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Diet Composition and Cardiometabolic Risk Reduction in Adults With SCI

Primary Purpose

Obesity, Spinal Cord Injuries, Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
eHealth Behavioral Lifestyle Intervention Device: Telecoach
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

19 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lakeshore Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Low Carbohydrate Diet

Standard Diet

Arm Description

Outcomes

Primary Outcome Measures

Adherence to prescribed macronutrient composition as measured by multiple pass 24 hour dietary recall
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.

Secondary Outcome Measures

Full Information

First Posted
December 8, 2015
Last Updated
May 24, 2021
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT02630524
Brief Title
Diet Composition and Cardiometabolic Risk Reduction in Adults With SCI
Official Title
Diet Composition and Cardiometabolic Risk Reduction in Adults With SCI
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
May 2020 (Actual)
Study Completion Date
June 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Spinal Cord Injuries, Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low Carbohydrate Diet
Arm Type
Experimental
Arm Title
Standard Diet
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
eHealth Behavioral Lifestyle Intervention Device: Telecoach
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adherence to prescribed macronutrient composition as measured by multiple pass 24 hour dietary recall
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Lakeshore Foundation
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States

12. IPD Sharing Statement

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Diet Composition and Cardiometabolic Risk Reduction in Adults With SCI

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