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

Primary Purpose

Diabetes Mellitus

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Motivational Interview support and Dietitian support
Activity tracker plus usual care
Personalized physical activity prescription
Sponsored by
Clalit Health Services
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes Mellitus focused on measuring Activity tracker; Arab population; Physical Activity

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Group A

    Group B

    Group C

    Arm Description

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

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

    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.

    Outcomes

    Primary Outcome Measures

    Physical activity level assessed through average weekly steps

    Secondary Outcome Measures

    Fasting glucose levels
    HbA1C levels
    Body Mass Index
    Lipid profile
    Blood pressure
    Energy intake 500< kcal/d <6000 kcal/d
    Waist circumference
    Fat intake 15 <gram/day<200
    Protein intake 10<gram/day<300
    Iron intake 0<mg/day<50
    Folic acid intake 15< μg/day<3000
    Vitamin A intake 20< μg RAE/day<2500
    Vitamin C intake 0<mg/day<2500

    Full Information

    First Posted
    January 24, 2019
    Last Updated
    February 3, 2019
    Sponsor
    Clalit Health Services
    Collaborators
    Hebrew University of Jerusalem
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03821220
    Brief Title
    Improving Physical Activity Levels in the Arabic- Speaking Residents of East Jerusalem With Prediabetes
    Official Title
    Improving Physical Activity Levels in the Arabic- Speaking Residents of East Jerusalem With Prediabetes
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 15, 2019 (Anticipated)
    Primary Completion Date
    February 15, 2021 (Anticipated)
    Study Completion Date
    August 31, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Clalit Health Services
    Collaborators
    Hebrew University of Jerusalem

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes Mellitus
    Keywords
    Activity tracker; Arab population; Physical Activity

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    375 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A
    Arm Type
    Active Comparator
    Arm Description
    Patients will receive an activity tracker and written information for pre-diabetic, on top of their usual care.
    Arm Title
    Group B
    Arm Type
    Active Comparator
    Arm Description
    Patients will receive an activity tracker, written information for pre-diabetic, and personalized physical activity prescription, on top of their usual care.
    Arm Title
    Group C
    Arm Type
    Active Comparator
    Arm 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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Motivational Interview support and Dietitian support
    Intervention 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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Activity tracker plus usual care
    Intervention 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(s)
    Personalized physical activity prescription
    Intervention Description
    Each patient will receive a personalized prescription of recommended physical activity including type of activity, duration and frequency.
    Primary Outcome Measure Information:
    Title
    Physical activity level assessed through average weekly steps
    Time Frame
    six months
    Secondary Outcome Measure Information:
    Title
    Fasting glucose levels
    Time Frame
    six months
    Title
    HbA1C levels
    Time Frame
    six months
    Title
    Body Mass Index
    Time Frame
    six months
    Title
    Lipid profile
    Time Frame
    six months
    Title
    Blood pressure
    Time Frame
    six months
    Title
    Energy intake 500< kcal/d <6000 kcal/d
    Time Frame
    Six months
    Title
    Waist circumference
    Time Frame
    six months
    Title
    Fat intake 15 <gram/day<200
    Time Frame
    six months
    Title
    Protein intake 10<gram/day<300
    Time Frame
    six months
    Title
    Iron intake 0<mg/day<50
    Time Frame
    six months
    Title
    Folic acid intake 15< μg/day<3000
    Time Frame
    six months
    Title
    Vitamin A intake 20< μg RAE/day<2500
    Time Frame
    six months
    Title
    Vitamin C intake 0<mg/day<2500
    Time Frame
    six months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    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: 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% Treatment with diabetes drugs other than metformin, as prescribed in the medical file with regular or chronic medications Artificial lower limbs or inability to walk normally (eg: stroke with plegia) Chronic obstructive pulmonary disease Known heart disease (with impaired exercise tolerance) Pregnancy 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Amnon Lahad, MD
    Phone
    972-52-3293484
    Email
    amnonl@ekmd.huji.ac.il
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Amnon Lahad, MD
    Organizational Affiliation
    Clalit
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Individual participant data will not be shared

    Learn more about this trial

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

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