Trial Outcomes & Findings for FitEx for Endometrial Cancer Survivors: Initial Efficacy (NCT NCT05737745)
NCT ID: NCT05737745
Last Updated: 2025-05-09
Results Overview
Among survivors, compare changes in objective moderate-vigorous physical activity (MVPA) obtained from FitBits (continuous tracking) between intervention groups and usual care (FitEx-ECS vs. control and FitEx-ECS+yoga vs. control)
COMPLETED
NA
111 participants
Change from baseline to 8 weeks (post-intervention)
2025-05-09
Participant Flow
Participant milestones
| Measure |
Usual Care
Endometrial cancer survivors will receive standard survivorship care including a one-time educational newsletter about survivorship physical activity and nutrition recommendations. Fitbits will be given to track physical activity.
|
FitEx-ECS
Endometrial cancer survivors and their support team members (as a group of one survivor and their team) will complete the FitEx-ECS intervention program, with a focus on walking. Fitbits will be given to track physical activity.
Self-monitoring: Tracking physical activity and fruit/vegetable intake.
Group-dynamics: Survivors act as team captains, facilitating interactions between themselves and their support team members and providing goal directed feedback.
Weekly virtual sessions- Standard: Weekly 30 minute virtual sessions include support group/team building sessions and 15 minutes of physical activity.
Newsletters- Standard: Weekly newsletters support attainment of physical activity and nutrition goals.
|
FitEx-ECS+ Yoga
Endometrial cancer survivors and their support team members (as a group of one survivor and their team) will complete the FitEx-ECS+yoga intervention program, with a focus on postures, breathwork, and mindfulness. Fitbits will be given to track physical activity.
Self-monitoring: Tracking physical activity and fruit/vegetable intake.
Group-dynamics: Survivors act as team captains, facilitating interactions between themselves and their support team members and providing goal directed feedback.
Newsletters- Yoga: Weekly newsletters support attainment of physical activity and nutrition goals, while including mindfulness principles.
Weekly virtual sessions- Yoga: Weekly 30 minute virtual sessions include support group/team building sessions and 15 minutes of yoga.
|
|---|---|---|---|
|
Overall Study
STARTED
|
18
|
35
|
58
|
|
Overall Study
COMPLETED
|
18
|
29
|
57
|
|
Overall Study
NOT COMPLETED
|
0
|
6
|
1
|
Reasons for withdrawal
| Measure |
Usual Care
Endometrial cancer survivors will receive standard survivorship care including a one-time educational newsletter about survivorship physical activity and nutrition recommendations. Fitbits will be given to track physical activity.
|
FitEx-ECS
Endometrial cancer survivors and their support team members (as a group of one survivor and their team) will complete the FitEx-ECS intervention program, with a focus on walking. Fitbits will be given to track physical activity.
Self-monitoring: Tracking physical activity and fruit/vegetable intake.
Group-dynamics: Survivors act as team captains, facilitating interactions between themselves and their support team members and providing goal directed feedback.
Weekly virtual sessions- Standard: Weekly 30 minute virtual sessions include support group/team building sessions and 15 minutes of physical activity.
Newsletters- Standard: Weekly newsletters support attainment of physical activity and nutrition goals.
|
FitEx-ECS+ Yoga
Endometrial cancer survivors and their support team members (as a group of one survivor and their team) will complete the FitEx-ECS+yoga intervention program, with a focus on postures, breathwork, and mindfulness. Fitbits will be given to track physical activity.
Self-monitoring: Tracking physical activity and fruit/vegetable intake.
Group-dynamics: Survivors act as team captains, facilitating interactions between themselves and their support team members and providing goal directed feedback.
Newsletters- Yoga: Weekly newsletters support attainment of physical activity and nutrition goals, while including mindfulness principles.
Weekly virtual sessions- Yoga: Weekly 30 minute virtual sessions include support group/team building sessions and 15 minutes of yoga.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
6
|
1
|
Baseline Characteristics
Not all enrolled participants completed all intake questionnaires. For the usual care group: a question about race was not included in the baseline survey unintentionally, therefore this information was not captured.
Baseline characteristics by cohort
| Measure |
Usual Care
n=18 Participants
Endometrial cancer survivors will receive standard survivorship care including a one-time educational newsletter about survivorship physical activity and nutrition recommendations. Fitbits will be given to track physical activity.
|
FitEx-ECS
n=29 Participants
Endometrial cancer survivors and their support team members (as a group of one survivor and their team) will complete the FitEx-ECS intervention program, with a focus on walking. Fitbits will be given to track physical activity.
Self-monitoring: Tracking physical activity and fruit/vegetable intake.
Group-dynamics: Survivors act as team captains, facilitating interactions between themselves and their support team members and providing goal directed feedback.
Weekly virtual sessions- Standard: Weekly 30 minute virtual sessions include support group/team building sessions and 15 minutes of physical activity.
Newsletters- Standard: Weekly newsletters support attainment of physical activity and nutrition goals.
|
FitEx-ECS+ Yoga
n=57 Participants
Endometrial cancer survivors and their support team members (as a group of one survivor and their team) will complete the FitEx-ECS+yoga intervention program, with a focus on postures, breathwork, and mindfulness. Fitbits will be given to track physical activity.
Self-monitoring: Tracking physical activity and fruit/vegetable intake.
Group-dynamics: Survivors act as team captains, facilitating interactions between themselves and their support team members and providing goal directed feedback.
Newsletters- Yoga: Weekly newsletters support attainment of physical activity and nutrition goals, while including mindfulness principles.
Weekly virtual sessions- Yoga: Weekly 30 minute virtual sessions include support group/team building sessions and 15 minutes of yoga.
|
Total
n=104 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Race (NIH/OMB)
White
|
0 Participants
n=18 Participants • Not all enrolled participants completed all intake questionnaires. For the usual care group: a question about race was not included in the baseline survey unintentionally, therefore this information was not captured.
|
23 Participants
n=29 Participants • Not all enrolled participants completed all intake questionnaires. For the usual care group: a question about race was not included in the baseline survey unintentionally, therefore this information was not captured.
|
47 Participants
n=57 Participants • Not all enrolled participants completed all intake questionnaires. For the usual care group: a question about race was not included in the baseline survey unintentionally, therefore this information was not captured.
|
70 Participants
n=104 Participants • Not all enrolled participants completed all intake questionnaires. For the usual care group: a question about race was not included in the baseline survey unintentionally, therefore this information was not captured.
|
|
Age, Continuous
|
58 years
n=18 Participants • Not all participants included a date of birth so age could not be calculated
|
55 years
n=23 Participants • Not all participants included a date of birth so age could not be calculated
|
55.6 years
n=49 Participants • Not all participants included a date of birth so age could not be calculated
|
55.5 years
n=90 Participants • Not all participants included a date of birth so age could not be calculated
|
|
Sex: Female, Male
Female
|
18 Participants
n=18 Participants • Not all enrolled participants completed all intake questionnaires.
|
18 Participants
n=22 Participants • Not all enrolled participants completed all intake questionnaires.
|
41 Participants
n=47 Participants • Not all enrolled participants completed all intake questionnaires.
|
77 Participants
n=87 Participants • Not all enrolled participants completed all intake questionnaires.
|
|
Sex: Female, Male
Male
|
0 Participants
n=18 Participants • Not all enrolled participants completed all intake questionnaires.
|
4 Participants
n=22 Participants • Not all enrolled participants completed all intake questionnaires.
|
6 Participants
n=47 Participants • Not all enrolled participants completed all intake questionnaires.
|
10 Participants
n=87 Participants • Not all enrolled participants completed all intake questionnaires.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=18 Participants • Not all enrolled participants completed all intake questionnaires.
|
0 Participants
n=29 Participants • Not all enrolled participants completed all intake questionnaires.
|
1 Participants
n=57 Participants • Not all enrolled participants completed all intake questionnaires.
|
1 Participants
n=104 Participants • Not all enrolled participants completed all intake questionnaires.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=18 Participants • Not all enrolled participants completed all intake questionnaires.
|
20 Participants
n=29 Participants • Not all enrolled participants completed all intake questionnaires.
|
48 Participants
n=57 Participants • Not all enrolled participants completed all intake questionnaires.
|
86 Participants
n=104 Participants • Not all enrolled participants completed all intake questionnaires.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=18 Participants • Not all enrolled participants completed all intake questionnaires.
|
9 Participants
n=29 Participants • Not all enrolled participants completed all intake questionnaires.
|
8 Participants
n=57 Participants • Not all enrolled participants completed all intake questionnaires.
|
17 Participants
n=104 Participants • Not all enrolled participants completed all intake questionnaires.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=18 Participants • Not all enrolled participants completed all intake questionnaires. For the usual care group: a question about race was not included in the baseline survey unintentionally, therefore this information was not captured.
|
0 Participants
n=29 Participants • Not all enrolled participants completed all intake questionnaires. For the usual care group: a question about race was not included in the baseline survey unintentionally, therefore this information was not captured.
|
0 Participants
n=57 Participants • Not all enrolled participants completed all intake questionnaires. For the usual care group: a question about race was not included in the baseline survey unintentionally, therefore this information was not captured.
|
0 Participants
n=104 Participants • Not all enrolled participants completed all intake questionnaires. For the usual care group: a question about race was not included in the baseline survey unintentionally, therefore this information was not captured.
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=18 Participants • Not all enrolled participants completed all intake questionnaires. For the usual care group: a question about race was not included in the baseline survey unintentionally, therefore this information was not captured.
|
0 Participants
n=29 Participants • Not all enrolled participants completed all intake questionnaires. For the usual care group: a question about race was not included in the baseline survey unintentionally, therefore this information was not captured.
|
2 Participants
n=57 Participants • Not all enrolled participants completed all intake questionnaires. For the usual care group: a question about race was not included in the baseline survey unintentionally, therefore this information was not captured.
|
2 Participants
n=104 Participants • Not all enrolled participants completed all intake questionnaires. For the usual care group: a question about race was not included in the baseline survey unintentionally, therefore this information was not captured.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=18 Participants • Not all enrolled participants completed all intake questionnaires. For the usual care group: a question about race was not included in the baseline survey unintentionally, therefore this information was not captured.
|
0 Participants
n=29 Participants • Not all enrolled participants completed all intake questionnaires. For the usual care group: a question about race was not included in the baseline survey unintentionally, therefore this information was not captured.
|
0 Participants
n=57 Participants • Not all enrolled participants completed all intake questionnaires. For the usual care group: a question about race was not included in the baseline survey unintentionally, therefore this information was not captured.
|
0 Participants
n=104 Participants • Not all enrolled participants completed all intake questionnaires. For the usual care group: a question about race was not included in the baseline survey unintentionally, therefore this information was not captured.
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=18 Participants • Not all enrolled participants completed all intake questionnaires. For the usual care group: a question about race was not included in the baseline survey unintentionally, therefore this information was not captured.
|
0 Participants
n=29 Participants • Not all enrolled participants completed all intake questionnaires. For the usual care group: a question about race was not included in the baseline survey unintentionally, therefore this information was not captured.
|
0 Participants
n=57 Participants • Not all enrolled participants completed all intake questionnaires. For the usual care group: a question about race was not included in the baseline survey unintentionally, therefore this information was not captured.
|
0 Participants
n=104 Participants • Not all enrolled participants completed all intake questionnaires. For the usual care group: a question about race was not included in the baseline survey unintentionally, therefore this information was not captured.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=18 Participants • Not all enrolled participants completed all intake questionnaires. For the usual care group: a question about race was not included in the baseline survey unintentionally, therefore this information was not captured.
|
0 Participants
n=29 Participants • Not all enrolled participants completed all intake questionnaires. For the usual care group: a question about race was not included in the baseline survey unintentionally, therefore this information was not captured.
|
0 Participants
n=57 Participants • Not all enrolled participants completed all intake questionnaires. For the usual care group: a question about race was not included in the baseline survey unintentionally, therefore this information was not captured.
|
0 Participants
n=104 Participants • Not all enrolled participants completed all intake questionnaires. For the usual care group: a question about race was not included in the baseline survey unintentionally, therefore this information was not captured.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
18 Participants
n=18 Participants • Not all enrolled participants completed all intake questionnaires. For the usual care group: a question about race was not included in the baseline survey unintentionally, therefore this information was not captured.
|
6 Participants
n=29 Participants • Not all enrolled participants completed all intake questionnaires. For the usual care group: a question about race was not included in the baseline survey unintentionally, therefore this information was not captured.
|
8 Participants
n=57 Participants • Not all enrolled participants completed all intake questionnaires. For the usual care group: a question about race was not included in the baseline survey unintentionally, therefore this information was not captured.
|
32 Participants
n=104 Participants • Not all enrolled participants completed all intake questionnaires. For the usual care group: a question about race was not included in the baseline survey unintentionally, therefore this information was not captured.
|
PRIMARY outcome
Timeframe: Change from baseline to 8 weeks (post-intervention)Population: Minutes per day of moderate to vigorous physical activity (MVPA) over 7 days was compared from 8 weeks to baseline data. Participants need to have at least 4 days per week of wear time at each time point to be included.
Among survivors, compare changes in objective moderate-vigorous physical activity (MVPA) obtained from FitBits (continuous tracking) between intervention groups and usual care (FitEx-ECS vs. control and FitEx-ECS+yoga vs. control)
Outcome measures
| Measure |
Usual Care
n=16 Participants
Endometrial cancer survivors will receive standard survivorship care including a one-time educational newsletter about survivorship physical activity and nutrition recommendations. Fitbits will be given to track physical activity.
|
FitEx-ECS
n=8 Participants
Endometrial cancer survivors and their support team members (as a group of one survivor and their team) will complete the FitEx-ECS intervention program, with a focus on walking. Fitbits will be given to track physical activity.
Self-monitoring: Tracking physical activity and fruit/vegetable intake.
Group-dynamics: Survivors act as team captains, facilitating interactions between themselves and their support team members and providing goal directed feedback.
Weekly virtual sessions- Standard: Weekly 30 minute virtual sessions include support group/team building sessions and 15 minutes of physical activity.
Newsletters- Standard: Weekly newsletters support attainment of physical activity and nutrition goals.
|
FitEx-ECS+ Yoga
n=14 Participants
Endometrial cancer survivors and their support team members (as a group of one survivor and their team) will complete the FitEx-ECS+yoga intervention program, with a focus on postures, breathwork, and mindfulness. Fitbits will be given to track physical activity.
Self-monitoring: Tracking physical activity and fruit/vegetable intake.
Group-dynamics: Survivors act as team captains, facilitating interactions between themselves and their support team members and providing goal directed feedback.
Newsletters- Yoga: Weekly newsletters support attainment of physical activity and nutrition goals, while including mindfulness principles.
Weekly virtual sessions- Yoga: Weekly 30 minute virtual sessions include support group/team building sessions and 15 minutes of yoga.
|
|---|---|---|---|
|
Moderate to Vigorous Physical Activity of Endometrial Cancer Survivors
|
3.7 minutes per day of MVPA
Standard Deviation 26.4
|
12.14 minutes per day of MVPA
Standard Deviation 40.75
|
3.15 minutes per day of MVPA
Standard Deviation 25.5
|
SECONDARY outcome
Timeframe: Change from baseline to 8 weeks (post-intervention)Examine the change in quality of life (measured via Functional Assessment of Cancer Therapy - Endometrial (FACT-En)) between intervention and usual care conditions (FitEx-ECS versus control and FitEx-ECS+yoga versus control). Scoring: physical well-being (0-28), social well-being (0-28), emotional well-being (0-28), functional well-being (0-28), endometrial cancer sub-scale (0-64); higher scores indicate better quality of life
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from 8 weeks to 6 months (post-intervention)Examine the change in quality of life (measured via Functional Assessment of Cancer Therapy - Endometrial) between intervention and usual care conditions (FitEx-ECS versus control and FitEx-ECS+yoga versus control). Scoring: physical well-being (0-28), social well-being (0-28), emotional well-being (0-28), functional well-being (0-28), endometrial cancer sub-scale (0-64); higher scores indicate better quality of life
