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

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)

Study Overview

• Status: Unknown
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Behavioral: Activity tracker plus usual care; Behavioral: Personalized physical activity prescription; Behavioral: Motivational Interview support and Dietitian support

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 Type: Interventional
• Enrollment (Anticipated): 375
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amnon Lahad, MD; Phone Number: 972-52-3293484; Email: amnonl@ekmd.huji.ac.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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: 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Physical activity level assessed through average weekly steps	six months

Secondary Outcome Measures

Outcome Measure	Time Frame
Fasting glucose levels	six months
HbA1C levels	six months
Body Mass Index	six months
Lipid profile	six months
Blood pressure	six months
Energy intake 500< kcal/d <6000 kcal/d	Six months
Waist circumference	six months
Fat intake 15 <gram/day<200	six months
Protein intake 10<gram/day<300	six months
Iron intake 0<mg/day<50	six months
Folic acid intake 15< μg/day<3000	six months
Vitamin A intake 20< μg RAE/day<2500	six months
Vitamin C intake 0<mg/day<2500	six months

Collaborators and Investigators

• Sponsor: Clalit Health Services
• Collaborators: Hebrew University of Jerusalem
• Investigators: Principal Investigator: Amnon Lahad, MD, clalit

Study record dates

Study Major Dates

• Study Start (Anticipated): February 15, 2019
• Primary Completion (Anticipated): February 15, 2021
• Study Completion (Anticipated): August 31, 2021

Study Registration Dates

• First Submitted: January 24, 2019
• First Submitted That Met QC Criteria: January 27, 2019
• First Posted (Actual): January 29, 2019

Study Record Updates

• Last Update Posted (Actual): February 5, 2019
• Last Update Submitted That Met QC Criteria: February 3, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Activity tracker; Arab population; Physical Activity
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Prediabetic State
• Other Study ID Numbers: 0201-17-COM2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Individual participant data will not be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No