TriangleNCT04000880 · OUTCOME
Levels of Stress (Patient Reported Outcome)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- score on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- Pre-intervention (Baseline), 12-month post-intervention
What was measured
Participants complete the 14-item Perceived Stress Scale (PSS-14), a validated self-report instrument that measures the degree to which individuals perceive their lives as unpredictable, uncontrollable, and overloaded over the past month. Each item is rated on a 5-point scale (0 = never to 4 = very often). Positively stated items are reverse scored, and item responses are summed to generate a raw total score (range: 0 to 56). The outcome measure is a T-score calculated using standard normalization procedures. Range = 0 to 100. Higher T-scores indicate greater perceived stress (worse outcome).
Analysis population: The number of participants analyzed differ between baseline and 12 months due to withdrawal by participant or loss to follow up.
Groups in this outcome
Project 1: Diet-Exercise
Participants will receive and participate in web-based sessions that focus on diet for 6 months, followed by exercise for another 6 months. Participants will be encouraged to track their diet and weight for the first 6 months and to log their data in the intervention website, during the second 6 months they will be asked to log their physical activity data (minutes and step counts). Tailored feedback and goal recommendations will be provided through the website. Participants will also receive access to resources for relevant behavioral topics. All participants will be invited to participate in the secret Facebook group for the project (though participation is optional).
Project 2: Exercise-Diet
Participants will receive and participate in web-based sessions that focus on diet for 6 months, followed by exercise for another 6 months. Participants will be encouraged to track their diet and weight for the first 6 months and to log their data in the intervention website, during the second 6 months they will be asked to log their physical activity data (minutes and step counts). Tailored feedback and goal recommendations will be provided through the website. Participants will also receive access to resources for relevant behavioral topics. All participants will be invited to participate in the secret Facebook group for the project (though participation is optional).
Project 3: Combined Diet and Exercise
Participants will receive the diet and exercise content simultaneously in combined web-based sessions. Participants will receive and participate in web-based sessions that focus on diet and exercise for 12 months. Participants will be encouraged to track their diet, weight and physical activity data (minutes and step counts). Tailored feedback and goal recommendations will be provided through the website. Participants will also receive access to resources for relevant behavioral topics. All participants will be invited to participate in the secret Facebook group for the project (though participation is optional).
| Group | Source count |
|---|---|
| Project 1: Diet-Exercise | 144 |
| Project 2: Exercise-Diet | 142 |
| Project 3: Combined Diet and Exercise | 221 |
Reported measurements
Pre-intervention (Baseline)
| Group | Source count |
|---|---|
| Project 1: Diet-Exercise | 144 |
| Project 2: Exercise-Diet | 142 |
| Project 3: Combined Diet and Exercise | 221 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Project 1: Diet-Exercise | 50.44 | 9.38 | Not reported | Not reported | Not reported |
| Project 2: Exercise-Diet | 50.76 | 9.43 | Not reported | Not reported | Not reported |
| Project 3: Combined Diet and Exercise | 50.49 | 10.20 | Not reported | Not reported | Not reported |
12-month post-intervention
| Group | Source count |
|---|---|
| Project 1: Diet-Exercise | 67 |
| Project 2: Exercise-Diet | 64 |
| Project 3: Combined Diet and Exercise | 114 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Project 1: Diet-Exercise | 48.07 | 11.86 | Not reported | Not reported | Not reported |
| Project 2: Exercise-Diet | 48.97 | 9.20 | Not reported | Not reported | Not reported |
| Project 3: Combined Diet and Exercise | 49.80 | 8.53 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 9.38
- value
- 50.44
- group Id
- OG001
- spread
- 9.43
- value
- 50.76
- group Id
- OG002
- spread
- 10.20
- value
- 50.49
- denoms
- counts
- group Id
- OG000
- value
- 144
- group Id
- OG001
- value
- 142
- group Id
- OG002
- value
- 221
- units
- Participants
- title
- Pre-intervention (Baseline)
- categories
- measurements
- group Id
- OG000
- spread
- 11.86
- value
- 48.07
- group Id
- OG001
- spread
- 9.20
- value
- 48.97
- group Id
- OG002
- spread
- 8.53
- value
- 49.80
- denoms
- counts
- group Id
- OG000
- value
- 67
- group Id
- OG001
- value
- 64
- group Id
- OG002
- value
- 114
- units
- Participants
- title
- 12-month post-intervention
- denoms
- counts
- group Id
- OG000
- value
- 144
- group Id
- OG001
- value
- 142
- group Id
- OG002
- value
- 221
- units
- Participants
- description
- Participants complete the 14-item Perceived Stress Scale (PSS-14), a validated self-report instrument that measures the degree to which individuals perceive their lives as unpredictable, uncontrollable, and overloaded over the past month. Each item is rated on a 5-point scale (0 = never to 4 = very often). Positively stated items are reverse scored, and item responses are summed to generate a raw total score (range: 0 to 56). The outcome measure is a T-score calculated using standard normalization procedures. Range = 0 to 100. Higher T-scores indicate greater perceived stress (worse outcome).
- dispersion Type
- Standard Deviation
- groups
- description
- Participants will receive and participate in web-based sessions that focus on diet for 6 months, followed by exercise for another 6 months. Participants will be encouraged to track their diet and weight for the first 6 months and to log their data in the intervention website, during the second 6 months they will be asked to log their physical activity data (minutes and step counts). Tailored feedback and goal recommendations will be provided through the website. Participants will also receive access to resources for relevant behavioral topics. All participants will be invited to participate in the secret Facebook group for the project (though participation is optional).
- id
- OG000
- title
- Project 1: Diet-Exercise
- description
- Participants will receive and participate in web-based sessions that focus on diet for 6 months, followed by exercise for another 6 months. Participants will be encouraged to track their diet and weight for the first 6 months and to log their data in the intervention website, during the second 6 months they will be asked to log their physical activity data (minutes and step counts). Tailored feedback and goal recommendations will be provided through the website. Participants will also receive access to resources for relevant behavioral topics. All participants will be invited to participate in the secret Facebook group for the project (though participation is optional).
- id
- OG001
- title
- Project 2: Exercise-Diet
- description
- Participants will receive the diet and exercise content simultaneously in combined web-based sessions. Participants will receive and participate in web-based sessions that focus on diet and exercise for 12 months. Participants will be encouraged to track their diet, weight and physical activity data (minutes and step counts). Tailored feedback and goal recommendations will be provided through the website. Participants will also receive access to resources for relevant behavioral topics. All participants will be invited to participate in the secret Facebook group for the project (though participation is optional).
- id
- OG002
- title
- Project 3: Combined Diet and Exercise
- param Type
- MEAN
- population Description
- The number of participants analyzed differ between baseline and 12 months due to withdrawal by participant or loss to follow up.
- reporting Status
- POSTED
- time Frame
- Pre-intervention (Baseline), 12-month post-intervention
- title
- Levels of Stress (Patient Reported Outcome)
- type
- OTHER_PRE_SPECIFIED
- unit Of Measure
- score on a scale
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice