Obesity Clinical Trials

Find Obesity Clinical Trials Near You

Developing Nutrition Care Integrated Into Pain Rehabilitation: a Feasibility and Non-Randomized, Controlled Quasi-Experimental Study

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The investigators' purpose is to develop and test the feasibility, usability, and satisfaction of the Diet4painrelief app as a platform for implementing nutrition care in a specialist pain rehabilitation clinic. The Diet4painrelief will consist of two components: a) a screening tool for nutrition status b) an individually tailored behavior change program aiming to improve the dietary habits and behaviors of patients living with chronic pain. Part I: Included 20 patients with complex chronic pain to examine the feasibility and outcomes of evidence-based Interdisciplinary Pain Rehabilitation Program (IPRP) integrated with nutrition care. The Diet4painrelief includes a screening tool to assess basic nutritional status as well as their intake of key unhealthy and healthy foods and drinks (through three 24hour-dietary recordings or food diary). Thereafter, the patients receive a personalized behavior change program for dietary optimization. The investigators will design and adapt 6 modules in the digital platform (Diet4painrelief app) based on the International Association for the Study of Pain (IASP) recommendations (6 aspects about 'nutrition and pain') and Sweden's food culture. Clinical outcomes using patient-reported data on socio-demographics, pain aspects, psychometric data, physical disability, and quality of life will be measured at three occasions: first appointment (Pre-IPRP), immediately after completing the rehabilitation program (Post-IPRP), and at a 12-month follow-up (FU-IPRP). Blood samples will be taken to identify biomarkers at the same occasions that provide objective information on metabolic and nutritional abnormalities and further to evaluate the effect of the dietary intervention on changing of pain rehabilitation outcomes. Part II: Included 192 patients with complex chronic pain. Half of the participants receive IPRP and nutrition care (described above) and the other half receive standard IPRP.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Self reported Body Mass Index (BMI)\>=25;

• Written consent to participate and attend to the pain rehabilitation program due to disabling chronic pain (on sick leave or experiencing major interference in daily life due to chronic pain)

• Agreement not to participate in other parallel treatments for weight reduction

• Not currently using medications of weight reduction

• Available to get access to internet via own mobile/cellphone.

Locations
Other Locations
Sweden
Pain and Rehabilitation clinic
RECRUITING
Linköping
Contact Information
Primary
Huan-Ji Dong, PhD, MD
huanji.dong@liu.se
+46730488933
Time Frame
Start Date: 2024-08-01
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 200
Treatments
Active_comparator: Standard IPRP
The IPRP is delivered in a group format to eight patients by an interdisciplinary team consisting of a rehabilitation physician, physiotherapist, occupational therapist, and psychologist. The program includes an 8 week treatment phase followed by a 4 week implementation period, with interdisciplinary team evaluation at week 12 (T1). Standardized Patient reported outcome measures (PROMs) assessing sociodemographic factors, pain, function, and psychological profiles are collected at baseline (T0), post-IPRP (T1) and at 12-month follow-up (T2).
Experimental: IPRP and nutrition care
All patients will go through the screening of nutrition status, dietitian counselling, mhealth installation and test, and interviews after the IPRP intervention. Briefly, the dietitian will make personalized dietary plans together with patients. The dietitian then breaks these areas into small, manageable goals that fit the participant's situation (for example, work schedule, home environment, family needs, or cooking skills) and align with the ongoing IPRP sessions. Diet4painrelief as a digital tool will be used by dietician to follow up the progress of each participant.
Related Therapeutic Areas
Sponsors
Collaborators: Ostergotland County Council, Sweden
Leads: Linkoeping University

This content was sourced from clinicaltrials.gov