Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Other |
Number of patients with 5% weight loss (in FAST-BWL) |
To assess the proportion of women in the FAST-BWL arm who maintain =5% weight loss at 6 months. |
6 months |
|
| Other |
Number of participants with AA genotype and 5% weight loss |
To assess prevalence of AA genotype of MnSOD in breast cancer survivors with excess weight and if a greater proportion of women with the AA genotype achieve =5% weight loss and improvement in biomarkers at 6 months compared to the women who do not. |
6 months |
|
| Other |
Number of participants with AA genotype and Contrave |
To determine if women who display the AA genotype of MnSOD and undergo addition of Contrave to BWL have greater weight loss compared to women who do not receive Contrave. |
6 months |
|
| Primary |
Number of patients with 5 percent weight loss (in SLOW-BWL) |
To assess the rate of SLOW-BWL patients attaining at least 5% weight loss of their baseline body weight at 6 months with the addition of Contrave to BWL at week 9. |
6 months |
|
| Secondary |
Change in HbA1c levels among SLOW-BWL participants who achieve =5% weight loss |
To compare HbA1c (%) levels at 2 and 6 months to baseline levels among SLOW-BWL who achieve =5% weight loss. |
Baseline, 2 months and 6 Months |
|
| Secondary |
Change in HbA1c levels among SLOW-BWL women who achieve =5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss |
To compare HbA1c (%) levels at 2 and 6 months to baseline levels among SLOW-BWL women who achieve =5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss. |
Baseline, 2 months and 6 Months |
|
| Secondary |
Change in HbA1c levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve =5% weight loss at 6 months vs those who are unable to |
To compare HbA1c (%) levels at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve =5% weight loss at 6 months vs those who are unable to. |
Baseline, 2 months and 6 Months |
|
| Secondary |
Change in IGF1 levels among SLOW-BWL participants who achieve =5% weight loss |
To compare Insulin-like growth factor 1 (IGF1) (ng/mL) levels at 2 and 6 months to baseline levels among SLOW-BWL who achieve =5% weight loss. |
Baseline, 2 months and 6 Months |
|
| Secondary |
Change in IGF1 levels among SLOW-BWL women who achieve =5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss |
To compare IGF1 (ng/mL) levels at 2 and 6 months to baseline levels among SLOW-BWL women who achieve =5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss |
Baseline, 2 months and 6 Months |
|
| Secondary |
Change in IGF1 levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve =5% weight loss at 6 months vs those who are unable to |
To compare IGF1 (ng/mL) levels at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve =5% weight loss at 6 months vs those who are unable to. |
Baseline, 2 months and 6 Months |
|
| Secondary |
Change in Fasting glucose levels among SLOW-BWL participants who achieve =5% weight loss |
To compare fasting glucose (mg/dL) levels at 2 and 6 months to baseline levels among SLOW-BWL who achieve =5% weight loss. |
Baseline, 2 months and 6 Months |
|
| Secondary |
Change in Fasting glucose levels among SLOW-BWL women who achieve =5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss |
To compare fasting glucose (mg/dL) levels at 2 and 6 months to baseline levels among SLOW-BWL women who achieve =5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss. |
Baseline, 2 months and 6 Months |
|
| Secondary |
Change in Fasting glucose levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve =5% weight loss at 6 months vs those who are unable to |
To compare fasting glucose (mg/dL) levels at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve =5% weight loss at 6 months vs those who are unable to. |
Baseline, 2 months and 6 Months |
|
| Secondary |
Change in Fasting lipids levels among SLOW-BWL participants who achieve =5% weight loss |
To compare fasting lipids (mg/dL) levels at 2 and 6 months to baseline levels among SLOW-BWL who achieve =5% weight loss. |
Baseline, 2 months and 6 Months |
|
| Secondary |
Change in Fasting lipids levels among SLOW-BWL women who achieve =5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss |
To compare fasting lipids (mg/dL) levels at 2 and 6 months to baseline levels among SLOW-BWL women who achieve =5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss. |
