Sedentary BehaviorNCT04297189
A Pilot Program Measuring Effectiveness of Health Coaching Interventions
A study testing Coaching and health information intervention in people with Sedentary Behavior and Nutritional and Metabolic Disease, run by Hadassah Medical Organization at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Sedentary Behavior, Nutritional and Metabolic Disease
- What is being tested?
- Coaching and health information intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 1 May 2019to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnancy
- Women with significant untreated psychiatric diagnosis
- Insulin-dependent diabetes
- End-stage renal disease
- Unstable Angina
- Women who are not fluent in Hebrew
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- 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.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Hadassah Medical Organization
Jerusalem, 91120
Tanya Reinfeld, RN, 972586616951, tanyar@hadassah.org.il
Donna Zwas, MD MPH, 972-504048274, donnaz1818@gmail.com
About this study
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.
Read the 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).
- Being tested
- Coaching and health information intervention
- Medical subject headings
- Sedentary Behavior, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coaching and health information interventionBehavioural
8 session intervention with,group meetings with coaching tools and health information on nutrition and physical activity and coping with stress.
| Study group | Role | What they receive |
|---|---|---|
| Coaching Intervention | Experimental | Single arm pilot study of coaching intervention Receives: Behavioral: Coaching and health information intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
self efficacy
Change in (improved) self efficacy as assessed by Tschannen-Moran Moore score
Measured: 1 year
Behavioral change
achieved 80% of the goal they set in first meeting or achieved the goal 80% of the time
Measured: 1 year
Secondary outcomes (4)
nutrition
adaptation of the Israeli Ministry of Health Diet Scale
Measured: 1 year
physical activity
increase in self-report of exercise in minutes per week
Measured: 1 year
weight
kg
Measured: 1 year
experiential avoidance
Reduction on experiential avoidance as measured on the Brief Experiential Avoidance Scale
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start1 May 2019
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary BehaviorStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Donna R Zwas, Hadassah Medical Organization
- Investigators
- Tanya Reinfeld, RN, Study director, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04297189
- Sponsor's protocol ID
- HMO-0018-19
- Status last verified
- Apr 2023
- First submitted
- 27 Oct 2019
- Last updated
- 25 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Program Measuring Effectiveness of Health Coaching Interventions
- ClinicalTrials.gov ID
- NCT04297189
- Acronym / sponsor ID
- HMO-0018-19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 5 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coaching Intervention | Experimental | Behavioral: Coaching and health information interventionSingle arm pilot study of coaching intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- Pregnancy
- Women with significant untreated psychiatric diagnosis
- Insulin-dependent diabetes
- End-stage renal disease
- Unstable Angina
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coaching and health information intervention8 session intervention with,group meetings with coaching tools and health information on nutrition and physical activity and coping with stress. | Behavioural | Coaching Intervention |
Primary outcome
self efficacy
Time frame: 1 year
Change in (improved) self efficacy as assessed by Tschannen-Moran Moore score
Behavioral change
Time frame: 1 year
achieved 80% of the goal they set in first meeting or achieved the goal 80% of the time
4 secondary outcomes
nutrition
Time frame: 1 year
physical activity
Time frame: 1 year
weight
Time frame: 1 year
experiential avoidance
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tanya Reinfeld, RN study director
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coaching and health information intervention in people with Sedentary Behavior and Nutritional and Metabolic Disease, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Donna Zwas, MD MPH (972504048274, donnaz1818@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
self efficacy (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.