Trial Outcomes & Findings for Lifestyle Intervention for the Reduction of Breast Cancer Risk in Normal Weight Women (NCT NCT04267796)

Last Updated: 2026-08-12

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%

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

Target enrollment

40 participants

Primary outcome timeframe

4 months

Results posted on

2026-08-12

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

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

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

PRIMARY outcome

Timeframe: 4 months

Population: Eligibility rate will be calculated as the number of eligible women identified divided by the total number completing a DXA scan.

Outcome measures

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 months

Population: 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

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 months

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.

Outcome measures

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

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Waitlist Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

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

Phone: 713-745-3123

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

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=1 Participants	0 Participants n=1 Participants	0 Participants n=1 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=1 Participants	18 Participants n=1 Participants	36 Participants n=1 Participants
Age, Categorical >=65 years	2 Participants n=1 Participants	2 Participants n=1 Participants	4 Participants n=1 Participants
Sex: Female, Male Female	20 Participants n=1 Participants	20 Participants n=1 Participants	40 Participants n=1 Participants
Sex: Female, Male Male	0 Participants n=1 Participants	0 Participants n=1 Participants	0 Participants n=1 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=1 Participants	1 Participants n=1 Participants	3 Participants n=1 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=1 Participants	19 Participants n=1 Participants	37 Participants n=1 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=1 Participants	0 Participants n=1 Participants	0 Participants n=1 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=1 Participants	0 Participants n=1 Participants	0 Participants n=1 Participants
Race (NIH/OMB) Asian	6 Participants n=1 Participants	6 Participants n=1 Participants	12 Participants n=1 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=1 Participants	0 Participants n=1 Participants	0 Participants n=1 Participants
Race (NIH/OMB) Black or African American	0 Participants n=1 Participants	1 Participants n=1 Participants	1 Participants n=1 Participants
Race (NIH/OMB) White	14 Participants n=1 Participants	12 Participants n=1 Participants	26 Participants n=1 Participants
Race (NIH/OMB) More than one race	0 Participants n=1 Participants	1 Participants n=1 Participants	1 Participants n=1 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=1 Participants	0 Participants n=1 Participants	0 Participants n=1 Participants
Region of Enrollment United States	20 participants n=1 Participants	20 participants n=1 Participants	40 participants n=1 Participants