Diet Composition and Cardiometabolic Risk Reduction in Adults With SCI

May 24, 2021 updated by: Brooks C. Wingo, PhD, University of Alabama at Birmingham
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Lakeshore Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low Carbohydrate Diet
Behavioral: 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.
Active Comparator: Standard Diet
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to prescribed macronutrient composition as measured by multiple pass 24 hour dietary recall
Time Frame: 6 months
Participants will record 3 days of food intake at each measurement time point. Calories and macronutrient values from the 3 days will be averaged. We will calculate an adherence score using methodology described by Alhassan et al. Adherence will be measured as the difference between recorded intake and prescribed intake of the macronutrient of interest for each group (i.e., carbohydrates for the low carbohydrate group, fat for the standard group). For example, if a participant in the low carbohydrate group is prescribed a limit of 50g of CHO/day, and recorded intake is 70g, the adherence score will be 20. A score of 0 indicates meeting recommended values, and higher scores indicate poorer adherence than lower scores.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2016

Primary Completion (Actual)

May 1, 2020

Study Completion (Actual)

June 1, 2020

Study Registration Dates

First Submitted

December 8, 2015

First Submitted That Met QC Criteria

December 14, 2015

First Posted (Estimate)

December 15, 2015

Study Record Updates

Last Update Posted (Actual)

May 25, 2021

Last Update Submitted That Met QC Criteria

May 24, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F151001005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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