Baseline, 2 months and 6 Months |
|
| Secondary |
Change in Fasting lipids levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve =5% weight loss at 6 months vs those who are unable to |
To compare fasting lipids (mg/dL) levels at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve =5% weight loss at 6 months vs those who are unable to. |
6 Months |
|
| Secondary |
Change in Fasting insulin levels among SLOW-BWL participants who achieve =5% weight loss |
To compare fasting insulin (mIU/L) levels at 2 and 6 months to baseline levels among SLOW-BWL who achieve =5% weight loss. |
Baseline, 2 months and 6 Months |
|
| Secondary |
Change in Fasting insulin levels among SLOW-BWL women who achieve =5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss |
To compare fasting insulin (mIU/L) levels at 2 and 6 months to baseline levels among SLOW-BWL women who achieve =5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss. |
Baseline, 2 months and 6 Months |
|
| Secondary |
Change in Fasting insulin levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve =5% weight loss at 6 months vs those who are unable to |
To compare fasting insulin (mIU/L) levels at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve =5% weight loss at 6 months vs those who are unable to. |
Baseline, 2 months and 6 Months |
|
| Secondary |
Change in Adiponectin levels among SLOW-BWL women who achieve =5% weight loss |
To compare adiponectin (ng/mL) levels at 2 and 6 months to baseline levels among SLOW-BWL who achieve =5% weight loss. |
Baseline, 2 months and 6 Months |
|
| Secondary |
Change in Adiponectin levels among SLOW-BWL women who achieve =5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss |
To compare adiponectin (ng/mL) levels at 2 and 6 months to baseline levels among SLOW-BWL women who achieve =5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss. |
Baseline, 2 months and 6 Months |
|
| Secondary |
Change in Adiponectin levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve =5% weight loss at 6 months vs those who are unable to |
To compare adiponectin (ng/mL) levels at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve =5% weight loss at 6 months vs those who are unable to. |
Baseline, 2 months and 6 Months |
|
| Secondary |
Change in Leptin levels among SLOW-BWL participants who achieve =5% weight loss |
To compare leptin (ng/mL) levels at 2 and 6 months to baseline levels among SLOW-BWL who achieve =5% weight loss. |
Baseline, 2 months and 6 Months |
|
| Secondary |
Change in Leptin levels among SLOW-BWL women who achieve =5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss |
To compare leptin (ng/mL) levels at 2 and 6 months to baseline levels among SLOW-BWL women who achieve =5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss. |
Baseline, 2 months and 6 Months |
|
| Secondary |
Change in Leptin levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve =5% weight loss at 6 months vs those who are unable to |
To compare leptin (ng/mL) levels at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve =5% weight loss at 6 months vs those who are unable to |
Baseline, 2 months and 6 Months |
|
| Secondary |
Change in Microbiome composition among SLOW-BWL participants who achieve =5% weight loss |
To compare microbiome composition (ratio of bacteroides and firmacutes) at 2 and 6 months to baseline levels among SLOW-BWL who achieve =5% weight loss. |
Baseline, 2 months and 6 Months |
|
| Secondary |
Change in Microbiome composition among SLOW-BWL women who achieve =5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss |
To compare microbiome composition (ratio of bacteroides and firmacutes) at 2 and 6 months to baseline levels among SLOW-BWL women who achieve =5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss. |
Baseline, 2 months and 6 Months |
|
| Secondary |
Change in Microbiome composition among FAST-BWL vs SLOW-BWL, as well as participants who achieve =5% weight loss at 6 months vs those who are unable to |
To compare microbiome composition (ratio of bacteroides and firmacutes) at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve =5% weight loss at 6 months vs those who are unable to. |
Baseline, 2 months and 6 Months |
|
| Secondary |
Change in Scores on Godin Leisure-Time Exercise questionnaire among SLOW-BWL participants who achieve =5% weight loss |
To compare Godin (score range start from 0 with no upper limit but higher scores indicate more exercise) scores at 2 and 6 months to baseline levels among SLOW-BWL who achieve =5% weight loss. |
Baseline, 2 months and 6 Months |
|
| Secondary |
Change in Scores on Godin Leisure-Time Exercise questionnaire among SLOW-BWL women who achieve =5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss |
To compare Godin (score range start from 0 with no upper limit but higher scores indicate more exercise) scores at 2 and 6 months to baseline levels among SLOW-BWL women who achieve =5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss. |
Baseline, 2 months and 6 Months |
|
| Secondary |
Change in Scores on Godin Leisure-Time Exercise questionnaire among FAST-BWL vs SLOW-BWL, as well as participants who achieve =5% weight loss at 6 months vs those who are unable to |
To compare Godin (score range start from 0 with no upper limit but higher scores indicate more exercise) scores at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve =5% weight loss at 6 months vs those who are unable to. |
Baseline, 2 months and 6 Months |
|
| Secondary |
Change in Scores on Pittsburgh Sleep Quality Index (PSQI) questionnaire among SLOW-BWL participants who achieve =5% weight loss |
To compare PSQI (scores range 0-21 with higher scores indicating poorer sleep) scores at 2 and 6 months to baseline levels among SLOW-BWL who achieve =5% weight loss. |
Baseline, 2 months and 6 Months |
|
| Secondary |
Change in Scores on Pittsburgh Sleep Quality Index (PSQI) questionnaire among SLOW-BWL women who achieve =5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss |
To compare PSQI (scores range 0-21 with higher scores indicating poorer sleep) scores at 2 and 6 months to baseline levels among SLOW-BWL women who achieve =5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss. |
Baseline, 2 months and 6 Months |
|
| Secondary |
Change in Scores on Pittsburgh Sleep Quality Index (PSQI) questionnaire among FAST-BWL vs SLOW-BWL, as well as participants who achieve =5% weight loss at 6 months vs those who are unable to |
To compare PSQI (scores range 0-21 with higher scores indicating poorer sleep) scores at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve =5% weight loss at 6 months vs those who are unable to. |
Baseline, 2 months and 6 Months |
|
| Secondary |
Change in Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function - Short Form questionnaire among SLOW-BWL participants who achieve =5% weight loss |
To compare Physical Function - Short Form (scores range 10-50 with higher scores indicating better physical functioning) scores at 2 and 6 months to baseline levels among SLOW-BWL who achieve =5% weight loss. |
Baseline, 2 months and 6 Months |
|
| Secondary |
Change in Scores on PROMIS Physical Function - Short Form questionnaire among SLOW-BWL women who achieve =5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss |
To compare Physical Function - Short Form (scores range 10-50 with higher scores indicating better physical functioning) scores at 2 and 6 months to baseline levels among SLOW-BWL women who achieve =5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss. |
Baseline, 2 months and 6 Months |
|
| Secondary |
Change in Scores on PROMIS Physical Function - Short Form questionnaire among FAST-BWL vs SLOW-BWL, as well as participants who achieve =5% weight loss at 6 months vs those who are unable to |
To compare Physical Function - Short Form (scores range 10-50 with higher scores indicating better physical functioning) scores at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve =5% weight loss at 6 months vs those who are unable to. |
Baseline, 2 months and 6 Months |
|
| Secondary |
Change in Scores on PROMIS Pain Interference - Short Form questionnaire among SLOW-BWL participants who achieve =5% weight loss |
To compare Pain Interference - Short Form (scores range 6-30 with lower scores indicating less pain interference) scores at 2 and 6 months to baseline levels among SLOW-BWL who achieve =5% weight loss. |
Baseline, 2 months and 6 Months |
|
| Secondary |
Change in Scores on PROMIS Pain Interference - Short Form questionnaire among SLOW-BWL women who achieve =5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss |
To compare Pain Interference - Short Form (scores range 6-30 with lower scores indicating less pain interference) scores at 2 and 6 months to baseline levels among SLOW-BWL women who achieve =5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss. |
Baseline, 2 months and 6 Months |
|
| Secondary |
Change in Scores on PROMIS Pain Interference - Short Form questionnaire among FAST-BWL vs SLOW-BWL, as well as participants who achieve =5% weight loss at 6 months vs those who are unable to |
To compare Pain Interference - Short Form (scores range 6-30 with lower scores indicating less pain interference) scores at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve =5% weight loss at 6 months vs those who are unable to. |
Baseline, 2 months and 6 Months |
|
| Secondary |
Change in Scores on PROMIS Fatigue - Short Form questionnaire among SLOW-BWL participants who achieve =5% weight loss |
To compare Fatigue - Short Form (scores range 7-35 with higher scores indicating more fatigue) scores at 2 and 6 months to baseline levels among SLOW-BWL who achieve =5% weight loss. |
Baseline, 2 months and 6 Months |
|
| Secondary |
Change in Scores on PROMIS Fatigue - Short Form questionnaire among SLOW-BWL women who achieve =5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss |
To compare Fatigue - Short Form (scores range 7-35 with higher scores indicating more fatigue) scores at 2 and 6 months to baseline levels among SLOW-BWL women who achieve =5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss. |
Baseline, 2 months and 6 Months |
|
| Secondary |
Change in Scores on PROMIS Fatigue - Short Form questionnaire among FAST-BWL vs SLOW-BWL, as well as participants who achieve =5% weight loss at 6 months vs those who are unable to |
To compare Fatigue - Short Form (scores range 7-35 with higher scores indicating more fatigue) scores at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve =5% weight loss at 6 months vs those who are unable to. |
Baseline, 2 months and 6 Months |
|
| Secondary |
Change in Scores on PROMIS Emotional Distress - Depression - Short Form questionnaire among SLOW-BWL participants who achieve =5% weight loss |
To compare Depression - Short Form (scores range 8-40 with lower scores indicating lower levels of depression) scores at 2 and 6 months to baseline levels among SLOW-BWL who achieve =5% weight loss. |
Baseline, 2 months and 6 Months |
|
| Secondary |
Change in Scores on PROMIS Emotional Distress - Depression - Short Form questionnaire among SLOW-BWL women who achieve =5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss |
To compare Depression - Short Form (scores range 8-40 with lower scores indicating lower levels of depression) scores at 2 and 6 months to baseline levels among SLOW-BWL women who achieve =5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss. |
Baseline, 2 months and 6 Months |
|
| Secondary |
Change in Scores on PROMIS Emotional Distress - Depression - Short Form questionnaire among FAST-BWL vs SLOW-BWL, as well as participants who achieve =5% weight loss at 6 months vs those who are unable to |
To compare Depression - Short Form (scores range 8-40 with lower scores indicating lower levels of depression) scores at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve =5% weight loss at 6 months vs those who are unable to. |
Baseline, 2 months and 6 Months |
|
| Secondary |
Change in Scores on PROMIS Emotional Distress - Anxiety - Short Form questionnaire among SLOW-BWL participants who achieve =5% weight loss |
To compare Anxiety - Short Form (scores range 7-35 with lower scores indicating lower levels of anxiety) scores at 2 and 6 months to baseline levels among SLOW-BWL who achieve =5% weight loss. |
Baseline, 2 months and 6 Months |
|
| Secondary |
Change in Scores on PROMIS Emotional Distress - Anxiety - Short Form questionnaire among SLOW-BWL women who achieve =5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss |
To compare Anxiety - Short Form (scores range 7-35 with lower scores indicating lower levels of anxiety) scores at 2 and 6 months to baseline levels among SLOW-BWL women who achieve =5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss. |
Baseline, 2 months and 6 Months |
|
| Secondary |
Change in Scores on PROMIS Emotional Distress - Anxiety - Short Form questionnaire among FAST-BWL vs SLOW-BWL, as well as participants who achieve =5% weight loss at 6 months vs those who are unable to |
