Trial Outcomes & Findings for Lifestyle Intervention for the Reduction of Breast Cancer Risk in Normal Weight Women (NCT NCT04267796)
NCT ID: NCT04267796
Last Updated: 2026-04-16
Results Overview
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%
ACTIVE_NOT_RECRUITING
NA
40 participants
4 months
2026-04-16
Participant Flow
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.
Participant milestones
| Measure |
Intervention Group
Participants will be randomized to a 16-week intervention to improve body composition (decrease fat mass and increase lean mass)
|
Waitlist Control Group
Participants will receive the intervention after a 16-week waiting period
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
17
|
16
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
| Measure |
Intervention Group
Participants will be randomized to a 16-week intervention to improve body composition (decrease fat mass and increase lean mass)
|
Waitlist Control Group
Participants will receive the intervention after a 16-week waiting period
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
Baseline Characteristics
Lifestyle Intervention for the Reduction of Breast Cancer Risk in Normal Weight Women
Baseline characteristics by cohort
| Measure |
Intervention Group
n=20 Participants
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
|
Waitlist Control Group
n=20 Participants
Participants will receive the intervention after a 16-week waiting period
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=193 Participants
|
18 Participants
n=193 Participants
|
36 Participants
n=386 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=193 Participants
|
2 Participants
n=193 Participants
|
4 Participants
n=386 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=193 Participants
|
20 Participants
n=193 Participants
|
40 Participants
n=386 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=193 Participants
|
1 Participants
n=193 Participants
|
3 Participants
n=386 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=193 Participants
|
19 Participants
n=193 Participants
|
37 Participants
n=386 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=193 Participants
|
6 Participants
n=193 Participants
|
12 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=193 Participants
|
1 Participants
n=193 Participants
|
1 Participants
n=386 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=193 Participants
|
12 Participants
n=193 Participants
|
26 Participants
n=386 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=193 Participants
|
1 Participants
n=193 Participants
|
1 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=193 Participants
|
20 participants
n=193 Participants
|
40 participants
n=386 Participants
|
PRIMARY outcome
Timeframe: 4 monthsPopulation: Eligibility rate will be calculated as the number of eligible women identified divided by the total number completing a DXA scan.
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%
Outcome measures
| Measure |
Total Number of Participants Completing a DXA Scan
n=95 Participants
Total number of participants completing a DXA scan
|
Waitlist Control Group
Participants will receive the intervention after a 16-week waiting period
|
|---|---|---|
|
Eligibility Rate
|
46 Participants
|
—
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: Adherence is ONLY calculated for the intervention group.
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%
Outcome measures
| Measure |
Total Number of Participants Completing a DXA Scan
n=20 Participants
Total number of participants completing a DXA scan
|
Waitlist Control Group
Participants will receive the intervention after a 16-week waiting period
|
|---|---|---|
|
Intervention Adherence
|
17 Participants
|
—
|
SECONDARY outcome
Timeframe: 8 monthsRetention 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.
Outcome measures
| Measure |
Total Number of Participants Completing a DXA Scan
n=20 Participants
Total number of participants completing a DXA scan
|
Waitlist Control Group
n=20 Participants
Participants will receive the intervention after a 16-week waiting period
|
|---|---|---|
|
Retention Rate
|
17 Participants
|
18 Participants
|
Adverse Events
Intervention Group
Waitlist Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Karen M Basen-Engquist
The University of Texas MD Anderson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place