Clinical trial · Interventional
Group-Based Lifestyle Intervention in Measuring Biomarker Levels in Participants at High Risk for Breast Cancer
Diet, Exercise and Estrogen Metabolites Study (DEEM)
NCT01874184CI-TRIAL-00020599DEEMcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This randomized clinical trial studies a group-based lifestyle intervention or usual care in measuring biomarker levels in participants at high risk for breast cancer. Studying the effects that changes to daily eating and exercise habits can have on the body's hormone levels and the body's ability to activate proteins may help doctors identify interventions for individuals at high risk for breast cancer.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Atypical Ductal Breast Hyperplasia | Breast Atypical Ductal Hyperplasia | ALIAS | 0.90 |
| Atypical Lobular Breast Hyperplasia | Breast Atypical Lobular Hyperplasia | ALIAS | 0.90 |
| BRCA1 Mutation Carrier | — | UNRESOLVED | — |
| BRCA2 Mutation Carrier | — | UNRESOLVED | — |
| Ductal Breast Carcinoma in Situ | Breast Ductal Carcinoma In Situ | ALIAS | 0.90 |
| Lobular Breast Carcinoma in Situ | Breast Lobular Carcinoma In Situ | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| behavioral dietary intervention | Behavioral | — | UNRESOLVED |
| counseling intervention | Other | — | UNRESOLVED |
| exercise intervention | Behavioral | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (DEEM intervention)
- description
- Participants take part in weekly 2-hour group counseling sessions for 6 months with taper beginning at 3 months. Group sessions include education, group process, and experiential learning on the benefits of physical activity, balanced nutrition, and mindfulness techniques. Participants set goals for changing their dietary habits with the help of a mental health counselor and are also encouraged to exercise 3-4 times per week, including experiential group activities such as brisk walking, yoga, Zumba, and group fitness.
- interventionNames
- Other: counseling intervention
- Behavioral: behavioral dietary intervention
- Behavioral: exercise intervention
- Other: questionnaire administration
- Other: laboratory biomarker analysis
- type
- NO_INTERVENTION
- label
- Arm II (usual care)
- description
- Participants receive their usual care and are provided with study materials on healthy diet and exercise at the end of the study.
Primary outcomes (9)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 35 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Women will be considered at high risk for developing breast cancer if they fulfill one of the following criteria: * A Gail model risk of \>= 1.7% over 5 * Claus model lifetime risk of \> 20% * Tyrer-Cuzick model lifetime risk \> 20% * Personal history of breast biopsy showing atypical ductal hyperplasia (ADH), atypical lobular hyperplasia (ALH) or lobular carcinoma in situ (LCIS) * Ductal carcinoma in situ (DCIS) that has been previously treated; patients must be at least 2 months from completion of primary therapy not currently on hormonal therapy * Deleterious mutation in breast cancer (BRCA)1 or BRCA2 another gene known to increase the risk of developing breast cancer * Risk assessment of 20% chance or greater of carrying a BRCA1/2 gene mutation; the BRCAPRO model will be used to assess this risk * Body mass index (BMI) * For postmenopausal women: a BMI of \> 28 and \< 40 * For premenopausal women: a BMI of \> 25 and \< 40 * Willingness to provide informed consent * Physically able to undertake a moderate exercise program (assessed at the clinic visit) * Participant has the ability to attend weekly group counseling sessions and subsequent clinic visits * Participant has the ability to communicate in English * Participant agrees to be randomly assigned Exclusion Criteria: * Women who are currently engaged in more than 90 min of moderate to vigorous exercise per week at the time of recruitment * Alcohol/drug abuse or significant mental illness, as assessed by study personnel * Previous diagnosis of invasive cancer within the past 5 years (in situ breast cancer and simple basal or squamous cell carcinoma not included) * Plans to leave the geographic area within six months * Contraindications for treadmill testing or entry into a training program * Pregnant women or women planning to be pregnant in the following year will not be admitted in to the study
References
Publications (1)
- DERIVEDStone SA, Han CJ, Senn T, Korde LA, Allott K, Reding S, Whittington D, Reding KW. Sex Hormones in Women With Elevated Breast Cancer Risk Undergoing Weight Loss. West J Nurs Res. 2019 Nov;41(11):1602-1622. doi: 10.1177/0193945918820672. Epub 2019 Jan 7. PMID 30616442