Nutrition and Pain Study

NCT ID: NCT07179588

Last Updated: 2025-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2027-06-01

Brief Summary

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The purpose of this research is to assess the effectiveness of a nutrition intervention on diet quality in managing pain in individuals with spinal cord injury (SCI).

Detailed Description

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Conditions

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SCI - Spinal Cord Injury

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nutrition Group

Participants will be in this group for up to 4 months.

Group Type EXPERIMENTAL

Nutrition Education Program

Intervention Type BEHAVIORAL

The participants will attend a monthly nutrition education session for 4 months (total 4 sessions). The sessions will be available in person and over teleconference platforms (i.e., Zoom). Each session will be up to 1-hour, which will include nutrition guidelines to manage diet quality.

Nutrition Counseling

Intervention Type BEHAVIORAL

Participant will meet with a registered dietitian for one-on-one diet consults once a month for 4 months. These sessions can be in-person or via Zoom. Each session will be up to 1 hour, and will be done to assess if the nutrition guidelines taught during the education sessions are being implemented.

Interventions

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Nutrition Education Program

The participants will attend a monthly nutrition education session for 4 months (total 4 sessions). The sessions will be available in person and over teleconference platforms (i.e., Zoom). Each session will be up to 1-hour, which will include nutrition guidelines to manage diet quality.

Intervention Type BEHAVIORAL

Nutrition Counseling

Participant will meet with a registered dietitian for one-on-one diet consults once a month for 4 months. These sessions can be in-person or via Zoom. Each session will be up to 1 hour, and will be done to assess if the nutrition guidelines taught during the education sessions are being implemented.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Adults (≥18 y)
* With SCI (motor complete or incomplete American Spinal Injury Association Impairment Scale (AIS) A-D, paraplegia or ventilator-independent tetraplegia)
* Have chronic pain

Exclusion Criteria

* Adults unable to consent Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women (self-report)
* Prisoners
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Academy of Spinal Cord Injury Professionals, Inc.

UNKNOWN

Sponsor Role collaborator

University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Elizabeth Felix

Research Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elizabeth Felix, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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University of Miami

Miami, Florida, United States

Site Status

Countries

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United States

Central Contacts

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Elizabeth Felix, PhD

Role: CONTACT

3052434497

Facility Contacts

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Alicia Sneij, PhD

Role: primary

3052436078

Other Identifiers

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20250188

Identifier Type: -

Identifier Source: org_study_id

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