Diet Composition and Cardiometabolic Risk Reduction in Adults With SCI
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Adherence to prescribed macronutrient composition as measured by multiple pass 24 hour dietary recall
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 60 Years (Adult)
- Sex
- 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
Arms & Interventions
Low Carbohydrate Diet
Intervention: eHealth Behavioral Lifestyle Intervention Device: Telecoach (Behavioral)
Standard Diet
Intervention: eHealth Behavioral Lifestyle Intervention Device: Telecoach (Behavioral)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Brooks C. Wingo, PhD
Assistant Professor
University of Alabama at Birmingham