Diet Composition and Cardiometabolic Risk Reduction in Adults With SCI

Obesity Clinical Trial

Official title:

Diet Composition and Cardiometabolic Risk Reduction in Adults With SCI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02630524
• Other study ID #: F151001005
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: June 2020

Study information

• Verified date: May 2021
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Obesity
• Spinal Cord Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	Lakeshore Foundation	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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