NCT06669455

An Integrated and Personalized Lifestyle Approach for People With Parkinson's Disease

SENSS (Stress, Exercise, Nutrition, Sleep, Self-management): An Integrated, Personalized and Stepped Care Lifestyle Approach for People With Parkinson's Disease: A Randomized Controlled Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 256 (estimated)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to investigate the effects of a combined lifestyle program on the quality of life in people with Parkinson's Disease. Participants will be randomly assigned to one of two groups, both receiving standard care, a Parkinson Lifestyle Decision aid and an intake meeting with a lifestyle coach. One group will work on their goals independently, while the other group will get guidance from the lifestyle coach throughout the 12-month program. The program focuses on self-management, exercise, nutrition, sleep and stress. Participants will complete questionnaires after 0, 6 and 12 months, and use a wearable sensor for two weeks. The main outcome is quality of life over 12 months, measured with the PDQ-39 questionnaire. The study also examines personal goal achievements, symptom changes, and the economic effects of the program.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
BEHAVIORAL	Personalized and combined lifestyle approach	In the SENSS approach five different and complementary lifestyle domains (self-management, exercise, nutrition, sleep and stress) are combined. The process will be guided by a lifestyle coach. The intervention is personalised for each participant. The personal goals are decided based on 'shared decision making' together with the lifestyle coach after using a Parkinson lifestyle decision aid. The level of guidance needed throughout the intervention is based on a 'stepped care approach'.

Timeline

• Start date: 2024-11-12
• Primary completion: 2027-03-01
• Completion: 2027-03-01
• First posted: 2024-11-01
• Last updated: 2026-04-01

Locations

1 site across 1 country: Netherlands