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Clinical Safety and Regulatory Information

Clinical safety and regulatory information (including intended use)

Gro Health is a world-leading behavioural change platform that is used to self-manage physical and mental health and wellbeing. The app is a Medical Device (Class I MDD; Class IIa MDR awaiting notified body approval) in the UK and Europe with CE mark. Our MHRA number is 8939.

The app and its contents has been co-developed with behavioural change experts (led by Charlotte Summers), clinicians and healthcare professionals (including from University Coventry & Warwickshire Hospitals NHS Trust, Royal College of GPs, British Psychological Society, British Dietitians Association) to ensure it meets the needs of service users. The contents of the app have been approved by QISMET for the provision of self-management structured education (QIS 2020 and SS2Q). 

The app uses behavioural change techniques (such as goal setting, re-appraisal, human counselling and peer support) to encourage and reinforce particular behaviours. You can read more about the architecture and behavioural change techniques used within Gro Health, as it is built upon a proprietary peer-reviewed digital behavioural change framework.

Evidence of the app's use and benefits

Gro Health provides multi-platform access to remotely monitored (where delivered by clinical teams) behavioural change support. 

Users are able to log their health over time and connect with popular wearables and health services. Users can engage in a library of on-demand behaviour change programmes providing Cognitive Behavioral Therapy (CBT), Acceptance Commitment Therapy (ACT), Mindfulness Based Therapy (MBT), on-demand activities, sleep aids, mindfulness techniques and exercises, and human 1-to-1 and group coaching for counselling and guidance. 

The app delivers therapeutic care in areas including weight management, mental health, hypertension, sleep, and cardiovascular disease. 

The app has published, peer-reviewed evidence demonstrating improvements in the symptoms of stress, anxiety and depression after 12 weeks of use. The nutrition stream of the program enables you to choose from a variety of evidence-based nutrition programmes demonstrated to support weight loss and improvements in glycemic control

Gro Health is a Fellow to the Royal College of GP's Innovation Programme.

Read more about the impact of Gro Health on mental wellbeing

Intended use

Most people will find Gro Health a useful too to provide mental and physical health and wellbeing information. Gro Health is intended to provide mental health and wellbeing support for people diagnosed with:

  • Major depressive disorder
  • Depression
  • Stress
  • Generalised anxiety disorder

Gro Health is used to support weight loss in adults diagnosed with:

  • Major depressive disorder
  • Depression
  • Stress
  • Generalised anxiety disorder
  • Obesity
  • Pre-diabetes
  • Type 2 diabetes
  • Polycystic ovarian syndrome
  • Non-alcoholic fatty liver disease

Gro Health is used to support weight loss as a family wellbeing intervention to support improvements in mental and physical health.

Contraindications (who should not use the app)

Please speak to a healthcare professional before starting any change to your lifestyle. Please do not use the app if you have any of the following, unless at the referral/request of your healthcare professional:

  • Pregnancy or breastfeeding
  • History of eating disorders
  • Severe mental illness or cognitive impairment
  • Porphyria
  • Carnitine deficiency (primary), carnitine palmitoyltransferase (CPT) I or II deficiency, Carnitine translocase deficiency, beta-oxidation defects, medium-chain acyl dehydrogenase deficiency (MCAD), long-chain acyl dehydrogenase deficiency (LCAD), short-chain acyl dehydrogenase deficiency (SCAD), long-chain 3-hydroxyacyl-CoA deficiency, medium-chain 3-hydroxyacyl-CoA deficiency, pyruvate carboxylase deficiency

Evidence base for the app

The platform has been developed with people, patients, healthcare professionals and professional bodies from around the world. The following evidence-base has been used as a foundation to develop the app and its contents: 

  • Silva, D. A., Coutinho, E. D. S. F., Ferriani, L. O., & Viana, M. C. (2020). Depression subtypes and obesity in adults: A systematic review and meta‚Äźanalysis. Obesity Reviews, 21(3), e12966.
  • Inta, D., Wölnerhanssen, B. K., Meyer-Gerspach, A. C., Lang, E., Schweinfurth, N., Mallien, A. S., ... & Lang, U. E. (2020). Common Pathways in Depression and Obesity: The Role of Gut Microbiome and Diets. Current Behavioral Neuroscience Reports, 1-7.
  • Snorgaard, O., Poulsen, G. M., Andersen, H. K., & Astrup, A. (2017). Systematic review and meta-analysis of dietary carbohydrate restriction in patients with type 2 diabetes. BMJ Open Diabetes Research and Care, 5(1).
  • Milior G, Lecours C, Samson L, et al. Fractalkine receptor deficiency impairs microglial and neuronal responsiveness to chronic stress. Brain Behav Immun 2016; 55: 114-25.
  • Lyons WE, Mamounas LA, Ricaurte GA, et al. Brain-derived neurotrophic factor-deficient mice develop aggressiveness and hyperphagia in conjunction with brain serotonergic abnormalities. Proc Natl Acad Sci U S A 1999; 96(26): 15239-44.
  • Jiang H, Ling Z, Zhang Y, et al. Altered fecal microbiota composition in patients with major depressive disorder. Brain Behav Immun 2015; 48: 186-94.
  • Kelly JR, Borre Y, C OB, et al. Transferring the blues: Depression-associated gut microbiota induces neurobehavioural changes in the rat. J Psychiatr Res 2016; 82: 109-18.
  • Polyak A, Ferenczi S, Denes A, et al. The fractalkine/Cx3CR1 system is implicated in the development of metabolic visceral adipose tissue inflammation in obesity. Brain Behav Immun 2014; 38: 25-35.
  • Arab, A., Mehrabani, S., Moradi, S., & Amani, R. (2019). The association between diet and mood: A systematic review of current literature. Psychiatry research, 271, 428-437.
  • Chung, Y. C. E., Chen, H. C., Chou, H. C. L., Chen, I. M., Lee, M. S., Chuang, L. C., ... & Kuo, P. H. (2019). Exploration of microbiota targets for major depressive disorder and mood related traits. Journal of Psychiatric Research, 111, 74-82.
  • Patel, N. A., & Butte, A. J. (2020). Characteristics and challenges of the clinical pipeline of digital therapeutics. NPJ digital medicine, 3(1), 1-5.
  • Torous, J., Myrick, K. J., Rauseo-Ricupero, N., & Firth, J. (2020). Digital mental health and COVID-19: Using technology today to accelerate the curve on access and quality tomorrow. JMIR mental health, 7(3), e18848.
  • Gal, R., May, A. M., van Overmeeren, E. J., Simons, M., & Monninkhof, E. M. (2018). The effect of physical activity interventions comprising wearables and smartphone applications on physical activity: a systematic review and meta-analysis. Sports medicine-open, 4(1), 42.
  •  Fleming, T., Bavin, L., Lucassen, M., Stasiak, K., Hopkins, S., & Merry, S. (2018). Beyond the trial: systematic review of real-world uptake and engagement with digital self-help interventions for depression, low mood, or anxiety. Journal of medical Internet research, 20(6), e199.
  • Hanson P, Summers C, Panesar A, Oduro-Donkor D, Lange M, Menon V, Barber TM. Low Carb Program Health App Within a Hospital-Based Obesity Setting: Observational Service Evaluation. JMIR Form Res. 2021 Sep 23;5(9):e29110.
  • Puigdomenech, E., Martin, A., Lang, A., Adorni, F., Gomez, S. F., McKinstry, B., ... & PEGASO Fit For Future Consortium. (2019). Promoting healthy teenage behaviour across three European countries through the use of a novel smartphone technology platform, PEGASO fit for future: study protocol of a quasi-experimental, controlled, multi-Centre trial. BMC medical informatics and decision making, 19(1), 278.
  • Scheelbeek, P., Green, R., Papier, K., Knuppel, A., Alae-Carew, C., Balkwill, A., ... & Dangour, A. D. (2020). Health impacts and environmental footprints of diets that meet the Eatwell Guide recommendations: analyses of multiple UK studies. BMJ open, 10(8), e037554.
  • Smith, D. M., Vogel, C., Campbell, M., Alwan, N., & Moon, G. (2021). Adult diet in England: where is more support needed to achieve dietary recommendations?. PLOS ONE, 16(6), e0252877.
  • Summers, C., Wu, P., & Taylor, A. J. (2021). Supporting Mental Health During the COVID-19 Pandemic Using a Digital Behavior Change Intervention: An Open-Label, Single-Arm, Pre-Post Intervention Study. JMIR Formative Research, 5(10), e31273.

Clinical and technical safety

We are committed to clinical and technical excellence. DDM’s services are delivered in compliance with clinical safety requirements: NHS Data Security & Protection Toolkit (our ODS number is: 8K787), DSCN 14/2009, DCB0129 and DCB0160. Effective application of clinical risk management, clinical risk and safety is managed by the DDM's Clinical Safety Officer, an appropriate, practicing physician skilled and experienced to provide safety and governance. All clinical guidance and references within the platform are aligned to National Institution for Health and Care Excellence (NICE) and/or nationally accepted guidelines. Citations for all claims are available on request. 

