The Emirates Heart Health Project: A Family-based Diet and Exercise Intervention in Obese and Overweight Patients

Summary

Participation Requirements

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Introduction Non-communicable diseases overtook infectious diseases as the leading cause of death in the past century, and despite concerted efforts, continue to result in the deaths of millions worldwide each year. Despite methodological challenges, a growing body of literature gives mixed evidence...

Introduction Non-communicable diseases overtook infectious diseases as the leading cause of death in the past century, and despite concerted efforts, continue to result in the deaths of millions worldwide each year. Despite methodological challenges, a growing body of literature gives mixed evidence that links these diseases with modern lifestyles, which include an increased intake of calorie-dense nonnutritive foods combined with a lack of physical activity leading to obesity (1,2) and overweight (3) which increases the risk of developing cardiovascular disease (4, 5) as well as cancer (6). These trends are mirrored in the country of the United Arab Emirates (UAE), as well as in the specific location of this clinical trial, the emirate of Abu Dhabi (7, 8). Existing knowledge The latest available data from the Abu Dhabi Department of Health show that cardiovascular disease (CVD) is the leading cause of death among the population of the emirate of Abu Dhabi (7, 8). This trend has been stable over time despite concerted efforts. Particularly striking is that CVD was listed as the cause of death in over 39% of those over the age of 45. In those over 60 years of age, CVD outweighs the combined effect of the second, third and fourth leading causes of death, cancer, respiratory diseases, and infectious disease, respectively. (7) A survey showed that a sub-optimal diet was the leading risk factor for cardio-metabolic disease (CMD) deaths and estimated that this accounted for 72% of CMD deaths in the UAE. In particular, the low consumption of whole grains was responsible for 22% of CMD deaths in the UAE. Other risk factors included high levels of processed meat, red meat, and sugar sweetened beverages (5). Studies done in the UAE show that despite knowledge of healthy diet and exercise, barriers exist to lifestyle change. A survey of patients in the UAE with type 2 diabetes showed only 3% met numerous guidelines' recommendations for 150 minutes of moderate intensity aerobic activity or 75 minutes of vigorous aerobic activity per week (9). The reasons given for not exercising included cultural reasons (29.2%), "exercise is boring" (20.3%), and lack of family support (4.1%). Despite access to appointments with dieticians in primary health centers on an individual basis, rates of obesity, overweight, and CVD risk factors have remained stable. In the setting of the traditional culture of the nationals of the UAE (Emiratis), family-based interventions that specifically address cultural and religious norms and accommodate family obligations may have a greater benefit than individual-centred appointments. There may be greater adherence to physical activity and healthy eating habits if the family commits to this new lifestyle together. Need for a trial: To the investigators' knowledge, no study has investigated the effect of family-based lifestyle interventions led by a health coach in the UAE. Need for a trial: To the investigators' knowledge, no study has investigated the effect of family based lifestyle interventions led by a health coach and supported by technological aids such as fitness trackers and smartphone applications to track dietary intake. In the setting of the traditional culture of the nationals of the UAE, family based interventions that specifically address cultural and religious mores and accommodate family obligations may have a greater benefit than individual dietician visits. There may also be greater adherence to physical activity and health eating habits if the family commits to this lifestyle together. Comparators The current practice in Kanad Hospital is to refer individual overweight and obese Emiratis to dieticians for co-management. A 1:1 age and sex matched control group will be selected from consecutive patients attending the dietician clinic. The study is designed to assess the superiority of the Emirates Heart Health Program (EHHP) intervention over current usual practice, and if proven superior, can guide future practice, health insurance coverage and allocation of government resources. Objectives Research hypothesis: The Emirates Heart Health Program (EHHP), a family based diet and exercise intervention using a family health coach with technological aids, has additional benefit in reducing cardiovascular risk factors when compared to the current usual management of obese and overweight patients in the emirate of Abu Dhabi, United Arab Emirates. Study Objectives: Primary objective: to determine if the EHHP is superior to usual current practices in reduction of weight and BMI in obese and overweight Emiratis. Secondary objectives: to determine in obese and overweight Emiratis, if the EHHP is superior to usual current practices in: Reduction in systolic and diastolic blood pressure Reduction in hemoglobin A1c Reduction in total cholesterol, LDL cholesterol and triglycerides Increasing HDL. Study setting: Study recruitment will take place in the outpatient clinics of Kanad Hospital in the emirate of Abu Dhabi, United Arab Emirates. This center serves a region of 766,900 with a patient population that is 30% Emirati (11). Methods and analysis Trial design The EHHP is designed as a nonrandomized, controlled, unblinded single-center superiority trial with two parallel groups. Randomization will be performed as individual randomization with a 1:1 age and gender matched allocation. Interventions For the intervention group, a health coach will deliver a 16 session program with weekly teaching sessions and discussion that will take place in the family's home. These teaching sessions have been contextualized from the DPP material to suit local culture and customs and translated from English