Clinical trial NCT04259710: Do Implementation Intentions Increase Average Daily Step Count.
Official title: Pedometer Program:Every Step Counts
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sedentary Behavior
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2020-02-06
Enrollment: 280
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Stage 1: Comparison of intervention groups to pedometer only group. Stage 2: Comparison of intervention with implementation intentions to intervention alone
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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-

1. 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.
2. 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.
3. Examining the effect of self-efficacy on increasing the amount of steps among program participants.
4. Examining the effect of the program on a measure of burnout in the workplace among program participants.
5. Examining the impact of a program designed to increase physical activity (through walking) on self-report of nutrition behavior.
6. Examining the correlation between emotional self-regulation as measured on a self-report measure and success in increasing steps.
7. 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.

Eligibility criteria: Inclusion Criteria:

* Hadassah employees, volunteers and retirees
* able to commit to 12 week program
* no medical contraindication to physical activity

Exclusion Criteria:

* unable to walk
* unable to maintain and use the pedometer
* unable to provide informed consent

Primary outcomes:
measure: Step count
timeFrame: 13 weeks
Secondary outcomes:
measure: Blood pressure
timeFrame: 13 weeks
measure: Body mass index
timeFrame: 13 weeks
measure: waist circumference
timeFrame: 13 weeks
measure: Percentage increase in steps
timeFrame: 13 weeks
measure: self report of burnout
timeFrame: 13 weeks
measure: resting heart rate
timeFrame: 13 weeks
measure: physical activity self efficacy
timeFrame: 13 weeks
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization, Jerusalem, Israel
Study officials:
affiliation: Hadassah Medical Organization
name: Donna R Zwas, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: