Diet Composition and Cardiometabolic Risk Reduction in Adults With SCI

Study Overview
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Brief Summary
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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.

Official Title
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Diet Composition and Cardiometabolic Risk Reduction in Adults With SCI

Conditions
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Obesity, Spinal Cord Injuries, Diabetes

Intervention / Treatment
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* Behavioral: eHealth Behavioral Lifestyle Intervention Device: Telecoach


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low Carbohydrate Diet<br> | Behavioral: eHealth Behavioral Lifestyle Intervention Device: Telecoach<br>* 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.<br>|
| Active Comparator: Standard Diet<br> | Behavioral: eHealth Behavioral Lifestyle Intervention Device: Telecoach<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |