Sedentary LifestyleEarly Phase 1NCT04522141

Testing Self-Control as a Behavior Change Mechanism to Increase Physical Activity

A Early Phase 1 study of Sedentary Lifestyle and Self-control, run by Brandeis University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 35 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Sedentary Lifestyle, Self-control
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 81 participants
Where: 1 siteUnited States
Study dates: 15 Oct 2020to 30 Jan 2022
Phase: Early Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 35 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Brandeis University
Waltham, Massachusetts, 02454

Other trials in United States

About this study

Read the detailed description

It is widely known that being physically active is beneficial for one's health and well-being, yet only a small percentage of adults engage in the recommended amounts of physical activity. Research has shown that health-damaging behaviors such as a sedentary lifestyle can be attributed in part to a lack of self-control. There is some evidence that self-control strategies can be improved with targeted interventions. The overall aim of the proposed 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 and older adults. To test the effect of this self-control intervention, participants will be randomized into two conditions: The self-control treatment group and the control group. Both groups will track their daily physical activity using a Fitbit step counter over eight weeks. Additionally, the self-control intervention group will receive a 7-week smartphone-based self-control intervention to learn strategies how to potentiate desirable impulses or weaken undesirable ones. It is expected that the self-control treatment group will show greater increases in physical activity and that changes will last longer compared to the control group. Self-control is expected to mediate the relationship between condition and physical activity. It is predicted that the self-control treatment group will show greater changes in self-control compared to the control group and that people who increase more in self-control also increase more in their physical activity. Two versions of the MindHike smartphone application will be used to communicate with all participants. The self-control treatment group will receive a version delivering a self-control intervention. The control group will receive a minimal version without the interventional components. Both groups are matched in terms of contact frequency.

Conditions: Sedentary Lifestyle, Self-control
Being tested: Self-control intervention, Control condition
Keywords: Physical exercise, Behavior change
Medical subject headings: Sedentary Behavior, Self-Control, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Self-control interventionBehavioural
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.
Control conditionBehavioural
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.

Study groups in NCT04522141
Study group	Role	What they receive
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. Receives: 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. Receives: Behavioral: Control condition

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7

Secondary outcomes (7)

Big Five Personality Traits
The Big Five Inventory 2 was used to assess the Big Five personality traits. Items are assessed from 1 (disagree strongly) to 5 (agree strongly). A mean across all items per personality trait will be calculated. A higher score means a higher score on a personality trait.
Measured: Baseline (Pretest) T1, Week 8 (Posttest) T2, Week 12 (Follow-up) T3
Exercise Self-efficacy
Nine items were used to assess how sure participants are that they will exercise under certain circumstances (e.g., when you are feeling under pressure or when you are away from home). Items were assessed from 1 (very sure) to 4 (not at all sure). A mean across all items will be calculated. A higher score means lower exercise self-efficacy.
Measured: Baseline (Pretest) T1, Week 8 (Posttest) T2, Week 12 (Follow-up) T3
Satisfaction With Life
The Satisfaction with life scale was used to assess satisfaction with life. Items were assessed from 1 (disagree strongly) to 7 (agree strongly). A mean across all items will be calculated. A higher score means a higher satisfaction with life.
Measured: Baseline (Pretest) T1, Week 8 (Posttest) T2, Week 12 (Follow-up) T3
Sense of Control
12 items were used to assess sense of control. The scale consisted of two subscales: personal mastery (e.g., I can do just about anything I really set my mind to) and perceived constraints (e.g., What happens in my life is often beyond my control). All items were rated on a scale ranging from strongly agree (1) to strongly disagree (7). All items were coded so that a higher score reflected greater personal mastery and greater perceived constraints, respectively.
Measured: Baseline (Pretest) T1, Week 8 (Posttest) T2, Week 12 (Follow-up) T3
Stop & Go Switch Task
To measure attention switching and inhibitory control, we used the newly developed online app version of the Stop \& Go Switch Task (SGST). The SGST requires alternating between the "normal" condition (i.e., respond "Go" to the stimulus "Green" and "Stop" to the stimulus "Red") and the "reverse" condition (i.e., respond "Stop" to the stimulus "Green" and "Go" to the stimulus "Red"). For the SGST, the total number of correct responses across the mixed trials were calculated. Total range: 0 - 32. A higher score means a better outcome.
Measured: Baseline (Pretest) T1, Week 8 (Posttest) T2, Week 12 (Follow-up) T3
Backward Digit Span Test
To measure working memory capacity, we used the backward digit span test from the WAIS-III. The task includes increasingly longer series of digits, ranging from two to eight digits. Participants attempt to repeat them in the reverse order from which they were shown. The score is the longest string that is repeated exactly in reverse order. Digits are presented at a rate of one per second, beginning with a set size of two digits and progressing to eight digits. The accuracy score is the largest set size that was correctly reproduced. Possible range: 0 - 8. A higher score means a better outcome.
Measured: Baseline (Pretest) T1, Week 8 (Posttest) T2, Week 12 (Follow-up) T3
Immediate Word List Recall Task
Immediate episodic memory for verbal materials are tested using free recall of a word list drawn from the Rey Auditory-Verbal Learning Test. Participants are instructed to read carefully a list of 15 words which are presented at a rate of one second per word, and then to recall as many words as possible. In scoring the accuracy measure, one point is given for each correct response. Possible range: 0 - 15. A higher score means a better outcome.
Measured: Baseline (Pretest) T1, Week 8 (Posttest) T2, Week 12 (Follow-up) T3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Oct 202030 Jan 2022

