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Pilot of IMPACT Intervention at the University of New Mexico

NCT ID: NCT04166994

Last Updated: 2024-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-01

Study Completion Date

2023-01-13

Brief Summary

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Kidney transplant recipients (KTR) are at greater risk of weight gain, diabetes and cardiovascular events post-transplant; but medications are limited in their effectiveness, and patients may face contraindications and unwanted side effects, given their complex post-transplant immunosuppression regimen. The investigators will pilot a randomized-controlled trial to test the feasibility and acceptability of a culturally-appropriate, multi-behavior (diet and exercise) lifestyle intervention for 20 American Indian, Hispanic/Latino(a), and White KTRs. Critical components of the pilot trial include: (a) an individually tailored exercise and diet plan with a physical therapist/exercise physiologist and a registered dietitian nutritionist, who will work closely with the post-transplant team to carefully monitor patient stability; and, (b) the use of the Twistle Patient Engagement Platform to follow-up with participants between their scheduled appointments and to collect all questionnaire data.

Detailed Description

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In Improving Healthcare Outcomes in American Indian and Hispanic Transplant Recipients Using Culturally-Tailored Novel Technology (IMPACT), the investigators will pilot the feasibility and acceptability of a culturally-tailored, multi-behavior lifestyle intervention using a novel technology for 14-20 AI, HL, and White KT recipients. Because of KT recipients' varied stability immediately post-transplant, and the need to individually monitor their post-transplant immunosuppression regimen, a critical component of IMPACT will be an individually-tailored exercise and diet plan with a physical therapist/exercise physiologist and a registered dietitian nutritionist, who will work closely with the post-transplant team to carefully monitor patient stability. IMPACT will combine a personalized assessment of the patient's food preferences and access to exercise resources within their environment (based on a standard list of factors developed by the nutrition and rehabilitation experts) along with clinical specifications from the transplant team. The study is innovative because it addresses previous limitations, while adapting the intervention to meet the needs of the culturally-diverse ESKD population. The final innovation of the IMPACT Pilot is the use of the Twistle Patient Engagement Platform to follow-up with participants between their scheduled appointments, ensure adherence to the intervention, collect all questionnaire data, and enhance participant retention.

Conditions

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Kidney Replacement

Keywords

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Diet Exercise

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Control Trial
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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IMPACT Intervention

Incorporate a rehabilitation approach to slowly increasing KT recipients' physical activity in addition to individualized dietary intervention at every post-transplant appointment through six months post-transplant, with follow-up at 12 months post-transplant.

Group Type EXPERIMENTAL

Exercise and diet

Intervention Type BEHAVIORAL

IMPACT Intervention

Usual Care

No exercise or diet specialization.

Group Type OTHER

No Intervention: Usual Care

Intervention Type OTHER

No exercise or diet specialization.

Interventions

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Exercise and diet

IMPACT Intervention

Intervention Type BEHAVIORAL

No Intervention: Usual Care

No exercise or diet specialization.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Received kidney transplant at UNMH
2. Greater than 18 years of age
3. Mentally competent

Exclusion Criteria

1. Children under the age of 18
2. Incarcerated patients
3. Pregnant women
4. Active systemic infection
5. Non-skin malignancy or melanoma in the past 2 years
6. Known cognitive impairment
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of New Mexico

OTHER

Sponsor Role lead

Responsible Party

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Larissa Myaskovsky, PhD

Associate Professor, Director: CHEK-D

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Larissa Myaskovsky, PhD

Role: PRINCIPAL_INVESTIGATOR

University of New Mexico

Locations

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University of New Mexico

Albuquerque, New Mexico, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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19-413 IMPACT

Identifier Type: -

Identifier Source: org_study_id