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

NCT ID: NCT03821220

Last Updated: 2019-02-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 375 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-15
• Study Completion Date: 2021-08-31

Brief 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)

Detailed 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.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group A

Patients will receive an activity tracker and written information for pre-diabetic, on top of their usual care.

Group Type: ACTIVE_COMPARATOR

Activity tracker plus usual care

Intervention Type: BEHAVIORAL

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.

Group B

Patients will receive an activity tracker, written information for pre-diabetic, and personalized physical activity prescription, on top of their usual care.

Group Type: ACTIVE_COMPARATOR

Activity tracker plus usual care

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

Each patient will receive a personalized prescription of recommended physical activity including type of activity, duration and frequency.

Group C

Patients will receive an activity tracker, written information for pre-diabetic, personalized physical activity prescription, three sessions of motivational interview support from trained physician assistants, and two session of dietitian support, on top of their usual care.

Group Type: ACTIVE_COMPARATOR

Motivational Interview support and Dietitian support

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

Each patient will receive a personalized prescription of recommended physical activity including type of activity, duration and frequency.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Personalized physical activity prescription

Each patient will receive a personalized prescription of recommended physical activity including type of activity, duration and frequency.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hebrew University of Jerusalem

OTHER

Sponsor Role: collaborator

Clalit Health Services

OTHER

Sponsor Role: lead

Responsible Party

Prof. Amnon Lahad

Director of Medical Quality unit and Chairman department of Family Medicine, Clalit Health Services, Jerusalem district

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amnon Lahad, MD

Role: PRINCIPAL_INVESTIGATOR

Clalit

Central Contacts

Amnon Lahad, MD

Role: CONTACT

amnonl@ekmd.huji.ac.il

972-52-3293484

Other Identifiers

0201-17-COM2

Identifier Type: -

Identifier Source: org_study_id