Impact of a Health and Mental Health Promotion Intervention Among Jordanians and Syrians.

NCT03721848 | Completed

• 1 other identifier: 17390
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

Given the heightened risk of NCDs and mental health issues, it is critical for Jordanians and Syrian refugees to have access to prevention based health services. To address this need, the following project seeks to examine the capacity of Primary Care Health Centers to provide preventive services to empower patients to manage NCDs and potential mental health issues for those who are experiencing distress. The primary research question in this evaluation study is: Does prevention-based health and mental health services in primary health clinics improve health status of Jordanians and Syrian refugees? This research proposal will consist of three study conditions examining:

• Condition 1: an existing NCD preventive intervention consisting of 24 sessions, which are 45 minutes covering diabetes, hypertension, obesity, reproductive health, cardiovascular diseases, allergies and smoking;
• Condition 2: The existing NCD preventive intervention with 4 added mental health awareness sessions covering traumatic stress reactions, individual strategies for coping with stress and traumatic events and collective strategies for coping with stress and trauma;
• Condition 3: Treatment as usual A group randomized study will be conducted in three clinics with patients of the respective clinics. The clinics will be identified prior to the study based on similar demographics, service utilization and staff capacity. Once the three clinics are identified they will be selected to one of the three study conditions. This research will be conducted in collaboration with the University of Illinois (UIUC), AmeriCares, and the Royal Health Awareness Society (RHAS) of Jordan. AmeriCares will work as the operational humanitarian organization collaborating with and providing support to RHAS and UIUC. RHAS's healthy community clinic is a community-based health project launched in 2011 conducted with the Ministry of Health (MOH). The project aims to build the capacity of participating Health Centers to provide better preventative services to empower patients to manage their diseases and reduce future complications. The Healthy Community Clinic, established within existing MOH facilities, provides medical practitioners with the training and resources necessary to implement management and prevention-based care to patients in underserved communities.

Conditions

Mental Stress; Hypertension; Diabetes

Outcome Measures

Primary Outcomes (6)

• Health Behavior-Fruit Intake frequency (Assessing Change)

  Likert 5 point question assessing frequency of fruit intake within a week (a. none, b. 1-2 times per week, c. 3-4 times per week, d. 5 + times per week.

  Baseline, Six Months, 12 Months, 18 months

• Health Behavior-Vegetable Intake (Assessing Change)

  Likert 5 point question assessing frequency of vegetable intake within a week (a. none, b. 1-2 times per week, c. 3-4 times per week, d. 5 + times per week.

  Baseline, Six Months, 12 Months, 18 months

• Health Behavior-Bread Intake (Assessing Change)

  Likert 5 point question assessing frequency of bread intake within a week (a. none, b. 1-2 times per week, c. 3-4 times per week, d. 5 + times per week.

  Baseline, Six Months, 12 Months, 18 months

• Incidence of Smoking (Assessing Change)

  Yes/no question asking participants if they smoke. If they answer yet to smoking they are prompted to ask how many cigarettes per week.

  Baseline, Six Months, 12 Months, 18 months

• Health Behavior- Level of Physical Activity (Assessing Change)

  Question inquiring how much physical activity participants get per week. Likert question Ranging from a. 30 minutes b.30 min to 1 hour c. 1-2 hours, d. 2-5 hours, e. more than 5 hours

  Baseline, Six Months, 12 Months, 18 months

• Health Behavior-Amount of Red Meat Intake (Assessing Change)

  Likert 5 point question assessing frequency of red meat intake within a week (a. none, b. 1-2 times per week, c. 3-4 times per week, d. 5 + times per week.

  Baseline, Six Months, 12 Months, 18 months

Secondary Outcomes (9)

• Duke Health Profile (Assessing Change)

  Baseline, Six Months, 12 Months, 18 months

• Blood Pressure (Assessing Change)

  Baseline, Six Months, 12 Months, 18 months

• BMI (Assessing Change)

  Baseline, Six Months, 12 Months, 18 months

• Laboratory tests: fasting blood glucose (Assessing Change)

  Baseline, Six Months, 12 Months, 18 months

• Laboratory tests: HbA1c (Assessing Change)

  Baseline, Six Months, 12 Months, 18 months

Study Arms (3)

Healthy Community Clinic: NCD+MH

EXPERIMENTAL

The arm of this study consists of a 28 session intervention, which are 45 minutes and meet 2-3 times a month providing health awareness on non-communicable diseases diabetes, hypertension, obesity, reproductive health, cardiovascular diseases, allergies; smoking; traumatic stress reactions, individual strategies for coping with stress and traumatic events and collective strategies for coping with stress and trauma.

Behavioral: Healthy community clinic NCD+MH

Healthy Community Clinic: NCD

ACTIVE COMPARATOR

The arm of this study consists of a 24 session intervention, which are 45 minutes and meet 2 times a month providing health awareness on non-communicable disease diabetes, hypertension, obesity, reproductive health, cardiovascular diseases, allergies; smoking.

Behavioral: Healthy community clinic NCD

Treatment as usual

NO INTERVENTION

This is treatment as usual where there is no intervention, but patients attend the clinic for treatment of non-communicable diseases.

Interventions

Healthy community clinic NCD+MH BEHAVIORAL

NCD+MH Awareness Intervention Overview: i. Patients are assigned, at minimum, one health awareness lecture per month with a total of 28 lectures possible ii. Patients attend lectures on specific topics given by MoH staff, mainly nurses. iii. Topics tackled include: Diabetes, Hypertension, Asthma, Cardiovascular Disease, Reproductive Health, Healthy Nutrition, Smoking, Emotional Wellness, Stress Relief and Positive Coping. iv. Group nutrition and physical fitness counselling are incorporated into most health awareness lectures

Healthy Community Clinic: NCD+MH

Healthy community clinic NCD BEHAVIORAL

i. Patients are assigned, at minimum, one health awareness lecture per month with a total of 24 lectures possible ii. Patients attend lectures on specific topics given by MoH staff, mainly nurses. iii. Topics tackled include: Diabetes, Hypertension, Asthma, Cardiovascular Disease, Reproductive Health, Healthy Nutrition, and Smoking iv. Group nutrition and physical fitness counselling are incorporated into most health awareness lectures

Healthy Community Clinic: NCD

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Obesity, defined as BMI ≥ 30
• Fasting blood glucose ≥ 100 ml/dl
• Systolic blood pressure ≥ 120 mmHg and/or diastolic blood pressure ≥ 80 mmHg
• Self-reported uncontrolled dyslipidaemia, cholesterol \>240, LDL \>190, HDL \< 40 ad/or TG \>500
• Asthma
• Diabetes
• Hypertension
• Renal dysfunction: also known as renal insufficiency or renal failure; assessed by self-report
• Heart failure: also known as congestive heart disease or chronic heart failure; assessed by self-report
• Functional disability: defined as any long-term activity limitation due to disease or injury; assessed by self-report
• Liver dysfunction: also known as liver failure, acute or chronic; assessed by self-report
• Uncontrolled Resistant Hypertension: defined as blood pressure remaining above the threshold despite lifestyle modifications and concurrent use of at least three antihypertensive medications from different classes with one being a diuretic10-11assessed by self-report
• Pregnant women

Sponsors & Collaborators

• University of Illinois at Urbana-Champaign: lead
• Americares: collaborator
• Royal Health Awareness Society: collaborator

Study Sites (1)

Royal health Awareness Society

Amman, Jordan

Location

Related Publications (1)

• Powell TM, Shin OJ, Li SJ, Hsiao Y. Post-traumatic stress, social, and physical health: A mediation and moderation analysis of Syrian refugees and Jordanians in a border community. PLoS One. 2020 Oct 23;15(10):e0241036. doi: 10.1371/journal.pone.0241036. eCollection 2020.

  PMID: 33095832 DERIVED

MeSH Terms

Conditions

Stress, Psychological; Hypertension; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Tara Powell, PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: * Condition 1: an existing NCD preventive intervention consisting of 24 sessions, which are 45 minutes covering diabetes, hypertension, obesity, reproductive health, cardiovascular diseases, allergies and smoking; * Condition 2: The existing NCD preventive intervention with 4 added mental health awareness sessions covering traumatic stress reactions, individual strategies for coping with stress and traumatic events and collective strategies for coping with stress and trauma; * Condition 3: Treatment as usual

Study Record Dates

• First Submitted: August 21, 2018
• First Posted: October 26, 2018
• Study Start: April 30, 2017
• Primary Completion: July 30, 2017
• Study Completion: April 30, 2019
• Last Updated: August 26, 2019

Record last verified: 2019-08

Locations

JO (1)