviors and Some Related Factors in Kidney Transplant Recipients. Hedayati, P., Shahgholian, N., Ghadami, A.[2023]

In a study of 100 adult kidney transplant patients, it was found that while patients showed good compliance with their immunosuppressive medications, their adherence to other recommended lifestyle behaviors was only partial.

The study highlights the importance of thorough assessments and education for kidney transplant patients to enhance their understanding and compliance with lifestyle changes necessary for successful long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compliance of kidney transplant patients to the recommended lifestyle behaviours: single centre experience. Gheith, OA., El-Saadany, SA., Abuo Donia, SA., et al.[2008]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06640179

NCT06640179 | Feasibility and Plausible Effectiveness of a ... 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 ...

2. thelancet.com thelancet.com/journals/lanhl/article/PIIS2666-7568(24)00138-7/fulltext

the Active Care after Transplantation (ACT) multicentre ... A lifestyle intervention is safe and feasible in people who have received kidney transplants, paving the way for lifestyle intervention studies ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11951324/

Physical activity interventions in adult kidney transplant ... Exercise training or increasing physical activity may confer several benefits in adult KTRs, especially through the improvements in CRF and HDL which have been ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2468024925002098

Effect of Exercise or Combined Exercise and Diet ... We investigated whether a lifestyle intervention consisting of exercise or exercise combined with diet improve self-reported sleep and fatigue among KTRs.

5. umcgresearch.org umcgresearch.org/w/lifestyle-intervention-improves-physical-functioning-in-kidney-transplant-recipients

Lifestyle Intervention Improves Physical Functioning in ... A lifestyle intervention is safe, feasible and effective in kidney transplant recipients, improving physical functioning despite their complex ...

6. kireports.org kireports.org/article/S2468-0249(25)00209-8/fulltext

Effect of Exercise or Combined Exercise and Diet ... We investigated whether a lifestyle intervention consisting of exercise or exercise combined with diet improve self-reported sleep and fatigue among KTRs.