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| ID | Type | Description | Link |
|---|---|---|---|
| 5K23HL148017 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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This randomized controlled trial examines the feasibility, acceptability, and preliminary impact of an adapted positive psychology-motivational interviewing (PP-MI) intervention for physical activity among patients who have recently undergone bariatric surgery compared to an enhanced usual care control.
This study will test a positive psychology-motivational interviewing (PP-MI) intervention for physical activity promotion in patients who have had bariatric surgery within the past 6-12 months compared to an enhanced usual care control. The investigators will enroll and randomize 58 participants. Study participation includes attending four study visits (two at baseline, one at 10 weeks, and one at 24 weeks). Participants will be randomized either to a 10-week physical activity intervention that includes once-weekly phone calls, a written manual, and a Fitbit activity tracker, or provision of the Fitbit alone. Primary outcomes include the feasibility and acceptability of the intervention. Secondary outcomes include changes in physical activity and other psychological, behavioral, and physiological outcomes at 10 and 24 weeks compared to the control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Positive Psychology-Motivational Interviewing Intervention | Experimental | Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics. |
|
| Physical Activity Education Control | Active Comparator | Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Positive Psychology-Motivational Interviewing | Behavioral | Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Intervention Sessions Completed | Feasibility will be measured by examining the number of completed intervention sessions for individuals randomized to the PP-MI intervention. The intervention will be considered feasible if at least 7/10 sessions are completed, on average. | 10 weeks |
| Intervention Acceptability | After each of the 10 weekly intervention sessions, participants will rate that week's PP and goal-setting topics on how easy they were to complete and how helpful they were. Ratings will be measured on a 10-point Likert scale (1=very difficult/not at all helpful, 10=very easy/very helpful). Ratings for each category (e.g., ease of PP exercises) will be averaged across the 10 sessions to calculate a single value for that participant. The intervention will be considered acceptable if average ease and utility ratings are at least 7/10. | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Moderate to Vigorous Physical Activity (MVPA) | We will use ActiGraph GT3X-BT accelerometers to objectively measure physical activity for 1 week at each assessment. MVPA will be measured in minutes/week. | Baseline, 10-Week Follow-Up, 24-Week Follow-Up |
| Change in Steps |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emily H Feig, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36201380 | Derived | Feig EH, Harnedy LE, Thorndike AN, Psaros C, Healy BC, Huffman JC. A Positive Emotion-Focused Intervention to Increase Physical Activity After Bariatric Surgery: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2022 Oct 6;11(10):e39856. doi: 10.2196/39856. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Positive Psychology-Motivational Interviewing Intervention | Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics. Positive Psychology-Motivational Interviewing: Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics. |
| FG001 | Physical Activity Education Control | Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist. Physical Activity Education Control: Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Positive Psychology-Motivational Interviewing Intervention | Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics. Positive Psychology-Motivational Interviewing: Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics. |
| 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 | Number of Intervention Sessions Completed | Feasibility will be measured by examining the number of completed intervention sessions for individuals randomized to the PP-MI intervention. The intervention will be considered feasible if at least 7/10 sessions are completed, on average. | Posted | Mean | Standard Deviation | Sessions completed | 10 weeks |
|
Adverse events were reported from enrollment until the end of follow-up, up to 32 weeks.
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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 | Positive Psychology-Motivational Interviewing Intervention | Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics. Positive Psychology-Motivational Interviewing: Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain and constipation | Gastrointestinal disorders | CTCAE-5 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall, fracture | Injury, poisoning and procedural complications | CTCAE-5 | Systematic Assessment | Patient reported falling down stairs and fracturing her foot. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Emily Feig | Massachusetts General Hospital | 617-724-9140 | efeig@mgh.harvard.edu |
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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 | Jun 14, 2024 | Feb 2, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 13, 2025 | Feb 27, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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A research assistant blinded to study condition will conduct follow-up assessment visits.
