Therapeutic Lifestyle Intervention Targeting Enhanced Cardiometabolic Health and Function for Persons with Chronic Spinal Cord Injury in Caregiver/Care-Receiver Co-Treatment: A Study Protocol of a Multisite Randomized Controlled Trial

Int. J. Environ. Res. Public Health, 2023 · DOI: 10.3390/ijerph20196819 · Published: September 25, 2023

Spinal Cord Injury Cardiovascular Science

Simple Explanation

Chronic spinal cord injury (SCI) increases the risk of cardiometabolic diseases (CMD). This study will assess the effects of a 6-month therapeutic lifestyle intervention (TLI) adapted from the National Diabetes Prevention Program (DPP) for individuals with chronic SCI. The study also examines the impact of a complementary caregiver program on the health and function of SCI caregivers, evaluating user acceptance and satisfaction. Caregivers will be randomized to ‘behavioral support’ or ‘control condition’. The intervention includes circuit resistance training, a calorie-restricted Mediterranean-style diet, and educational sessions on diet/exercise goals, self-monitoring, psychological and social challenges, cognitive behavioral therapy, and motivational interviewing.

Study Duration

6 Months

Participants

30 dyadic couples (30 SCI; 30 caregivers = 60)

Evidence Level

RCT protocol

Key Findings

1
The study evaluates the effects and durability of a structured, multi-modal intervention on health and function for SCI patients and their caregivers.
2
The results and intervention material will be disseminated to professionals and consumers for broader implementation, potentially guiding long-term rehabilitation strategies.
3
The trial will enhance the validity and applicability of current recommended guidelines for CMD risks in SCI and address the growing health concerns for their caregivers.

Research Summary

This study protocol outlines a multisite randomized controlled trial (RCT) to assess the impact of a 6-month comprehensive therapeutic lifestyle intervention (TLI) on individuals with chronic spinal cord injury (SCI) and their caregivers. The TLI, adapted from the National Diabetes Prevention Program (DPP), includes exercise, nutritional modification, and behavioral support, targeting cardiometabolic health and overall function. The study also examines a complementary caregiver curriculum (CCC) to determine its effects on caregiver health and whether it enhances the benefits for SCI participants. The trial aims for broader implementation of the intervention.

Practical Implications

Improved Cardiometabolic Health

The intervention aims to reduce cardiometabolic risk factors, such as obesity, dyslipidemia, and impaired glucose metabolism, in individuals with SCI.

Enhanced Caregiver Well-being

The caregiver program seeks to improve the health, function, and quality of life of caregivers, while also reducing their perceived burden.

Broader Implementation

The dissemination of results and intervention materials can facilitate widespread adoption of the TLI in clinical practice and community settings.

Study Limitations

1
Blinding is not achievable in this intervention study.
2
Preliminary data specific to this type of multi-modal and comprehensive TLI in SCI are not available for a direct calculation of ES.
3
Attrition of 20% is assumed, potentially affecting the analytic sample size.

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