Adaptive Nutrition and Exercise Weight Loss (A-NEW) Study

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (Other)

Overall Status

Recruiting

CT.gov ID

NCT04499950

Collaborator

American Institute for Cancer Research (Other), Breast Cancer Research Foundation (Other), Wellspan-Hopkins Cancer Health Services Research Fund (Other)

Enrollment

Location

Arms

20.7

Anticipated Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a single arm phase II study designed to determine the effects of pharmacotherapy and a remote behavioral weight loss intervention on weight loss in breast cancer survivors who are overweight or obese, and the impact of successful weight loss on serum biomarkers and gut microbiome.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Overweight or Obesity	Drug: Contrave Behavioral: Behavioral Weight Loss	Phase 2

Detailed Description

The investigators will evaluate the extent to which implementation of a chronic weight loss medication, Contrave® (Naltrexone/Bupropion), is associated with achieving ≥5% weight loss. All patients will receive the POWER-remote behavioral weight loss intervention (BWL) and have a behavioral coach for the duration of the 6 month study. During months 1-3, the behavioral coach will call weekly. From months 4-6, the behavioral coach will call monthly. At week 9, those who lose ≥5%, designated fast responders, will continue with BWL alone (FAST-BWL) while those who lose <5%, designated slow responders, will continue BWL and initiate Contrave (SLOW-BWL). The SLOW-BWL arm will receive at least 16 weeks of Contrave (as per Federal Drug Administration [FDA] recommended administration) starting at week 9 and discontinue if ≥5% weight loss is not achieved at month 6. During month 3, all participants continue to have weekly calls with the behavioral coach and will be asked about symptoms, which may be related to initiation of pharmacotherapy; any symptoms are reported to the PI for further evaluation. In addition to total weight loss, the investigators will evaluate biomarkers associated with obesity, microbiome and cardiometabolic factors.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

55 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Other

Official Title:

A Phase II Single Arm Adaptive Weight Loss Study in Women With Early Stage Breast Cancer

Actual Study Start Date :

Feb 8, 2021

Anticipated Primary Completion Date :

Nov 1, 2022

Anticipated Study Completion Date :

Nov 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SLOW-BWL All patients will receive the POWER-remote behavioral weight loss intervention (BWL) and have a behavioral coach for the duration of the 6 month study. During months 1-3, the behavioral coach will call weekly. From months 4-6, the behavioral coach will call monthly. At week 9, those who lose <5%, designated slow responders, will continue BWL and initiate Contrave (SLOW-BWL). The SLOW-BWL arm will receive at least 16 weeks of Contrave [as per the Food and Drug Administration (FDA) recommended administration] starting at week 9 and discontinue if ≥5% weight loss is not achieved at month 6.	Drug: Contrave Initiate Contrave at 1 tab in morning (AM) for Week 9; then 1 tab in AM and 1 tab in evening (PM) for Week 10; then 2 tab in AM and 1 tab in PM for Week 11; then 2 tab in AM and 2 tab in PM for week 12; then constant dose for months 4-6. Other Names: Naltrexone/Bupropion Behavioral: Behavioral Weight Loss 6 months of behavioral weight loss. First 3 months are weekly calls with coach and then transition to monthly calls for months 4-6.
Active Comparator: FAST-BWL All patients will receive the POWER-remote behavioral weight loss intervention (BWL) and have a behavioral coach for the duration of the 6 month study. During months 1-3, the behavioral coach will call weekly. From months 4-6, the behavioral coach will call monthly. At week 9, those who lose ≥5%, designated fast responders, will continue with BWL alone (FAST-BWL)	Behavioral: Behavioral Weight Loss 6 months of behavioral weight loss. First 3 months are weekly calls with coach and then transition to monthly calls for months 4-6.

Arm

Intervention/Treatment

Experimental: SLOW-BWL

All patients will receive the POWER-remote behavioral weight loss intervention (BWL) and have a behavioral coach for the duration of the 6 month study. During months 1-3, the behavioral coach will call weekly. From months 4-6, the behavioral coach will call monthly. At week 9, those who lose <5%, designated slow responders, will continue BWL and initiate Contrave (SLOW-BWL). The SLOW-BWL arm will receive at least 16 weeks of Contrave [as per the Food and Drug Administration (FDA) recommended administration] starting at week 9 and discontinue if ≥5% weight loss is not achieved at month 6.

Drug: Contrave

Initiate Contrave at 1 tab in morning (AM) for Week 9; then 1 tab in AM and 1 tab in evening (PM) for Week 10; then 2 tab in AM and 1 tab in PM for Week 11; then 2 tab in AM and 2 tab in PM for week 12; then constant dose for months 4-6.

Other Names:

Naltrexone/Bupropion

Behavioral: Behavioral Weight Loss

6 months of behavioral weight loss. First 3 months are weekly calls with coach and then transition to monthly calls for months 4-6.

Active Comparator: FAST-BWL

Behavioral: Behavioral Weight Loss

6 months of behavioral weight loss. First 3 months are weekly calls with coach and then transition to monthly calls for months 4-6.

Outcome Measures

Primary Outcome Measures

Number of patients with 5 percent weight loss (in SLOW-BWL) [6 months]
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.

Secondary Outcome Measures

Change in HbA1c levels among SLOW-BWL participants who achieve ≥5% weight loss [Baseline, 2 months and 6 Months]
To compare HbA1c (%) levels at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.
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 [Baseline, 2 months and 6 Months]
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.
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 [Baseline, 2 months and 6 Months]
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.
Change in IGF1 levels among SLOW-BWL participants who achieve ≥5% weight loss [Baseline, 2 months and 6 Months]
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.
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 [Baseline, 2 months and 6 Months]
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
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 [Baseline, 2 months and 6 Months]
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.
Change in Fasting glucose levels among SLOW-BWL participants who achieve ≥5% weight loss [Baseline, 2 months and 6 Months]
To compare fasting glucose (mg/dL) levels at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.
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 [Baseline, 2 months and 6 Months]
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.
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 [Baseline, 2 months and 6 Months]
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.
Change in Fasting lipids levels among SLOW-BWL participants who achieve ≥5% weight loss [Baseline, 2 months and 6 Months]
To compare fasting lipids (mg/dL) levels at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.
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 [Baseline, 2 months and 6 Months]
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.
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 [6 Months]
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.
Change in Fasting insulin levels among SLOW-BWL participants who achieve ≥5% weight loss [Baseline, 2 months and 6 Months]
To compare fasting insulin (mIU/L) levels at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.
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 [Baseline, 2 months and 6 Months]
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.
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 [Baseline, 2 months and 6 Months]
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.
Change in Adiponectin levels among SLOW-BWL women who achieve ≥5% weight loss [Baseline, 2 months and 6 Months]
To compare adiponectin (ng/mL) levels at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.
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 [Baseline, 2 months and 6 Months]
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.
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 [Baseline, 2 months and 6 Months]
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.
Change in Leptin levels among SLOW-BWL participants who achieve ≥5% weight loss [Baseline, 2 months and 6 Months]
To compare leptin (ng/mL) levels at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.
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 [Baseline, 2 months and 6 Months]
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.
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 [Baseline, 2 months and 6 Months]
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
Change in Microbiome composition among SLOW-BWL participants who achieve ≥5% weight loss [Baseline, 2 months and 6 Months]
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.
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 [Baseline, 2 months and 6 Months]
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.
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 [Baseline, 2 months and 6 Months]
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.
Change in Scores on Godin Leisure-Time Exercise questionnaire among SLOW-BWL participants who achieve ≥5% weight loss [Baseline, 2 months and 6 Months]
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.
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 [Baseline, 2 months and 6 Months]
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.
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 [Baseline, 2 months and 6 Months]
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.
Change in Scores on Pittsburgh Sleep Quality Index (PSQI) questionnaire among SLOW-BWL participants who achieve ≥5% weight loss [Baseline, 2 months and 6 Months]
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.
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 [Baseline, 2 months and 6 Months]
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.
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 [Baseline, 2 months and 6 Months]
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.
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 [Baseline, 2 months and 6 Months]
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.
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 [Baseline, 2 months and 6 Months]
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.
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 [Baseline, 2 months and 6 Months]
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.
Change in Scores on PROMIS Pain Interference - Short Form questionnaire among SLOW-BWL participants who achieve ≥5% weight loss [Baseline, 2 months and 6 Months]
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.
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 [Baseline, 2 months and 6 Months]
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.
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 [Baseline, 2 months and 6 Months]
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.
Change in Scores on PROMIS Fatigue - Short Form questionnaire among SLOW-BWL participants who achieve ≥5% weight loss [Baseline, 2 months and 6 Months]
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.
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 [Baseline, 2 months and 6 Months]
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.
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 [Baseline, 2 months and 6 Months]
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.
Change in Scores on PROMIS Emotional Distress - Depression - Short Form questionnaire among SLOW-BWL participants who achieve ≥5% weight loss [Baseline, 2 months and 6 Months]
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.
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 [Baseline, 2 months and 6 Months]
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.
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 [Baseline, 2 months and 6 Months]
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.
Change in Scores on PROMIS Emotional Distress - Anxiety - Short Form questionnaire among SLOW-BWL participants who achieve ≥5% weight loss [Baseline, 2 months and 6 Months]
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.
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 [Baseline, 2 months and 6 Months]
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.
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 [Baseline, 2 months and 6 Months]
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.
Change in Scores on Sexual Function questionnaire among SLOW-BWL participants who achieve ≥5% weight loss [Baseline, 2 months and 6 Months]
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.
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 [Baseline, 2 months and 6 Months]
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.
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 [Baseline, 2 months and 6 Months]
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.
Change in NCI quick food scan comparison among SLOW-BWL participants who achieve ≥5% weight loss [Baseline, 2 months and 6 Months]
To compare NCI quick food scan scores at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.
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 [Baseline, 2 months and 6 Months]
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.
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 [Baseline, 2 months and 6 Months]
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.
Change in Scores on Functional Assessment of Cancer Therapy-Endocrine Subscale (FACT-ES) among SLOW-BWL participants who achieve ≥5% weight loss [Baseline, 2 months and 6 Months]
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.
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 [Baseline, 2 months and 6 Months]
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.
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 [Baseline, 2 months and 6 Months]
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.
Change in Minutes of Moderate to Vigorous Physical Activity (MVPA) [Baseline, 2 months and 6 Months]
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.
Change in Number of daily steps [Baseline, 2 months and 6 Months]
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.

