Trial Outcomes & Findings for Testing Self-Control as a Behavior Change Mechanism to Increase Physical Activity (NCT NCT04522141)
NCT ID: NCT04522141
Last Updated: 2022-10-13
Results Overview
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.
COMPLETED
EARLY_PHASE1
81 participants
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)
2022-10-13
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
39
|
|
Overall Study
COMPLETED
|
41
|
39
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
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|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Testing Self-Control as a Behavior Change Mechanism to Increase Physical Activity
Baseline characteristics by cohort
| Measure |
Self-control Treatment Group
n=42 Participants
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.
|
Control Group
n=38 Participants
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.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.90 years
STANDARD_DEVIATION 7.16 • n=5 Participants
|
49.24 years
STANDARD_DEVIATION 11.28 • n=7 Participants
|
46.96 years
STANDARD_DEVIATION 9.54 • n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
42 participants
n=5 Participants
|
38 participants
n=7 Participants
|
80 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Control Group
n=38 Participants
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.
|
Self-control Treatment Group
n=37 Participants
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.
|
|---|---|---|
|
Objective Physical Activity
Average daily steps baseline week (week 1)
|
6671.81 Average Daily Steps
Standard Deviation 4213.50
|
6184.45 Average Daily Steps
Standard Deviation 3084.61
|
|
Objective Physical Activity
Average daily steps between pretest and posttest (weeks 2-8)
|
6932.25 Average Daily Steps
Standard Deviation 6071.56
|
6647.71 Average Daily Steps
Standard Deviation 2787.96
|
|
Objective Physical Activity
Average daily steps between posttest and follow-up (weeks 9-12)
|
6722.13 Average Daily Steps
Standard Deviation 4638.01
|
6426.23 Average Daily Steps
Standard Deviation 3167.05
|
PRIMARY outcome
Timeframe: Baseline (Pretest) T1, Week 8 (Posttest) T2, Week 12 (Follow-up) T3Population: Please note that some participants did not answer all questions/questionnaires because they were allowed to skip questions hence the discrepancy between measures.
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.
Outcome measures
| Measure |
Control Group
n=33 Participants
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.
|
Self-control Treatment Group
n=38 Participants
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.
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|---|---|---|
|
Self-Reported Physical Activity
T1
|
2460.11 MET minutes/week
Standard Deviation 4157.84
|
1598.95 MET minutes/week
Standard Deviation 2461.04
|
|
Self-Reported Physical Activity
T2
|
3122.72 MET minutes/week
Standard Deviation 3811.26
|
3268.70 MET minutes/week
Standard Deviation 3754.73
|
|
Self-Reported Physical Activity
T3
|
2778.18 MET minutes/week
Standard Deviation 3586.78
|
3891.36 MET minutes/week
Standard Deviation 6362.59
|
PRIMARY outcome
Timeframe: Baseline (Pretest) T1, Week 8 (Posttest) T2, Week 12 (Follow-up) T3Population: Please note that some participants did not answer all questions/questionnaires because they were allowed to skip questions hence the discrepancy between measures.
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.
Outcome measures
| Measure |
Control Group
n=38 Participants
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.
|
Self-control Treatment Group
n=42 Participants
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.
|
|---|---|---|
|
Self-Control
T1
|
3.42 units on a scale
Standard Deviation 0.75
|
3.32 units on a scale
Standard Deviation 0.60
|
|
Self-Control
T2
|
3.62 units on a scale
Standard Deviation 0.76
|
3.54 units on a scale
Standard Deviation 0.63
|
|
Self-Control
T3
|
3.63 units on a scale
Standard Deviation 0.75
|
3.63 units on a scale
Standard Deviation 0.65
|
PRIMARY outcome
Timeframe: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7Population: Please note that some participants did not answer all questions/questionnaires because they were allowed to skip questions hence the discrepancy between measures.
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.
Outcome measures
| Measure |
Control Group
n=36 Participants
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.
|
Self-control Treatment Group
n=41 Participants
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.
|
|---|---|---|
|
Weekly Self-Control
Week 7
|
6.46 units on a scale
Standard Deviation 1.44
|
6.53 units on a scale
Standard Deviation 1.49
|
|
Weekly Self-Control
Week 1
|
6.28 units on a scale
Standard Deviation 1.48
|
5.81 units on a scale
Standard Deviation 1.31
|
|
Weekly Self-Control
Week 2
|
6.14 units on a scale
Standard Deviation 1.66
|
6.07 units on a scale
Standard Deviation 1.50
|
|
Weekly Self-Control
Week 3
|
6.52 units on a scale
Standard Deviation 1.52
|
6.11 units on a scale
Standard Deviation 1.51
|
|
Weekly Self-Control
Week 4
|
6.37 units on a scale
Standard Deviation 1.61
|
6.26 units on a scale
Standard Deviation 1.32
|
|
Weekly Self-Control
Week 5
|
6.53 units on a scale
Standard Deviation 1.56
|
6.13 units on a scale
Standard Deviation 1.40
|
|
Weekly Self-Control
Week 6
|
6.52 units on a scale
Standard Deviation 1.55
|
6.49 units on a scale
Standard Deviation 1.30
|
SECONDARY outcome
Timeframe: Baseline (Pretest) T1, Week 8 (Posttest) T2, Week 12 (Follow-up) T3Population: Please note that some participants did not answer all questions/questionnaires because they were allowed to skip questions hence the discrepancy between measures.
