An Intensive Lifestyle Intervention Program in CKD (Move to Health 2) (MTHL2)
|ClinicalTrials.gov Identifier: NCT02842957|
Recruitment Status : Unknown
Verified October 2017 by Samuel A. Headley, Springfield College.
Recruitment status was: Active, not recruiting
First Posted : July 25, 2016
Last Update Posted : October 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Kidney Disease||Behavioral: Lifestyle Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Intensive Lifestyle Intervention Program in CKD (Move to Health 2)|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||December 2, 2017|
|Estimated Study Completion Date :||December 15, 2017|
Experimental: Lifestyle intervention
Behavioral: The Lifestyle arm is the experimental group that will be exposed to an intensive, individualized approach aimed at assisting these CKD patients to adhere to lifestyle changes that are expected to be beneficial to their health and wellbeing. Patients will receive direction to implement a plant based diet, along with more physical activity in their lives. They will be assisted with the optimal use of their prescribed medications by pharmacy professionals and they will receive behavioral counseling by experts in that area.
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.
No Intervention: Usual Care
The Usual Care arm will continue to receive the current standard of care involving all the services provided at a contemporary nephrology practice in Western Massachusetts
- Physical Function Measure [ Time Frame: 6 month intervention ]Short Physical Performance Battery
- KDQOL-SF [ Time Frame: 6 months ]The KDQOL-36™ is a short form that includes the SF-12 as generic core supplemented with multi-item scales targeted at particular concerns of individuals with kidney disease (i.e. the burden of kidney disease, symptoms/problems of kidney disease, and effects of kidney disease scales on daily life).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02842957
|United States, Massachusetts|
|Springfield, Massachusetts, United States, 01109|