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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

PLOS ONE · 10 authors, 9 centres

AI SUMMARY

FIDELITY 100%

POPULATIONOverweight and obese UAE nationals aged 18 years or older with a BMI ≥ 25

INTERVENTIONA 16-week family-based intervention delivered in the home by a health coach, incorporating diet and exercise guidance monitored by a wearable fitness tracker.

COMPARISONClusters enter the intervention in a randomized order, with each serving as its own pre-intervention control in a stepped-wedge design.

This summary was generated by AI from a single paper. It has not been reviewed by a clinician and is not clinical advice. Verify against the source before acting on it.

AGENT 01 · STRUCTURED SUMMARY

TRACE TO SOURCE

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TL;DR

This paper outlines the protocol for a stepped-wedge, family-cluster randomized controlled trial testing a health-coach guided diet and exercise intervention.

Full summary

784 CHARS

This is a protocol for a stepped-wedge, family-cluster randomized controlled trial named the Emirates Heart Health Project (EHHP). The study aims to test a health-coach guided diet and exercise intervention for overweight and obese Emirati adults. Eligible participants (BMI ≥ 25) will be enrolled in family clusters, each receiving 16 weekly home teaching sessions. The primary outcome is pre- to post-intervention weight reduction. Secondary outcomes are changes in various cardiovascular risk factors, including blood pressure and lipid levels. The analysis will use a mixed linear model. Key limitations acknowledged include reliance on a single health coach, potential for loss to follow-up in later clusters, and limited resources for dietary assessment and long-term follow-up.

PICO

PPOPULATION

Overweight and obese UAE nationals aged 18 years or older with a BMI ≥ 25

IINTERVENTION

A 16-week family-based intervention delivered in the home by a health coach, incorporating diet and exercise guidance monitored by a wearable fitness tracker.

OOUTCOME

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.

STUDY TYPE

other

SPECIALTY

cardiology

SUMMARISED BY

AI pipeline

FIDELITY CHECK

100% · A

ORIGINAL PAPER

PMC10085020

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

PLOS ONE

READ THE FULL PAPER

ABSTRACT

Introduction Cardiovascular disease (CVD) is the most common cause of death both globally and in the United Arab Emirates. Despite public health measures and health education, the rates of death from CVD remain stable. Barriers previously identified to lifestyle changes include cultural reasons, boredom, and lack of family support. The Emirates Heart Health Project (EHHP) seeks to support healthy lifestyle changes through a family-based intervention using a health coach and fitness tracker. Methods and analysis The EHHP is a stepped-wedge cluster-randomized trial with each cluster comprised of members of an extended family. Eligible participants will be ≥ 18 years of age, with BMI ≥ 25, have Emirati citizenship and be able to give informed consent for study participation. The cluster will have 16 weekly teaching sessions in the participants’ family home by a health coach who will review individual weight, diet and exercise (monitored by a wearable fitness tracker). The clusters will have pre-intervention assessments of their weight and CVD risk profile and enter the intervention in randomized order. Each cluster will have a post-intervention assessment of the same measures. The primary outcome is weight reduction from baseline. Secondary outcomes will include change in CVD risk factors such as systolic and diastolic blood pressure, hemoglobin A1c, total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides, waist circumference, and BMI. A mixed linear model will be used for analysis, where the parameters measured at the end of each 16-week episode will be the outcome values. These will be analyzed such that baseline values (measured just prior to the start of an episode) will be fixed covariables. Random effects are the family units. This trial has been registered with the NIH at clinicaltrials.gov ( NCT04688684 ) and is being reported using the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) and TIDieR (Template for intervention description and replication) framework. Trial registration Clinicaltrials.gov NCT04688684 .

CITATION EXPORT

Jeffrey K. King, Mohamud Sheek-Hussein, Nico J. D. Nagelkerke et al.. 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. PLOS ONE. (2023). https://doi.org/10.1371/journal.pone.0282502

AUTHORS

10 · 9 CENTRES

Jeffrey K. King, Mohamud Sheek-Hussein, Nico J. D. Nagelkerke, Alexander Kieu, Saif Al-Shamsi, Javaid Nauman, Nicholas Hoque, Romona D. Govender, Iffat ElBarazi, Kristoffer Crawford

1 Department of Family Medicine, College of Medicine and Health Sciences, United Arab Emirates University, Al Ain, Abu Dhabi, United Arab Emirates
2 Home Based Primary Care, Division of Geriatrics and Extended Care, Greater Los Angeles, Department of Veterans Affairs, Los Angeles, California, United States of America
3 Institute of Public Health, College of Medicine and Health Sciences, United Arab Emirates University, Al Ain, Abu Dhabi, United Arab Emirates
4 Department of Bioengineering, Imperial College London, London, United Kingdom
5 Kanad Hospital, Al Ain, Abu Dhabi, United Arab Emirates
6 Department of Internal Medicine, College of Medicine and Health Sciences, United Arab Emirates University, Al Ain, Abu Dhabi, United Arab Emirates
7 Department of Pediatrics, College of Medicine and Health Sciences, United Arab Emirates University, Al Ain, Abu Dhabi, United Arab Emirates
8 School of Public Health, Loma Linda University, Loma Linda, California, United States of America
Endocrinology and Metabolism Population Sciences Institute, Tehran University of Medical Sciences, ISLAMIC REPUBLIC OF IRAN

EDITOR / REVIEWER

Ozra Tabatabaei-Malazy