Emirates Heart Health Project (EHHP): A protocol for a stepped-wedge family-cluster randomized-controlled trial of a health-coach guided diet and exercise intervention to reduce weight and cardiovascular risk in overweight and obese UAE nationals

{"Background": "Cardiovascular disease (CVD) is the leading cause of death in the United Arab Emirates and globally. In the emirate of Abu Dhabi, CVD accounted for 1,198 of 3,262 total deaths in 2017 (36.7%), and over 39% of deaths in those over age 45. Despite government screening programs like Weqaya (since 2008) and free access to dieticians, obesity clinics, and pharmacotherapy, CVD mortality has remained stable. Surveys in the UAE show that only 3% of patients with type 2 diabetes meet guideline-recommended physical activity targets, with barriers including cultural reasons (29.2%), boredom with exercise (20.3%), and lack of family support (4.1%). The Emirates Heart Health Project (EHHP) was designed to address these barriers through a culturally sensitive, family-based intervention leveraging a health coach, wearable fitness trackers, and smartphone communication, adapted from the proven Diabetes Prevention Program (DPP).", "Methods": "The EHHP is a stepped-wedge cluster-randomized controlled trial conducted at Kanad Hospital in Abu Dhabi, UAE. Each cluster consists of members of an extended family (minimum 8 participants per family). Eligible participants are Emirati citizens aged \u2265 18 years with BMI \u2265 25 who can provide informed consent. Exclusion criteria include current or planned use of weight-loss pharmacotherapy, bariatric surgery within 6 months, or current cancer diagnosis. Clusters are randomized to receive the intervention in a stepped fashion using random number generation. Pre-intervention, participants receive usual care (individual dietician visits). The intervention consists of 16 weekly in-home teaching sessions delivered by a single health coach (Arabic-speaking, with 30 years of local experience and a psychology degree), who reviews each participant's weight, dietary logbook, and Fitbit Charge 3 exercise data. The curriculum is a culturally and linguistically adapted version of the DPP. The primary outcome is weight reduction from baseline. Secondary outcomes include changes in systolic and diastolic blood pressure, hemoglobin A1c, total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, waist circumference, and BMI. A mixed linear model will be used for analysis, with baseline values as fixed covariables and family units as random effects. The target sample size is 10 clusters, calculated to achieve 80% power at a one-sided 5% significance level, assuming a natural fluctuation in cluster mean weight change of 3.5% and a target weight reduction of 7%. An interim analysis will be performed after 4 clusters complete the intervention.", "Key Results": "This is a protocol paper; no results are reported. The study is registered at clinicaltrials.gov (NCT04688684) and approved by the Kanad Hospital Research Ethics Committee (authorization #2012.15, approved March 16, 2021). The trial is being reported using SPIRIT and TIDieR frameworks.", "Clinical Implications": "If the EHHP demonstrates a clinically significant reduction in weight and cardiovascular risk factors, it would provide evidence for a scalable, family-based approach to lifestyle modification in the UAE, a setting where individual-based interventions have had limited success. The intervention directly addresses documented barriers to lifestyle change, including cultural factors, lack of family support, and boredom with exercise. A 5\u20137% weight reduction is associated with clinically significant improvement in glycemic control and cardiovascular risk factors per American Diabetes Association guidelines. The study could inform policy changes, resource allocation, and future research targeting the leading cause of mortality in the UAE. Limitations include the use of a single health coach (limiting generalizability), potential for contamination across clusters, lack of an enduring usual care arm, and inability to collect detailed dietary intake data due to resource constraints."}