Pilot of IMPACT Intervention at the University of New Mexico

NCT04166994 | Completed DMC

• 1 other identifier: 19-413 IMPACT
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Kidney Replacement

Keywords

Diet; Exercise

Outcome Measures

Primary Outcomes (6)

• Intervention Acceptability: Satisfaction

  Client Satisfaction Questionnaire, rated 1-4, where higher satisfaction will indicate greater intervention acceptability

  12 months

• Intervention Acceptability: Usability

  System Usability Scale, rated 1-5, where higher scores indicate ease of usability

  12 months

• Intervention feasibility: Retention

  Retention rates

  Through study completion, an average of 1 year

• Intervention feasibility: Missing data

  Estimates of the expected rates of missing data

  Through study completion, an average of 1 year

• Intervention feasibility: Attrition

  Participant attrition will be measured by counting participants who do not continue with the study

  Through study completion, an average of 1 year

• Intervention feasibility: Participation

  Time required for study participation during every intervention session

  Through study completion, an average of 1 year

Secondary Outcomes (6)

• Medical records outcomes: Weight

  Through study completion, an average of 1 year

• Medical records outcomes: Lipids

  Through study completion, an average of 1 year

• Medical records outcomes: HbA1c

  Through study completion, an average of 1 year

• Patient reported outcomes: Sleep

  Baseline, 1 year

• Patient reported outcomes: QOL

  Baseline, 1 year

Study Arms (2)

IMPACT Intervention

EXPERIMENTAL

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.

Behavioral: Exercise and diet

Usual Care

OTHER

No exercise or diet specialization.

Other: No Intervention: Usual Care

Interventions

Exercise and diet BEHAVIORAL

IMPACT Intervention

IMPACT Intervention

No Intervention: Usual Care OTHER

No exercise or diet specialization.

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Received kidney transplant at UNMH
• Greater than 18 years of age
• Mentally competent

You may not qualify if:

• Children under the age of 18
• Incarcerated patients
• Pregnant women
• Active systemic infection
• Non-skin malignancy or melanoma in the past 2 years
• Known cognitive impairment

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise; Diet

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Larissa Myaskovsky, PhD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Director: CHEK-D

Model Details: Randomized Control Trial

Study Record Dates

• First Submitted: October 30, 2019
• First Posted: November 18, 2019
• Study Start: November 1, 2020
• Primary Completion: January 13, 2023
• Study Completion: January 13, 2023
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)