Diabetes MellitusNCT03821220
Improving Physical Activity Levels in the Arabic- Speaking Residents of East Jerusalem With Prediabetes
A study testing Motivational Interview support and Dietitian support and Personalized physical activity prescription in people with Diabetes Mellitus, run by Clalit Health Services.
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… Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Motivational Interview support and Dietitian support and Personalized physical activity prescription
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 375 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2019to 31 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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)
Read the 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
- Being tested
- Motivational Interview support and Dietitian support, Activity tracker plus usual care, Personalized physical activity prescription
- Keywords
- Activity tracker; Arab population; Physical Activity
- Medical subject headings
- Diabetes Mellitus, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Interview support and Dietitian supportBehavioural
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 careBehavioural
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 prescriptionBehavioural
Each patient will receive a personalized prescription of recommended physical activity including type of activity, duration and frequency.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Patients will receive an activity tracker and written information for pre-diabetic, on top of their usual care. Receives: Behavioral: Activity tracker plus usual care |
| Group B | Active comparator | Patients will receive an activity tracker, written information for pre-diabetic, and personalized physical activity prescription, on top of their usual care. Receives: Behavioral: Activity tracker plus usual care; Behavioral: Personalized physical activity prescription |
| Group C | Active comparator | 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. Receives: Behavioral: Motivational Interview support and Dietitian support; Behavioral: Activity tracker plus usual care; Behavioral: Personalized physical activity prescription |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity level assessed through average weekly steps
Measured: six months
Secondary outcomes (13)
Fasting glucose levels
Measured: six months
HbA1C levels
Measured: six months
Body Mass Index
Measured: six months
Lipid profile
Measured: six months
Blood pressure
Measured: six months
Energy intake 500< kcal/d <6000 kcal/d
Measured: Six months
Waist circumference
Measured: six months
Fat intake 15 <gram/day<200
Measured: six months
Protein intake 10<gram/day<300
Measured: six months
Iron intake 0<mg/day<50
Measured: six months
Folic acid intake 15< μg/day<3000
Measured: six months
Vitamin A intake 20< μg RAE/day<2500
Measured: six months
Vitamin C intake 0<mg/day<2500
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2019
- Study start15 Feb 2019 (estimated)
- Primary completion15 Feb 2021 (estimated)
- Study completion31 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 375 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clalit Health Services
- Sponsor type
- University, hospital or other
- Collaborators
- Hebrew University of Jerusalem
- Responsible party
- Principal investigator, Prof. Amnon Lahad, Clalit Health Services
- Investigators
- Amnon Lahad, MD, Principal investigator, Clalit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03821220
- Sponsor's protocol ID
- 0201-17-COM2
- Status last verified
- Feb 2019
- First submitted
- 24 Jan 2019
- Last updated
- 5 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Physical Activity Levels in the Arabic- Speaking Residents of East Jerusalem With Prediabetes
- ClinicalTrials.gov ID
- NCT03821220
- Acronym / sponsor ID
- 0201-17-COM2
- Conditions
- Diabetes Mellitus
- Keywords
- Activity tracker; Arab population; Physical Activity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 375 participants (estimated)
- Lead sponsor
- Clalit Health ServicesUniversity, hospital or other
- Collaborators
- Hebrew University of Jerusalem
- Study start
- 15 Feb 2019 (estimated)
- Primary completion
- 15 Feb 2021 (estimated)
- Study completion
- 31 Aug 2021 (estimated)
- First posted
- 29 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Behavioral: Activity tracker plus usual carePatients will receive an activity tracker and written information for pre-diabetic, on top of their usual care. |
| Group B | Active comparator | Behavioral: Activity tracker plus usual care, Behavioral: Personalized physical activity prescriptionPatients will receive an activity tracker, written information for pre-diabetic, and personalized physical activity prescription, on top of their usual care. |
| Group C | Active comparator | Behavioral: Motivational Interview support and Dietitian support, Behavioral: Activity tracker plus usual care, Behavioral: Personalized physical activity prescriptionPatients 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. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational Interview support and Dietitian supportThree 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. | Behavioural | Group C |
| Activity tracker plus usual careEach 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. | Behavioural | Group A, Group B, Group C |
| Personalized physical activity prescriptionEach patient will receive a personalized prescription of recommended physical activity including type of activity, duration and frequency. | Behavioural | Group B, Group C |
Primary outcome
Physical activity level assessed through average weekly steps
Time frame: six months
13 secondary outcomes
Fasting glucose levels
Time frame: six months
HbA1C levels
Time frame: six months
Body Mass Index
Time frame: six months
Lipid profile
Time frame: six months
Blood pressure
Time frame: six months
Energy intake 500< kcal/d <6000 kcal/d
Time frame: Six months
Waist circumference
Time frame: six months
Fat intake 15 <gram/day<200
Time frame: six months
Protein intake 10<gram/day<300
Time frame: six months
Iron intake 0<mg/day<50
Time frame: six months
Folic acid intake 15< μg/day<3000
Time frame: six months
Vitamin A intake 20< μg RAE/day<2500
Time frame: six months
Vitamin C intake 0<mg/day<2500
Time frame: six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
- Individual participant dataSharing planned: No. Individual participant data will not be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amnon Lahad, MD principal investigator
Clalit
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interview support and Dietitian support and Personalized physical activity prescription in people with Diabetes Mellitus, run by Clalit Health Services.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amnon Lahad, MD (972-52-3293484, amnonl@ekmd.huji.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity level assessed through average weekly steps (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2019.