The app has been evaluated, approved and validated by the Clinical Team, led by the Clinical Safety Officer. 

  • The Clinical Safety Officer for this intervention is Dr Peter Foley.
  • The Caldicott Guardian is Michaela de la Fosse.
  • The Data Protection Officer is Amar Singh.

All can be contacted here.

Communications and peer support

All peer-to-peer communications (community, 1-to-1 coaching, comments) are moderated to ensure a safe, inclusive, 24/7 peer-to-peer community. A team of human operators are moderators of the forum. There are also algorithms/filters to prevent spam and/or offensive content. All communications within the platform are logged at event level and audited weekly. Some posts may be removed or hidden to ensure continuity of the service. 

Risk and hazard management process

DDM is committed to clinical and technical safety. As ISO27001, ISO9000 and ISO20000 accredited providers, DDM has embedded management and clinical risk systems in place to ensure the technical security, clinical safety and quality of its systems and the data within it. 

All data collected, processed and stored is done so utilising AES-256 encryption in-transit and at-rest in the country of participant signup. The transfer of data is via network only Transfer Layer Security (TLS) 1.2 only. This includes the transmission of data from DDM services to its hosts (Microsoft Azure). Remote access to infrastructure holding data is monitored on a daily basis. 

DDM has a clinical risk measurement, evaluation and management process overseen by the Clinical Safety Officer. The risk/hazard assessment process follows DDM’s standard Clinical Risk Management System approach. Risks may also be identified in other ways during the development and use of the Gro Health such as discovery during design of a solution by supplier or NHS Organisation; participant engagement; feedback; in-app message; testing of amended functionality; ad-hoc testing of live service functionality; reporting of an incident or problem within the live service; and identification by a member of staff within the supplier or NHS Organisation.  A full Hazard Log is maintained and updated by the Clinical Safety Team.

For each identified hazard, the following information will be defined and recorded as: hazard number; name and description; potential clinical impact, possible causes and existing controls – these are identified existing controls or measures that are currently in place and will remain in place post-implementation that provide mitigation again the hazard, i.e. will be used as part of the initial Hazard Risk Assessment. Each Hazard is reviewed by the Clinical Safety Team and appropriate stakeholders to estimate and evaluate clinical risk and controls, and record the outcome. For each identified hazard, estimation is made of the clinical risk. The estimation process follows that established by the safety processes defined in SCCI 0129. All and any apps and/or products belonging to third parties that are included within a release must be assessed thoroughly.

DDM continually monitors its services. The contents of the app are reviewed every month by the Clinical Safety Team, or as peer-reviewed evidence emerges. In-app telemetry and feedback sent to our support team (in-app or on the web) helps us to identify and address inequities and inequalities in engagement and/or health outcomes.

If you would like to raise a risk or hazard, please contact us

Risks associated with the app

Safety of apps is an emerging issue. DDM has conducted several studies and continues to research the benefits and risks related to app use. 

Unless you have been referred to the app by a qualified healthcare professional, do not use the app if you are diagnosed with any of the conditions listed under Contraindications. 

Please consult your doctor before using this app. The app is not intended to replace the relationship with your doctor/physician. Follow the advice of your doctor.

Risks associated with the use of the app for participants with type 2 diabetes taking medications are hypoglycemia and tiredness. People with hypertension (high blood pressure) taking hypertensive medications may experience dizziness. Do not use the app if you are at risk of problems resulting from changes to your diet or activity. Risks identified by participants with polycystic ovarian syndrome are pregnancy. Risks identified for participants with long COVID are tiredness and fatigue; please go at your own pace and consult your doctor if you feel unusually tired.

If you become pregnant while using the app, there may be implications on the way the app could help you. Please consult your healthcare professional. 

Blue light from phones and tablets can cause eye strain and speed up blindness. It's also not advised to stare at your phone in the dark. Try not to use your phone before bed. The blue light emitted by your phone can affect the production of the hormone which controls your sleep-wake cycle, or circadian rhythm. This can disrupt your sleep. Find more information in the Sleep area of the Gro Health app. 

Be aware that by using a mobile phone and holding it consistently in your hand, and when moving the thumb rapidly over the keypad can put a great deal of strain on tendons in the arm and cause repetitive strain injury (RSI).