Diet Composition and Cardiometabolic Risk Reduction in Adults With SCI

The University of Alabama at Birmingham

Status: Completed

Conditions: Diabetes; Spinal Cord Injuries; Obesity

Treatments: Behavioral: eHealth Behavioral Lifestyle Intervention Device: Telecoach

Study type: Interventional

Funder types: Other

Identifiers

NCT02630524

F151001005

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 19 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Low Carbohydrate Diet

Experimental group

Treatment:

Behavioral: eHealth Behavioral Lifestyle Intervention Device: Telecoach

Standard Diet

Active Comparator group

Treatment:

Behavioral: eHealth Behavioral Lifestyle Intervention Device: Telecoach