NCT03124537

Brief Summary

The goal of this study is to develop a smart phone app to administer a behavior change program that helps adults to increase daily steps by planning where, when, and with whom to walk. The investigators tested the effectiveness of the walking program app for increasing the number of daily steps among sedentary older adults. The investigators examined the effects on self-efficacy and social integration/support.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

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

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
6 months until next milestone

Study Start

First participant enrolled

October 16, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 9, 2019

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

October 20, 2020

Completed
Last Updated

October 20, 2020

Status Verified

October 1, 2020

Enrollment Period

1.4 years

First QC Date

April 13, 2017

Results QC Date

July 8, 2020

Last Update Submit

October 17, 2020

Conditions

Keywords

Physical ExerciseBehavior Change

Outcome Measures

Primary Outcomes (1)

  • Number of Steps Walked

    Number of steps recorded daily on the phone app, weekly step averages

    Daily for one month

Secondary Outcomes (7)

  • Exercise Self-efficacy

    Baseline and one month from the start of the intervention

  • Exercise Control Beliefs

    Baseline and one month from the start of the intervention

  • Social Contact Through the App

    During the one month intervention

  • Daily Mood and Energy Levels

    Daily

  • Self-Reported Vigorous Physical Activity

    Baseline and one month from the start of the intervention

  • +2 more secondary outcomes

Study Arms (2)

App Control Condition

EXPERIMENTAL

The control group will just have the App with the accelerometer program to set step goals and to count and record steps for 1 month

Behavioral: App Condition Control

App Experimental condition

EXPERIMENTAL

The experimental condition will set step goals and have the schedule, map, and social components for 1 month.

Behavioral: App Experimental condition

Interventions

This group were given the app to 1) count their steps, 2) add walks to their daily schedules, 3) create maps of their walking routes, and 4) text friends to invite them for a walk. Participants are asked to set a daily step goal and they can see how many steps they've taken each day since using the app. 2) There is an interface where participants can create maps based on walking routes. 3) They will also have the option to use a daily schedule to plan certain times in the day that they can walk. 4) The social feature gives participants the option to message friends, co-workers, or neighbors in one's contact list to invite them for a walk. They were also asked to respond to two questions twice a day about their mood and energy levels.

App Experimental condition

This group received the app with the first component, the ability to count steps and set daily step goals. This group will also be able to track walks to see the time, distance, and steps of each walk, but not see these walks displayed as a map. This group will monitor their daily steps over a one-month period, and will be asked to use the app as much as possible. They were also asked to respond to two questions twice a day about their mood and energy levels.

App Control Condition

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Sedentary adults, who own an iphone with step-tracking capabilities (5s or later).
  • Participants must be fit enough to walk for at least 20 minutes at a time.

You may not qualify if:

  • Cognitive impairment
  • A recent (within the past 6 months) cardiovascular event, or fall.
  • A doctor has advised them not to walk
  • Anyone who already exercises regularly: walks for exercise more than 30 minutes per day, or does other forms of exercise 150 minutes per week or more, will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brandeis University

Waltham, Massachusetts, 02454, United States

Location

Related Publications (2)

  • Sullivan AN, Lachman ME. Behavior Change with Fitness Technology in Sedentary Adults: A Review of the Evidence for Increasing Physical Activity. Front Public Health. 2017 Jan 11;4:289. doi: 10.3389/fpubh.2016.00289. eCollection 2016.

    PMID: 28123997BACKGROUND
  • Bisson AN, Sorrentino V, Lachman ME. Walking and Daily Affect Among Sedentary Older Adults Measured Using the StepMATE App: Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 Dec 1;9(12):e27208. doi: 10.2196/27208.

MeSH Terms

Conditions

Sedentary BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

Title
Alycia Bisson
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 App features they are given. They are not aware of whether they are in an experimental or control condition.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Both conditions will receive the App for use on an iphone. The control group will just have the accelerometer program to set step goals and to count steps. The experimental condition will have the accelerometer to set goals and count steps in addition to the schedule, map and social components.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychology

Study Record Dates

First Submitted

April 13, 2017

First Posted

April 24, 2017

Study Start

October 16, 2017

Primary Completion

March 29, 2019

Study Completion

July 9, 2019

Last Updated

October 20, 2020

Results First Posted

October 20, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations