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Research protocol

Objectives To design and implement an integrated Coaching based intervention research project in extension of the ongoing prevalence study in the participating clinics.

Abstract Seafarers and fishermen have an increased risk for diabetes and hypertension as part of the metabolic syndrome including overweight and obesity. Pre-diabetes increases the risk of developing type 2 diabetes, heart disease, and stroke. In Spain, 22% of those with overweight and 41% of those with obesity have diabetes. The fishermen have 2 times higher risk for diabetes compared to the seafarers. Thankfully, you can reverse the damage of pre-diabetes and we can help you. In view of the good research results from the coaching interventions non-maritime areas e.g.: [1] [2] [3],[4] we are challenged to try-out using similar methods including Coaching with the partner maritime medical clinics as an extension of the ongoing prevalence study of diabetes type 2. The study population will be seafarers with newly diagnosed pre-diabetes and overweight in the maritime medical clinics. The purpose is to educate and support the seafarers by their own efforts based on study materials specific developed for seafarers and supported by coaches to normalise elevated blood sugars, to provide good health for them. We take the advantage that the seafarers have to come to health examnination anyway biannually that reduce the costs, facilitates the study, reduces the number of non responders and increase the quality of the project by including coaches, medical doctors and researchers with good knowledge on the seafarers work, health and life

VIDEO SPEAK

"Around 84 million Americans have pre-diabetes and almost 90% don’t even know it. An individual is pre-diabetic when their blood

sugar levels are higher than normal, but aren’t high enough to be diagnosed with type 2 diabetes. Pre-diabetes increases the risk of developing type 2 diabetes, heart disease, and stroke. In Spain, 22% of the fishermen and seafarers with overweight and 41% of those with obesity have pre-diabetes or diabetes. The fishermen have x2 times the risk for diabetes compared to the seafarers. Thankfully, you can reverse the damage of pre-diabetes and we can help you. We have a supporting program with weekly Zoom meetings starting with your health examination in the maritime medical clinics. Our 16 week pre-diabetes coaching program is designed to inspire and support seafarers how to prevent the further development from pre-diabetes to manifest type 2 diabetes. This program targets individuals with an A1c between 5.7% and 6.4% who are currently not taking medication for diabetes.

Our "International Maritime DM2 Coaching Program" (IMDCP) offers individual patient-centred support, delivered with personal meetings and online. Health coaching focuses on increasing patients' skills and confidence to manage their own condition and set achievable goals - engaging patients to make informed decisions.

Introduction

The program combines the biannual, mandatory clinical fit-for-duty health examinations for seafarers and fishermen in a Public Health perspective with biannual screening for Diabetes Type 2 and Hypertension and a pilot intervention project using Coaching support to the seafarers and fishermen who wants to join the trial and learn more about how they can prevent diabetes themselves.

Background[edit | edit source]

Seafarers, have a great inequity in health at work with a higher risk of overweight, metabolic syndrome, diabetes type 2 and hypertension and a need for accurate early diagnosis and prevention[5] [6] [7] [8] [9][10]While the objective one hundred years ago for the fit-for-duty medical examinations was purely related to the safety of the seafarers and the ships, now the ILO guidelines inspire to include protocols related to the general health of seafarers beyond the fit-for-duty protocol. The focus on early diagnosis of Type 2 diabetes and hypertension seems to be a good choice for intervention based on the evidence that pre-hypertension and pre-diabetes mellitus Type 2 can be reversed by non-pharmacological and pharmacological measures [11] [12][13][14][15]Screening in medical practice for hypertension can cause validity issues, and more research is needed [16][17][18].

Objectives[edit | edit source]

The Diabetes Health Coaching study is a randomized controlled trial designed to evaluate the effect of a 4 months Zoom-based diabetes health coaching intervention in seafarers with new diagnosed pre-diabetes mellitus (T2DM) on glycated haemoglobin (A1C) on the start and at the end and weekly self administrated glycometer, self-care behaviours. The purpose of this pilot study is to help the seafarers and fishermen to normalise their blood pressure, bloodsugar and their BMI.


Methods

The eligibility criteria are: a) adults > 18 years of age; b) a diagnosis of T2DM pre-diabetes; c) A1C of 5,7%-6,4% (fasting glucose 100-125 mg/dl) at randomization, d) All values of Body Mass Index included, e) Ability to read, write and understand English or Spanish; f) Have telephone/internet access at home and on the ships.

