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

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

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04522141
Enrollment
81
Registered
2020-08-21
Start date
2020-10-15
Completion date
2022-01-30
Last updated
2022-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sedentary Lifestyle, Self-control

Keywords

Physical exercise, Behavior change

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.

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.

Interventions

BEHAVIORALSelf-control intervention

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.

BEHAVIORALControl condition

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.

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
Brandeis University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
35 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Objective Physical ActivityAverage 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 ActivityBaseline (Pretest) T1, Week 8 (Posttest) T2, Week 12 (Follow-up) T3International 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-ControlBaseline (Pretest) T1, Week 8 (Posttest) T2, Week 12 (Follow-up) T3The 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-ControlWeek 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7The 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.

Secondary

MeasureTime frameDescription
Stop & Go Switch TaskBaseline (Pretest) T1, Week 8 (Posttest) T2, Week 12 (Follow-up) T3To 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.
Big Five Personality TraitsBaseline (Pretest) T1, Week 8 (Posttest) T2, Week 12 (Follow-up) T3The 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.
Immediate Word List Recall TaskBaseline (Pretest) T1, Week 8 (Posttest) T2, Week 12 (Follow-up) T3Immediate 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.
Backward Digit Span TestBaseline (Pretest) T1, Week 8 (Posttest) T2, Week 12 (Follow-up) T3To 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.
Exercise Self-efficacyBaseline (Pretest) T1, Week 8 (Posttest) T2, Week 12 (Follow-up) T3Nine 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.
Satisfaction With LifeBaseline (Pretest) T1, Week 8 (Posttest) T2, Week 12 (Follow-up) T3The 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.
Sense of ControlBaseline (Pretest) T1, Week 8 (Posttest) T2, Week 12 (Follow-up) T312 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Self-control Treatment Group
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. Self-control intervention: 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.
42
Control Group
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. Control condition: 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.
38
Total80

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyWithdrawal by Subject10

Baseline characteristics

CharacteristicSelf-control Treatment GroupTotalControl Group
Age, Continuous44.90 years
STANDARD_DEVIATION 7.16
46.96 years
STANDARD_DEVIATION 9.54
49.24 years
STANDARD_DEVIATION 11.28
Ethnicity (NIH/OMB)
Hispanic or Latino
4 Participants4 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
38 Participants76 Participants38 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
7 Participants8 Participants1 Participants
Race (NIH/OMB)
Black or African American
6 Participants11 Participants5 Participants
Race (NIH/OMB)
More than one race
2 Participants4 Participants2 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
27 Participants57 Participants30 Participants
Region of Enrollment
United States
42 participants80 participants38 participants
Sex: Female, Male
Female
33 Participants62 Participants29 Participants
Sex: Female, Male
Male
9 Participants18 Participants9 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 420 / 39
other
Total, other adverse events
0 / 420 / 39
serious
Total, serious adverse events
0 / 420 / 39

Outcome results

Primary

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.

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)

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Self-control Treatment GroupObjective Physical ActivityAverage daily steps baseline week (week 1)6184.45 Average Daily StepsStandard Deviation 3084.61
Self-control Treatment GroupObjective Physical ActivityAverage daily steps between pretest and posttest (weeks 2-8)6647.71 Average Daily StepsStandard Deviation 2787.96
Self-control Treatment GroupObjective Physical ActivityAverage daily steps between posttest and follow-up (weeks 9-12)6426.23 Average Daily StepsStandard Deviation 3167.05
Control GroupObjective Physical ActivityAverage daily steps baseline week (week 1)6671.81 Average Daily StepsStandard Deviation 4213.5
Control GroupObjective Physical ActivityAverage daily steps between pretest and posttest (weeks 2-8)6932.25 Average Daily StepsStandard Deviation 6071.56
Control GroupObjective Physical ActivityAverage daily steps between posttest and follow-up (weeks 9-12)6722.13 Average Daily StepsStandard Deviation 4638.01
Comparison: Main effectp-value: 0.038Mixed Models Analysis
Comparison: Time by condition interactionp-value: 0.941Mixed Models Analysis
Primary

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.

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

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

ArmMeasureGroupValue (MEAN)Dispersion
Self-control Treatment GroupSelf-ControlT13.32 units on a scaleStandard Deviation 0.6
Self-control Treatment GroupSelf-ControlT23.54 units on a scaleStandard Deviation 0.63
Self-control Treatment GroupSelf-ControlT33.63 units on a scaleStandard Deviation 0.65
Control GroupSelf-ControlT13.42 units on a scaleStandard Deviation 0.75
Control GroupSelf-ControlT23.62 units on a scaleStandard Deviation 0.76
Control GroupSelf-ControlT33.63 units on a scaleStandard Deviation 0.75
Comparison: Main effectp-value: <0.001Mixed Models Analysis
Comparison: Time by condition interactionp-value: 0.411Mixed Models Analysis
Primary

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.

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

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

ArmMeasureGroupValue (MEAN)Dispersion
Self-control Treatment GroupSelf-Reported Physical ActivityT11598.95 MET minutes/weekStandard Deviation 2461.04
Self-control Treatment GroupSelf-Reported Physical ActivityT23268.70 MET minutes/weekStandard Deviation 3754.73
Self-control Treatment GroupSelf-Reported Physical ActivityT33891.36 MET minutes/weekStandard Deviation 6362.59
Control GroupSelf-Reported Physical ActivityT12460.11 MET minutes/weekStandard Deviation 4157.84
Control GroupSelf-Reported Physical ActivityT23122.72 MET minutes/weekStandard Deviation 3811.26
Control GroupSelf-Reported Physical ActivityT32778.18 MET minutes/weekStandard Deviation 3586.78
Comparison: Main effectp-value: 0.003Mixed Models Analysis
Comparison: Time by condition interactionp-value: 0.027Mixed Models Analysis
Primary

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.

Time frame: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7

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

ArmMeasureGroupValue (MEAN)Dispersion
Self-control Treatment GroupWeekly Self-ControlWeek 36.11 units on a scaleStandard Deviation 1.51
Self-control Treatment GroupWeekly Self-ControlWeek 56.13 units on a scaleStandard Deviation 1.4
Self-control Treatment GroupWeekly Self-ControlWeek 15.81 units on a scaleStandard Deviation 1.31
Self-control Treatment GroupWeekly Self-ControlWeek 66.49 units on a scaleStandard Deviation 1.3
Self-control Treatment GroupWeekly Self-ControlWeek 46.26 units on a scaleStandard Deviation 1.32
Self-control Treatment GroupWeekly Self-ControlWeek 76.53 units on a scaleStandard Deviation 1.49
Self-control Treatment GroupWeekly Self-ControlWeek 26.07 units on a scaleStandard Deviation 1.5
Control GroupWeekly Self-ControlWeek 76.46 units on a scaleStandard Deviation 1.44
Control GroupWeekly Self-ControlWeek 26.14 units on a scaleStandard Deviation 1.66
Control GroupWeekly Self-ControlWeek 36.52 units on a scaleStandard Deviation 1.52
Control GroupWeekly Self-ControlWeek 16.28 units on a scaleStandard Deviation 1.48
Control GroupWeekly Self-ControlWeek 46.37 units on a scaleStandard Deviation 1.61
Control GroupWeekly Self-ControlWeek 56.53 units on a scaleStandard Deviation 1.56
Control GroupWeekly Self-ControlWeek 66.52 units on a scaleStandard Deviation 1.55
Comparison: Main effect weekly self-controlp-value: <0.001Mixed Models Analysis
Comparison: Time by condition interaction weekly self-controlp-value: 0.176Mixed Models Analysis
Secondary

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.

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

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

ArmMeasureGroupValue (MEAN)Dispersion
Self-control Treatment GroupBackward Digit Span TestT15.17 score on a scaleStandard Deviation 2.84
Self-control Treatment GroupBackward Digit Span TestT24.30 score on a scaleStandard Deviation 3.13
Self-control Treatment GroupBackward Digit Span TestT34.11 score on a scaleStandard Deviation 3.5
Control GroupBackward Digit Span TestT14.63 score on a scaleStandard Deviation 2.81
Control GroupBackward Digit Span TestT24.17 score on a scaleStandard Deviation 2.66
Control GroupBackward Digit Span TestT33.11 score on a scaleStandard Deviation 3.06
Comparison: Main effectp-value: 0.005Mixed Models Analysis
Comparison: Time by condition interactionp-value: 0.555Mixed Models Analysis
Secondary

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.

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

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

ArmMeasureGroupValue (MEAN)Dispersion
Self-control Treatment GroupBig Five Personality TraitsT2 Neuroticism2.80 units on a scaleStandard Deviation 0.88
Self-control Treatment GroupBig Five Personality TraitsT1 Conscientiousness3.87 units on a scaleStandard Deviation 0.72
Self-control Treatment GroupBig Five Personality TraitsT3 Extraversion3.44 units on a scaleStandard Deviation 0.68
Self-control Treatment GroupBig Five Personality TraitsT2 Consientiousness3.92 units on a scaleStandard Deviation 0.66
Self-control Treatment GroupBig Five Personality TraitsT1 Extraversion3.41 units on a scaleStandard Deviation 0.72
Self-control Treatment GroupBig Five Personality TraitsT3 Conscientiousness3.88 units on a scaleStandard Deviation 0.67
Self-control Treatment GroupBig Five Personality TraitsT1 Agreeableness3.95 units on a scaleStandard Deviation 0.62
Self-control Treatment GroupBig Five Personality TraitsT3 Neuroticism2.76 units on a scaleStandard Deviation 0.89
Self-control Treatment GroupBig Five Personality TraitsT1 Neuroticism2.82 units on a scaleStandard Deviation 0.91
Self-control Treatment GroupBig Five Personality TraitsT1 Open-Mindedness4.07 units on a scaleStandard Deviation 0.54
Self-control Treatment GroupBig Five Personality TraitsT2 Agreeableness3.90 units on a scaleStandard Deviation 0.59
Self-control Treatment GroupBig Five Personality TraitsT2 Open-Mindedness3.93 units on a scaleStandard Deviation 0.69
Self-control Treatment GroupBig Five Personality TraitsT2 Extraversion3.49 units on a scaleStandard Deviation 0.65
Self-control Treatment GroupBig Five Personality TraitsT3 Open-Mindedness3.92 units on a scaleStandard Deviation 0.63
Self-control Treatment GroupBig Five Personality TraitsT3 Agreeableness3.70 units on a scaleStandard Deviation 0.63
Control GroupBig Five Personality TraitsT3 Open-Mindedness3.99 units on a scaleStandard Deviation 0.82
Control GroupBig Five Personality TraitsT1 Neuroticism2.90 units on a scaleStandard Deviation 1
Control GroupBig Five Personality TraitsT1 Extraversion3.34 units on a scaleStandard Deviation 0.86
Control GroupBig Five Personality TraitsT2 Extraversion3.43 units on a scaleStandard Deviation 0.87
Control GroupBig Five Personality TraitsT3 Extraversion3.35 units on a scaleStandard Deviation 0.93
Control GroupBig Five Personality TraitsT1 Agreeableness3.89 units on a scaleStandard Deviation 0.66
Control GroupBig Five Personality TraitsT2 Agreeableness3.85 units on a scaleStandard Deviation 0.63
Control GroupBig Five Personality TraitsT3 Agreeableness3.78 units on a scaleStandard Deviation 0.63
Control GroupBig Five Personality TraitsT1 Conscientiousness3.90 units on a scaleStandard Deviation 0.8
Control GroupBig Five Personality TraitsT2 Consientiousness3.89 units on a scaleStandard Deviation 0.81
Control GroupBig Five Personality TraitsT2 Neuroticism2.82 units on a scaleStandard Deviation 0.89
Control GroupBig Five Personality TraitsT3 Neuroticism2.83 units on a scaleStandard Deviation 0.94
Control GroupBig Five Personality TraitsT1 Open-Mindedness4.04 units on a scaleStandard Deviation 0.82
Control GroupBig Five Personality TraitsT2 Open-Mindedness4.05 units on a scaleStandard Deviation 0.76
Control GroupBig Five Personality TraitsT3 Conscientiousness3.78 units on a scaleStandard Deviation 0.71
Comparison: Main effectp-value: >0.05Mixed Models Analysis
Comparison: Time by condition interactionp-value: >0.05Mixed Models Analysis
Secondary

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.

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

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

ArmMeasureGroupValue (MEAN)Dispersion
Self-control Treatment GroupExercise Self-efficacyT12.43 units on a scaleStandard Deviation 0.89
Self-control Treatment GroupExercise Self-efficacyT22.33 units on a scaleStandard Deviation 0.78
Self-control Treatment GroupExercise Self-efficacyT32.26 units on a scaleStandard Deviation 0.81
Control GroupExercise Self-efficacyT12.48 units on a scaleStandard Deviation 0.95
Control GroupExercise Self-efficacyT22.15 units on a scaleStandard Deviation 0.8
Control GroupExercise Self-efficacyT32.14 units on a scaleStandard Deviation 0.74
Comparison: Main effectp-value: 0.031Mixed Models Analysis
Comparison: Time by condition interactionp-value: 0.26Mixed Models Analysis
Secondary

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.

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

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

ArmMeasureGroupValue (MEAN)Dispersion
Self-control Treatment GroupImmediate Word List Recall TaskT17.57 score on a scaleStandard Deviation 3.17
Self-control Treatment GroupImmediate Word List Recall TaskT26.84 score on a scaleStandard Deviation 2.44
Self-control Treatment GroupImmediate Word List Recall TaskT37.42 score on a scaleStandard Deviation 2.7
Control GroupImmediate Word List Recall TaskT15.84 score on a scaleStandard Deviation 2.58
Control GroupImmediate Word List Recall TaskT26.69 score on a scaleStandard Deviation 3.37
Control GroupImmediate Word List Recall TaskT37.41 score on a scaleStandard Deviation 2.8
Comparison: Main effectp-value: 0.206Mixed Models Analysis
Comparison: Time by condition interactionp-value: 0.026Mixed Models Analysis
Secondary

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.

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

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

ArmMeasureGroupValue (MEAN)Dispersion
Self-control Treatment GroupSatisfaction With LifeT14.55 units on a scaleStandard Deviation 1.4
Self-control Treatment GroupSatisfaction With LifeT24.64 units on a scaleStandard Deviation 1.57
Self-control Treatment GroupSatisfaction With LifeT34.75 units on a scaleStandard Deviation 1.41
Control GroupSatisfaction With LifeT14.00 units on a scaleStandard Deviation 1.49
Control GroupSatisfaction With LifeT24.24 units on a scaleStandard Deviation 1.61
Control GroupSatisfaction With LifeT34.08 units on a scaleStandard Deviation 1.58
Comparison: Main effectp-value: 0.016Mixed Models Analysis
Comparison: Time by condition interactionp-value: 0.363Mixed Models Analysis
Secondary

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.

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

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

ArmMeasureGroupValue (MEAN)Dispersion
Self-control Treatment GroupSense of ControlT2 Personal Mastery5.59 units on a scaleStandard Deviation 1.08
Self-control Treatment GroupSense of ControlT1 Perceived Constraints3.33 units on a scaleStandard Deviation 1.35
Self-control Treatment GroupSense of ControlT1 Personal Mastery5.64 units on a scaleStandard Deviation 1.2
Self-control Treatment GroupSense of ControlT2 Perceived Constraints3.35 units on a scaleStandard Deviation 1.44
Self-control Treatment GroupSense of ControlT3 Perceived Constraints3.25 units on a scaleStandard Deviation 1.52
Self-control Treatment GroupSense of ControlT3 Personal Mastery5.75 units on a scaleStandard Deviation 0.98
Control GroupSense of ControlT3 Perceived Constraints3.48 units on a scaleStandard Deviation 1.44
Control GroupSense of ControlT1 Personal Mastery5.75 units on a scaleStandard Deviation 1.27
Control GroupSense of ControlT2 Personal Mastery5.66 units on a scaleStandard Deviation 1.03
Control GroupSense of ControlT3 Personal Mastery5.41 units on a scaleStandard Deviation 1.32
Control GroupSense of ControlT1 Perceived Constraints3.23 units on a scaleStandard Deviation 1.34
Control GroupSense of ControlT2 Perceived Constraints3.32 units on a scaleStandard Deviation 1.43
Comparison: Main effectp-value: >0.05Mixed Models Analysis
Comparison: Time by condition interactionp-value: >0.05Mixed Models Analysis
Secondary

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.

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

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

ArmMeasureGroupValue (MEAN)Dispersion
Self-control Treatment GroupStop & Go Switch TaskT127.32 score on a scaleStandard Deviation 3.07
Self-control Treatment GroupStop & Go Switch TaskT224.08 score on a scaleStandard Deviation 6.19
Self-control Treatment GroupStop & Go Switch TaskT326.46 score on a scaleStandard Deviation 4.2
Control GroupStop & Go Switch TaskT124.72 score on a scaleStandard Deviation 7.48
Control GroupStop & Go Switch TaskT225.14 score on a scaleStandard Deviation 6.3
Control GroupStop & Go Switch TaskT325.44 score on a scaleStandard Deviation 4.53
Comparison: Main effectp-value: 0.389Mixed Models Analysis
Comparison: Time by condition interactionp-value: 0.516Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026