To compare Anxiety - Short Form (scores range 7-35 with lower scores indicating lower levels of anxiety) scores at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve =5% weight loss at 6 months vs those who are unable to. |
Baseline, 2 months and 6 Months |
|
| Secondary |
Change in Scores on Sexual Function questionnaire among SLOW-BWL participants who achieve =5% weight loss |
To compare Sexual Function (scores range 4-20 with lower scores indicating better sexual functioning) scores at 2 and 6 months to baseline levels among SLOW-BWL who achieve =5% weight loss. |
Baseline, 2 months and 6 Months |
|
| Secondary |
Change in Scores on Sexual Function questionnaire among SLOW-BWL women who achieve =5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss |
To compare Sexual Function (scores range 4-20 with lower scores indicating better sexual functioning) scores at 2 and 6 months to baseline levels among SLOW-BWL women who achieve =5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss. |
Baseline, 2 months and 6 Months |
|
| Secondary |
Change in Scores on Sexual Function questionnaire among FAST-BWL vs SLOW-BWL, as well as participants who achieve =5% weight loss at 6 months vs those who are unable to |
To compare Sexual Function (scores range 4-20 with lower scores indicating better sexual functioning) scores at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve =5% weight loss at 6 months vs those who are unable to. |
Baseline, 2 months and 6 Months |
|
| Secondary |
Change in NCI quick food scan comparison among SLOW-BWL participants who achieve =5% weight loss |
To compare NCI quick food scan scores at 2 and 6 months to baseline levels among SLOW-BWL who achieve =5% weight loss. |
Baseline, 2 months and 6 Months |
|
| Secondary |
Change in NCI quick food scan comparison among SLOW-BWL women who achieve =5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss |
To compare NCI quick food scan scores at 2 and 6 months to baseline levels among SLOW-BWL women who achieve =5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss. |
Baseline, 2 months and 6 Months |
|
| Secondary |
Change in NCI quick food scan comparison among FAST-BWL vs SLOW-BWL, as well as participants who achieve =5% weight loss at 6 months vs those who are unable to |
To compare NCI quick food scan scores at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve =5% weight loss at 6 months vs those who are unable to. |
Baseline, 2 months and 6 Months |
|
| Secondary |
Change in Scores on Functional Assessment of Cancer Therapy-Endocrine Subscale (FACT-ES) among SLOW-BWL participants who achieve =5% weight loss |
To compare FACT-ES (scores range 0-76 with higher scores indicating poorer functional assessment) scores at 2 and 6 months to baseline levels among SLOW-BWL who achieve =5% weight loss. |
Baseline, 2 months and 6 Months |
|
| Secondary |
Change in Scores on Functional Assessment of Cancer Therapy-Endocrine Subscale (FACT-ES) among SLOW-BWL women who achieve =5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss |
To compare FACT-ES (scores range 0-76 with higher scores indicating poorer functional assessment) scores at 2 and 6 months to baseline levels among SLOW-BWL women who achieve =5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss. |
Baseline, 2 months and 6 Months |
|
| Secondary |
Change in Scores on Functional Assessment of Cancer Therapy-Endocrine Subscale (FACT-ES) among FAST-BWL vs SLOW-BWL, as well as participants who achieve =5% weight loss at 6 months vs those who are unable to |
To compare FACT-ES (scores range 0-76 with higher scores indicating poorer functional assessment) scores at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve =5% weight loss at 6 months vs those who are unable to. |
Baseline, 2 months and 6 Months |
|
| Secondary |
Change in Minutes of Moderate to Vigorous Physical Activity (MVPA) |
To compare minutes of MVPA reported in Fitbit at 2 and 6 months to baseline levels among SLOW-BWL who achieved =5% weight loss vs the SLOW-BWL who did not achieve 5% weight loss. |
Baseline, 2 months and 6 Months |
|
| Secondary |
Change in Number of daily steps |
To compare the number of daily steps reported in Fitbit at 2 and 6 months to baseline levels among SLOW-BWL who achieved =5% weight loss vs the SLOW-BWL who did not achieve 5% weight loss. |
Baseline, 2 months and 6 Months |
|