Table 1. Lab. Blood Glucose test values in the clinics to decide who can participate
Blood Glucose A1C limits Fasting glucose limits
Normal ≤ 39mmol/L (5,6%) ≤ 100mg/dl
Pre-diabetes 39-47 mmol/L (5,7%-6,4%) 100-125 mg/dl
Diabetes ≥ 48 mmol/L (6,5%) ≥ 126 mg/dl

From April 1 2024 to June 2024, xx patients in each of the participating maritime medical clinics, completing the elegibility criteria are asked to participate and randomised into the trial. Over a month or so, each clinic, selects xx matched pairs for age, gender, and ship type (fishing/merchant ship) and randomize them for the intervention and the control group. In this way the baseline characteristics of the participants are equally distributed across the intervention and control group and the information is given to the research group.

Table 2. Example of data from maritime clinic on prevalence, is the basis for the study
GEN AGE WORK SMO HTN DM-A1c DM-FG BMI BMI-gr PHY FRU
M 23 SeaEngine Non-Smoker Stage 1 Pre Normal 25,5 Over High None

When the seafarer accepts to participate, the data from the "prevalence study" form the basis for the intervention study, where the seafarer collects data every week on the recorded variables, that forms the basis for evaluating the effect of the trial.

Table 3. Weekly meetings, seafarer and coach keep Excel records in the Intervention group.
Date Med Kg Act Fruit FBS DIA BP SYS BP Study Smoke

Y/N

Place

sea/

home

Start. Nov None 95 low low 140 91 145 Y Y SEA
Goal 0 85 high high fine 85 135 Y N

Separate start meetings are held with each of the participants in the Intervention group to be informed on the objectives of the trial. Both of them are asked to contact the same clinic or another clinic after 4 months to register A1C, weight and the other variables. The Diabetes Health Coaching study is in a position to evaluate a potential treatment alternative and approach for Pre-diabetes (T2DM), and will examine the effect of the intervention on clinical outcomes, self-care behaviours and cost-effectiveness.

Table 4. Blood Glucose Monitorering System for self-testing, values
Fasting Post prandial Random *
Normal ≤ 126 mg/dl ≤ 200mg/dl ≤ 200mg/dl
Diabetes. ≥ 126 mg/dl ≥ 200 mg/dl ≥ 200 mg/dl

A fasting glycemia that is, without calorie intake for at least 8 hours). A post prandial glycemia equal to or greater than 200 mg/dl two hours after eating. A random glycemia equal to or greater than 200 mg/dL in a patient with symptoms

Table 5. Schedule for the 16 weekly online meetings with seafarer and coach
Week > 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 End
Intervention Clinic (1) Weekly Zoom Coach meetings for the intervention group Clinic
Controls Clinic No meetings for the control group Clinic

(1) Start and end meetings at the clinic, first meeting is the obligatory medical heath examination.

The "International Maritime research based Diabetes2/HTN Coaching Program" (IMDCP) offers individual patient-centred support, delivered with personal meetings online. Health coaching focuses on increasing patients' skills and confidence to manage their own condition and set achievable goals - engaging patients to make informed decisions. Our 4 month pre-diabetes coaching program is designed to teach members how to prevent the development of manifest type 2 diabetes. This program targets individuals with an A1c between 5.7% and 6.4% who are currently not taking medication for diabetes. The program is done in close collaboration between the maritime medical doctors, the Seafarers the Coaches and the researchers. For the diagnosis of diabetes, these values ​​are considered as in Table 1.

Discussion

Our 16 week pre-diabetes coaching program is designed to inspire and support seafarers how to prevent the further development from pre-diabetes to manifest type 2 diabetes. This program targets individuals with an A1c between 5.7% and 6.4% who are currently not taking medication for diabetes.

The "International Maritime Diabetes and Hypertension Coaching Program" (IMDCP) offers individual patient-centred support, delivered with personal meetings online. Health coaching focuses on increasing patients' skills and confidence to manage their own condition and set achievable goals - engaging patients to make informed decisions. Our one year pre-diabetes coaching program is designed to teach members how to prevent the development of type 2 diabetes from pre-diabetes. This program targets seafarers with an A1c between 5.7% and 6.4% who are currently not taking medication for diabetes. The program is done in close collaboration between the Maritime Medical Doctors, the Seafarers and the Coaches.

Our health Health Coaches are medical doctors, researchers in maritime health, nurses or social workers in maritime medicine and other health persons. By personal meetings and online support the objective is to activate internal strengths and external resources to make sustainable and healthy lifestyle behavior changes. Health coaches use a personal-centered approach wherein the seafarers decide their goals, engage in active learning processes, and self-monitor behaviors to increase accountability, all within the context of an interpersonal relationship with a health coach.

Health coaches work to educate and motivate the seafarers on making changes in their lives by placing an emphasis on Nutrition and Exercise in weekly, progressive goals. Along with weekly calls from their dedicated coach and access to online tracking tools, participants receive weekly emails to support them in their lifestyle change.

CONTENTS OF THE 16 WEEKS COACHING
To be done by the Seafarer at start
Glucometer &

Blood pressure monitor

The Seafarers are asked to buy a Glucometer [19] and a blood pressure monitor [20]
Course fees None for the first participants, but later
To be done by the Coach at start
Explain the Excel sheet for weekly self-recordings (Table 3)
To be done by the Seafarer and the Coach every week
To be done by the Seafarer: Complete the questionnaire with the results at the end of each week

Measure Blood pressure self-test on two selected days every week

Make the Glucosemeter fasting self test and your weight

Add all the results to the Excel sheet

Read and be orientated on the materials for the next week meeting

To be done by the Coach: Stay orientated on the seafarers results and the goals in Excel file

Talk about the results and the goals

Talk about the readings for this week

Information on the next weeks materials for readings

Note difficulties in the course and do adequate improvements

Elaborate and sign a course certificate after 16 weeks participation

The specific subjects week by week
Week 1 Prevention What is preventive healthcare? [21] "Dont cure - make prevention"[22] How can I reduce my risk of type 2 diabetes and Hypertension?[23]
Week 2 Pre-diabetes What is pre-diabetes type 2 & how to stay healthy(CDC)[24]

Pre-diabetes is a serious health condition: What you need to know (Safety4Sea)[25]

Physical fit How to stay fit? [26]

Best exercises for prediabetes [27] ISWAN How to do a proper workout on board[28]

Week 3 Blood pressure. High bloodpressure (Hypertension) What is blood pressure?[29]Exercise: A drug-free approach to lowering high blood pressure

[30] Controling hypertension at sea, Gard[31]

Week 4 Blood glucose How to use the Glucometer?

How to use the Glucometer [32] [33] Normal Values[34] Readings for the next meeting

Diabetes & work Supporting seafarers with pre-diabetes on board [35]
Week 5 Welbeing on board Welbeing courses for seafarers [36]

American Club: How to manage seafarers’ mental health challenges[37]

Week 6 Overweight. What is overweight, the health risks and how to prevent[38]
Obesity What is obesity, the health risks and how to prevent? [39]
T2DM Tablets Tablets (Metformin) is not the first choice of prevention[40][41]
Week 8 Sleep and rest Cope with sleep and nightwork [42]
Week 9 Healthy food Cooking course for young seafarers [43]Healthy Eating Diabetes, online Harvard University [44][45]
Fish and T2DM What is the best seafood for T2DM?[46]
Meats Meats for diabetes 2 [47]
Week 10 Snack Type 2 Diabetes-Friendly Snacks for When You’re Short on Time [48]
Week 11 Drink type What to drink as prediabetic [49]
Week 12 Alcohol Alcohol and diabetes 2[50]. Calories in different types of alcohol [51] What should my daily intake of calories be? [52]
Week 13 Fibers in the food Best high fiber snacks for diabetes[53]
Week 14 Dental care ISWAN Dental care for seafarers[54]
Week 15 Social welbeeing ISWAN Seafarers welfare, fitness to prevent Diabetes type 2 [55]
Week16 Evaluation and research The seafarer hands out the Excel sheet to the Coach.

Evaluation! Were the goals obtained?

Hand out of signed certificates

Any proposals for improvement.

Research projects

References[edit | edit source]

  1. ↑ Pre-diabetes Coaching Program "Empower your employees to improve their health through lifestyle changes https://www.healthcheck360.com/prediabetes-program
  2. ↑ The Effectiveness of Patient Activation Intervention on Type 2 Diabetes Mellitus Glycemic Control and Self-Management Behaviors: A Systematic Review of RCTs Almutairi, Nasser et al.Primary Care Diabetes 14, no. 1 (February 2020): 12–20. https://doi.org/10.1016/j.pcd.2019.08.009.
  3. ↑ The Diabetes Health Coaching Randomized Controlled Trial: Rationale, Design and Baseline Characteristics of Adults Living With Type 2 Diabetes. Sherifali, Diana et al. Canadian Journal of Diabetes 43, no. 7 (October 1, 2019): 477–82. https://doi.org/10.1016/j.jcjd.2018.10.004
  4. ↑ Reversing Type 2 Diabetes in a Primary Care-Anchored eHealth Lifestyle Coaching Programme in Denmark: A Randomised Controlled Trial. Christensen, JR, Ditte Hjorth Laursen et al.” Nutrients 14, no. 16 (August 19, 2022)https://doi.org/10.3390/nu14163424.
  5. ↑ Nittari G, Tomassoni D, Di Canio M, Traini E, Pirillo I, Minciacchi A, et al. Overweight among seafarers working on board merchant ships. BMC Public Health. 2019 Jan 9;19(1):45
  6. ↑ Oldenburg M, Jensen H-J, Latza U, Baur X. Coronary risks among seafarers aboard German-flagged ships. Int Arch Occup Environ Health. 2008 May;81(6):735–41
  7. ↑ Tu M, Jepsen JR. Hypertension among Danish seafarers. Int Marit Health. 2016;67(4):196–204
  8. ↑ Herttua K, Ahrenfeldt LJ, Paljarvi T. Risk of major chronic diseases in transport, rescue and security industries: a longitudinal register-based study. Occup Environ Med. 2022 Mar;79(3):162–8.
  9. ↑ Kaerlev L, Dahl S, Nielsen PS, Olsen J, Hannerz H, Jensen A, et al. Hospital contacts for chronic diseases among danish seafarers and fishermen: a population-based cohort study. Scand J Public Health. 2007;35(5):481–9.
  10. ↑ Baygi F, Djalalinia S, Qorbani M, Dejman M, Nielsen JB. Lifestyle interventions in the maritime settings: a systematic review. Environ Health Prev Med. 2020;25:10
  11. ↑ New Guidance on Blood Pressure Management in Low-Risk Adults with Stage 1 Hypertension [Internet]. American College of Cardiology. [cited 2022 Feb 7]. Available from: https://www.acc.org/latest-in-cardiology/articles/2021/06/21/13/05/http%3a%2f%2fwww.acc.org%2flatest-in-cardiology%2farticles%2f2021%2f06%2f21%2f13%2f05%2fnew-guidance-on-bp-management-in-low-risk-adults-with-stage-1-htn
  12. ↑ Alderman MH. Non-pharmacological treatment of hypertension. The Lancet. 1994 Jul 30;344(8918):307–11
  13. ↑ Baygi F, Mohammadi-Nasrabadi F, Zyriax B-C, Jensen OC, Bygvraa DA, Oldenburg M, et al. Global overview of dietary outcomes and dietary intake assessment methods in maritime settings: a systematic review. BMC Public Health. 2021 Aug 21;21(1):1579
  14. ↑ Baygi F, Mohammadi-Nasrabadi F, Zyriax B-C, Heitmann BL. Healthy nutrition for seafarers during and after COVID-19 pandemic. Int Marit Health. 2022;73(1):56–7
  15. ↑ Taylor R, Al-Mrabeh A, Sattar N. Understanding the mechanisms of reversal of type 2 diabetes. Lancet Diabetes Endocrinol 2019 Sep 1;7(9):726–36
  16. ↑ Guirguis-Blake, Janelle M., Corinne V. Evans, Elizabeth M. Webber, Erin L. Coppola, Leslie A. Perdue, og Meghan Soulsby Weyrich. “Screening for Hypertension in Adults: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force”. JAMA 325, nr. 16 (27. april 2021): 1657–69. https://doi.org/10.1001/jama.2020.21669
  17. ↑ Ugeskriftet.dk. “To screen or not to screen – for højt blodtryk?” Set 3. april 2022. https://ugeskriftet.dk/videnskab/screen-or-not-screen-hojt-blodtryk
  18. ↑ Tu, Mingshan, og Jorgen Riis Jepsen. “Hypertension among Danish Seafarers”. International Maritime Health 67, nr. 4 (2016): 196–204. https://doi.org/10.5603/IMH.2016.0037
  19. ↑ https://www.girodmedical.es/diagnostico-medico/medicina-general/glucometro.html?gclid=CjwKCAiAsIGrBhAAEiwAEzMlCz636IZl6_pYjqjyYxrciMvfindOYEuoGMp45kCW1z766IozzJ_rqhoCuJEQAvD_BwE
  20. ↑ https://www.promofarma.com/en/blood-pressure-monitors/c-539
  21. ↑ https://en.wikipedia.org/wiki/Preventive_healthcare
  22. ↑ https://www.preventionatsea.com/
  23. ↑ https://www.diabetes.org.uk/diabetes-the-basics/types-of-diabetes/type-2/can-diabetes-be-prevented
  24. ↑ https://www.cdc.gov/diabetes/index.html
  25. ↑ Prediabetes is a serious health condition what you need to know https://safety4sea.com/cm-prediabetes-is-a-serious-health-condition-what-you-need-to-know (Safety4sea)
  26. ↑ https://nfa.dk/da/Vaerktoejer/Andre-vaerktoejer/Smaaoevelser
  27. ↑ https://www.fitterfly.com/blog/best-exercises-for-prediabetes/
  28. ↑ https://safety4sea.com/how-to-do-a-proper-work-out-on board/%20How%20to%20do%20a%20proper%20work%20out%20on%20board
  29. ↑ https://www.cdc.gov/bloodpressure/about.htm.
  30. ↑ https://www.mayoclinic.org/diseases-conditions/high-blood-pressure/in-depth/high-blood-pressure/art-20045206
  31. ↑ https://www.gard.no/web/articles?documentId=34050827
  32. ↑ https://www.accu-chek.com/blog/glucose-meter-accuracy#:~:text=FDA%3A%20Readings%20are%2095%20percent,has%20proven%20to%20be%20accurate
  33. ↑ https://www.frederiksen-scientific.dk/webshop/biologi/fysiologi/blod/glucometer-contour-next
  34. ↑ https://www.preving.com/ca/glucemia-postprandial/
  35. ↑ https://www.diabetes.org.uk/guide-to-diabetes/life-with-diabetes/employment/employers
  36. ↑ https://www.missiontoseafarers.org/wecare/training
  37. ↑ https://safety4sea.com/american-club-how-to-manage-seafarers-mental-health-challenges/
  38. ↑ https://www.seafarerswelfare.org/seafarer-health-information-programme/overweight/overweight-a-guide-for-seafarers
  39. ↑ http://handbook.maritimemedicine.com/index.php/obesity
  40. ↑ https://www.johnmuirhealth.com/health-education/conditions-treatments/diabetes-articles/managing-pre-diabetes-preventing-diabetes.html
  41. ↑ https://www.gard.no/web/articles?documentId=30704649
  42. ↑ https://shw.dk/nyheder/2023/9/6/nyt-at-sea-magasin-stort-tema-om-svn-og-natarbejde
  43. ↑ https://shw.dk/madlavningskursus?locale=en
  44. ↑ https://pll.harvard.edu/course/healthy-eating-type-2-diabetes
  45. ↑ https://www.lark.com/resources/what-to-eat-for-prediabetes
  46. ↑ https://www.everydayhealth.com/type-2-diabetes/diet/the-best-seafood-for-diabetes/
  47. ↑ https://www.medicalnewstoday.com/articles/meats-for-diabetes
  48. ↑ https://www.healthline.com/health/type-2-diabetes/grab-and-go-snacks#nuts
  49. ↑ https://www.healthline.com/health/diabetes/drinks-for-diabetics
  50. ↑ https://diabetes.org/health-wellness/alcohol-and-diabetes
  51. ↑ https://medlineplus.gov/ency/patientinstructions/000886.htm
  52. ↑ https://www.nhs.uk/common-health-questions/food-and-diet/what-should-my-daily-intake-of-calories-be/#:~:text=An%20ideal%20daily%20intake%20of,women%20and%202%2C500%20for%20men.
  53. ↑ https://www.eatingwell.com/article/8048547/best-high-fiber-snacks-for-diabetes/
  54. ↑ https://www.seafarerswelfare.org/seafarer-health-information-programme/dental/dental-care-a-guide-for-seafarers
  55. ↑ https://www.seafarerswelfare.org/seafarer-health-information-programme/fit-on-board
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