Trial Outcomes & Findings for Adaptive Nutrition and Exercise Weight Loss (A-NEW) Study (NCT NCT04499950)
NCT ID: NCT04499950
Last Updated: 2025-03-06
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
53 participants
Primary outcome timeframe
6 months
Results posted on
2025-03-06
Participant Flow
Participant milestones
| Measure |
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.
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.
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.
|
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 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.
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
15
|
|
Overall Study
COMPLETED
|
38
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Adaptive Nutrition and Exercise Weight Loss (A-NEW) Study
Baseline characteristics by cohort
| Measure |
SLOW-BWL
n=38 Participants
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.
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.
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.
|
FAST-BWL
n=15 Participants
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 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.
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
32 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Continuous
|
56.5 years
n=5 Participants
|
61 years
n=7 Participants
|
59 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White/ Caucasian
|
24 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
12 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
38 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Breast Cancer Stage
Stage 0 (Ductal carcinoma in situ (DCIS))
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Breast Cancer Stage
Stage 1
|
23 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Breast Cancer Stage
Stage 2
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Breast Cancer Stage
Stage 3
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Only 32 participants in the SLOW-BWL arm completed intervention per protocol
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.
Outcome measures
| Measure |
SLOW-BWL
n=32 Participants
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.
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.
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.
|
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 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.
|
|---|---|---|
|
Number of Patients With 5 Percent Weight Loss (in SLOW-BWL)
|
16 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, 2 months and 6 MonthsTo report the change in scores at 2 and 6 months to baseline among FAST-BWL vs SLOW-BWL arms for Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function. The total score ranges from 33.5 to 61.7. The higher the score, the better the physical function.
Outcome measures
| Measure |
SLOW-BWL
n=38 Participants
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.
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.
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.
|
FAST-BWL
n=15 Participants
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 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.
|
|---|---|---|
|
Change in Scores on Patient-Reported Outcomes Measurement Information System (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 to 2 months
|
2 units on a scale
Interval 0.0 to 5.0
|
3 units on a scale
Interval -2.0 to 6.0
|
|
Change in Scores on Patient-Reported Outcomes Measurement Information System (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
2 months to 6 months
|
0.0 units on a scale
Interval -0.8 to 3.3
|
1.1 units on a scale
Interval 0.0 to 9.0
|
SECONDARY outcome
Timeframe: Baseline, 2 months and 6 MonthsTo report the change in scores at 2 and 6 months to baseline among FAST-BWL vs SLOW-BWL arms for Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference. The total score ranges from 41.0-67.4. The lower the score, the better the pain interference.
Outcome measures
| Measure |
SLOW-BWL
n=38 Participants
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.
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.
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.
|
FAST-BWL
n=15 Participants
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 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.
|
|---|---|---|
|
Change in Scores on Patient-Reported Outcomes Measurement Information System (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 to 2 months
|
-1.1 units on a scale
Interval -4.1 to 1.3
|
0.0 units on a scale
Interval -7.2 to 0.0
|
|
Change in Scores on Patient-Reported Outcomes Measurement Information System (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
2 months to 6 months
|
0.0 units on a scale
Interval -1.3 to 1.3
|
0.0 units on a scale
Interval -4.2 to 0.0
|
SECONDARY outcome
Timeframe: Baseline, 2 months and 6 MonthsTo report the change in scores at 2 and 6 months to baseline among FAST-BWL vs SLOW-BWL arms for Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue. The total score ranges from 39.6 to 62.0. The lower the score, the less the fatigue.
Outcome measures
| Measure |
SLOW-BWL
n=38 Participants
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.
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.
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.
|
FAST-BWL
n=15 Participants
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 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.
|
|---|---|---|
|
Change in Scores on Patient-Reported Outcomes Measurement Information System (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 to 2 months
|
0.0 units on a scale
Interval -5.0 to 3.2
|
0.0 units on a scale
Interval -4.1 to 3.9
|
|
Change in Scores on Patient-Reported Outcomes Measurement Information System (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
2 months to 6 months
|
1.6 units on a scale
Interval -2.0 to 5.3
|
-0.7 units on a scale
Interval -3.4 to 3.1
|
SECONDARY outcome
Timeframe: Baseline, 2 months and 6 MonthsTo report the change in scores at 2 and 6 months to baseline among FAST-BWL vs SLOW-BWL arms for Patient-Reported Outcomes Measurement Information System (PROMIS) Depression. The total score ranges from 37.1-71.4. The lower the score, the less depression.
