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Diet Composition and Cardiometabolic Risk Reduction in Adults With SCI

Sponsor
University of Alabama at Birmingham (Other)
Overall Status
Completed
CT.gov ID
NCT02630524
Collaborator
(none)
48
Enrollment
1
Location
2
Arms
46
Actual Duration (Months)
1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: eHealth Behavioral Lifestyle Intervention Device: Telecoach
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Diet Composition and Cardiometabolic Risk Reduction in Adults With SCI
Actual Study Start Date :
Aug 1, 2016
Actual Primary Completion Date :
May 1, 2020
Actual Study Completion Date :
Jun 1, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Lakeshore Foundation Birmingham Alabama United States 35209

Sponsors and Collaborators

  • University of Alabama at Birmingham

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Brooks C. Wingo, PhD, Assistant Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT02630524
Other Study ID Numbers:
  • F151001005
First Posted:
Dec 15, 2015
Last Update Posted:
May 25, 2021
Last Verified:
May 1, 2021
Additional relevant MeSH terms:
Spinal Cord Injuries

Study Results

No Results Posted as of May 25, 2021