Do Implementation Intentions Increase Average Daily Step Count.

NCT04259710 | Unknown

• 1 other identifier: HMO0523-18
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

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.

Conditions

Sedentary Behavior

Outcome Measures

Primary Outcomes (1)

• Step count

  Average step count over 5 days of the last week of participation in the protocol

  13 weeks

Secondary Outcomes (7)

• Blood pressure

  13 weeks

• Body mass index

  13 weeks

• waist circumference

  13 weeks

• Percentage increase in steps

  13 weeks

• self report of burnout

  13 weeks

Study Arms (3)

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.

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.

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.

Behavioral: Goal-setting intervention; Behavioral: Goal setting with implementation intentions

Interventions

Goal-setting intervention BEHAVIORAL

The participant will meet weekly with the investigator, report steps and set goals for the following week.

Pedometer and intervention; Pedometer, intervention and implementation intentions

Goal setting with implementation intentions BEHAVIORAL

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, intervention and implementation intentions

Pedometer only BEHAVIORAL

the participant will be given a pedometer and instructed how to use it.

Pedometer only

Eligibility Criteria

• Age: 18 Years - 90 Years
• Gender Eligibility Details: participant eligibility is based on self-representation of gender identity.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Organization, Jerusalem, Israel

Jerusalem, 91120, Israel

RECRUITING

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Donna R Zwas, MD MPH

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lori' Sloman, BSN

CONTACT

972-54-494-2639; lori@hadassah.org.il

Elisheva Leiter, PhD

CONTACT

972-54-3329044; elisheva@hadassah.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Cardiologist

Model Details: Stage 1: Comparison of intervention groups to pedometer only group. Stage 2: Comparison of intervention with implementation intentions to intervention alone

Study Record Dates

• First Submitted: December 4, 2019
• First Posted: February 6, 2020
• Study Start: October 21, 2014
• Primary Completion: January 1, 2024
• Study Completion: March 30, 2024
• Last Updated: April 25, 2023

Record last verified: 2023-04

Locations

IL (1)