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

Study Overview
=================
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.

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.

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

Conditions
-----------------
Breast Cancer, Overweight or Obesity

Intervention / Treatment
-----------------
* Drug: Contrave
* Behavioral: Behavioral Weight Loss


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SLOW-BWL<br>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<br>* 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.<br>* Other names: Naltrexone/Bupropion;Behavioral: Behavioral Weight Loss<br>* 6 months of behavioral weight loss. First 3 months are weekly calls with coach and then transition to monthly calls for months 4-6.<br>|
| Active Comparator: FAST-BWL<br>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<br>* 6 months of behavioral weight loss. First 3 months are weekly calls with coach and then transition to monthly calls for months 4-6.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |