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

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

Sponsors

Lead Sponsor: Clalit Health Services

Collaborator: Hebrew University of Jerusalem

Source Clalit Health Services
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.

Overall Status Not yet recruiting
Start Date 2019-02-15
Completion Date 2021-08-31
Primary Completion Date 2021-02-15
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Physical activity level assessed through average weekly steps six months
Secondary Outcome
Measure Time Frame
Fasting glucose levels six months
HbA1C levels six months
Body Mass Index six months
Lipid profile six months
Blood pressure six months
Energy intake 500< kcal/d <6000 kcal/d Six months
Waist circumference six months
Fat intake 15 <gram/day<200 six months
Protein intake 10<gram/day<300 six months
Iron intake 0<mg/day<50 six months
Folic acid intake 15< μg/day<3000 six months
Vitamin A intake 20< μg RAE/day<2500 six months
Vitamin C intake 0<mg/day<2500 six months
Enrollment 375
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Motivational Interview support and Dietitian support

Description: 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.

Arm Group Label: Group C

Intervention Type: Behavioral

Intervention Name: Activity tracker plus usual care

Description: 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

Intervention Name: Personalized physical activity prescription

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

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

Gender:

All

Minimum Age:

40 Years

Maximum Age:

70 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Amnon Lahad, MD Principal Investigator Clalit
Overall Contact Contact information is only displayed when the study is recruiting subjects.
Verification Date

2019-02-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Clalit Health Services

Investigator Full Name: Prof. Amnon Lahad

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

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: Group A

Type: Active Comparator

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

Label: Group B

Type: Active Comparator

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

Label: Group C

Type: Active Comparator

Description: 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.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: None (Open Label)

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