ObesityNCT02630524
Diet Composition and Cardiometabolic Risk Reduction in Adults With SCI
A study testing eHealth Behavioral Lifestyle Intervention Device: Telecoach in people with Obesity and Spinal Cord Injuries, run by University of Alabama at Birmingham at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 19 to 60 years
- Conditions the study is for
- Obesity, Spinal Cord Injuries, Diabetes
- What is being tested?
- eHealth Behavioral Lifestyle Intervention Device: Telecoach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- heart disease
- renal disease
- active pressure sore
- persons on medically restricted diets
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Obesity, Spinal Cord Injuries, Diabetes
- Being tested
- eHealth Behavioral Lifestyle Intervention Device: Telecoach
- Medical subject headings
- Obesity, Spinal Cord Injuries, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eHealth Behavioral Lifestyle Intervention Device: TelecoachBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Low Carbohydrate Diet | Experimental | Not described Receives: Behavioral: eHealth Behavioral Lifestyle Intervention Device: Telecoach |
| Standard Diet | Active comparator | Not described Receives: Behavioral: eHealth Behavioral Lifestyle Intervention Device: Telecoach |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2015 (estimated)
- Study startAug 2016
- Primary completionMay 2020
- Study completionJun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brooks C. Wingo, PhD, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02630524
- Sponsor's protocol ID
- F151001005
- Status last verified
- May 2021
- First submitted
- 8 Dec 2015
- Last updated
- 25 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet Composition and Cardiometabolic Risk Reduction in Adults With SCI
- ClinicalTrials.gov ID
- NCT02630524
- Acronym / sponsor ID
- F151001005
- Conditions
- Obesity, Spinal Cord Injuries, Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- May 2020 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 15 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Carbohydrate Diet | Experimental | Behavioral: eHealth Behavioral Lifestyle Intervention Device: Telecoach |
| Standard Diet | Active comparator | Behavioral: eHealth Behavioral Lifestyle Intervention Device: Telecoach |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- heart disease
- renal disease
- active pressure sore
- persons on medically restricted diets
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eHealth Behavioral Lifestyle Intervention Device: TelecoachParticipants 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. | Behavioural | Low Carbohydrate Diet, Standard Diet |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eHealth Behavioral Lifestyle Intervention Device: Telecoach in people with Obesity and Spinal Cord Injuries, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to prescribed macronutrient composition as measured by multiple pass 24 hour dietary recall (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2021.