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OpenTrials
Completed

NCT Number: NCT02630524

Diet Composition and Cardiometabolic Risk Reduction in Adults With SCI

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.

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Key information

Conditions

Obesity Body Weight Central Nervous System Diseases Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nervous System Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

19 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lakeshore Foundation

Birmingham, Alabama, 35209, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

eHealth Behavioral Lifestyle Intervention Device: Telecoach

Behavioral

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Dec 15, 2015
Registry last updated
May 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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