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| ID | Type | Description | Link |
|---|---|---|---|
| 5P30AG048785 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-control intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Physical Activity | Average daily steps baseline week, average daily steps between pretest and posttest, and average daily steps between posttest and followup. A higher score means more steps. | Average daily steps baseline week (week 1); average daily steps between pretest and posttest (week 2-8); average daily steps between posttest and followup (week 9-12) |
| Self-Reported Physical Activity | International Physical Activity Questionnaire - short version. A continuous score will be calculated expressed as MET (Metabolic Equivalents) minutes per week: Total MET-min/week = (Walk METs*min*days) + (Mod METs*min*days) + Vig METs*min*days). A higher score means higher level of physical activity. | Baseline (Pretest) T1, Week 8 (Posttest) T2, Week 12 (Follow-up) T3 |
| Self-Control | The Brief Self-Control Scale was used to measure self-control. Items are assessed from 1 (not at all) to 5 (very much). A mean across all items will be calculated. A higher score means a higher score in self-control. | Baseline (Pretest) T1, Week 8 (Posttest) T2, Week 12 (Follow-up) T3 |
| Weekly Self-Control | The Brief Self-Control Scale was used to measure weekly self-control. Items are assessed from 1 (not at all) to 5 (very much). A mean across all items will be calculated. A higher score means a higher score in self-control. Participants were asked to answer the items with respect to the last week. | Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (Pretest) T1, Week 8 (Posttest) T2, Week 12 (Follow-up) T3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Margie Lachman, PhD | Brandeis University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brandeis University | Waltham | Massachusetts | 02454 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37042306 | Derived | 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. | |
| 33276145 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
One participant did not complete the baseline (pretest) but provided activity data.
Not all participants answered all questions/questionnaires because they were allowed to skip questions hence the discrepancy between measures.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | Average Daily Steps | Average daily steps baseline week (week 1); average daily steps between pretest and posttest (week 2-8); average daily steps between posttest and followup (week 9-12) |
|
3 months
[Not specified]
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mirjam Stieger | Lucerne University of Applied Sciences and Arts | 0041798852810 | mirjam.stieger@hslu.ch |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 9, 2020 | Mar 11, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 17, 2020 | Mar 11, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D057185 | Sedentary Behavior |
| D000068356 | Self-Control |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D012919 | Social Behavior |
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|
| Control condition | Behavioral | 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. |
|
| 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. | 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. | 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. | 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. | 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. | 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. | Baseline (Pretest) T1, Week 8 (Posttest) T2, Week 12 (Follow-up) T3 |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. |
|
|
|
| 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. | Please note that some participants did not answer all questions/questionnaires because they were allowed to skip questions hence the discrepancy between measures. | Posted | Mean | Standard Deviation | MET minutes/week | Baseline (Pretest) T1, Week 8 (Posttest) T2, Week 12 (Follow-up) T3 |
|
|
|
|
| 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. | Please note that some participants did not answer all questions/questionnaires because they were allowed to skip questions hence the discrepancy between measures. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Pretest) T1, Week 8 (Posttest) T2, Week 12 (Follow-up) T3 |
|
|
|
|
| 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. | Please note that some participants did not answer all questions/questionnaires because they were allowed to skip questions hence the discrepancy between measures. | Posted | Mean | Standard Deviation | units on a scale | Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 |
|
|
|
|
| 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. | Please note that some participants did not answer all questions/questionnaires because they were allowed to skip questions hence the discrepancy between measures. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Pretest) T1, Week 8 (Posttest) T2, Week 12 (Follow-up) T3 |
|
|
|
|
| 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. | Please note that some participants did not answer all questions/questionnaires because they were allowed to skip questions hence the discrepancy between measures. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Pretest) T1, Week 8 (Posttest) T2, Week 12 (Follow-up) T3 |
|
|
|
|
| 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. | Please note that some participants did not answer all questions/questionnaires because they were allowed to skip questions hence the discrepancy between measures. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Pretest) T1, Week 8 (Posttest) T2, Week 12 (Follow-up) T3 |
|
|
|
|
| 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. | Please note that some participants did not answer all questions/questionnaires because they were allowed to skip questions hence the discrepancy between measures. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Pretest) T1, Week 8 (Posttest) T2, Week 12 (Follow-up) T3 |
|
|
|
|
| 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. | Please note that some participants did not answer all questions/questionnaires because they were allowed to skip questions hence the discrepancy between measures. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Pretest) T1, Week 8 (Posttest) T2, Week 12 (Follow-up) T3 |
|
|
|
|
| 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. | Please note that some participants did not answer all questions/questionnaires because they were allowed to skip questions hence the discrepancy between measures. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Pretest) T1, Week 8 (Posttest) T2, Week 12 (Follow-up) T3 |
|
|
|
|
| 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. | Please note that some participants did not answer all questions/questionnaires because they were allowed to skip questions hence the discrepancy between measures. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Pretest) T1, Week 8 (Posttest) T2, Week 12 (Follow-up) T3 |
|
|
|
|
| 0 |
| 42 |
| 0 |
| 42 |
| 0 |
| 42 |
| EG001 | 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. | 0 | 39 | 0 | 39 | 0 | 39 |
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| T3 |
|
| Mixed Models Analysis |
| 0.027 |
Controlled for age, sex, education, race, self-reported functional health, and self-reported health status. |
| Superiority |
| T3 |
|
| Mixed Models Analysis |
| 0.411 |
Controlled for age, sex, education, race, self-reported functional health, and self-reported health status. |
| Superiority |
| Week 3 |
|
| Week 4 |
|
| Week 5 |
|
| Week 6 |
|
| Week 7 |
|
| Mixed Models Analysis |
| 0.176 |
Controlled for age, sex, education, race, self-reported functional health, and self-reported health status |
| Superiority |
| T3 Extraversion |
|
| T1 Agreeableness |
|
| T2 Agreeableness |
|
| T3 Agreeableness |
|
| T1 Conscientiousness |
|
| T2 Consientiousness |
|
| T3 Conscientiousness |
|
| T1 Neuroticism |
|
| T2 Neuroticism |
|
| T3 Neuroticism |
|
| T1 Open-Mindedness |
|
| T2 Open-Mindedness |
|
| T3 Open-Mindedness |
|
| Mixed Models Analysis |
| > .05 |
Analyses are controlled for age, sex, education, race, self-reported functional health, and self-reported health status. |
| Superiority |
| T3 |
|
| Mixed Models Analysis |
Controlled for age, sex, education, race, self-reported functional health, and self-reported health status. |
| 0.260 |
| Superiority |
| T3 |
|
| Mixed Models Analysis |
| 0.363 |
Controlled for age, sex, education, race, self-reported functional health, and self-reported health status. |
| Superiority |
| T3 Personal Mastery |
|
| T1 Perceived Constraints |
|
| T2 Perceived Constraints |
|
| T3 Perceived Constraints |
|
| Mixed Models Analysis |
| > .05 |
Analyses are controlled for age, sex, education, race, self-reported functional health, and self-reported health status. |
| Superiority |
| T3 |
|
| Mixed Models Analysis |
| 0.516 |
Controlled for age, sex, education, race, self-reported functional health, and self-reported health status. |
| Superiority |
| T3 |
|
| Mixed Models Analysis |
| 0.555 |
Controlled for age, sex, education, race, self-reported functional health, and self-reported health status. |
| Superiority |
| T3 |
|
| Mixed Models Analysis |
| 0.026 |
Controlled for age, sex, education, race, self-reported functional health, and self-reported health status. |
| Superiority |