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from 8 weeks to 6 months (post-intervention)Examine the change in fruit/vegetable intake (measured via Behavioral Risk Factor Surveillance System (BRFSS F/V) survey) between intervention and usual care conditions (FitEx-ECS versus control and FitEx-ECS+yoga versus control).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from baseline to 8 weeks (post-intervention)Examine the change in fruit/vegetable intake (measured via Behavioral Risk Factor Surveillance System (BRFSS F/V) survey) between intervention and usual care conditions (FitEx-ECS versus control and FitEx-ECS+yoga versus control).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from baseline to 8 weeks (post-intervention)Examine the change in flourishing (measured via The Flourishing Index) between intervention and usual care conditions (FitEx-ECS versus control and FitEx-ECS+yoga versus control). Scoring: 0-10, with higher scores indication more satisfaction/flourishing
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from 8 weeks to 6 months (post-intervention)Examine the change in flourishing (measured via The Flourishing Index) between intervention and usual care conditions (FitEx-ECS versus control and FitEx-ECS+yoga versus control). Scoring: 0-10, with higher scores indication more satisfaction/flourishing
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from baseline to 8 weeks (post-intervention)Examine the change in yoga self-efficacy (measured via the Yoga Self-Efficacy Scale) between intervention and usual care conditions (FitEx-ECS versus control and FitEx-ECS+yoga versus control). Scoring: (12-108) higher scores indicate higher efficacy for yoga
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from 8 weeks to 6 months (post-intervention)Examine the change in yoga self-efficacy (measured via the Yoga Self-Efficacy Scale) between intervention and usual care conditions (FitEx-ECS versus control and FitEx-ECS+yoga versus control). Scoring: (12-108) higher scores indicate higher efficacy for yoga
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from baseline to 8 weeks (post-intervention)Examine the change in social support (measured via the Sallis Social Support for Exercise Survey) between intervention and usual care conditions (FitEx-ECS versus control and FitEx-ECS+yoga versus control). Scoring: higher numbers indicate more support
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from 8 weeks to 6 months (post-intervention)Examine the change in social support (measured via the Sallis Social Support for Exercise Survey) between intervention and usual care conditions (FitEx-ECS versus control and FitEx-ECS+yoga versus control). Scoring: higher numbers indicate more support
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from baseline to 8 weeks (post-intervention)Examine the change in self-compassion (measured via the Neff 12 item Self-Compassion Scale Short Form (SCS-SF) ) between intervention and usual care conditions (FitEx-ECS versus control and FitEx-ECS+yoga versus control). Scoring: (1, 5) with higher scores indicating more self-compassion
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from 8 weeks to 6 months (post-intervention)Examine the change in self-compassion (measured via the Neff 12 item Self-Compassion Scale Short Form (SCS-SF) ) between intervention and usual care conditions (FitEx-ECS versus control and FitEx-ECS+yoga versus control). Scoring: (1, 5) with higher scores indicating more self-compassion
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from baseline to 8 weeks (post-intervention)Examine the change in habit formation around exercise (measured via Self-Reported Behavior Automaticity Index) between intervention and usual care conditions (FitEx-ECS versus control and FitEx-ECS+yoga versus control). Scoring (1,7), higher scores indicate more automaticity/habit formation
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from 8 weeks to 6 months (post-intervention)Examine the change in habit formation around exercise (measured via Self-Reported Behavior Automaticity Index) between intervention and usual care conditions (FitEx-ECS versus control and FitEx-ECS+yoga versus control). Scoring (1,7), higher scores indicate more automaticity/habit formation
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from 8 weeks to 6 months (post-intervention)Examine the change in national physical activity goal attainment (measured via The Stanford Leisure-Time Activity Categorical Item (L-Cat)) between intervention and usual care conditions (FitEx-ECS versus control and FitEx-ECS+yoga versus control).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from baseline to 8 weeks (post-intervention)Examine the change in national physical activity goal attainment (measured via The Stanford Leisure-Time Activity Categorical Item (L-Cat)) between intervention and usual care conditions (FitEx-ECS versus control and FitEx-ECS+yoga versus control). Scoring: responses are categorical
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from 8 weeks to 6 months (post-intervention)Among survivors, compare changes in objective moderate-vigorous physical activity (MVPA) obtained from FitBits between intervention groups and usual care (FitEx-ECS vs. control and FitEx-ECS+yoga vs. control)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from baseline to 8 weeks (post-intervention)Among survivors, compare changes in objective moderate-vigorous physical activity (MVPA) obtained from FitBits between intervention groups (FitEx-ECS vs. FitEx-ECS+yoga)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from 8 weeks to 6 months (post-intervention)Among survivors, compare changes in objective moderate-vigorous physical activity (MVPA) obtained from FitBits between intervention groups (FitEx-ECS vs. FitEx-ECS+yoga)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from baseline to 8 weeks (post-intervention)Examine the change in flourishing (measured via The Flourishing Index) between intervention groups (FitEx-ECS vs. FitEx-ECS+yoga) Scoring: 0-10, with higher scores indication more satisfaction/flourishing
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from 8 weeks to 6 months (post-intervention)Examine the change in flourishing (measured via The Flourishing Index) between intervention groups (FitEx-ECS vs. FitEx-ECS+yoga) Scoring: 0-10, with higher scores indication more satisfaction/flourishing
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from baseline to 8 weeks (post-intervention)Examine the change in yoga self-efficacy (measured via the Yoga Self-Efficacy Scale) between intervention groups (FitEx-ECS vs. FitEx-ECS+yoga) Scoring: (12-108) higher scores indicate higher efficacy for yoga
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from 8 weeks to 6 months (post-intervention)Examine the change in yoga self-efficacy (measured via the Yoga Self-Efficacy Scale) between intervention groups (FitEx-ECS vs. FitEx-ECS+yoga) Scoring: (12-108) higher scores indicate higher efficacy for yoga
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from baseline to 8 weeks (post-intervention)Examine the change in social support (measured via the Sallis Social Support for Exercise Survey) between intervention groups (FitEx-ECS vs. FitEx-ECS+yoga) Scoring: higher numbers indicate more support
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from 8 weeks to 6 months (post-intervention)Examine the change in social support (measured via the Sallis Social Support for Exercise Survey) between intervention groups (FitEx-ECS vs. FitEx-ECS+yoga) Scoring: higher numbers indicate more support
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from baseline to 8 weeks (post-intervention)Examine the change in self-compassion (measured via the Neff 12 item Self-Compassion Scale Short Form (SCS-SF)) between intervention groups (FitEx-ECS vs. FitEx-ECS+yoga) Scoring: (1, 5) with higher scores indicating more self-compassion
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from 8 weeks to 6 months (post-intervention)Examine the change in self-compassion (measured via the Neff 12 item Self-Compassion Scale Short Form (SCS-SF)) between intervention groups (FitEx-ECS vs. FitEx-ECS+yoga) Scoring: (1, 5) with higher scores indicating more self-compassion
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from baseline to 8 weeks (post-intervention)Examine the change in habit formation around exercise (measured via Self-Reported Behavior Automaticity Index) between intervention groups (FitEx-ECS vs. FitEx-ECS+yoga) Scoring (1,7), higher scores indicate more automaticity/habit formation
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from baseline to 8 weeks (post-intervention)Examine the change in national physical activity goal attainment (measured via The Stanford Leisure-Time Activity Categorical Item (L-Cat)) between intervention groups (FitEx-ECS vs. FitEx-ECS+yoga)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from 8 weeks to 6 months (post-intervention)Examine the change in national physical activity goal attainment (measured via The Stanford Leisure-Time Activity Categorical Item (L-Cat)) between intervention groups (FitEx-ECS vs. FitEx-ECS+yoga)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from 8 weeks to 6 months (post-intervention)Examine the change in habit formation around exercise (measured via Self-Reported Behavior Automaticity Index) between intervention groups (FitEx-ECS vs. FitEx-ECS+yoga) Scoring (1,7), higher scores indicate more automaticity/habit formation
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from baseline to 8 weeks (post-intervention)Examine the change in fruit/vegetable intake (measured via Behavioral Risk Factor Surveillance System (BRFSS F/V) survey) between intervention groups (FitEx-ECS vs. FitEx-ECS+yoga)
Outcome measures
Outcome data not reported
Adverse Events
Usual Care
FitEx-ECS
FitEx-ECS+ Yoga
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Shannon Armbruster MD, MPH
Virginia Tech Carilion Clinic
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place