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

NCT03821220 | Unknown

• 1 other identifier: 0201-17-COM2
• Study Type: interventional
• Target: 375
• Locations: 0 countries
• Sites: N/A

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)

Conditions

Diabetes Mellitus

Keywords

Activity tracker; Arab population; Physical Activity

Outcome Measures

Primary Outcomes (1)

• Physical activity level assessed through average weekly steps

  six months

Secondary Outcomes (13)

• Fasting glucose levels

  six months

• HbA1C levels

  six months

• Body Mass Index

  six months

• Lipid profile

  six months

• Blood pressure

  six months

Study Arms (3)

Group A

ACTIVE COMPARATOR

Patients will receive an activity tracker and written information for pre-diabetic, on top of their usual care.

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.

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.

Behavioral: Motivational Interview support and Dietitian support; Behavioral: Activity tracker plus usual care; Behavioral: Personalized physical activity prescription

Interventions

Motivational Interview support and Dietitian support BEHAVIORAL

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.

Group C

Activity tracker plus usual care BEHAVIORAL

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.

Group A; Group B; Group C

Personalized physical activity prescription BEHAVIORAL

Each patient will receive a personalized prescription of recommended physical activity including type of activity, duration and frequency.

Group B; Group C

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Clalit Health Services: lead
• Hebrew University of Jerusalem: collaborator

MeSH Terms

Conditions

Diabetes Mellitus; Motor Activity

Interventions

Fitness Trackers

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Diagnostic Equipment; Equipment and Supplies; Wearable Electronic Devices; Electrical Equipment and Supplies

Study Officials

• Amnon Lahad, MD

  Clalit

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amnon Lahad, MD

CONTACT

972-52-3293484; amnonl@ekmd.huji.ac.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Medical Quality unit and Chairman department of Family Medicine, Clalit Health Services, Jerusalem district

Study Record Dates

• First Submitted: January 24, 2019
• First Posted: January 29, 2019
• Study Start: February 15, 2019
• Primary Completion: February 15, 2021
• Study Completion: August 31, 2021
• Last Updated: February 5, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share