|
| Physical Activity Education Control | Behavioral | Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist. |
|
Measured by Actigraph accelerometer, in number of steps per day. |
| Baseline, 10-Week Follow-Up, 24-Week Follow-Up |
| Change in Light Physical Activity | Measured by Actigraph accelerometer, in minutes per day. | Baseline, 10-Week Follow-Up, 24-Week Follow-Up |
| Change in Positive Affect | The positive affect items on the Positive and Negative Affect Schedule (PANAS), a well-validated scale used in other intervention trials and in patients with medical illnesses, will be used to measure positive affect (Range: 10-50). Higher scores indicate higher levels of positive affect. | Baseline, 10-Week Follow-Up, 24-Week Follow-Up |
| Change in Optimism | The Life Orientation Test-Revised (LOT-R) is a well-validated 6-item instrument used to measure dispositional optimism (Range: 0-24). Higher scores indicate higher levels of optimism. | Baseline, 10-Week Follow-Up, 24-Week Follow-Up |
| Change in Depressive Symptoms | The Hospital Anxiety and Depression Scale (HADS)-depression subscale will be used to measure depression. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients (Range: 0-21). Higher scores indicate higher levels of depression. | Baseline, 10-Week Follow-Up, 24-Week Follow-Up |
| Change in Anxiety | The Hospital Anxiety and Depression Scale (HADS)-anxiety subscale will be used to measure anxiety. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients (Range: 0-21). Higher scores indicate higher levels of anxiety. | Baseline, 10-Week Follow-Up, 24-Week Follow-Up |
| Change in Exercise Identity | The Exercise Identity Scale (EIS) is a well-validated, 9-item measure that will be used to assess exercise identity (Range: 9-63). Higher scores indicate stronger exercise identity. | Baseline, 10-Week Follow-Up, 24-Week Follow-Up |
| Change in General Self-Efficacy | Self-efficacy will be measured using the General Self Efficacy scale (GSE), a validated measure of self-efficacy, given its links to improved adherence. The range for total scores is 10-40 with higher scores indicate greater self-efficacy. Mean total scores are reported. | Baseline, 10-Week Follow-Up, 24-Week Follow-Up |
| Change in Exercise-specific Self-efficacy | Exercise-specific self-efficacy will be measured by the Self-Efficacy for Exercise scale (SEE), a validated scale which assesses self-efficacy for exercise (Range: 0-90). Higher scores indicate higher self-efficacy. | Baseline, 10-Week Follow-Up, 24-Week Follow-Up |
| Change in Internalized Weight Bias | The Weight Bias Internalization Scale - Modified (WBIS-M) is a well-validated, 11-item measure that will be used to measure internalized weight bias (Range: 1-7). Higher scores indicate greater internalized weight bias. | Baseline, 10-Week Follow-Up, 24-Week Follow-Up |
| Change in Bariatric Surgery-specific Diet and Vitamin Adherence | The Bariatric Surgery Self-Management Questionnaire (BSSQ) is a validated measure that will be used to assess adherence to diet and vitamin recommendations after bariatric surgery. The range of scores is 0-66 with higher scores indicating better adherence to diet and vitamin recommendations. Mean total scores are reported. | Baseline, 10-Week Follow-Up, 24-Week Follow-Up |
| Change in Self-Reported Physical Activity | The International Physical Activity Questionnaire (IPAQ) - Short Form is a well-validated 7-day physical activity recall assessment for physical activity. Activity will be measured by the number of MET-minutes of moderate or greater activity per week. | Baseline, 10-Week Follow-Up, 24-Week Follow-Up |
| Change in Body Mass Index | Body mass index (kilograms/meters squared) will be calculated with body weight and height measured on a calibrated scale. | Baseline, 10-Week Follow-Up, 24-Week Follow-Up |
| Change in Systolic Blood Pressure (Millimeters of Mercury) | Blood pressure will be measured by a nurse. | Baseline, 10-Week Follow-Up, 24-Week Follow-Up |
| Change in Aerobic Capacity and Endurance | The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. | Baseline, 10-Week Follow-Up, 24-Week Follow-Up |
| Change in Body Composition | The measurement of body fat in relation to lean body mass will be measured using bio-electrical impedance. | Baseline, 10-Week Follow-Up, 24-Week Follow-Up |
| Change in A1C | Hemoglobin A1C will be measured via blood draw. | Baseline, 10-Week Follow-Up, 24-Week Follow-Up |