to Arabic. The material for each session follows a set structure and is largely scripted for standardization. The health coach will review each participant's weight, dietary logbook, and exercise records weekly and provide additional support as needed. Measurement of height, weight, blood pressure and blood samples will occur in the primary health center at study enrollment, at 8 weeks into the intervention, and at the conclusion of the intervention period. Age and gender matched controls from the same hospital's dietician practice will be followed for the same period of time, and outcome measures from both the intervention and control groups will be compared at the conclusion of the intervention to assess for a statistically significant difference. The DPP, on which the EHHP is based, is a flexible, individualized program that allows each participant to follow the preference according to individual needs. For example, participants that are completely sedentary at study enrollment are advised to gradually and consistently increase physical activity with the goal of performing 150 minutes a week of moderate aerobic exercise by the end of the intervention, rather than starting at some preset amount of exercise in week 1. The health coach will be monitoring each participant's attendance of the weekly teaching sessions, offering make up teaching as needed on an individual basis while encouraging participation in the family's efforts at adhering to the program. The health coach will also be monitoring each participant's progress in increasing physical activity and making healthy dietary choices. Each participant will be encouraged to ask for help, advice, and support from the health coach during the intervention period. Participants with diabetes, hypertension, or other comorbid conditions will be encouraged to continue any individual treatment plans under the ongoing care of the primary physician and specialists. Participants are advised that medications may need to be adjusted by the preexisting care team in case weight loss results in significant changes in blood sugar or blood pressure. As long as the participant agrees to continue in the study, enrollment in the study will be continued; the only criteria for stopping the intervention will be withdrawal of participant consent. Prior studies performed in the UAE have faced the challenge of retention of participants during the study period. Similar challenges exist for the usual care of obese and overweight patients as loss to follow up with the dietician and obesity clinic team is quite common. The health coach is the primary measure that will improve adherence and participant retention, as the therapeutic relationship is established. The investigators have selected an initial health coach who speaks Arabic, has worked in this country for over thirty years as a medical interpreter within the government health system, is familiar and fluent in local customs and practices, and has a degree in psychology. In addition, the health coach has experience in working with this patient population as a clinical care coordinator, who is typically responsible for arranging and reminding patients of follow up appointments. Outcomes Primary outcome measure The primary outcome measure is the difference between the two treatment arms in the proportion of participants that achieve a weight loss of 7% from each individual's baseline weight. This aligns with the American Diabetes Association guidelines on the management of diabetes, as it is associated with a clinically significant improvement in glycemic control and cardiovascular risk factors. Weight is also a recognized goal of the anticipated participants and easily measured and analyzed. Secondary outcome measures Secondary measures include the absolute and relative change pre and post intervention in: Systolic blood pressure Diastolic blood pressure Hemoglobin A1c Total cholesterol HDL cholesterol LDL cholesterol Triglycerides Participant timeline The primary outcome in this study is change in weight and the secondary outcomes are changes in blood pressure, hemoglobin A1c, and lipid parameters. These will be assessed at baseline in eligible family members after enrollment and informed consent. Age and gender matched controls will be assigned based on consecutive individuals presenting to the hospital's dietician. The sixteen sessions will then be delivered with inter-session coaching and follow up. After completion of the final session, the participant will have repeat weight and blood pressure measurement, along with a repeat blood draw to assess the hemoglobin A1c and lipid parameters. Sample size The sample size was calculated on the basis of the primary hypothesis, i.e that the EHHP intervention would result in a statistically significant greater proportion of participants achieving a 7% or greater reduction in body weight when compared to age and gender matched patients undergoing usual care in the same clinic. Therefore, the study has been powered to detect a 7% difference in weight using a two sided significance level of 5% and a power of 80%. The more conservative drop-out rate of 50% reflecting the past corporate experiences of the investigation team has been assumed. This resulted in an anticipated allocation of 214 patients in each arm of the trial. (ClinCalc, Rosner B., Fundamentals of Biostatistics. 7th ed. Boston, MA: Brooks/Cole; 2011) An adaptive interim analysis will be performed after the results for the primary endpoint are available for 107 participants in each arm of the trial, which is 50% of the calculated required sample size. The following type I error rates and decision boundaries are specified: Overall one sided type I error rate: 0.025 Boundary for the one-sided p-value of the first stage for accepting the null hypothesis within the interim analysis: a0 = 0.5. One-sided local type I error rate for testing the null-hypothesis within the interim analysis: a1 = 0.01012 If the trial will be continued with a second stage after the interim analysis, the results of the interim analysis can be taken into account for a recalculation of the required sample size. If the sample size recalculation leads to the conclusion that more than 300 patients are required in the intervention arm, the study will be stopped as the relative benefit is judged to be of minor importance. Recruitment Participants will be recruited from Kanad Hospital based on the eligibility criteria, participant interest and consent. The hospital dietician will then identify for each enrolled participant a consecutively presenting age and sex matched patient seen in their dietician practice for enrolment in the matched control group. Screening and recruitment will continue until the required sample size is reached or the grant expires, whichever comes first. Participants will be allowed to keep the activity tracker at the conclusion of the intervention. Allocation Due to the limited timeframe of the grant and the limited resources available to the investigators, it is not possible to compare family units undergoing the intervention directly with family units undergoing the usual care of receiving individual visits with the dietician and obesity clinic team. In addition, variation in the size of the family units makes a family to family comparison impractical. Therefore, it was decided to pursue a strategy of assigning individual age and gender matched controls to each study participant. If a positive result is obtained, additional funding and health coaches could be requested to allow for the assessment of similar sized families in the interventional and control arms. Blinding Due to the nature of the intervention, it is not possible or practical to blind the participants in the interventional and control arms, as the participants in the interventional arm will be meeting and being coached in family meetings, whereas individuals in the control group will be having individual appointments with the dietician without health coaching support and without being supplied activity trackers for personal use. Similarly, the health coach will only be working with the study participants in the interventional arm. The investigators performing the clinical portions of the study as care providers (enrolment and ordering the appropriate labs) will be un-blinded to the allocation (AK, KC, NH); however, those performing the statistical analyses and assessing the outcomes (RDG, SS, JN, MSH, AK, IB) will be blinded to the allocation by de-identifying both study participants and the corresponding age and sex matched controls. This de-identified database will be administered by JK along with the health coach. Those assessing the outcomes will then be supplied with this de-identified data which will be separated into groups (interventional and control arms) as well as for potential sub-group analysis based on age, sex, initial BMI, etc. Data collection Primary outcome Weight: Increased weight is associated with significant reversible risk factors for cardiovascular disease and as such the American Diabetes Association guidelines for the management of prediabetes and diabetes recommend lifestyle changes to achieve a weight reduction of 7% in obese and overweight patients. Weight will be measured in the hospital outpatient clinic at enrollment (baseline) and after the study intervention. The clinic which will provide biometric and lab measurements is part of the government ambulatory care system, which is accredited by the Joint Commission International (JCI), and as such has appropriate and internationally accepted protocols for the calibration of the scales used in the clinic according to the manufacturers' recommendations. It is customary for a staff nurse to measure the patient's weight at each clinic visit, and this data is stored in the electronic medical record. Each study participant will also have access to a scale within the home for weekly weight measurements, which will allow the health coach to monitor participants' weight as well as to provide any needed individualized support. The age and gender matched control patients will have weight data reviewed and recorded at the times nearest to the matched study participant. The ongoing relationship between the health coach and study participants is expected to be protective of retention in the interventional arm. However, in cases of study discontinuation or withdrawal, the data for the intervention participants will be classified under intention to treat, i.e, the data of those in the intervention arm who do not complete the intervention will still have be considered as for study participants. Secondary outcomes In addition to the primary outcome described above, the secondary outcomes of blood pressure, hemoglobin A1c, and lipid parameters will also be obtained in the clinic at enrollment (baseline) and after completing the intervention. The blood pressure is measured by an automated oscillometric sphygmomanometer which undergoes routine calibration as explained above. The laboratory tests are performed by a single accredited laboratory. The control patients will again have blood pressure measurements and appropriate lab data reviewed and recorded at the times nearest the matched study participant. The intervention arm will be compared against the control arm for significant differences in both the primary and secondary outcomes. The T-test will be used for continuous outcomes. For subgroup analyses, linear regression will be employed, examining the residual to assess model assumptions and goodness-of-fit. For all tests, 2 sided p-values will be used with ? <= 0.05 level of significance. P-values will be reported to four decimal places with p-values less than 0.001 reported as p < 0.001. Method of analysis Primary outcome Weight: Greater reduction than control in % reduction from baseline weight (T-test) Secondary outcomes Systolic blood pressure: Greater reduction than control in % reduction from baseline systolic BP (T-test) Diastolic blood pressure: Greater reduction than control in % reduction from baseline diastolic BP (T-test) Hemoglobin A1c: Greater reduction than control in % reduction from baseline Hgb A1c (T-test) Total cholesterol: Greater reduction than control in % reduction from baseline total cholesterol (T-test) HDL cholesterol: Greater increase than control in % increase from baseline HDL (T-test) LDL cholesterol: Greater reduction than control in % reduction from baseline LDL (T-test) Triglycerides: Greater reduction than control in % reduction from baseline triglycerides (T-test) Data monitoring Data will be reported to the Kanad Hospital Research Ethics Committee (KHREC), which is independent of the study organizers and the University of the United Arab Emirates. This committee is responsible for establishing the ethical nature of all research involving human subjects within Kanad Hospital and monitoring the progress of each approved study, and stopping any study that has concerns regarding ethical matters or participant safety. During the time of recruitment, interim analyses will be supplied confidentially to KHREC along with any additional requested data. Currently, an interim analysis is planned when recruitment reaches 50% of the calculated sample size (i.e 107 study participants); however, the frequency of the interim reports will be ultimately be determined by the Ethics Committee. After review of the interim data, the Ethics Committee will advise the investigators if the effect of the intervention has been proved to be significantly different from the controls beyond a reasonable doubt. If this occurs, the study will be completed prior to the anticipated study date. Due to the anticipated benign nature of the intervention and the stringent oversight supplied by KHREC, a dedicated Data Monitoring Committee is not needed for this study. Harms Since this is a nonpharmacological study, no significant risk of harm is anticipated. Each study participant will continue separately under the care of the primary care physician. As part of the informed consent, each participant is aware that any medications are taken for hypertension or diabetes may need to be adjusted if the clinical situation changes due to weight loss. An adverse event, for the purposes of the study, will be defined as any occurrence of a potentially or actually negative nature with respect to the participant's health. The most likely adverse event would be hypoglycemia in those participants who may be taking certain medications for diabetes. The study team considered excluding patients on medications for diabetes from the trial, but ultimately decided to retain these patients in order to assess the real world effect of the package of interventions on the overweight and obese populations. The potential for adverse effects is highlighted in the informed consent form, along with the contact information for the principal investigator (JK). The health coach has been made aware of the symptoms of hypoglycemia, and which medications place participants at risk. The coach is aware of the standard response to hypoglycemia, and will educate any participants on the identified high risk medications on how to initially manage hypoglycemia, as well as the need to follow up with the primary physician or emergency services after the initial management phase. At each session, the health coach will ask the participants who are present if any problems were encountered, and any potential adverse events will be reported to the principal investigator for further investigation. This report will include the nature of the adverse event, severity, and potential causes. Severe events or events that cannot be attributed to other causes other than the study intervention will be reported to the Ethics Committee within 24 hours. Consent Eligible individuals will be asked to invite family members to participate together in the study. These family members will then undergo screening for eligibility as well. Interested individuals who meet the eligibility criteria will then read the informed consent either in English or Arabic. Any questions or concerns will be addressed by one of the investigators in either English or Arabic, with translation as needed. All of the investigators are medical doctors and experienced researchers. Once this process is completed, and all questions and concerns are addressed, those who are interested in participating will be enrolled upon signing the informed consent form in the appropriate language (English or Arabic). One of the inclusion criteria is the ability of each potential participant to give informed consent for enrollment in the trial; if there is any concern on the investigators' part regarding the capacity of that individual to give consent, that person will be excluded from the study. Confidentiality The biometric and lab data will be stored as usual in the participants' electronic medical record, which is access restricted, password protected, and otherwise safeguarded by the information technology team of Kanad Hospital. Participants' data will not be released outside of the study without individual written permission, except as requested for monitoring purposes by KHREC or as legally required by local or national government authorities. Access to data Only those investigators who perform clinical duties at the involved hospital will have access to the original pre and post-intervention biometric and lab data via the participants' electronic medical record. Once the data has been de-identified, all of the investigators will have access to de-identified biometric and lab data. The health coach and investigators will have access to the data supplied by each participant on a weekly basis, which includes but is not limited to weight, caloric intake, minutes and type of exercise, and correspondence. This access will be discontinued after the aggregate data has been analyzed and published. Ancillary and post-trial care All Emiratis who are eligible for this study have comprehensive health insurance which will cover, at no cost to the participant, any needed medical care. No additional compensation is anticipated or required due to benign nature of the intervention. Should this study provide evidence of a clinically significant benefit to those who underwent the study intervention, the age and gender matched controls will be contacted at the conclusion of the study and invited to receive the same intervention at the discretion of Kanad Hospital

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