NCT03124563

Brief Summary

The study goal is to design an intervention utilizing implementation intentions to help participants prospectively plan and visualize ways to increase activity for the next day among working adults who do not currently exercise or use an activity monitor. Investigators will assess the level of and changes in physical activity, and how this relates to various individual factors that are related to exercise and health, including self-efficacy, control beliefs, and cognition.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2015

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 24, 2017

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

January 14, 2019

Completed
Last Updated

January 14, 2019

Status Verified

July 1, 2018

Enrollment Period

1.3 years

First QC Date

April 13, 2017

Results QC Date

September 12, 2017

Last Update Submit

July 19, 2018

Conditions

Keywords

ExerciseHealth BehaviorAging

Outcome Measures

Primary Outcomes (2)

  • Steps

    Weekly average of daily step counts with Fitbit (averaged across 7 days at Week 1 and averaged across 7 days at Week 5).

    Week 1 & Week 5

  • Activity Intensity

    Weekly average of daily time spent in moderate to vigorous intensity activity (averaged across 7 days at Week 1 and averaged across 7 days at Week 5).

    Week 1 & Week 5

Secondary Outcomes (4)

  • Cognitive Composite Score

    Baseline (Pre-Test) and Week 5 (Post-Test )

  • Exercise Control Beliefs

    Baseline (Pre-Test) and Week 5 (Post-Test )

  • Exercise Self-efficacy

    Baseline (Pre-Test) and Week 5 (Post-Test )

  • Exercise Self-efficacy Beliefs - Time Composite

    Baseline (Pre-Test) and Week 5 (Post-Test )

Study Arms (2)

Control group

EXPERIMENTAL

Participants will wear a Fitbit Zip to record their daily activity data, which will be deidentified and aggregated with an online platform called Fitabase. Participants in the control group will be matched with the intervention group for how much contact they have with the researcher.

Behavioral: Control Group

Implementation Intention Condition

EXPERIMENTAL

Participants will wear a Fitbit Zip to record their daily activity data, which will be deidentified and aggregated with an online platform called Fitabase. Participants in this arm will receive all components of the intervention: scheduling, maps, and activity goals.

Behavioral: Implementation Intention Condition

Interventions

Control GroupBEHAVIORAL

Participants will wear a Fitbit Zip for 5 weeks to record their daily activity data. The first week of the study will provide a baseline measurement of activity. After this week, participants in this condition will begin receiving daily emails asking them to report their step count in a questionnaire. Participants in the control group will be matched with the intervention group for how much contact they have with the researcher.

Control group

Participants will wear a Fitbit Zip for 5 weeks to record their daily activity data. The first week of the study will provide a baseline measurement of activity. After this week, participants will be asked to increase their steps incrementally by 2,000 steps each week for the subsequent four weeks. To help achieve their step goals, they will receive maps of different routes near their home and/or work of varying distances and step counts. They will be asked to review their schedule for the next day and identify times when they could add steps into their schedules, and to record their daily step data in the daily questionnaire.

Implementation Intention Condition

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Currently working full time
  • Not engaged in regular exercise
  • years of age or older

You may not qualify if:

  • Not healthy enough to engage in a walking intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Robinson SA, Lachman ME. Perceived Control and Aging: A Mini-Review and Directions for Future Research. Gerontology. 2017;63(5):435-442. doi: 10.1159/000468540. Epub 2017 Apr 8.

    PMID: 28391279BACKGROUND
  • Robinson, S. A. & Lachman, M. E. (2016). Perceived Control and Behavior Change: A Personalized Approach. In F. Infurna & J. Reich (Eds.), Perceived Control: Theory, Research, and Practice in the First 50 Years (pp. 201-227). New York, New York: Oxford University Press.

    BACKGROUND

MeSH Terms

Conditions

Sedentary BehaviorMotor ActivityHealth Behavior

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Results Point of Contact

Title
Dr. Margie E. Lachman
Organization
Brandeis University

Study Officials

  • Margie Lachman, Ph.D.

    Brandeis University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The participants are aware of the nature of the intervention. They are not aware if they are the experimental or control group.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2017

First Posted

April 24, 2017

Study Start

June 1, 2015

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

January 14, 2019

Results First Posted

January 14, 2019

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share