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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03821220
Recruitment Status : Not yet recruiting
First Posted : January 29, 2019
Last Update Posted : February 5, 2019
Sponsor:
Collaborator:
Hebrew University of Jerusalem
Information provided by (Responsible Party):
Prof. Amnon Lahad, 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)

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Behavioral: Motivational Interview support and Dietitian support Behavioral: Activity tracker plus usual care Behavioral: Personalized physical activity prescription Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 375 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Improving Physical Activity Levels in the Arabic- Speaking Residents of East Jerusalem With Prediabetes
Estimated Study Start Date : February 15, 2019
Estimated Primary Completion Date : February 15, 2021
Estimated Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group A
Patients will receive an activity tracker and written information for pre-diabetic, on top of their usual care.
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.

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

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

Active Comparator: 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.
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.

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.

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




Primary Outcome Measures :
  1. Physical activity level assessed through average weekly steps [ Time Frame: six months ]

Secondary Outcome Measures :
  1. Fasting glucose levels [ Time Frame: six months ]
  2. HbA1C levels [ Time Frame: six months ]
  3. Body Mass Index [ Time Frame: six months ]
  4. Lipid profile [ Time Frame: six months ]
  5. Blood pressure [ Time Frame: six months ]
  6. Energy intake 500< kcal/d <6000 kcal/d [ Time Frame: Six months ]
  7. Waist circumference [ Time Frame: six months ]
  8. Fat intake 15 <gram/day<200 [ Time Frame: six months ]
  9. Protein intake 10<gram/day<300 [ Time Frame: six months ]
  10. Iron intake 0<mg/day<50 [ Time Frame: six months ]
  11. Folic acid intake 15< μg/day<3000 [ Time Frame: six months ]
  12. Vitamin A intake 20< μg RAE/day<2500 [ Time Frame: six months ]
  13. Vitamin C intake 0<mg/day<2500 [ Time Frame: six months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03821220


Contacts
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Contact: Amnon Lahad, MD 972-52-3293484 amnonl@ekmd.huji.ac.il

Sponsors and Collaborators
Clalit Health Services
Hebrew University of Jerusalem
Investigators
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Principal Investigator: Amnon Lahad, MD Clalit
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Responsible Party: Prof. Amnon Lahad, Director of Medical Quality unit and Chairman department of Family Medicine, Clalit Health Services, Jerusalem district, Clalit Health Services
ClinicalTrials.gov Identifier: NCT03821220    
Other Study ID Numbers: 0201-17-COM2
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will not be shared

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Amnon Lahad, Clalit Health Services:
Activity tracker; Arab population; Physical Activity
Additional relevant MeSH terms:
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Prediabetic State
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases