NCT04522141

Brief Summary

The goal of this study is to test self-control as a behavior change mechanism for physical activity and to investigate whether a smartphone-based self-control intervention can increase physical activity among sedentary middle-aged adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
81

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Oct 2020

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

August 12, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 21, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

October 15, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2022

Completed
9 months until next milestone

Results Posted

Study results publicly available

October 13, 2022

Completed
Last Updated

October 13, 2022

Status Verified

September 1, 2022

Enrollment Period

11 months

First QC Date

August 12, 2020

Results QC Date

March 12, 2022

Last Update Submit

September 16, 2022

Conditions

Sedentary LifestyleSelf-control

Keywords

Physical exerciseBehavior change

Outcome Measures

Primary Outcomes (4)

  • Objective Physical Activity

    Average daily steps baseline week, average daily steps between pretest and posttest, and average daily steps between posttest and followup. A higher score means more steps.

    Average daily steps baseline week (week 1); average daily steps between pretest and posttest (week 2-8); average daily steps between posttest and followup (week 9-12)

  • Self-Reported Physical Activity

    International Physical Activity Questionnaire - short version. A continuous score will be calculated expressed as MET (Metabolic Equivalents) minutes per week: Total MET-min/week = (Walk METs\*min\*days) + (Mod METs\*min\*days) + Vig METs\*min\*days). A higher score means higher level of physical activity.

    Baseline (Pretest) T1, Week 8 (Posttest) T2, Week 12 (Follow-up) T3

  • Self-Control

    The Brief Self-Control Scale was used to measure self-control. Items are assessed from 1 (not at all) to 5 (very much). A mean across all items will be calculated. A higher score means a higher score in self-control.

    Baseline (Pretest) T1, Week 8 (Posttest) T2, Week 12 (Follow-up) T3

  • Weekly Self-Control

    The Brief Self-Control Scale was used to measure weekly self-control. Items are assessed from 1 (not at all) to 5 (very much). A mean across all items will be calculated. A higher score means a higher score in self-control. Participants were asked to answer the items with respect to the last week.

    Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7

Secondary Outcomes (7)

  • Big Five Personality Traits

    Baseline (Pretest) T1, Week 8 (Posttest) T2, Week 12 (Follow-up) T3

  • Exercise Self-efficacy

    Baseline (Pretest) T1, Week 8 (Posttest) T2, Week 12 (Follow-up) T3

  • Satisfaction With Life

    Baseline (Pretest) T1, Week 8 (Posttest) T2, Week 12 (Follow-up) T3

  • Sense of Control

    Baseline (Pretest) T1, Week 8 (Posttest) T2, Week 12 (Follow-up) T3

  • Stop & Go Switch Task

    Baseline (Pretest) T1, Week 8 (Posttest) T2, Week 12 (Follow-up) T3

  • +2 more secondary outcomes

Study Arms (2)

Self-control treatment group

EXPERIMENTAL

The self-control treatment group will wear a Fitbit step counter across 8 weeks. In addition, they will use the MindHike smartphone application across 8 weeks. Each day, the app sends the a reminder to wear the Fitbit as well as a short interventional input targeting self-control.

Behavioral: Self-control intervention

Control group

ACTIVE COMPARATOR

The control group will wear a Fitbit step counter across 8 weeks. In addition, they will use the MindHike smartphone application across 8 weeks. Each day, the app sends the a reminder to wear the Fitbit.

Behavioral: Control condition

Interventions

Self-control interventionBEHAVIORAL

Participants will wear a Fitbit for 8 weeks to record their daily activity data. The first week of the study will provide a baseline measurement of activity. Across the 8 weeks, participants receive daily reminders to wear their Fitbit. After the baseline week, participants will also receive interventional components that target self-control via the smartphone application MindHike. This intervention should help them achieve their activity goals. The self-control intervention teaches strategies how to potentiate desirable impulses and how to avoid undesirable impulses in daily life.

Self-control treatment group
Control conditionBEHAVIORAL

Participants will wear a Fitbit for 8 weeks to record their daily activity data. The first week of the study will provide a baseline measurement of activity. Participants in this condition receive daily reminders to wear their Fitbit through the MindHike smartphone application. Participants in the control group will be matched with the self-control intervention group for how much contact they have with the app and the researchers.

Control group

Eligibility Criteria

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

You may qualify if:

  • between 35-65 years of age
  • fluent in English
  • fit enough to walk for at least 20 min at a time
  • owns a smartphone

You may not qualify if:

  • experienced a fall or heart problem/condition in the last 6 months
  • is currently participating in an exercise program to increase physical activity
  • is already physically active (physically active = exercise regularly 3 times per week, or more for at least 30min)
  • was advised by a doctor to not walk due to health conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brandeis University

Waltham, Massachusetts, 02454, United States

Location

Related Publications (2)

  • Stieger M, Allemand M, Lachman ME. Effects of a digital self-control intervention to increase physical activity in middle-aged adults. J Health Psychol. 2023 Sep;28(10):984-996. doi: 10.1177/13591053231166756. Epub 2023 Apr 12.

    PMID: 37042306DERIVED

  • Stieger M, Allemand M, Lachman ME. Targeting self-control as a behavior change mechanism to increase physical activity: Study protocol of a randomized controlled trial. Contemp Clin Trials. 2021 Jan;100:106236. doi: 10.1016/j.cct.2020.106236. Epub 2020 Dec 1.

    PMID: 33276145DERIVED

MeSH Terms

Conditions

Sedentary BehaviorSelf-ControlMotor Activity

Condition Hierarchy (Ancestors)

BehaviorSocial Behavior

Results Point of Contact

Title
Dr. Mirjam Stieger
Organization
Lucerne University of Applied Sciences and Arts
mirjam.stieger@hslu.ch
0041798852810

Study Officials

  • Margie Lachman, PhD

    Brandeis University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Minnie and Harold Fierman Professor of Psychology

Study Record Dates

First Submitted

August 12, 2020

First Posted

August 21, 2020

Study Start

October 15, 2020

Primary Completion

August 31, 2021

Study Completion

January 30, 2022

Last Updated

October 13, 2022

Results First Posted

October 13, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)