Diet Composition and Cardiometabolic Risk Reduction in Adults With SCI
1 other identifier
interventional
48
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable obesity
Started Aug 2016
Longer than P75 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 8, 2015
CompletedFirst Posted
Study publicly available on registry
December 15, 2015
CompletedStudy Start
First participant enrolled
August 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedMay 25, 2021
May 1, 2021
3.8 years
December 8, 2015
May 24, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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.
6 months
Study Arms (2)
Low Carbohydrate Diet
EXPERIMENTALStandard Diet
ACTIVE COMPARATORInterventions
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.
Eligibility Criteria
You may qualify if:
- SCI ≥ 1 year post injury
- able to use arms for exercise
- BMI of 22-50 kg/m2
- 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
You may not qualify if:
- heart disease
- renal disease
- active pressure sore
- persons on medically restricted diets
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lakeshore Foundation
Birmingham, Alabama, 35209, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
December 8, 2015
First Posted
December 15, 2015
Study Start
August 1, 2016
Primary Completion
May 1, 2020
Study Completion
June 1, 2020
Last Updated
May 25, 2021
Record last verified: 2021-05