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Lifestyle Intervention for Kidney Transplant Recipients (HEAL Trial)

N/A

Waitlist Available

Research Sponsored by University of Kansas Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥18 years.

Be older than 18 years old

Must not have

Currently prescribed an anti-obesity medication.

Resting systolic blood pressure ≥160 mmHg or resting diastolic blood pressure ≥100 mmHg or not on stable hypertension treatment for at least 6 months.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study whether implementing a lifestyle intervention can help prevent weight gain in patients who have undergone kidney transplantation compared to those receiving standard medical care alone. The study will look at factors such as adherence

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While this trial focuses on lifestyle interventions that typically do not cause severe side effects like medications might, participants may experience muscle soreness from increased physical activity or digestive changes due to new diets.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking medication for weight loss.

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My blood pressure is high and I haven't been on stable treatment for 6 months.

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I have had weight loss surgery in the past.

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I am not pregnant, breastfeeding, or planning to become pregnant and agree to use double barrier contraception if of childbearing age.

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I have heart issues like failure, chest pain, irregular heartbeat, or had heart surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Body Weight

Secondary study objectives

Adverse and Serious Adverse Events

Body Fat Mass

Body Mass Index

+18 more

Other study objectives

Lifestyle and Health History

Medication History

Post-Intervention Qualitative Interview

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Standard Medical Care plus Lifestyle InterventionExperimental Treatment4 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 CareActive Control2 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Diet

2000

Completed Phase 4

~15070

Physical Activity

2019

Completed Phase 3

~4760