First posted21 Aug 2020
Study start15 Oct 2020
Primary completion31 Aug 2021
Study completion30 Jan 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Sedentary LifestyleStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Early Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 81 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04522141
Sponsor's protocol ID: 20100R
Other IDs: 5P30AG048785
Status last verified: Sep 2022
First submitted: 12 Aug 2020
Last updated: 13 Oct 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 37042306
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.
PubMed 33276145

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Sedentary Lifestyle trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Testing Self-Control as a Behavior Change Mechanism to Increase Physical Activity
ClinicalTrials.gov ID: NCT04522141
Acronym / sponsor ID: 20100R
Conditions: Sedentary Lifestyle, Self-control
Keywords: Physical exercise, Behavior change
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 81 participants (actual)
Lead sponsor: Brandeis UniversityUniversity, hospital or other
Collaborators: National Institute on Aging (NIA)
Study start: 15 Oct 2020 (actual)
Primary completion: 31 Aug 2021 (actual)
Study completion: 30 Jan 2022 (actual)
First posted: 21 Aug 2020 (actual)
Results: Posted 13 Oct 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Self-control treatment group	Experimental	Behavioral: Self-control interventionThe 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.
Control group	Active comparator	Behavioral: Control conditionThe 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.

Who may qualify

Ages: 35 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Self-control interventionParticipants 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.	Behavioural	Self-control treatment group
Control conditionParticipants 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.	Behavioural	Control group

Primary outcome

Objective Physical Activity
Time frame: 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)
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.
Self-Reported Physical Activity
Time frame: Baseline (Pretest) T1, Week 8 (Posttest) T2, Week 12 (Follow-up) T3
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.
Self-Control
Time frame: Baseline (Pretest) T1, Week 8 (Posttest) T2, Week 12 (Follow-up) T3
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.
Weekly Self-Control
Time frame: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7
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.

7 secondary outcomes

Big Five Personality Traits
Time frame: Baseline (Pretest) T1, Week 8 (Posttest) T2, Week 12 (Follow-up) T3
Exercise Self-efficacy
Time frame: Baseline (Pretest) T1, Week 8 (Posttest) T2, Week 12 (Follow-up) T3
Satisfaction With Life
Time frame: Baseline (Pretest) T1, Week 8 (Posttest) T2, Week 12 (Follow-up) T3
Sense of Control
Time frame: Baseline (Pretest) T1, Week 8 (Posttest) T2, Week 12 (Follow-up) T3
Stop & Go Switch Task
Time frame: Baseline (Pretest) T1, Week 8 (Posttest) T2, Week 12 (Follow-up) T3
Backward Digit Span Test
Time frame: Baseline (Pretest) T1, Week 8 (Posttest) T2, Week 12 (Follow-up) T3
Immediate Word List Recall Task
Time frame: Baseline (Pretest) T1, Week 8 (Posttest) T2, Week 12 (Follow-up) T3

Results and safety

Results posted to the registry on 13 Oct 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Self-control Treatment Group	42	41
Control Group	39	39

Primary outcome: Objective Physical Activity

Time frame: 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). Mean (Standard Deviation). Unit: Average Daily Steps

Measure	Self-control Treatment Group n = 37	Control Group n = 38
Average daily steps baseline week (week 1)	6184.45 (3084.61)	6671.81 (4213.50)
Average daily steps between pretest and posttest (weeks 2-8)	6647.71 (2787.96)	6932.25 (6071.56)
Average daily steps between posttest and follow-up (weeks 9-12)	6426.23 (3167.05)	6722.13 (4638.01)

Self-control Treatment Group vs Control Group: p = 0.038, Mixed Models Analysis
Self-control Treatment Group vs Control Group: p = 0.941, Mixed Models Analysis

Population analysed: Please note that some participants did not answer all questions/questionnaires because they were allowed to skip questions hence the discrepancy between measures. Some participants did not provide their step data.

Primary outcome: Self-Reported Physical Activity

Time frame: Baseline (Pretest) T1, Week 8 (Posttest) T2, Week 12 (Follow-up) T3. Mean (Standard Deviation). Unit: MET minutes/week

Measure	Self-control Treatment Group n = 38	Control Group n = 33
T1	1598.95 (2461.04)	2460.11 (4157.84)
T2	3268.70 (3754.73)	3122.72 (3811.26)
T3	3891.36 (6362.59)	2778.18 (3586.78)

Self-control Treatment Group vs Control Group: p = 0.003, Mixed Models Analysis
Self-control Treatment Group vs Control Group: p = 0.027, Mixed Models Analysis

Population analysed: Please note that some participants did not answer all questions/questionnaires because they were allowed to skip questions hence the discrepancy between measures.

Primary outcome: Self-Control

Time frame: Baseline (Pretest) T1, Week 8 (Posttest) T2, Week 12 (Follow-up) T3. Mean (Standard Deviation). Unit: units on a scale

Measure	Self-control Treatment Group n = 42	Control Group n = 38
T1	3.32 (0.60)	3.42 (0.75)
T2	3.54 (0.63)	3.62 (0.76)
T3	3.63 (0.65)	3.63 (0.75)

Self-control Treatment Group vs Control Group: p < .001, Mixed Models Analysis
Self-control Treatment Group vs Control Group: p = 0.411, Mixed Models Analysis

Population analysed: Please note that some participants did not answer all questions/questionnaires because they were allowed to skip questions hence the discrepancy between measures.

Primary outcome: Weekly Self-Control

Time frame: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7. Mean (Standard Deviation). Unit: units on a scale

Measure	Self-control Treatment Group n = 41	Control Group n = 36
Week 1	5.81 (1.31)	6.28 (1.48)
Week 2	6.07 (1.50)	6.14 (1.66)
Week 3	6.11 (1.51)	6.52 (1.52)
Week 4	6.26 (1.32)	6.37 (1.61)
Week 5	6.13 (1.40)	6.53 (1.56)
Week 6	6.49 (1.30)	6.52 (1.55)
Week 7	6.53 (1.49)	6.46 (1.44)

Self-control Treatment Group vs Control Group: p < .001, Mixed Models Analysis
Self-control Treatment Group vs Control Group: p = 0.176, Mixed Models Analysis

Population analysed: Please note that some participants did not answer all questions/questionnaires because they were allowed to skip questions hence the discrepancy between measures.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Self-control Treatment Group	0 of 42 (0%)	0 of 42 (0%)	0 of 42
Control Group	0 of 39 (0%)	0 of 39 (0%)	0 of 39

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37042306Stieger 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.
Derived from this study: PubMed 33276145Stieger 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Margie Lachman, PhD principal investigator

Brandeis University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study of Sedentary Lifestyle and Self-control, run by Brandeis University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Physical Activity (time frame: 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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04522141, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2022.