Improving Physical Activity Levels in the Arabic- Speaking Residents of East Jerusalem With Prediabetes

Diabetes Mellitus Clinical Trial

Official title:

Improving Physical Activity Levels in the Arabic- Speaking Residents of East Jerusalem With Prediabetes

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03821220
• Other study ID #: 0201-17-COM2
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 15, 2019
• Est. completion date: August 31, 2021

Study information

• Verified date: February 2019
• Source: Clalit Health Services
• Contact: Amnon Lahad, MD
• Phone: 972-52-3293484
• Email: amnonl[@]ekmd.huji.ac.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This three-arm clinical trial aims to improve levels of physical activity among Arabic- speaking residents of East Jerusalem with prediabetes. Levels of daily physical activity (assessed through activity trackers), dietary habits and self-assessed health will be compared between patients that receive only the activity tracker and written information (group A), receive the activity tracker, written information and a personalized physical activity prescription (group B), and those that receive in addition also intensive follow-up with motivational interview by physician assistants and a dietitian (group C)

Description:

This is a three-arm clinical trial studying the effect of providing activity trackers with intensive motivational interview by trained physician assistants, and dietitian counselling, on the levels of daily physical activity among Arabic- speaking residents of East Jerusalem with prediabetes from Clalit Health Services. In addition, this study will also assess healthy dietary changes, and self assessed health and quality of life.

The study will compare three groups (total 375, each group 125):

Group A - will receive activity trackers and written educational handouts in addition to their usual care.

Group B - will receive all of group A intervention components and also a personalized physical activity prescription.

Group C - will receive all of group B components and also intensive motivational interview support by trained physician assistants (3 sessions), and dietitian support (two sessions).

Each participant will be followed-up for six months, with data collection occurring at baseline, three months and six months. Data collection will include average weekly steps, blood pressure, anthropometric measurements, routine blood tests (including fasting glucose, HbA1C, and lipid profile), physical activity survey, Mediterranean dietary habits survey, Food Frequency Questionnaire, and quality of life survey.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 375
• Est. completion date: August 31, 2021
• Est. primary completion date: February 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

Pre-diabetes patients - Impaired fasting glucose at least twice between 100-125 mg/dL in the two years prior to the study; or HbA1C 5.7%-6.4% twice in the two years prior to the study; or one test of fasting glucose of 100-125 mg/dL, and one test of HbA1C between 5.7%-6.4% in the two years prior to the study.

Exclusion Criteria:

1. Diabetes including a doctor's diagnosis based on a medical file or a recurrence of fasting blood glucose values above 126 mg/dL in the year preceding the study or a glucose value greater than 200 mg/dL in the year prior to the study or HbA1C above 6.5%

2. Treatment with diabetes drugs other than metformin, as prescribed in the medical file with regular or chronic medications

3. Artificial lower limbs or inability to walk normally (eg: stroke with plegia)

4. Chronic obstructive pulmonary disease

5. Known heart disease (with impaired exercise tolerance)

6. Pregnancy

7. Medical conditions:

• a cardiac event/ Transient ischemic attack in the last year

• Cerebrovascular attack with residual impairment

• Surgery that required hospitalization in the last year

• Injury to lower limbs that prevents regular walking

• Malignancy excluding skin cancer small cell carcinoma or basal cell carcinoma

Related Conditions & MeSH terms

• Diabetes Mellitus
• Prediabetic State

Intervention

Behavioral:
• Motivational Interview support and Dietitian support
Three sessions of a structured motivational support intervention. Each patient will be required to set a SMART physical activity personal objective. The sessions will cover possible barriers and facilitators, enhancing self-efficacy, and feedback. In addition two sessions with a dietitian to discuss ways to improve current health habits.
• Activity tracker plus usual care
Each patient will receive their own activity tracker (vivofit 3) with instructions on use, in addition to usual care, and written handouts for pre-diabetic patients.
• Personalized physical activity prescription
Each patient will receive a personalized prescription of recommended physical activity including type of activity, duration and frequency.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Clalit Health Services	Hebrew University of Jerusalem

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical activity level assessed through average weekly steps		six months
Secondary	Fasting glucose levels		six months
Secondary	HbA1C levels		six months
Secondary	Body Mass Index		six months
Secondary	Lipid profile		six months
Secondary	Blood pressure		six months
Secondary	Energy intake 500< kcal/d <6000 kcal/d		Six months
Secondary	Waist circumference		six months
Secondary	Fat intake 15 <gram/day<200		six months
Secondary	Protein intake 10<gram/day<300		six months
Secondary	Iron intake 0<mg/day<50		six months
Secondary	Folic acid intake 15< µg/day<3000		six months
Secondary	Vitamin A intake 20< µg RAE/day<2500		six months
Secondary	Vitamin C intake 0<mg/day<2500		six months