Outcome measures
| Measure |
SLOW-BWL
n=38 Participants
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.
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.
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.
|
FAST-BWL
n=15 Participants
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 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.
|
|---|---|---|
|
Change in Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Depression - 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 to 2 months
|
0.0 units on a scale
Interval -6.2 to 0.0
|
0.0 units on a scale
Interval -1.5 to 0.8
|
|
Change in Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Depression - Among FAST-BWL vs SLOW-BWL, as Well as Participants Who Achieve ≥5% Weight Loss at 6 Months vs Those Who Are Unable to
2 months to 6 months
|
0.0 units on a scale
Interval -2.0 to 0.0
|
-1.8 units on a scale
Interval -8.4 to 0.0
|
SECONDARY outcome
Timeframe: Baseline, 2 months and 6 MonthsTo report the change in scores at 2 and 6 months to baseline among FAST-BWL vs SLOW-BWL arms for Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety. Scores range 36.3-71.5, with higher scores representing more severe anxiety symptoms.
Outcome measures
| Measure |
SLOW-BWL
n=38 Participants
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.
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.
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.
|
FAST-BWL
n=15 Participants
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 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.
|
|---|---|---|
|
Change in Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Anxiety - 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 to 2 months
|
0.0 units on a scale
Interval -3.7 to 1.3
|
0.0 units on a scale
Interval -0.6 to 2.4
|
|
Change in Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Anxiety - Among FAST-BWL vs SLOW-BWL, as Well as Participants Who Achieve ≥5% Weight Loss at 6 Months vs Those Who Are Unable to
2 months to 6 months
|
0 units on a scale
Interval -6.0 to 2.0
|
-1 units on a scale
Interval -3.0 to 1.0
|
SECONDARY outcome
Timeframe: Baseline, 2 months and 6 MonthsTo report the change in scores at 2 and 6 months to baseline among FAST-BWL vs SLOW-BWL arms for Medical Outcomes Study (MOS) Sexual Function. Score range 0-100 with higher score indicating less functioning. Four items are rated on a 5-point scale (1=not a problem, 2=little of a problem, 3=somewhat of a problem, 4=very much of a problem, and 5=not applicable).
Outcome measures
| Measure |
SLOW-BWL
n=38 Participants
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.
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.
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.
|
FAST-BWL
n=15 Participants
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 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.
|
|---|---|---|
|
Change in Scores on the Medical Outcomes Study (MOS) Sexual Functioning Scale 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 to 2 months
|
0 units on a scale
Interval -9.0 to 0.0
|
0 units on a scale
Interval -12.0 to 0.0
|
|
Change in Scores on the Medical Outcomes Study (MOS) Sexual Functioning Scale Among FAST-BWL vs SLOW-BWL, as Well as Participants Who Achieve ≥5% Weight Loss at 6 Months vs Those Who Are Unable to
2 months to 6 months
|
0 units on a scale
Interval 0.0 to 0.0
|
0 units on a scale
Interval -12.0 to 0.0
|
SECONDARY outcome
Timeframe: Baseline, 2 months and 6 MonthsTo report the change in scores at 2 and 6 months to baseline among FAST-BWL vs SLOW-BWL arms for Functional Assessment of Cancer Therapy-Endocrine Subscale (FACT-ES). Scores ranging from 39.0 to 73.0. Higher scores indicate greater impact from symptoms.
Outcome measures
| Measure |
SLOW-BWL
n=38 Participants
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.
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.
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.
|
FAST-BWL
n=15 Participants
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 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.
|
|---|---|---|
|
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 to 2 months
|
3 units on a scale
Interval -2.0 to 6.0
|
2 units on a scale
Interval 1.0 to 4.0
|
|
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
2 months to 6 months
|
6 units on a scale
Interval 0.0 to 10.0
|
4 units on a scale
Interval 2.0 to 8.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsTo assess the proportion of women in the FAST-BWL arm who maintain ≥5% weight loss at 6 months.
Outcome measures
| Measure |
SLOW-BWL
n=15 Participants
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.
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.
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.
|
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 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.
|
|---|---|---|
|
Number of Patients With 5% Weight Loss (in FAST-BWL)
|
13 Participants
|
—
|
Adverse Events
SLOW-BWL
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
FAST-BWL
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SLOW-BWL
n=38 participants at risk
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.
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.
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.
|
FAST-BWL
n=15 participants at risk
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 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.
|
|---|---|---|
|
Gastrointestinal disorders
constipation
|
52.6%
20/38 • Initiation of drug up to 6 months
|
13.3%
2/15 • Initiation of drug up to 6 months
|
|
Gastrointestinal disorders
Nausea
|
42.1%
16/38 • Initiation of drug up to 6 months
|
6.7%
1/15 • Initiation of drug up to 6 months
|
|
Gastrointestinal disorders
dry mouth
|
36.8%
14/38 • Initiation of drug up to 6 months
|
6.7%
1/15 • Initiation of drug up to 6 months
|
|
Gastrointestinal disorders
Diarrhea
|
26.3%
10/38 • Initiation of drug up to 6 months
|
6.7%
1/15 • Initiation of drug up to 6 months
|
|
Gastrointestinal disorders
Abdominal pain
|
18.4%
7/38 • Initiation of drug up to 6 months
|
6.7%
1/15 • Initiation of drug up to 6 months
|
|
Gastrointestinal disorders
Bloating
|
7.9%
3/38 • Initiation of drug up to 6 months
|
0.00%
0/15 • Initiation of drug up to 6 months
|
|
Gastrointestinal disorders
Vomiting
|
10.5%
4/38 • Initiation of drug up to 6 months
|
0.00%
0/15 • Initiation of drug up to 6 months
|
|
Psychiatric disorders
Insomnia
|
31.6%
12/38 • Initiation of drug up to 6 months
|
0.00%
0/15 • Initiation of drug up to 6 months
|
|
Psychiatric disorders
Anxiety
|
15.8%
6/38 • Initiation of drug up to 6 months
|
0.00%
0/15 • Initiation of drug up to 6 months
|
|
Nervous system disorders
Headache
|
23.7%
9/38 • Initiation of drug up to 6 months
|
0.00%
0/15 • Initiation of drug up to 6 months
|
|
Nervous system disorders
Dizziness
|
7.9%
3/38 • Initiation of drug up to 6 months
|
6.7%
1/15 • Initiation of drug up to 6 months
|
|
General disorders
Fatigue
|
21.1%
8/38 • Initiation of drug up to 6 months
|
6.7%
1/15 • Initiation of drug up to 6 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/38 • Initiation of drug up to 6 months
|
6.7%
1/15 • Initiation of drug up to 6 months
|
|
Vascular disorders
Hot flashes
|
13.2%
5/38 • Initiation of drug up to 6 months
|
0.00%
0/15 • Initiation of drug up to 6 months
|
|
Ear and labyrinth disorders
Tinnitus
|
7.9%
3/38 • Initiation of drug up to 6 months
|
0.00%
0/15 • Initiation of drug up to 6 months
|
|
Nervous system disorders
Tremor
|
10.5%
4/38 • Initiation of drug up to 6 months
|
0.00%
0/15 • Initiation of drug up to 6 months
|
|
Nervous system disorders
Dysgeusia
|
5.3%
2/38 • Initiation of drug up to 6 months
|
0.00%
0/15 • Initiation of drug up to 6 months
|
|
Musculoskeletal and connective tissue disorders
Arthalgia
|
2.6%
1/38 • Initiation of drug up to 6 months
|
13.3%
2/15 • Initiation of drug up to 6 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
10.5%
4/38 • Initiation of drug up to 6 months
|
0.00%
0/15 • Initiation of drug up to 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place