Table 1.

WHO trial registration data set (V.1.3.1)

Data category	Information32
Primary registry and trial identifying number	ClinicalTrials.gov (NCT03369080) and (NCT03689023)
Date of registration in primary registry	12 November 2017 and 26 September 2018
Secondary identifying numbers	The Committees on Health Research Ethics in the Capital Region of Denmark on 10 July 2018 (Journal-nr.: H-18018325) and the Danish Data Protection Agency (j.nr. VD-2018–380, I-Suite nr.: 6631) and (RH-2017–345, I-Suite nr.: 06052)
Source(s) of monetary or material support	This work was supported by a mutual cooperation about the research programme ‘Centre for Integrated Rehabilitation of Cancer Patients (CIRE)—Neuro/Psychology,’ between the University Hospitals Centre for Health Care Research, University hospital Copenhagen, Rigshospitalet, University College Copenhagen, Department of Nursing and Nutrition, and the NeuroScience Centre, Rigshospitalet
Primary sponsor	This work was supported by a mutual cooperation about the research programme ‘Centre for Integrated Rehabilitation of Cancer Patients (CIRE)—Neuro/Psychology,’ between the University Hospitals Centre for Health Care Research, University hospital Copenhagen, Rigshospitalet, University College Copenhagen, Department of Nursing and Nutrition, and the NeuroScience Centre, Rigshospitalet
Secondary sponsor(s)
Contact for public queries	Nicolaj Jersild Holm (nicolaj.jersild.holm@regionh.dk), phone: +45 38631963, Rigshospitalet, Neuroscience Center, Clinic for Spinal Cord Injuries, Havnevej 25, 3100, Hornbæk, Denmark
Contact for scientific queries	Nicolaj Jersild Holm (nicolaj.jersild.holm@regionh.dk), phone: +45 38631963, Rigshospitalet, Neuroscience Center, Clinic for Spinal Cord Injuries, Havnevej 25, 3100, Hornbæk, Denmark
Public title	Health promotion and cardiovascular risk reduction in people with spinal cord injury—physical activity, healthy diet and maintenance after discharge: study protocol for a national cohort study followed by a clinical intervention study
Scientific title	Health promotion and cardiovascular risk reduction in people with spinal cord injury—physical activity, healthy diet and maintenance after discharge: study protocol for a prospective national cohort study followed by a preintervention and postintervention study
Countries of recruitment	Denmark
Health condition(s) or problem(s) studied	Spinal cord Injury and the cardiovascular risk factor, including weight gain and consequences of an inactive lifestyle during and after the primary rehabilitation
Intervention(s)	A controlled premultimodal and postmultimodal pragmatic clinical intervention study, with 6 months of follow-up containing ‘new usual care’ consisting of a uniform and systematic institutional strategy incorporating targeted strategic patient education about cardiovascular risk factors, physical activity and a healthy diet lifestyle starting early in the primary rehabilitation process
	Comparator: a historic control conducted as a national prospective cohort study before ‘new usual care’
Key inclusion and exclusion criteria	Inclusion criteria: all patients who are 18 years or older, and with a spinal cord injury (SCI) within the last 12 months and admitted at clinic for spinal cord SCIs, are included regardless of aetiology to the SCI, neurological level or completeness of the lesion if informed consent is retrieved
	Exclusion criteria: exclusion criteria for VO2peak test in the study includes motor complete SCI at C4 level or above, and assisted ventilatory function. Other exclusion criteria are the presence of decubitus, severe spasticity or musculoskeletal problems considered at risk of aggravation during testing or preventing completion of the VO2peak test
Study type	Interventional: the study consists of a primary study designed as a controlled preclinical and postclinical intervention study and a historic control conducted as a prospective cohort study
	Allocation: the intervention in the primary study is a part of new standard care. Therefore randomisation or blinding is not appropriate
	Primary purpose: prevention
Date of first enrolment	November 2017
Target sample size	160
Recruitment status	Recruiting
Primary outcome(s)	Oxygen uptake measured as VO2peak
Key secondary outcomes	Body mass index, body composition (determined by dual energy X-ray absorptiometry), metabolic profile consisting of C reactive protein as a marker for inflammation, lipid profile describing total cholesterol, triglycerides, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol and haemoglobin A1c as a marker for carbohydrate metabolism, and blood pressure
Ethics Review	The project is approved by the Committees on Health Research Ethics in the Capital Region of Denmark on 10.07.2018 (Journal-nr.: H-18018325)
Completion data	June 2020
IPD sharing statement	Data can be accessed by request to the corresponding author after publications related to the PhD project are made