Other Outcome Measures

Number of patients with 5% weight loss (in FAST-BWL) [6 months]
To assess the proportion of women in the FAST-BWL arm who maintain ≥5% weight loss at 6 months.
Number of participants with AA genotype and 5% weight loss [6 months]
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.
Number of participants with AA genotype and Contrave [6 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Female, at least 3 months after completion of local therapy (e.g. surgery, radiation), and if applicable, adjuvant chemotherapy
Diagnosed within 10 years with histologically-confirmed ductal carcinoma in situ (DCIS) or stage I-III invasive carcinoma of the breast
Up to date with recommended screening mammography within one year
Current BMI ≥ 30 kg/m2 or BMI 27.0-29.9 kg/m2 with hypertension, non-insulin dependent diabetes or hyperlipidemia; and weight ≤ 400 lbs
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Willingness to change diet, physical activity, track behaviors, engage in weekly and monthly contacts and visit, and take chronic weight loss medication
Able to read and write the English language without assistance and daily access to the e-mail and/or smartphone
Patient is aware of her diagnosis, understands the study regimen, its requirements, risks, and discomforts, and is able and willing to sign an informed consent form.

Exclusion Criteria:

Serious/uncontrolled medical condition at the discretion of the Protocol Chair/designee likely to hinder accurate measurement of weight or any condition for which weight loss is contraindicated or would affect adipokine and inflammatory markers (e.g. active malignancy, end stage renal disease on dialysis, cirrhosis, autoimmune disease, adrenal disease, uncontrolled hypertension, seizure disorder, and history of bariatric surgery)
Pregnant or nursing within past 6 months, or plans to become pregnant in the next year
Currently enrolled or planning to enroll in a weight loss program (e.g. Weight Watchers, Jenny Craig, Nutrisystem and Medifast) or to take a chronic weight loss medication.
Diabetes on insulin or sulfonylureas within the past 3 months
Unstable psychiatric disorder or bulimia/anorexia nervosa
Alcohol, nicotine or substance abuse; or undergoing abrupt discontinuation of alcohol, benzodiazepine, barbiturate or anti-epileptic drug
Use of the following medications are excluded:
Monoamine oxidase (MAO) inhibitors (must be >14 days from discontinuation)
Thyroid medication use unless on stable doses for at least the past 3 months
Buproprion containing products or opiate agonists (must be >14 days from discontinuation)
Medications that cause weight loss (e.g., lorcaserin, phentermine, orlistat, Qsymia, Contrave) within the past 3 months
Medications that are likely to cause weight gain or prevent weight loss (e.g., corticosteroids, lithium, olanzapine, risperidone, clozapine, oral contraceptive pills, hormone replacement therapy) within the past 3 months. NOTE: An exception to this is that SSRI's and SNRI's are allowed if participant has been on stable doses for at least 3 months (if discontinued, a washout of 2 weeks from prior selective serotonin reuptake inhibitor (SSRI)/Serotonin-norepinephrine reuptake inhibitor (SNRI) use is required).
Medications that may affect adipokine or inflammatory markers (e.g., metformin, glitazones, steroids, angiotensin converting enzyme (ACE) inhibitors, beta blockers and statins) unless on stable doses ≥3 months prior to registration (if discontinued, a washout of 2 weeks from prior use is required). Concurrent NSAIDs are allowed if use is limited to <3 times per week; chronic NSAIDs are permitted on study only if use has been ≥3 times per week for at least 3 months prior to registration and is expected to continue.