NCT03821220

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 375 (estimated)
• Sponsor: Clalit Health Services · Academic / Other
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-02-15
• Primary completion: 2021-02-15
• Completion: 2021-08-31
• First posted: 2019-01-29
• Last updated: 2019-02-05