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

NCT04688684 | Unknown

• 1 other identifier: G00003405
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Data from Abu Dhabi's Department of Health document that the leading cause of death among the population of the emirate of Abu Dhabi is cardiovascular disease (CVD). Even with significant investment of time and resources, this has not improved over time. CVD was the cause of death in over 39% of deaths occurring in patients above 45 years of age. In those older than 60 years of age, CVD causes more deaths than cancer, respiratory diseases, and infectious disease combined. Eating an unhealthy diet is the leading risk factor for CVD-related deaths and one study estimated that the current diet accounted for 72% of CVD-related deaths in the United Arab Emirates (UAE). Interestingly, the limited intake of whole grains was associated with 22% of CVD-related deaths in the UAE. Other risk factors include consumption of processed meat, red meat, and sugar sweetened beverages. Despite recognition of what constitutes healthy diet and exercise practices by survey participants, barriers exist to lifestyle change. In one UAE study of patients with type 2 diabetes, only 3% of the 390 individuals surveyed met numerous guidelines' weekly recommendations for 150 minutes of moderate intensity aerobic activity or 90 minutes of vigorous aerobic activity. The most common reasons given in that study for not exercising included cultural reasons (29.2%), "exercise is boring" (20.3%), and lack of family support (4.1%). Widespread availability and access to outpatient dieticians has not lowered rates of obesity, overweight, and cardiovascular disease risk factors. To the investigators' knowledge, this would be the first study investigating the effect of a package of family based lifestyle interventions guided by a health coach. This package of interventions would be supported by technology such as a smartphone application to record dietary intake and the use of wearable fitness trackers to track physical activity. The nationals of the UAE (called Emiratis),have retained traditional cultural values, including strong ties to extended family, which may lead to better adherence to family based rather than individual appointments and interventions, which could lower CVD risk.

Conditions

Overweight and Obesity; Cardiovascular Risk Factor

Keywords

overweight; obesity; cardiovascular risk; hypertension; hyperlipidemia; hemoglobin A1c

Outcome Measures

Primary Outcomes (1)

• Weight

  Weight (change from enrollment to end of intervention)

  16 weeks

Secondary Outcomes (7)

• Systolic blood pressure

  16 weeks

• Diastolic blood pressure

  16 weeks

• Hemoglobin A1c

  16 weeks

• Total cholesterol

  16 weeks

• HDL cholesterol

  16 weeks

Study Arms (1)

Family-based intervention

EXPERIMENTAL

These participants will undergo the health coach based intervention with fitness tracker and diet changes, which will be delivered to all family members who meet the inclusion criteria and are enrolled in the study.

Behavioral: Family-based diet and exercise intervention

Interventions

Family-based diet and exercise intervention BEHAVIORAL

The participants will meet together weekly as a family unit to receive education and planning to implement diet and lifestyle changes under the supervision of a health coach. This coach will also be available during the week by telephone or messaging for additional individualized support if needed.

Family-based intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Emirati citizenship
• Age 18 years or older
• Able to give informed consent for study participation
• BMI 25 or greater

You may not qualify if:

• Current or planned use of weight-loss pharmacotherapy;
• Recent (within 6 months) bariatric surgery;
• Current diagnosis of cancer.

Sponsors & Collaborators

• United Arab Emirates University: lead

Study Sites (1)

Kanad Hospital

Al Ain City, Abu Dhabi Emirate, United Arab Emirates

Location

Related Publications (8)

• Loney T, Aw TC, Handysides DG, Ali R, Blair I, Grivna M, Shah SM, Sheek-Hussein M, El-Sadig M, Sharif AA, El-Obaid Y. An analysis of the health status of the United Arab Emirates: the 'Big 4' public health issues. Glob Health Action. 2013 Feb 5;6:20100. doi: 10.3402/gha.v6i0.20100.

  PMID: 23394856 BACKGROUND

• Afshin A, Micha R, Khatibzadeh S, Fahimi S, Shi P, Powles J, Singh G, Yakoob MY, Abdollahi M, Al-Hooti S, Farzadfar F, Houshiar-Rad A, Hwalla N, Koksal E, Musaiger A, Pekcan G, Sibai AM, Zaghloul S, Danaei G, Ezzati M, Mozaffarian D; 2010 Global Burden of Diseases, Injuries, and Risk Factors Study: NUTRItrition and ChrOnic Diseases Expert Group (NUTRICODE), and Metabolic Risk Factors of ChrOnic Diseases Collaborating Group. The impact of dietary habits and metabolic risk factors on cardiovascular and diabetes mortality in countries of the Middle East and North Africa in 2010: a comparative risk assessment analysis. BMJ Open. 2015 May 20;5(5):e006385. doi: 10.1136/bmjopen-2014-006385.

  PMID: 25995236 BACKGROUND

• Ratner R, Goldberg R, Haffner S, Marcovina S, Orchard T, Fowler S, Temprosa M; Diabetes Prevention Program Research Group. Impact of intensive lifestyle and metformin therapy on cardiovascular disease risk factors in the diabetes prevention program. Diabetes Care. 2005 Apr;28(4):888-94. doi: 10.2337/diacare.28.4.888.

  PMID: 15793191 BACKGROUND

• Diabetes Prevention Program Outcomes Study Research Group; Orchard TJ, Temprosa M, Barrett-Connor E, Fowler SE, Goldberg RB, Mather KJ, Marcovina SM, Montez M, Ratner RE, Saudek CD, Sherif H, Watson KE. Long-term effects of the Diabetes Prevention Program interventions on cardiovascular risk factors: a report from the DPP Outcomes Study. Diabet Med. 2013 Jan;30(1):46-55. doi: 10.1111/j.1464-5491.2012.03750.x.

  PMID: 22812594 BACKGROUND

• Diabetes Prevention Program Research Group. Long-term effects of lifestyle intervention or metformin on diabetes development and microvascular complications over 15-year follow-up: the Diabetes Prevention Program Outcomes Study. Lancet Diabetes Endocrinol. 2015 Nov;3(11):866-75. doi: 10.1016/S2213-8587(15)00291-0. Epub 2015 Sep 13.

  PMID: 26377054 BACKGROUND

• Nathan DM, Bennett PH, Crandall JP, Edelstein SL, Goldberg RB, Kahn SE, Knowler WC, Mather KJ, Mudaliar S, Orchard TJ, Temprosa M, White NH; Research Group. Does diabetes prevention translate into reduced long-term vascular complications of diabetes? Diabetologia. 2019 Aug;62(8):1319-1328. doi: 10.1007/s00125-019-4928-8. Epub 2019 Jul 4.

  PMID: 31270584 BACKGROUND

• Al-Kaabi J, Al-Maskari F, Saadi H, Afandi B, Parkar H, Nagelkerke N. Physical activity and reported barriers to activity among type 2 diabetic patients in the United arab emirates. Rev Diabet Stud. 2009 Winter;6(4):271-8. doi: 10.1900/RDS.2009.6.271. Epub 2009 Dec 30.

  PMID: 20043039 BACKGROUND

• King JK, Sheek-Hussein M, Nagelkerke NJD, Kieu A, Al-Shamsi S, Nauman J, Hoque N, Govender RD, ElBarazi I, Crawford K. 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 Apr 10;18(4):e0282502. doi: 10.1371/journal.pone.0282502. eCollection 2023.

  PMID: 37036843 DERIVED

MeSH Terms

Conditions

Overweight; Obesity; Hypertension; Hyperlipidemias

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases

Study Officials

• Jeffrey K King, MD

  Assistant professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeffrey K King, MD

CONTACT

971501364601; jking@uaeu.ac.ae

Mohamud Sheek Hussein, MD

CONTACT

971 3 7137456; jking@uaeu.ac.ae

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Stepped wedge cluster randomized trial

Study Record Dates

• First Submitted: December 23, 2020
• First Posted: December 30, 2020
• Study Start: June 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: March 15, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)