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A Pilot Program Measuring Effectiveness of Health Coaching Interventions

Primary Purpose

Sedentary Behavior, Nutritional and Metabolic Disease

Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Coaching and health information intervention
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Sedentary Behavior

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Hadassah Medical OrganizationRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Coaching Intervention

Arm Description

Single arm pilot study of coaching intervention

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 27, 2019
Last Updated
April 23, 2023
Sponsor
Hadassah Medical Organization
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1. Study Identification

Unique Protocol Identification Number
NCT04297189
Brief Title
A Pilot Program Measuring Effectiveness of Health Coaching Interventions
Official Title
A Pilot Program Measuring Effectiveness of Health Coaching Interventions
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
October 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hadassah Medical Organization

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sedentary Behavior, Nutritional and Metabolic Disease

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
each participant will receive a coding number and the key will be kept in the primary investigator offices.
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Coaching Intervention
Arm Type
Experimental
Arm Description
Single arm pilot study of coaching intervention
Intervention Type
Behavioral
Intervention Name(s)
Coaching and health information intervention
Intervention Description
8 session intervention with,group meetings with coaching tools and health information on nutrition and physical activity and coping with stress.
Primary Outcome Measure Information:
Title
self efficacy
Description
Change in (improved) self efficacy as assessed by Tschannen-Moran Moore score
Time Frame
1 year
Title
Behavioral change
Description
achieved 80% of the goal they set in first meeting or achieved the goal 80% of the time
Time Frame
1 year
Secondary Outcome Measure Information:
Title
nutrition
Description
adaptation of the Israeli Ministry of Health Diet Scale
Time Frame
1 year
Title
physical activity
Description
increase in self-report of exercise in minutes per week
Time Frame
1 year
Title
weight
Description
kg
Time Frame
1 year
Title
experiential avoidance
Description
Reduction on experiential avoidance as measured on the Brief Experiential Avoidance Scale
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Donna Zwas, MD MPH
Phone
972504048274
Email
donnaz1818@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Rivka May, BS
Phone
972505406064
Email
rivkamay@hadassah.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tanya Reinfeld, RN
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Study Director
Facility Information:
Facility Name
Hadassah Medical Organization
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tanya Reinfeld, RN
Phone
972586616951
Email
tanyar@hadassah.org.il
First Name & Middle Initial & Last Name & Degree
Donna Zwas, MD MPH
Phone
972-504048274
Email
donnaz1818@gmail.com

12. IPD Sharing Statement

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A Pilot Program Measuring Effectiveness of Health Coaching Interventions

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