A Pilot Program Measuring Effectiveness of Health Coaching Interventions

Sedentary Behavior Clinical Trial

Official title:

A Pilot Program Measuring Effectiveness of Health Coaching Interventions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04297189
• Other study ID #: HMO-0018-19
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: October 31, 2025

Study information

• Verified date: April 2023
• Source: Hadassah Medical Organization
• Contact: Donna Zwas, MD MPH
• Phone: 972504048274
• Email: donnaz1818[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 31, 2025
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Metabolic Diseases
• Nutritional and Metabolic Disease
• Sedentary Behavior

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.

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	self efficacy	Change in (improved) self efficacy as assessed by Tschannen-Moran Moore score	1 year
Primary	Behavioral change	achieved 80% of the goal they set in first meeting or achieved the goal 80% of the time	1 year
Secondary	nutrition	adaptation of the Israeli Ministry of Health Diet Scale	1 year
Secondary	physical activity	increase in self-report of exercise in minutes per week	1 year
Secondary	weight	kg	1 year
Secondary	experiential avoidance	Reduction on experiential avoidance as measured on the Brief Experiential Avoidance Scale	1 year