Trial · NCT04499950
Adaptive Nutrition and Exercise Weight Loss (A-NEW) Study
NCT04499950, Phase 2, Completed, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; results first posted 2025-03-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Adaptive Nutrition and Exercise Weight Loss (A-NEW) Study. Trials, record NCT04499950. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04499950
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Adaptive Nutrition and Exercise Weight Loss (A-NEW) Study
- NCT number
- NCT04499950
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 53 participants, actual
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Conditions
- Breast Cancer, Overweight or Obesity
- Interventions
- Contrave, Behavioral Weight Loss
- First posted
- 2020-08-05
- Last updated
- 2025-03-06
- Results first posted
- 2025-03-06
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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, 2 months and 6 Months | To 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. |
| Secondary | 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, 2 months and 6 Months | To 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. |
| Secondary | 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, 2 months and 6 Months | To 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. |
| Secondary | 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, 2 months and 6 Months | To 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. |
| Secondary | 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, 2 months and 6 Months | To 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. |
| Secondary | 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, 2 months and 6 Months | To 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). |
| Secondary | Change in Scores on Functional Assessment of Cancer Therapy-Endocrine Subscale (FACT-ES) Among FAST-BWL vs SLOW-BWL, as Well as Participants Who Achieve ≥5% Weight Loss at 6 Months vs Those Who Are Unable to | Baseline, 2 months and 6 Months | To 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. |
| Other | 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. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients With 5 Percent Weight Loss (in SLOW-BWL) | 6 months | Only 32 participants in the SLOW-BWL arm completed intervention per protocol | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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, 2 months and 6 Months | units on a scale | MEDIAN | |
| SECONDARY | 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, 2 months and 6 Months | units on a scale | MEDIAN | |
| SECONDARY | 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, 2 months and 6 Months | units on a scale | MEDIAN | |
| SECONDARY | 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, 2 months and 6 Months | units on a scale | MEDIAN | |
| SECONDARY | 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, 2 months and 6 Months | units on a scale | MEDIAN | |
| SECONDARY | 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, 2 months and 6 Months | units on a scale | MEDIAN | |
| SECONDARY | Change in Scores on Functional Assessment of Cancer Therapy-Endocrine Subscale (FACT-ES) Among FAST-BWL vs SLOW-BWL, as Well as Participants Who Achieve ≥5% Weight Loss at 6 Months vs Those Who Are Unable to | Baseline, 2 months and 6 Months | units on a scale | MEDIAN | |
| OTHER_PRE_SPECIFIED | Number of Patients With 5% Weight Loss (in FAST-BWL) | 6 months | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients With 5 Percent Weight Loss (in SLOW-BWL) | SLOW-BWL | 16 | Participants | ||
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 | SLOW-BWL | Baseline to 2 months | 2 | Inter-Quartile Range 0 to 5 | units on a scale |
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 | FAST-BWL | Baseline to 2 months | 3 | Inter-Quartile Range -2 to 6 | units on a scale |
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 | SLOW-BWL | 2 months to 6 months | 0.0 | Inter-Quartile Range -0.8 to 3.3 | units on a scale |
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 | FAST-BWL | 2 months to 6 months | 1.1 | Inter-Quartile Range 0.0 to 9.0 | units on a scale |
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 | SLOW-BWL | Baseline to 2 months | -1.1 | Inter-Quartile Range -4.1 to 1.3 | units on a scale |
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 | FAST-BWL | Baseline to 2 months | 0.0 | Inter-Quartile Range -7.2 to 0.0 | units on a scale |
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 | SLOW-BWL | 2 months to 6 months | 0.0 | Inter-Quartile Range -1.3 to 1.3 | units on a scale |
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 | FAST-BWL | 2 months to 6 months | 0.0 | Inter-Quartile Range -4.2 to 0.0 | units on a scale |
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 | SLOW-BWL Baseline - 2 Months | Baseline to 2 months | 0.0 | Inter-Quartile Range -5.0 to 3.2 | units on a scale |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | SLOW-BWL | 38 | |
| Overall Study | STARTED | FAST-BWL | 15 | |
| Overall Study | COMPLETED | SLOW-BWL | 38 | |
| Overall Study | COMPLETED | FAST-BWL | 15 | |
| Overall Study | NOT COMPLETED | SLOW-BWL | 0 | |
| Overall Study | NOT COMPLETED | FAST-BWL | 0 |
Source ClinicalTrials.gov
Adverse events38
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | constipation | Gastrointestinal disorders | SLOW-BWL | 20 | 38 | |
| other | constipation | Gastrointestinal disorders | FAST-BWL | 2 | 15 | |
| other | Nausea | Gastrointestinal disorders | SLOW-BWL | 16 | 38 | |
| other | Nausea | Gastrointestinal disorders | FAST-BWL | 1 | 15 | |
| other | dry mouth | Gastrointestinal disorders | SLOW-BWL | 14 | 38 | |
| other | dry mouth | Gastrointestinal disorders | FAST-BWL | 1 | 15 | |
| other | Diarrhea | Gastrointestinal disorders | SLOW-BWL | 10 | 38 | |
| other | Diarrhea | Gastrointestinal disorders | FAST-BWL | 1 | 15 | |
| other | Abdominal pain | Gastrointestinal disorders | SLOW-BWL | 7 | 38 | |
| other | Abdominal pain | Gastrointestinal disorders | FAST-BWL | 1 | 15 |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SLOW-BWL | 0 | 38 |
| Total, all-cause mortality | FAST-BWL | 0 | 15 |
| Total, other adverse events | SLOW-BWL | 28 | 38 |
| Total, other adverse events | FAST-BWL | 4 | 15 |
| Total, serious adverse events | SLOW-BWL | 0 | 38 |
| Total, serious adverse events | FAST-BWL | 0 | 15 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| SLOW-BWL vs FAST-BWL: deaths from any cause | Trial comparisons |
| SLOW-BWL vs FAST-BWL: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04499950
GET https://conductscience.org/api/trials/v1/NCT04499950/results?page=2