NCT04297189

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 5, 2020

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
Last Updated

April 25, 2023

Status Verified

April 1, 2023

Enrollment Period

5.5 years

First QC Date

October 27, 2019

Last Update Submit

April 23, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • nutrition

    1 year

  • physical activity

    1 year

  • weight

    1 year

  • experiential avoidance

    1 year

Study Arms (1)

Coaching Intervention

EXPERIMENTAL

Single arm pilot study of coaching intervention

Behavioral: Coaching and health information intervention

Interventions

8 session intervention with,group meetings with coaching tools and health information on nutrition and physical activity and coping with stress.

Coaching Intervention

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, 91120, Israel

RECRUITING

MeSH Terms

Conditions

Sedentary BehaviorMetabolic Diseases

Condition Hierarchy (Ancestors)

BehaviorNutritional and Metabolic Diseases

Study Officials

  • Tanya Reinfeld, RN

    Hadassah Medical Organization

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
each participant will receive a coding number and the key will be kept in the primary investigator offices.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Cardiologist

Study Record Dates

First Submitted

October 27, 2019

First Posted

March 5, 2020

Study Start

May 1, 2019

Primary Completion

October 31, 2024

Study Completion

October 31, 2025

Last Updated

April 25, 2023

Record last verified: 2023-04

Locations