| Change in HDL Cholesterol | Lipids (HDL, LDL, Triglyceride) will be measured via blood draw. | Baseline, 10-Week Follow-Up, 24-Week Follow-Up |
| Change in Inflammation | C-reactive protein will be measured via blood draw as a measure of inflammation. | Baseline, 10-Week Follow-Up, 24-Week Follow-Up |
| Change in Physical Activity Enjoyment | Self-efficacy will be measured using the Physical Activity Enjoyment Scale (PACES), a validated measure of enjoyment during exercise. The range of total scores is 18-126 with higher scores indicating greater enjoyment during exercise. Mean total scores are reported. | Baseline, 10-Week Follow-Up, 24-Week Follow-Up |
| Change in Diastolic Blood Pressure (Millimeters of Mercury) | Blood pressure will be measured by a nurse. | Baseline, 10-Week Follow-Up, 24-Week Follow-Up |
| Change in LDL Cholesterol | Lipids (HDL, LDL, Triglyceride) will be measured via blood draw. | Baseline, 10-Week Follow-Up, 24-Week Follow-Up |
| Change in Triglycerides | Lipids (HDL, LDL, Triglyceride) will be measured via blood draw. | Baseline, 10-Week Follow-Up, 24-Week Follow-Up |
| Withdrawal by Subject |
|
| BG001 | Physical Activity Education Control | Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist. Physical Activity Education Control: Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist. |
| 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 | Count of Participants | Participants |
|
|
|
| Primary | Intervention Acceptability | After each of the 10 weekly intervention sessions, participants will rate that week's PP and goal-setting topics on how easy they were to complete and how helpful they were. Ratings will be measured on a 10-point Likert scale (1=very difficult/not at all helpful, 10=very easy/very helpful). Ratings for each category (e.g., ease of PP exercises) will be averaged across the 10 sessions to calculate a single value for that participant. The intervention will be considered acceptable if average ease and utility ratings are at least 7/10. | Posted | Mean | Standard Deviation | Scores on a scale | 10 weeks |
|
|
|
| Secondary | Change in Moderate to Vigorous Physical Activity (MVPA) | We will use ActiGraph GT3X-BT accelerometers to objectively measure physical activity for 1 week at each assessment. MVPA will be measured in minutes/week. | Number analyzed reflects the number of participants who provided data at the corresponding time point. | Posted | Mean | Standard Deviation | minutes/week | Baseline, 10-Week Follow-Up, 24-Week Follow-Up |
|
|
|
| Secondary | Change in Steps | Measured by Actigraph accelerometer, in number of steps per day. | Number analyzed reflects the number of participants who provided data at the corresponding time point. | Posted | Mean | Standard Deviation | steps/day | Baseline, 10-Week Follow-Up, 24-Week Follow-Up |
|
|
|
| Secondary | Change in Light Physical Activity | Measured by Actigraph accelerometer, in minutes per day. | Number analyzed reflects the number of participants who provided data at the corresponding time point. | Posted | Mean | Standard Deviation | minutes/day | Baseline, 10-Week Follow-Up, 24-Week Follow-Up |
|
|
|
| Secondary | Change in Positive Affect | The positive affect items on the Positive and Negative Affect Schedule (PANAS), a well-validated scale used in other intervention trials and in patients with medical illnesses, will be used to measure positive affect (Range: 10-50). Higher scores indicate higher levels of positive affect. | Number analyzed reflects the number of participants who provided data at the corresponding time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 10-Week Follow-Up, 24-Week Follow-Up |
|
|
|
| Secondary | Change in Optimism | The Life Orientation Test-Revised (LOT-R) is a well-validated 6-item instrument used to measure dispositional optimism (Range: 0-24). Higher scores indicate higher levels of optimism. | Number analyzed reflects the number of participants who provided data at the corresponding time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 10-Week Follow-Up, 24-Week Follow-Up |
|
|
|
| Secondary | Change in Depressive Symptoms | The Hospital Anxiety and Depression Scale (HADS)-depression subscale will be used to measure depression. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients (Range: 0-21). Higher scores indicate higher levels of depression. | Number analyzed reflects the number of participants who provided data at the corresponding time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 10-Week Follow-Up, 24-Week Follow-Up |
|
|
|
| Secondary | Change in Anxiety | The Hospital Anxiety and Depression Scale (HADS)-anxiety subscale will be used to measure anxiety. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients (Range: 0-21). Higher scores indicate higher levels of anxiety. | Number analyzed reflects the number of participants who provided data at the corresponding time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 10-Week Follow-Up, 24-Week Follow-Up |
|
|
|
| Secondary | Change in Exercise Identity | The Exercise Identity Scale (EIS) is a well-validated, 9-item measure that will be used to assess exercise identity (Range: 9-63). Higher scores indicate stronger exercise identity. | Number analyzed reflects the number of participants who provided data at the corresponding time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 10-Week Follow-Up, 24-Week Follow-Up |
|
|
|
| Secondary | Change in General Self-Efficacy | Self-efficacy will be measured using the General Self Efficacy scale (GSE), a validated measure of self-efficacy, given its links to improved adherence. The range for total scores is 10-40 with higher scores indicate greater self-efficacy. Mean total scores are reported. | Number analyzed reflects the number of participants who provided data at the corresponding time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 10-Week Follow-Up, 24-Week Follow-Up |
|
|
|
| Secondary | Change in Exercise-specific Self-efficacy | Exercise-specific self-efficacy will be measured by the Self-Efficacy for Exercise scale (SEE), a validated scale which assesses self-efficacy for exercise (Range: 0-90). Higher scores indicate higher self-efficacy. | Number analyzed reflects the number of participants who provided data at the corresponding time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 10-Week Follow-Up, 24-Week Follow-Up |
|
|
|
| Secondary | Change in Internalized Weight Bias | The Weight Bias Internalization Scale - Modified (WBIS-M) is a well-validated, 11-item measure that will be used to measure internalized weight bias (Range: 1-7). Higher scores indicate greater internalized weight bias. | Number analyzed reflects the number of participants who provided data at the corresponding time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 10-Week Follow-Up, 24-Week Follow-Up |
|
|
|
| Secondary | Change in Bariatric Surgery-specific Diet and Vitamin Adherence | The Bariatric Surgery Self-Management Questionnaire (BSSQ) is a validated measure that will be used to assess adherence to diet and vitamin recommendations after bariatric surgery. The range of scores is 0-66 with higher scores indicating better adherence to diet and vitamin recommendations. Mean total scores are reported. | Number analyzed reflects the number of participants who provided data at the corresponding time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 10-Week Follow-Up, 24-Week Follow-Up |
|
|
|
| Secondary | Change in Self-Reported Physical Activity | The International Physical Activity Questionnaire (IPAQ) - Short Form is a well-validated 7-day physical activity recall assessment for physical activity. Activity will be measured by the number of MET-minutes of moderate or greater activity per week. | Number analyzed reflects the number of participants who provided data at the corresponding time point. | Posted | Mean | Standard Deviation | minutes/week | Baseline, 10-Week Follow-Up, 24-Week Follow-Up |
|
|
|
| Secondary | Change in Body Mass Index | Body mass index (kilograms/meters squared) will be calculated with body weight and height measured on a calibrated scale. | Number analyzed reflects the number of participants who provided data at the corresponding time point. | Posted | Mean | Standard Deviation | Unit of Measure (kg/m^2) | Baseline, 10-Week Follow-Up, 24-Week Follow-Up |
|
|
|
| Secondary | Change in Systolic Blood Pressure (Millimeters of Mercury) | Blood pressure will be measured by a nurse. | Number analyzed reflects the number of participants who provided data at the corresponding time point. | Posted | Mean | Standard Deviation | millimeters of mercury (mm Hg) | Baseline, 10-Week Follow-Up, 24-Week Follow-Up |
|
|
|
| Secondary | Change in Aerobic Capacity and Endurance | The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. | Number analyzed reflects the number of participants who provided data at the corresponding time point. | Posted | Mean | Standard Deviation | meters | Baseline, 10-Week Follow-Up, 24-Week Follow-Up |
