An interventional study of Whole Food Ketogenic Diet and Whole Food Diet in Idiopathic Hypersomnia, Narcolepsy Type 1 (NT 1) and Narcolepsy Type 2 (NT2), sponsored by University of Sydney. Recruiting at 1 site in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-27.
Sponsored by University of Sydney · Not applicable, Interventional, and Treatment
The aim of this project is to learn about how a change in diet will affect sleepiness, quality of life and metabolic health in people living with narcolepsy and idiopathic hypersomnia. The dietary changes we will be testing are well researched and safe in a wide range of patient groups (such as in obesity, type one and two diabetes, cancer and dysfunction related to the nervous system) but has not been researched in conditions of hypersomnolence such as narcolepsy and idiopathic hypersomnia. It is important to test adjunct therapies and lifestyle changes such as dietary interventions to ensure that people living with hypersomnolence have a range of options in addition to medications, to improve their health.
If effective, this project will be tested in more people and may become a part of routine patient care. These dietary approaches have been shown to improve health and quality of life in people living with chronic pain, neurological conditions such as epilepsy and have been shown to be safe in these populations as well as people living with type one diabetes. This is a new area of research for people living with hypersomnolence.
The primary objectives of COMPANION are:
The secondary objectives are:
A prospective, mixed methods, randomised, single-centre, controlled trial (Hybrid Type 1) with two parallel groups comparing the feasibility of a WFKD to a WFD stratified by patient diagnosis of NT1, NT2 or IH. This project will determine whether patients with persistent HS can feasibly sustain dietary changes in addition to usual care, and if so, whether improvements in symptoms of daytime sleepiness, metabolic health and quality of life outcomes can be enhanced with a WFKD. At the core of this project is the delivery of a 12-week dietary intervention, in which all patients will be initially allocated to a WFD for three weeks. At the commencement of week four, participants will be randomised to either maintain consumption of this WFD or combine with carbohydrate restriction to form a WFKD for the remaining nine weeks.
The inclusion of a three-week run-in period for all patients provides confidence to the design that patients entering randomisation can engage with dietary change, and thus will provide our first indicator of feasibility. The WFD group from this point on will serve as a comparator in this randomised clinical trial.
52 studies on the registry are indexed under Idiopathic Hypersomnia; 23 are open to participants now.
This study's planned enrollment of 30 is below the median of 82 across 40 interventional studies indexed under Idiopathic Hypersomnia.
Browse Idiopathic Hypersomnia studies →University of Sydney is the lead sponsor of 94 studies on the registry; 26 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Following a 3 week whole food diet run-in, participants will reduce their carbohydrate intake to 30-50g per day to achieve nutritional ketosis.
Behavioral: Whole Food Ketogenic Diet
Participants will consume a whole-food diet focused on improving diet quality based on the NOVA classifications of unprocessed or minimally processed foods/ingredients (removal of NOVA category 4 foods from diet). This diet is high carbohydrate (45-65% of total energy coming from carbohydrate).
Behavioral: Whole Food Diet
Education around immediate changes to improve diet quality and barriers to dietary behaviour change. Participants will consume a whole-food diet focused on improving diet quality based on the NOVA classifications of unprocessed or minimally processed foods/ingredients (removal of NOVA category 4 foods from diet). This group will focus on the consumption of low-energy, nutrient dense whole foods with a targeted carbohydrate intake of 30-50g per day to achieve nutritional ketosis. The WFKD will adjust carbohydrate level for the individual participant to achieve average blood/urinary ketone levels of between 0.5 and 3.0 mmol/L (tested for objective feedback using a mix of urinary ketone sticks and finger prick blood measures).
Also known as: WFKD, Keto Diet, ketogenic diet
Education around immediate changes to improve diet quality and barriers to dietary behaviour change. Participants will consume a whole-food diet focused on improving diet quality based on the NOVA classifications of unprocessed or minimally processed foods/ingredients (removal of NOVA category 4 foods from diet). This diet is high carbohydrate (45-65% of total energy coming from carbohydrate, 20-35% from fat and 15-25% from protein) based on the Australian dietary guidelines focusing on the consumption of low-energy, nutrient dense whole foods. The higher carbohydrate diet reflects current contemporary 'standard care' dietary recommendations as outlined by the National Health and Medical Research Council's Australian Dietary Guidelines, and therefore represents the most appropriate control diet to compare to the effects of the proposed intervention.
Also known as: WFD, Minimally Processed Diet
Feasibility - using quantitative measures of feasibility
A suite of quantitative measures of feasibility (i.e. recruitment rate related to the number of patients considered for eligibility, screened, enrolled and the time frames associated with reaching the target sample size) will be measured during the 3-month dietary intervention. The primary outcomes will be triangulated with qualitative interviews to provide an overall assessment of trial feasibility. Results at 12 weeks and baseline will be compared.
Time frame: From enrolment to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.
Feasibility - using quantitative measures of tolerability
A suite of quantitative measures of tolerability (measured by dietary protocol adherence, rate of attrition during both the run in and intervention phase and quantity and nature of adverse events) will be measured during the 3-month dietary intervention. The primary outcomes will be triangulated with qualitative interviews to provide an overall assessment of trial feasibility. Results at 12 weeks and baseline will be compared.
Time frame: From enrolment to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.
Feasibility - using quantitative measures of compliance
A suite of quantitative measures of compliance (measured by capillary and urinary ketones and food diaries) will be measured during the 3-month dietary intervention. The primary outcomes will be triangulated with qualitative interviews to provide an overall assessment of trial feasibility. Results at 12 weeks and baseline will be compared.
Time frame: From enrolment to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.
Sleep Outcomes - average sleep onset latency
The key sleep efficacy outcome is the average sleep onset latency in minutes measured across 5 trials of the maintenance of wakefulness test (MWT) at 12 weeks compared with baseline.
Time frame: From baseline visit in week 0 to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.
Sleep Outcomes - markers of sleep micro-architecture
Markers of sleep micro-architecture during PSG including sleep onset latency, REM onset latency, sleep duration, sleep efficiency measured at 12 weeks compared with baseline.
Time frame: From baseline visit in week 0 to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.
Sleep Outcomes - Narcolepsy Severity Scale (for NT1 and NT2)
Change in Narcolepsy Severity Scale measured at 12 weeks compared with baseline and 3 weeks. The Narcolepsy Severity Scale is a 15-item self-reported outcome measure validated for use in NT1 patients. It evaluates the severity, frequency, and impact of the 5 main narcolepsy symptoms (EDS, cataplexy, hallucinations, sleep paralysis, and disrupted night-time sleep). Total score ranges from 0 to 57, with higher scores indicating more severe symptoms. Except for cataplexy, these narcolepsy symptoms are also relevant for some NT2 patients, and thus, we will use the Narcolepsy Severity Scale in both NT1 and NT2 patients.
Time frame: From enrolment to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.
Sleep Outcomes - Idiopathic Hypersomnia Severity Scale (for IH)
Change in Idiopathic Hypersomnia Severity Scale measured at 12 weeks compared with baseline and 3 weeks. The Idiopathic Hypersomnia Severity Scale is a self-reported measure validated in patients with IH. It is a 14-item questionnaire that measures aspects of night-time and daytime sleep symptoms and the sleep inertia related to each, as well as impaired daytime functioning due to hypersomnolence. Symptom frequency, intensity, and consequences are rated using a 3- or 4-point scale. Total score ranges from 0 to 50, with higher scores indicating more severe and frequent symptoms.
Time frame: From enrolment to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.
Sleep Outcomes - weekly cataplexy rate
Weekly cataplexy rate (in patients with NT1 only): patients will be asked the number of cataplectic events each day (and description if full or partial events) alongside the sleep diary in week 12 (prior to the final visit), compared to the week prior to baseline, and during week 3 (the week prior to randomisation).
Time frame: From enrolment to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.
