Diet Composition and Cardiometabolic Risk Reduction in Adults With SCI

NCT ID: NCT02630524

Last Updated: 2021-05-25

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

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2020-06-30

Brief Summary

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The purpose of this study is to examine the effectiveness of a low carbohydrate diet on increasing dietary adherence and improving cardiometabolic risk factors among adults with spinal cord injury (SCI). Seventy overweight/obese adults with SCI will be randomized to one of two groups: 1) a reduced carbohydrate diet or 2): a "standard" diet (STD). Participants will take part in a 6-month behavioral lifestyle intervention implemented through a novel eHealth platform specially designed for individuals with SCI.

Detailed Description

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Conditions

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Obesity Spinal Cord Injuries Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Low Carbohydrate Diet

Group Type EXPERIMENTAL

eHealth Behavioral Lifestyle Intervention Device: Telecoach

Intervention Type BEHAVIORAL

Participants will receive weekly/biweekly coaching sessions with a telecoach and use eHealth platform to log food and exercise, review daily goals, and find strategies for reaching goals.

Standard Diet

Group Type ACTIVE_COMPARATOR

eHealth Behavioral Lifestyle Intervention Device: Telecoach

Intervention Type BEHAVIORAL

Participants will receive weekly/biweekly coaching sessions with a telecoach and use eHealth platform to log food and exercise, review daily goals, and find strategies for reaching goals.

Interventions

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eHealth Behavioral Lifestyle Intervention Device: Telecoach

Participants will receive weekly/biweekly coaching sessions with a telecoach and use eHealth platform to log food and exercise, review daily goals, and find strategies for reaching goals.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* SCI ≥ 1 year post injury
* able to use arms for exercise
* BMI of 22-50 kg/m2
* 19-60 years old
* reliable access to internet and smartphone
* have the ability to converse in English
* ability to prepare own food or have input into person responsible for food preparation

Exclusion Criteria

* heart disease
* renal disease
* active pressure sore
* persons on medically restricted diets
Minimum Eligible Age

19 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Brooks C. Wingo, PhD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Lakeshore Foundation

Birmingham, Alabama, United States

Site Status

Countries

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United States

Other Identifiers

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F151001005

Identifier Type: -

Identifier Source: org_study_id

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