|
|
|
| Secondary | Change in Body Composition | The measurement of body fat in relation to lean body mass will be measured using bio-electrical impedance. | Number analyzed reflects the number of participants who provided data at the corresponding time point. | Posted | Mean | Standard Deviation | percentage of body fat | Baseline, 10-Week Follow-Up, 24-Week Follow-Up |
|
|
|
| Secondary | Change in A1C | Hemoglobin A1C will be measured via blood draw. | Number analyzed reflects the number of participants who provided data at the corresponding time point. | Posted | Mean | Standard Deviation | percentage of glycated hemoglobin | Baseline, 10-Week Follow-Up, 24-Week Follow-Up |
|
|
|
| Secondary | Change in HDL Cholesterol | Lipids (HDL, LDL, Triglyceride) will be measured via blood draw. | Number analyzed reflects the number of participants who provided data at the corresponding time point. | Posted | Mean | Standard Deviation | Milligrams (mg) per deciliter (dL) | Baseline, 10-Week Follow-Up, 24-Week Follow-Up |
|
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|
| Secondary | Change in Inflammation | C-reactive protein will be measured via blood draw as a measure of inflammation. | Number analyzed reflects the number of participants who provided data at the corresponding time point. | Posted | Mean | Standard Deviation | Milligrams per deciliter (mg/dL) | Baseline, 10-Week Follow-Up, 24-Week Follow-Up |
|
|
|
| Secondary | Change in Physical Activity Enjoyment | Self-efficacy will be measured using the Physical Activity Enjoyment Scale (PACES), a validated measure of enjoyment during exercise. The range of total scores is 18-126 with higher scores indicating greater enjoyment during exercise. Mean total scores are reported. | Number analyzed reflects the number of participants who provided data at the corresponding time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 10-Week Follow-Up, 24-Week Follow-Up |
|
|
|
| Secondary | Change in Diastolic Blood Pressure (Millimeters of Mercury) | Blood pressure will be measured by a nurse. | Number analyzed reflects the number of participants who provided data at the corresponding time point. | Posted | Mean | Standard Deviation | millimeters of mercury (mm Hg) | Baseline, 10-Week Follow-Up, 24-Week Follow-Up |
|
|
|
| Secondary | Change in LDL Cholesterol | Lipids (HDL, LDL, Triglyceride) will be measured via blood draw. | Number analyzed reflects the number of participants who provided data at the corresponding time point. | Posted | Mean | Standard Deviation | Milligrams (mg) per deciliter (dL) | Baseline, 10-Week Follow-Up, 24-Week Follow-Up |
|
|
|
| Secondary | Change in Triglycerides | Lipids (HDL, LDL, Triglyceride) will be measured via blood draw. | Number analyzed reflects the number of participants who provided data at the corresponding time point. | Posted | Mean | Standard Deviation | Milligrams (mg) per deciliter (dL) | Baseline, 10-Week Follow-Up, 24-Week Follow-Up |
|
|
|
| 1 |
| 29 |
| 2 |
| 29 |
| 1 |
| 29 |
| EG001 | Physical Activity Education Control | Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist. Physical Activity Education Control: Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist. | 0 | 29 | 0 | 29 | 3 | 29 |
| Cancer | General disorders | CTCAE-5 | Systematic Assessment | Patient reported being diagnosed with cancer. |
|
|
| Muscle sprain, joint injury | Injury, poisoning and procedural complications | CTCAE-5 | Systematic Assessment | Participant reported hurting her arm and shoulder. |
|
| Reproductive system and breast disorders (Other) | Reproductive system and breast disorders | CTCAE-5 | Systematic Assessment | Patient reported finding a lump in her breast. |
|
| Presyncope | Nervous system disorders | CTCAE-5 | Systematic Assessment | Patient reported feeling faint during blood draw. |
|
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| Title | Measurements |
|---|---|
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| Goal Setting Topics Utility |
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| 10-Week Follow-Up |
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| 24-Week Follow-Up |
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| 10-Week Follow-Up |
|
|
| 24-Week Follow-Up |
|
|
| 10-Week Follow-Up |
|
|
| 24-Week Follow-Up |
|
|