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.
Outcome measures
| Measure |
Control Group
n=38 Participants
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.
|
Self-control Treatment Group
n=42 Participants
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.
|
|---|---|---|
|
Big Five Personality Traits
T1 Extraversion
|
3.34 units on a scale
Standard Deviation .86
|
3.41 units on a scale
Standard Deviation .72
|
|
Big Five Personality Traits
T2 Extraversion
|
3.43 units on a scale
Standard Deviation .87
|
3.49 units on a scale
Standard Deviation .65
|
|
Big Five Personality Traits
T3 Extraversion
|
3.35 units on a scale
Standard Deviation .93
|
3.44 units on a scale
Standard Deviation .68
|
|
Big Five Personality Traits
T1 Agreeableness
|
3.89 units on a scale
Standard Deviation .66
|
3.95 units on a scale
Standard Deviation .62
|
|
Big Five Personality Traits
T2 Agreeableness
|
3.85 units on a scale
Standard Deviation .63
|
3.90 units on a scale
Standard Deviation .59
|
|
Big Five Personality Traits
T3 Agreeableness
|
3.78 units on a scale
Standard Deviation .63
|
3.70 units on a scale
Standard Deviation .63
|
|
Big Five Personality Traits
T1 Conscientiousness
|
3.90 units on a scale
Standard Deviation .80
|
3.87 units on a scale
Standard Deviation .72
|
|
Big Five Personality Traits
T2 Consientiousness
|
3.89 units on a scale
Standard Deviation .81
|
3.92 units on a scale
Standard Deviation .66
|
|
Big Five Personality Traits
T3 Conscientiousness
|
3.78 units on a scale
Standard Deviation .71
|
3.88 units on a scale
Standard Deviation .67
|
|
Big Five Personality Traits
T1 Neuroticism
|
2.90 units on a scale
Standard Deviation 1.00
|
2.82 units on a scale
Standard Deviation .91
|
|
Big Five Personality Traits
T2 Neuroticism
|
2.82 units on a scale
Standard Deviation .89
|
2.80 units on a scale
Standard Deviation .88
|
|
Big Five Personality Traits
T3 Neuroticism
|
2.83 units on a scale
Standard Deviation .94
|
2.76 units on a scale
Standard Deviation .89
|
|
Big Five Personality Traits
T1 Open-Mindedness
|
4.04 units on a scale
Standard Deviation .82
|
4.07 units on a scale
Standard Deviation .54
|
|
Big Five Personality Traits
T2 Open-Mindedness
|
4.05 units on a scale
Standard Deviation .76
|
3.93 units on a scale
Standard Deviation .69
|
|
Big Five Personality Traits
T3 Open-Mindedness
|
3.99 units on a scale
Standard Deviation .82
|
3.92 units on a scale
Standard Deviation .63
|
SECONDARY outcome
Timeframe: Baseline (Pretest) T1, Week 8 (Posttest) T2, Week 12 (Follow-up) T3Population: Please note that some participants did not answer all questions/questionnaires because they were allowed to skip questions hence the discrepancy between measures.
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.
Outcome measures
| Measure |
Control Group
n=37 Participants
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.
|
Self-control Treatment Group
n=42 Participants
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.
|
|---|---|---|
|
Exercise Self-efficacy
T1
|
2.48 units on a scale
Standard Deviation .95
|
2.43 units on a scale
Standard Deviation .89
|
|
Exercise Self-efficacy
T2
|
2.15 units on a scale
Standard Deviation .80
|
2.33 units on a scale
Standard Deviation .78
|
|
Exercise Self-efficacy
T3
|
2.14 units on a scale
Standard Deviation .74
|
2.26 units on a scale
Standard Deviation .81
|
SECONDARY outcome
Timeframe: Baseline (Pretest) T1, Week 8 (Posttest) T2, Week 12 (Follow-up) T3Population: Please note that some participants did not answer all questions/questionnaires because they were allowed to skip questions hence the discrepancy between measures.
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.
Outcome measures
| Measure |
Control Group
n=38 Participants
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.
|
Self-control Treatment Group
n=42 Participants
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.
|
|---|---|---|
|
Satisfaction With Life
T1
|
4.00 units on a scale
Standard Deviation 1.49
|
4.55 units on a scale
Standard Deviation 1.40
|
|
Satisfaction With Life
T2
|
4.24 units on a scale
Standard Deviation 1.61
|
4.64 units on a scale
Standard Deviation 1.57
|
|
Satisfaction With Life
T3
|
4.08 units on a scale
Standard Deviation 1.58
|
4.75 units on a scale
Standard Deviation 1.41
|
SECONDARY outcome
Timeframe: Baseline (Pretest) T1, Week 8 (Posttest) T2, Week 12 (Follow-up) T3Population: Please note that some participants did not answer all questions/questionnaires because they were allowed to skip questions hence the discrepancy between measures.
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.
Outcome measures
| Measure |
Control Group
n=38 Participants
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.
|
Self-control Treatment Group
n=42 Participants
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.
|
|---|---|---|
|
Sense of Control
T1 Personal Mastery
|
5.75 units on a scale
Standard Deviation 1.27
|
5.64 units on a scale
Standard Deviation 1.20
|
|
Sense of Control
T2 Personal Mastery
|
5.66 units on a scale
Standard Deviation 1.03
|
5.59 units on a scale
Standard Deviation 1.08
|
|
Sense of Control
T3 Personal Mastery
|
5.41 units on a scale
Standard Deviation 1.32
|
5.75 units on a scale
Standard Deviation .98
|
|
Sense of Control
T1 Perceived Constraints
|
3.23 units on a scale
Standard Deviation 1.34
|
3.33 units on a scale
Standard Deviation 1.35
|
|
Sense of Control
T2 Perceived Constraints
|
3.32 units on a scale
Standard Deviation 1.43
|
3.35 units on a scale
Standard Deviation 1.44
|
|
Sense of Control
T3 Perceived Constraints
|
3.48 units on a scale
Standard Deviation 1.44
|
3.25 units on a scale
Standard Deviation 1.52
|
SECONDARY outcome
Timeframe: Baseline (Pretest) T1, Week 8 (Posttest) T2, Week 12 (Follow-up) T3Population: Please note that some participants did not answer all questions/questionnaires because they were allowed to skip questions hence the discrepancy between measures.
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.
Outcome measures
| Measure |
Control Group
n=36 Participants
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.
|
Self-control Treatment Group
n=41 Participants
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.
|
|---|---|---|
|
Stop & Go Switch Task
T1
|
24.72 score on a scale
Standard Deviation 7.48
|
27.32 score on a scale
Standard Deviation 3.07
|
|
Stop & Go Switch Task
T2
|
25.14 score on a scale
Standard Deviation 6.30
|
24.08 score on a scale
Standard Deviation 6.19
|
|
Stop & Go Switch Task
T3
|
25.44 score on a scale
Standard Deviation 4.53
|
26.46 score on a scale
Standard Deviation 4.20
|
SECONDARY outcome
Timeframe: Baseline (Pretest) T1, Week 8 (Posttest) T2, Week 12 (Follow-up) T3Population: Please note that some participants did not answer all questions/questionnaires because they were allowed to skip questions hence the discrepancy between measures.
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.
Outcome measures
| Measure |
Control Group
n=38 Participants
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.
|
Self-control Treatment Group
n=42 Participants
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.
|
|---|---|---|
|
Backward Digit Span Test
T1
|
4.63 score on a scale
Standard Deviation 2.81
|
5.17 score on a scale
Standard Deviation 2.84
|
|
Backward Digit Span Test
T2
|
4.17 score on a scale
Standard Deviation 2.66
|
4.30 score on a scale
Standard Deviation 3.13
|
|
Backward Digit Span Test
T3
|
3.11 score on a scale
Standard Deviation 3.06
|
4.11 score on a scale
Standard Deviation 3.50
|
SECONDARY outcome
Timeframe: Baseline (Pretest) T1, Week 8 (Posttest) T2, Week 12 (Follow-up) T3Population: Please note that some participants did not answer all questions/questionnaires because they were allowed to skip questions hence the discrepancy between measures.
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.
Outcome measures
| Measure |
Control Group
n=38 Participants
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.
|
Self-control Treatment Group
n=42 Participants
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.
|
|---|---|---|
|
Immediate Word List Recall Task
T1
|
5.84 score on a scale
Standard Deviation 2.58
|
7.57 score on a scale
Standard Deviation 3.17
|
|
Immediate Word List Recall Task
T2
|
6.69 score on a scale
Standard Deviation 3.37
|
6.84 score on a scale
Standard Deviation 2.44
|
|
Immediate Word List Recall Task
T3
|
7.41 score on a scale
Standard Deviation 2.80
|
7.42 score on a scale
Standard Deviation 2.70
|
Adverse Events
Self-control Treatment Group
Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Mirjam Stieger
Lucerne University of Applied Sciences and Arts
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place