Sleep Outcomes - Karolinska Sleepiness Scale
Karolinska Sleepiness Scale (KSS): Participants will be asked to rate their sleepiness before each MWT trial using the KSS, a 9-point Likert scale designed to assess their state of sleepiness at any given time measured at 12 weeks compared to baseline. A higher KSS score indicates a higher level of subjective sleepiness.
Time frame: From enrolment to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.
Sleep Outcomes - Epworth Sleepiness Scale
Change in Epworth Sleepiness Scale: Participants will be asked to rate on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities to provide an indication of their daytime sleepiness measured at 12 weeks compared to baseline and 3 weeks. Higher scores suggest higher levels of excessive daytime sleepiness.
Time frame: From enrolment to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.
Sleep Outcomes - Psychomotor Vigilance Task (PVT)
The PVT will be used to assess sustained attention via a simple reaction time task. The device is a hand-held box with a red-light emitting diode display of a three-digit millisecond counter (PVT-192, Ambulatory Monitoring Inc, Ardsley, NY, USA). Participants are instructed to respond as fast as possible when they first see a visual stimulus appear. The time taken to respond to the stimulus is displayed in milliseconds (ms). During each 10-minute PVT session, visual stimuli appear at variable intervals between 2 to 10 seconds. The PVT response variables to be analysed are: a) mean reciprocal reaction time (RT); b) mean of the fastest 10% of RTs; c) mean reciprocal of slowest 10% of RTs; and, d) number of lapses (response time \>500ms). Tests will take place after each MWT trial.
Time frame: From enrolment to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.
Exploratory Sleep Outcomes - quantitative analysis of the EEG from PSG data
Quantitative analysis of the EEG from PSG data for assessment of sleep microarchitecture including power spectral analysis across all frequencies throughout the entire sleep period and separately in REM and non-REM sleep, K-complexes, and sleep spindles. These will be measured at 12 weeks compared to baseline.
Time frame: From enrolment to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.
Cardio-metabolic and Quality of Life Outcomes - high sensitivity C-reactive protein (hs-CRP)
The key metabolic efficacy outcome is the blood pathology-based measure of high sensitivity C-reactive protein (hs-CRP) at 12 weeks compared with baseline.
Time frame: From enrolment to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.
Cardio-metabolic and Quality of Life Outcomes - 36-Item Short Form Survey summary scores
The key quality of life efficacy outcome is the 36-Item Short Form Survey (SF-36) summary scores (Physical Component Summary score and the Mental Component Summary) at 12 weeks compared with baseline. The SF-36 is a 36-item, patient-reported measure of health status consisting of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability.
Time frame: From enrolment to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.
Cardio-metabolic and Quality of Life Outcomes - laboratory blood analyses
Laboratory Analyses for metabolic risk, inflammatory markers and hormones: A 25mL fasted blood sample will be collected by a trained professional at a commercial laboratory at baseline and at 3 months to assess cardio-metabolic risk and inflammatory status at baseline, end of week 3 and week 12. Outcome measures will include hs-CRP, erythrocyte sedimentation rate (ESR), fasting glucose and insulin \[HOMA-IR for insulin resistance\], blood lipids and lipoproteins and liver function.
Time frame: From enrolment to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.
Cardio-metabolic & Quality of Life Outcomes - anthropometry and vitals data
Anthropometry and vitals data: weight, waist circumference, neck circumference, heart rate and blood pressure will be measured at baseline and 12 weeks.
Time frame: From enrolment to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.
Cardio-metabolic & Quality of Life Outcomes - assessment of mood and quality of life using 36-Item Short Form Survey
Assessment of mood and quality of life will be assessed at baseline, 3 weeks and 12 weeks using the SF-36: The 36-Item Short Form Survey (SF-36) is a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status consisting of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability.
Time frame: From enrolment to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.
Cardio-metabolic & Quality of Life Outcomes - assessment of mood and quality of life using Hospital Anxiety and Depression Scale
Assessment of mood and quality of life will be assessed at baseline, 3 weeks and 12 weeks using the Hospital Anxiety and Depression Scale (HADS): The HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21). Higher scores indicate higher levels of anxiety or depression.
Time frame: From enrolment to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.
Cardio-metabolic & Quality of Life Outcomes - assessment of mood and quality of life using EQ-5D-5L
Assessment of mood and quality of life will be assessed at baseline, 3 weeks and 12 weeks using the EQ-5D-5L: The EQ-5D questionnaire comprises two parts. The first is the EQ-5D descriptive system, respondents are asked to tick boxes to indicate the level of problem respondents experience on each of the five dimensions. The combination of these ticks under each dimension describes that person's EQ-5D self-reported health state. The second part of the questionnaire is the EQ VAS, so called because it incorporates a Visual Analogue Scale. This captures the respondent's overall assessment of their health on a scale from 0 (worst health imaginable) to 100 (best health imaginable).
Time frame: From enrolment to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.
Cardio-metabolic & Quality of Life Outcomes - assessment of mood and quality of life using Clinical Global Impression
Assessment of mood and quality of life will be assessed at 12 weeks only using the Clinical Global Impression Instrument: rating scales are measures of symptom severity, treatment response and the efficacy of treatments. It is a brief 3-item observer-rated scale undertaken by the clinician at the end of an intervention period. It consists of a severity scale, an improvement scale and an efficacy index. Severity of illness is rated on a 7-point scale, ranging from 1 (normal) through to 7 (amongst the most severely ill patients). Global improvement is rated on a 7-point scale, ranging from 1 (very much improved) to 7 (very much worse). Efficacy index describes both therapeutic efficacy and treatment-related adverse events and range from 0 (marked improvement and no side-effects) to 16 (unchanged or worse and side-effects outweigh the therapeutic effects). Each component of the CGI is rated separately; the instrument does not yield a global score.
Time frame: At the end of 12 weeks for the last enrolled participant.
Demographics & diagnostic history
The following information will be collected via a survey at the time of enrolment: age, sex, health status, evidence of diagnosis as per inclusion criteria, time since diagnosis and medications relating to participant HS condition. The following demographics will be measured at the baseline and 12 week visits: height (baseline only), weight, waist circumference, office blood pressure.
Time frame: From enrolment to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.
Adherence and lived experience during intervention - diet satisfaction
Aim to characterise participant behaviour and lived experience through surveys including diet satisfaction: convenience, flexibility and enjoyment. The 45-item Dietary Satisfaction Questionnaire (DSat-45) uses seven scales to assess characteristics that influence diet satisfaction: Healthy Lifestyle, Convenience, Cost, Family Dynamics, Preoccupation with Food, Negative Aspects, and Planning and Preparation. The items are assessed using five responses ranging from 'Disagree Strongly' to 'Agree Strongly', which are scored from 1 to 5. Items are reverse-scored if necessary, so that higher scores indicate greater diet satisfaction, and scale scores are created by averaging scores across items. A Total Diet Satisfaction score is also calculated by averaging all item scores. This will be measured at the end of 3 and 12 weeks only.
Time frame: From the end of 3 weeks to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.
Adherence and lived experience during intervention - macronutrient/micronutrient change
Aim to characterise participant behaviour and lived experience through diaries including macronutrient/micronutrient change: Measurement of increased nutrient density or changes in macronutrient distribution assessed using 24-hour food recalls. Participants will use the ASA24 (2016, Australian version) developed by the National Cancer Institute (USA) and adapted to the Australian context by Australian researchers. It is a self-administered 24-hour dietary recall tool that enables a multiple, automatically coded food diary. It provides food choices based on the Australian Food, Supplement and Nutrient database (AUSNUT) 2011-13. Data will be collected prior to each telehealth consultation. This will be measured at baseline 3, 4, 6, 8, 10 and 12 weeks only.
Time frame: From enrolment to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.
Adherence and lived experience during intervention - dietary adherence measured by blood ketosis level
Aim to characterise participant behaviour and lived experience through objective measures of compliance including dietary adherence measured by ketosis level: The level of ketones achieved and duration of ketone levels within the nutritional ketosis range (0.5-3mmol/L) as ascertained by a finger-prick test using an Abbott Freestyle Optium Neo (https://www.youtube.com/watch?v=X819\_lhKpw0) and urinary dipsticks. All participants will measure morning and evening capillary ketones two days per week.
Time frame: From the baseline visit in week 0 to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.
Adherence and lived experience during intervention - dietary adherence measured by urine ketosis level
Aim to characterise participant behaviour and lived experience through objective measures of compliance including dietary adherence measured by ketosis level: The level of ketones achieved and duration of ketone levels within the nutritional ketosis range (0.5-3mmol/L) as ascertained by urinary dipsticks. All participants will measure afternoon/evening urinary ketone levels four times per week.
Time frame: From the baseline visit in week 0 to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.
Adherence and lived experience during intervention - habitual actigraphy sleep-wake data
Aim to characterise participant behaviour and lived experience through objective measures of compliance including habitual sleep-wake data: will be collected to describe temporal patterns of sleep and activity. This will be measured using 7-day actigraphy monitors (GeneActiv wrist watch) in the week prior to baseline visit, the end of week 3 and during week 12.
Time frame: From week -1 to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.
Adherence and lived experience during intervention - habitual sleep diary sleep-wake data
Aim to characterise participant behaviour and lived experience through diaries including habitual sleep-wake data: will be collected to describe temporal patterns of sleep and activity. This will be measured using a modified Karolinska sleep diary in the week prior to baseline visit, the end of week 3 and during week 12.
Time frame: From week -1 to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.
Adherence and lived experience during intervention - Patient Reported Experience Measures - Longitudinal PREM
Aim to characterise participant behaviour and lived experience through surveys including Patient Reported Experience Measures: collect information about the experience of health services, and the outcomes of health services, as described by patients. At baseline, the Longitudinal PREM will be collected. This survey collects information related to adults receiving care that extends over a long period of time and is seen as a longitudinal capture of a person's experience.
Time frame: From enrolment to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.
Adherence and lived experience during intervention - Patient Reported Experience Measures - Patient Assessment of Chronic Illness Care
Aim to characterise participant behaviour and lived experience through surveys including Patient Reported Experience Measures: collect information about the experience of health services, and the outcomes of health services, as described by patients. At baseline, the Patient Assessment of Chronic Illness Care (PACIC) will be collected. This survey collects information related to adults receiving care that extends over a long period of time and is seen as a longitudinal capture of a person's experience.
Time frame: From enrolment to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.
Adherence and lived experience during intervention - Patient Reported Experience Measures - Outpatient PREM
Aim to characterise participant behaviour and lived experience through surveys including Patient Reported Experience Measures: collect information about the experience of health services, and the outcomes of health services, as described by patients. At 12 weeks, the Outpatient PREM question set will be collected. This survey collects data capturing the patients' experiences of outpatient clinics and services.
Time frame: From enrolment to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.
Qualitative Data - semi-structured interviews
Qualitative data will be collected through semi-structured interviews related to the patient experience. Thematic analysis of these qualitative interviews will be conducted at three key timepoints during the intervention. These will align with: * The commencement of intervention (to characterise the patient lived experiences and expectations), * The end of the three-week whole food run in period (dietary change evaluation), * The end of the twelve-week intervention (process evaluation).
Time frame: From enrolment to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.
Qualitative Data - overall project evaluation
Overall project evaluation will be assessed using the implementation plan using the RE-AIM Framework and the CFIR framework. The implementation plan will evaluate the randomized controlled trial in synchrony with thematic analysis of a series of qualitative interviews conducted at three key timepoints during the intervention. These will align with the commencement of intervention (to characterise the patient lived experiences and expectations), at the end of the three-week whole food run in period (dietary change evaluation), and at the end of the twelve-week intervention (process evaluation). These interviews will provide a platform to better understand the patient experience during the intervention and will guide future iterations of the program. The evaluation methodology will use a combination of the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) and CFIR (Consolidated Framework for Implementation Research) dissemination and implementation frameworks.
Time frame: From enrolment to the completion of the last study visit at the end of 12 weeks for the last enrolled participant.
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