A Pilot Program Measuring Effectiveness of Health Coaching Interventions

Women will participate in a workshop within a group and individual meetings. the workshop will include providing information regarding guidelines for healthy eating, engaging in physical activity, personal training tools to build self-efficacy and to encourage implementing a healthy life style.

Study Overview

• Status: Recruiting
• Conditions: Sedentary Behavior; Nutritional and Metabolic Disease
• Intervention / Treatment: Behavioral: Coaching and health information intervention

Detailed Description

Participants are interviewed for eligibility and if appropriate sign consent and undergo measurements of weight, height and blood pressure.

At the first meeting there is a pre-study questionnaires and initial coaching session

Eight group meetings will take place and will include:

up-to-date knowledge on nutrition (by a dietitian), exercise (by a physiotherapist) and coping skills for stress (by a psychologist).

Additionally the meetings will also include coaching tools which the participants will practice during the session. The multidisciplinary team has been trained in coaching tools to evaluate in group settings.

In the last meeting, participants will be asked to fill out post study questionnaires measurements will be taken (weight and blood pressure).

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rivka May, BS; Phone Number: 972505406064; Email: rivkamay@hadassah.org.il

Study Locations

• Israel
  • Jerusalem, Israel, 91120
    • Recruiting
    • Hadassah Medical Organization
    • Contact: Tanya Reinfeld, RN; Phone Number: 972586616951; Email: tanyar@hadassah.org.il
    • Contact: Donna Zwas, MD MPH; Phone Number: 972-504048274; Email: donnaz1818@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• over age 18
• Women who agree to fill out questionnaires
• Women who agree to attend sessions (attending 80% of sessions)
• Women who are fluent in Hebrew

Exclusion Criteria:

• Pregnancy
• Women with significant untreated psychiatric diagnosis
• Insulin-dependent diabetes
• End-stage renal disease
• Unstable Angina
• Women who are not fluent in Hebrew
• Women currently treated by multidisciplinary staff (eg, heart failure, cardio rehabilitation)
• Women who have been enrolled in other programs of the center at the discretion of the staff will not be included in the study
• Women who do not want to make a healthy lifestyle change
• Failure to reach 75% of sessions during the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Coaching Intervention; Single arm pilot study of coaching intervention	Behavioral: Coaching and health information intervention; 8 session intervention with,group meetings with coaching tools and health information on nutrition and physical activity and coping with stress.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
self efficacy	Change in (improved) self efficacy as assessed by Tschannen-Moran Moore score	1 year
Behavioral change	achieved 80% of the goal they set in first meeting or achieved the goal 80% of the time	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
nutrition	adaptation of the Israeli Ministry of Health Diet Scale	1 year
physical activity	increase in self-report of exercise in minutes per week	1 year
weight	kg	1 year
experiential avoidance	Reduction on experiential avoidance as measured on the Brief Experiential Avoidance Scale	1 year

Collaborators and Investigators

• Sponsor: Hadassah Medical Organization

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Anticipated): October 31, 2024
• Study Completion (Anticipated): October 31, 2025

Study Registration Dates

• First Submitted: October 27, 2019
• First Submitted That Met QC Criteria: March 3, 2020
• First Posted (Actual): March 5, 2020

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 23, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases
• Other Study ID Numbers: HMO-0018-19

Drug and device information, study documents

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