Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2026-01-10 @ 1:13 PM
Study NCT ID:
NCT03821220
Status:
UNKNOWN
Last Update Posted:
2019-02-05
First Post:
2019-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Physical Activity Levels in the Arabic- Speaking Residents of East Jerusalem With Prediabetes
Sponsor:
Clalit Health Services
Organization:
Study Overview
Official Title:
Improving Physical Activity Levels in the Arabic- Speaking Residents of East Jerusalem With Prediabetes
Status:
UNKNOWN
Status Verified Date:
2019-02
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: