Sedentary BehaviorNCT04259710
Do Implementation Intentions Increase Average Daily Step Count.
A study testing Goal-setting intervention, Goal setting with implementation intentions and Pedometer only in people with Sedentary Behavior, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
Cardiovascular disease is the second major cause of death for women in Israel and the leading cause of death among women worldwide. Women have higher mortality rates after a coronary or cerebrovascular event compared to men, and receive less attention for prevention and treatment of heart disease. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sedentary Behavior
- What is being tested?
- Goal-setting intervention, Goal setting with implementation intentions and Pedometer only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 280 participants
- Where
- 1 siteIsrael
- Study dates
- 21 Oct 2014to 30 Mar 2024
- 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 to 90 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Hadassah employees, volunteers and retirees
- able to commit to 12 week program
- no medical contraindication to physical activity
Who cannot join
- unable to walk
- unable to maintain and use the pedometer
- unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Hadassah Medical Organization, Jerusalem, Israel
Jerusalem, 91120
Donna R Zwas, PhD,MPH, 011-972-2-6779451, dannaz@hadassah.org.il
Hadas Lemberg, PhD, 00 972 2 6777572, lhadas@hadassah.org.il
About this study
Official title: Pedometer Program:Every Step Counts
Cardiovascular disease is the second major cause of death for women in Israel and the leading cause of death among women worldwide. Women have higher mortality rates after a coronary or cerebrovascular event compared to men, and receive less attention for prevention and treatment of heart disease.
The risk factors for heart disease among women in Israel are high: 53% of women in the State of Israel are overweight or obese and 48% of women do not exercise.
Read more
Increasing physical activity can lower the risk of developing cardiovascular disease in women. The literature suggests that even minor changes in behavior can reduce the morbidity, mortality and costs to the health care system.
Pedometers have proven to be an effective tool for increasing physical activity, and have the potential to create change in health habits. The pedometer measures steps and is a simple measure that gives an estimate of the extent of exercise in terms of steps. The device is simple and user-friendly and serves as an indicator of movement as a result of health choices. The literature shows that when pedometers are integrated into a support program, they provide an incentive to increase physical activity. Supporting software includes, among other things - choosing personal goals, close tracking, and self-tracking and re balancing systems. "Implementation intention" is a strategy in the form of an "if-then plan" that can increase the likelihood of attaining one's goals. It is different than specifying a goal intentions as it specifies the when, where and how portions of goal-directed behavior. This study seeks to compare the increase in steps in participants randomly assigned in a 2:2:1 allocation to a goal-setting pedometer intervention, a goal-setting plus implementation intentions pedometer intervention vs pedometer only.
Read the detailed description
Goals-
- Increasing step count as measured by a pedometer in hospital employees. The overall goal is for each participant to reach 10,000 steps a day at the end of the 12 weeks of intervention.
- Comparison of increase in steps in participants who undergo an implementation intentions intervention in addition to a goal setting intervention to those who receive the goal setting intervention alone, to those assigned to pedometer without goal setting intervention. The goal setting intevention includes setting weekly goals with the investigator, and receiving weekly tips. The implementation intention group will fill out an action planning form 3 times during the course of the intervention. The pedometer only group will receive a pedometer and instructions as to it's use.
- Examining the effect of self-efficacy on increasing the amount of steps among program participants.
- Examining the effect of the program on a measure of burnout in the workplace among program participants.
- Examining the impact of a program designed to increase physical activity (through walking) on self-report of nutrition behavior.
- Examining the correlation between emotional self-regulation as measured on a self-report measure and success in increasing steps.
- Examining the effect of the program on physiological measures: BMI, blood pressure, pulse, and waist circumference.
Target population- Hadassah Medical Center employee and volunteers
sample size- 180 Hadassah employee and volunteers to be enrolled in the program, using the first to enroll method. The sample size was calculated based on an expected 1000 step difference between the intervention groups with implementation intentions vs the group without implementation intentions. change in the number of steps per day between the control group and the intervention groups, as shown in previous studies. Under a 2350 Sd assumption, a sample size of 87 participants in each group would provide a power of 80% to detect a 5% significance level change.
- Conditions
- Sedentary Behavior
- Being tested
- Goal-setting intervention, Goal setting with implementation intentions, Pedometer only
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goal-setting interventionBehavioural
The participant will meet weekly with the investigator, report steps and set goals for the following week.
Goal setting with implementation intentionsBehavioural
In addition to the standard goal-setting intervention, the participant will fill out a form that directs them to perform implementation intentions at weeks 1, 5 and 9.
Pedometer onlyBehavioural
the participant will be given a pedometer and instructed how to use it.
| Study group | Role | What they receive |
|---|---|---|
| Pedometer only | Placebo comparator | participants will be given a pedometer and instructed how to use it, but will not participate in the goal setting intervention. Receives: Behavioral: Pedometer only |
| Pedometer and intervention | Active comparator | participants will be given a pedometer and participate in a weekly goal setting meeting with the investigator and will receive weekly tips. Receives: Behavioral: Goal-setting intervention |
| Pedometer, intervention and implementation intentions | Experimental | participants will be given a pedometer and participate in the weekly goal setting as above. In addition, 3 times during the intervention they will fill out a form that encourages performance of implementation intentions. Receives: Behavioral: Goal-setting intervention; Behavioral: Goal setting with implementation intentions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Step count
Average step count over 5 days of the last week of participation in the protocol
Measured: 13 weeks
Secondary outcomes (7)
Blood pressure
systolic and diastolic blood pressure at final visit
Measured: 13 weeks
Body mass index
weight and height will be combined to report BMI in kg/m^2
Measured: 13 weeks
waist circumference
cm
Measured: 13 weeks
Percentage increase in steps
(average daily steps on final visit) - (average daily steps on first visit)/(average daily steps on first visit)
Measured: 13 weeks
self report of burnout
Shiron-Melamed burnout questionnaire 14 item scale, scores range from 14 to 98 with higher scores reflecting more burnout
Measured: 13 weeks
resting heart rate
heart rate measured over 60 seconds at rest
Measured: 13 weeks
physical activity self efficacy
Schwarzer physical activity self efficacy scale, range 4-20, higher score = higher self efficacy
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start21 Oct 2014
- Primary completion1 Jan 2024 (estimated)
- Study completion30 Mar 2024 (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.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Stage 1: Comparison of intervention groups to pedometer only group. Stage 2: Comparison of intervention with implementation intentions to intervention alone
- Masking
- None (open label)
- Enrolment
- 280 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
- Donna R Zwas, MD MPH, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04259710
- Sponsor's protocol ID
- HMO0523-18
- Status last verified
- Apr 2023
- First submitted
- 4 Dec 2019
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- 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
- Pedometer Program:Every Step Counts
- ClinicalTrials.gov ID
- NCT04259710
- Acronym / sponsor ID
- HMO0523-18
- Conditions
- Sedentary Behavior
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- 21 Oct 2014 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 6 Feb 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.
Cardiovascular disease is the second major cause of death for women in Israel and the leading cause of death among women worldwide. Women have higher mortality rates after a coronary or cerebrovascular event compared to men, and receive less attention for prevention and treatment of heart disease.
The risk factors for heart disease among women in Israel are high: 53% of women in the State of Israel are overweight or obese and 48% of women do not exercise.
Increasing physical activity can lower the risk of developing cardiovascular disease in women. The literature suggests that even minor changes in behavior can reduce the morbidity, mortality and costs to the health care system.
Pedometers have proven to be an effective tool for increasing physical activity, and have the potential to create change in health habits. The pedometer measures steps and is a simple measure that gives an estimate of the extent of exercise in terms of steps. The device is simple and user-friendly and serves as an indicator of movement as a result of health choices. The literature shows that when pedometers are integrated into a support program, they provide an incentive to increase physical activity. Supporting software includes, among other things - choosing personal goals, close tracking, and self-tracking and re balancing systems. "Implementation intention" is a strategy in the form of an "if-then plan" that can increase the likelihood of attaining one's goals. It is different than specifying a goal intentions as it specifies the when, where and how portions of goal-directed behavior. This study seeks to compare the increase in steps in participants randomly assigned in a 2:2:1 allocation to a goal-setting pedometer intervention, a goal-setting plus implementation intentions pedometer intervention vs pedometer only.
Detailed description
Goals-
- Increasing step count as measured by a pedometer in hospital employees. The overall goal is for each participant to reach 10,000 steps a day at the end of the 12 weeks of intervention.
- Comparison of increase in steps in participants who undergo an implementation intentions intervention in addition to a goal setting intervention to those who receive the goal setting intervention alone, to those assigned to pedometer without goal setting intervention. The goal setting intevention includes setting weekly goals with the investigator, and receiving weekly tips. The implementation intention group will fill out an action planning form 3 times during the course of the intervention. The pedometer only group will receive a pedometer and instructions as to it's use.
- Examining the effect of self-efficacy on increasing the amount of steps among program participants.
- Examining the effect of the program on a measure of burnout in the workplace among program participants.
- Examining the impact of a program designed to increase physical activity (through walking) on self-report of nutrition behavior.
- Examining the correlation between emotional self-regulation as measured on a self-report measure and success in increasing steps.
- Examining the effect of the program on physiological measures: BMI, blood pressure, pulse, and waist circumference.
Target population- Hadassah Medical Center employee and volunteers
sample size- 180 Hadassah employee and volunteers to be enrolled in the program, using the first to enroll method. The sample size was calculated based on an expected 1000 step difference between the intervention groups with implementation intentions vs the group without implementation intentions. change in the number of steps per day between the control group and the intervention groups, as shown in previous studies. Under a 2350 Sd assumption, a sample size of 87 participants in each group would provide a power of 80% to detect a 5% significance level change.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Stage 1: Comparison of intervention groups to pedometer only group. Stage 2: Comparison of intervention with implementation intentions to intervention alone
| Arm | Type | Receives |
|---|---|---|
| Pedometer only | Placebo comparator | Behavioral: Pedometer onlyparticipants will be given a pedometer and instructed how to use it, but will not participate in the goal setting intervention. |
| Pedometer and intervention | Active comparator | Behavioral: Goal-setting interventionparticipants will be given a pedometer and participate in a weekly goal setting meeting with the investigator and will receive weekly tips. |
| Pedometer, intervention and implementation intentions | Experimental | Behavioral: Goal-setting intervention, Behavioral: Goal setting with implementation intentionsparticipants will be given a pedometer and participate in the weekly goal setting as above. In addition, 3 times during the intervention they will fill out a form that encourages performance of implementation intentions. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Hadassah employees, volunteers and retirees
- able to commit to 12 week program
- no medical contraindication to physical activity
Key exclusion criteria (3 listed)
- unable to walk
- unable to maintain and use the pedometer
- unable to provide informed consent
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 |
|---|---|---|
| Goal-setting interventionThe participant will meet weekly with the investigator, report steps and set goals for the following week. | Behavioural | Pedometer and intervention, Pedometer, intervention and implementation intentions |
| Goal setting with implementation intentionsIn addition to the standard goal-setting intervention, the participant will fill out a form that directs them to perform implementation intentions at weeks 1, 5 and 9. | Behavioural | Pedometer, intervention and implementation intentions |
| Pedometer onlythe participant will be given a pedometer and instructed how to use it. | Behavioural | Pedometer only |
Primary outcome
Step count
Time frame: 13 weeks
Average step count over 5 days of the last week of participation in the protocol
7 secondary outcomes
Blood pressure
Time frame: 13 weeks
Body mass index
Time frame: 13 weeks
waist circumference
Time frame: 13 weeks
Percentage increase in steps
Time frame: 13 weeks
self report of burnout
Time frame: 13 weeks
resting heart rate
Time frame: 13 weeks
physical activity self efficacy
Time frame: 13 weeks
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.
Donna R Zwas, MD MPH principal investigator
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 Goal-setting intervention, Goal setting with implementation intentions and Pedometer only in people with Sedentary Behavior, 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 3 inclusion and 3 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. Some participants in this study may receive a placebo. 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 Lori' Sloman, BSN (972-54-494-2639, lori@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Step count (time frame: 13 weeks). 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.