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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-07636 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2019-0634 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Foundation for Women's Cancers | UNKNOWN |
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This trial studies how well a lifestyle intervention works in reducing breast cancer risk through changing body composition and decreasing inflammation in normal weight women. This trial may help researchers learn more about diet and exercise programs designed to decrease body fat in postmenopausal women who are of normal weight but have an elevated risk of breast cancer because of excess body fat.
PRIMARY OBJECTIVE:
I. Evaluate the feasibility of a diet and exercise intervention to decrease body fat in postmenopausal women with normal body mass index (BMI) but high body fat (trunk fat mass 9.4 kg, the 50th percentile of normal BMI women in the Women's Health Initiative [WHI]).
SECONDARY OBJECTIVE:
I. Assess preliminary efficacy of the intervention by evaluating the post-intervention differences between the intervention and control groups in:
IIa. Circulating markers of inflammation and metabolic dysfunction linked to both excess adiposity and breast cancer (high sensitivity C-reactive protein [hsCRP], fasting insulin, leptin, IL-6, triglycerides, sex hormone binding globulin [SHBG], adiponectin, and high density lipoprotein [HDL] cholesterol).
IIb. Body composition body fat, trunk fat mass, fat mass, lean mass, fat-free mass).
EXPLORATORY OBJECTIVE:
I. Exploratory outcomes include fitness (oxygen consumption VO2 peak, sit-to-stand test), behavior (physical activity, energy intake, macronutrient consumption), and quality of life (global health-related quality of life, physical functioning, sleep, menopausal symptoms).
OUTLINE: Participants are randomized to 1 of 2 groups.
GROUP I: Participants complete lifestyle intervention consisting of 1-3 sets of high-resistance circuit training sessions per week, up to 150 minutes of aerobic training per week, and diet recommendations from a health coach or registered dietitian twice per week for 16 weeks.
GROUP II: Participants are placed on a wait-list and then complete lifestyle intervention after 4 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (lifestyle intervention) | Experimental | Participants complete lifestyle intervention consisting of 1-3 sets of high-resistance circuit training sessions per week, up to 150 minutes of aerobic training per week, and diet recommendations from a health coach or registered dietitian twice per week for 16 weeks. |
|
| Group II (wait-list, lifestyle intervention) | Active Comparator | Participants are placed on a wait-list and then complete lifestyle intervention after 4 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aerobic Exercise | Other | Complete aerobic training |
|
| Measure | Description | Time Frame |
|---|---|---|
| Eligibility Rate | Eligibility rate will be calculated as the number of eligible women identified divided by the total number completing a DXA scan. Criteria for feasibility will be defined as an eligibility rate of ≥ 40% | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Intervention Adherence | Intervention adherence for an individual is defined as attending at least 22 of the sessions with the personal trainer and at least 11 of the health coaching sessions. The intervention adherence at the study level is then defined by the percentage of participants adhering to the intervention. Criteria for feasibility will be defined as a study intervention adherence rate of ≥ 75% |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen M Basen-Engquist | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center Website | View source |
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Participants were recruited between June 2021-December 2024; participants were enrolled from both the general population and from the MD Anderson employee pool via email blast.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Group | Participants will be randomized to a 16-week intervention to improve body composition (decrease fat mass and increase lean mass) |
| FG001 | Waitlist Control Group | Participants will receive the intervention after a 16-week waiting period |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group | Participants will be randomized to a 16-week intervention to improve body composition (decrease fat mass and increase lean mass) Questionnaire Administration: Ancillary studies Resistance Training: Complete high-resistance circuit training sessions |
| BG001 | Waitlist Control Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Eligibility Rate | Eligibility rate will be calculated as the number of eligible women identified divided by the total number completing a DXA scan. Criteria for feasibility will be defined as an eligibility rate of ≥ 40% | Eligibility rate will be calculated as the number of eligible women identified divided by the total number completing a DXA scan. | Posted | Count of Participants | Participants | 4 months |
|
|
4 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Group | Participants will be randomized to a 16-week intervention to improve body composition (decrease fat mass and increase lean mass) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Karen M Basen-Engquist | The University of Texas MD Anderson Cancer Center | 713-745-3123 | kbasenen@mdanderson.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 20, 2023 | Mar 26, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D004035 | Diet Therapy |
| D055070 | Resistance Training |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Dietary Intervention | Other | Receive diet recommendations from health coach or registered dietitian |
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| Quality-of-Life Assessment | Other | Ancillary studies |
|
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| Questionnaire Administration | Other | Ancillary studies |
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| Resistance Training | Other | Complete high-resistance circuit training sessions |
|
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| 4 months |
| Retention Rate | Retention will be assessed by the percentage of participants completing the 4-month study assessments. Criteria for feasibility will be defined as a retention rate of ≥ 80% in each arm. | 8 months |
Participants will receive the intervention after a 16-week waiting period |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Intervention Adherence | Intervention adherence for an individual is defined as attending at least 22 of the sessions with the personal trainer and at least 11 of the health coaching sessions. The intervention adherence at the study level is then defined by the percentage of participants adhering to the intervention. Criteria for feasibility will be defined as a study intervention adherence rate of ≥ 75% | Adherence is ONLY calculated for the intervention group. | Posted | Count of Participants | Participants | 4 months |
|
|
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| Secondary | Retention Rate | Retention will be assessed by the percentage of participants completing the 4-month study assessments. Criteria for feasibility will be defined as a retention rate of ≥ 80% in each arm. | Posted | Count of Participants | Participants | 8 months |
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|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Waitlist Control Group | Participants will receive the intervention after a 16-week waiting period | 0 | 20 | 0 | 20 | 0 | 20 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |