Clinical trial NCT03821220: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Activity tracker; Arab population; Physical Activity
Lead sponsor: Clalit Health Services
Sponsor class: OTHER
Collaborators: name: Hebrew University of Jerusalem
First posted: 2019-01-29
Enrollment: 375
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Physical activity level assessed through average weekly steps
timeFrame: six months
Secondary outcomes:
measure: Fasting glucose levels
timeFrame: six months
measure: HbA1C levels
timeFrame: six months
measure: Body Mass Index
timeFrame: six months
measure: Lipid profile
timeFrame: six months
measure: Blood pressure
timeFrame: six months
measure: Energy intake 500< kcal/d <6000 kcal/d
timeFrame: Six months
measure: Waist circumference
timeFrame: six months
measure: Fat intake 15 <gram/day<200
timeFrame: six months
measure: Protein intake 10<gram/day<300
timeFrame: six months
measure: Iron intake 0<mg/day<50
timeFrame: six months
measure: Folic acid intake 15< μg/day<3000
timeFrame: six months
measure: Vitamin A intake 20< μg RAE/day<2500
timeFrame: six months
measure: Vitamin C intake 0<mg/day<2500
timeFrame: six months
Other outcomes:
Locations:
Study officials:
affiliation: Clalit
name: Amnon Lahad, MD
role: PRINCIPAL_INVESTIGATOR
References: