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An Intensive Lifestyle Intervention Program in CKD (Move to Health 2)

NCT02842957 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2026-04-24

No results posted yet for this study

Summary

The primary purpose of the current 6-month study is to determine the effect of an integrated, comprehensive, individualized, intervention program including dietary, exercise, pharmacy, and behavioral counseling on patient performance of the short physical performance battery (SPPB) which gives an indication of an individual's ability to perform activities of daily living dependent upon lower extremity function. Additional objectives include the impact of the intervention on cardiovascular risk factors, and the impact of the intervention on other indices of physical function in stage 3-4 CKD patients. The investigators hypothesize that patients who participate in this integrated, intensive, individualized lifestyle intervention will have higher SPPB scores compared to individuals in the usual care group. The investigators also hypothesize that this approach will lead to higher adherence rates to the lifestyle recommendations and that those who adhere will also show better improvements in the measured variables over time compared to patients who are randomly assigned to the usual care group or who comply poorly with the various study components.

Conditions

Interventions

BEHAVIORAL

Lifestyle Intervention

Patients randomized to the lifestyle group will be given individual counseling regarding the implementation of a plant based diet. They will also be given a home based exercise program to complete. Patients will be assisted with the optimal use of their prescription medications and they will receive specific counseling regarding strategies to help them successfully change their behavior.

Sponsors & Collaborators

  • Relypsa, Inc.

    collaborator INDUSTRY

  • Springfield College

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2017-04-08
Completion
2017-04-08

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02842957 on ClinicalTrials.gov