Clinical trial · Interventional
Weight Management and Health Behavior Intervention in Lowering Cancer Risk for BRCA Positive and Lynch Syndrome Families
HEALTH4Families: Optimizing a Weight Management and Health Behavior Intervention for BRCA+ and Lynch Syndrome Families
NCT04125914CI-TRIAL-00108483active not recruitingN/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 trial studies how well weight management and health behavior intervention works in helping patients with hereditary breast and ovarian cancer and Lynch syndrome mutation carriers lose or maintain a healthy weight and lower their risk for cancer. Lifestyle behaviors such as physical activity, diet, and weight management may play a key role in preventing cancers and improving outcomes even in those with hereditary cancer syndromes.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hereditary Breast Carcinoma | Hereditary Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Hereditary Ovarian Carcinoma | Hereditary Ovarian Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Lynch Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Behavioral Dietary Intervention | Behavioral | — | UNRESOLVED |
| Other | — | UNRESOLVED | |
| Exercise Intervention | Behavioral | — | UNRESOLVED |
| Health Promotion and Education | Other | — | UNRESOLVED |
| Internet-Based Intervention | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Telephone-Based Intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Prevention (weight management, health behavior intervention)
- description
- Participants undergo weight management and health behavior intervention with a combination of 4 components for 16 weeks. TELEPHONE COACHING: Participants receive 1 phone call each week from a coach over 30-45 minutes to discuss diet, physical activity and goal setting. EMAIL COACHING: Participants receive 1 phone call to discuss the process over 10-15 minutes and then receive 1 email each week for 16 weeks. NO COACHING: Participants receive 1 phone call the first week over 10-15 minutes to discuss the process. TEXT MESSAGING: Participants receive 7-12 text messages comprising information about diet and physical activity each week for 16 weeks. SELF-MONITORING: Participants record their food intake and weight directly into the Fitbit website or application 4-7 days each week or 1 day each week for 16 weeks. FAMILY TEAM INTERVENTION: Participants receive 2 group phone calls and join a Facebook group that is monitored by research staff where they can interact with each other and coaches.
- interventionNames
- Behavioral: Behavioral Dietary Intervention
- Other: E-mail
- Behavioral: Exercise Intervention
- Other: Health Promotion and Education
- Other: Internet-Based Intervention
- Other: Questionnaire Administration
- Behavioral: Telephone-Based Intervention
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * HEALTH4Families only: Positive for either HBOC or LS predisposing mutations OR a family member of a mutation carrier (family members do not need to be biological relatives). * HEALTH4Families only: Index participant ONLY: Must have at least one family member who is eligible and consents to participation. * Have at least one of the following risk factors: * Body mass index (BMI) of 25 or higher * \< 5 servings of vegetables and fruits per day * \< 150 minutes per week of moderate intensity activity * 75 minutes per week of vigorous intensity activity * Able to read and write English. * Have a cellular telephone and are able and willing to send and receive text messages. * Access to internet via desktop or mobile device. * Capable of participating in moderate-vigorous unsupervised exercise. * HEALTH4CPC only: Patient in MD Anderson's Cancer Prevention Center coming in to the clinic for one of the following appointment types: consult and new patient screening appointments * HEALTH4CPC only: Female. * HEALTH4CPC only: Lives in the Houston area or surrounding counties (within 150 miles of MD Anderson's main campus). * HEALTH4CPC only: Has a smartphone. Exclusion Criteria: * Unable to walk without crutches, walker, cane, or other assistive device. * Women who are pregnant or nursing (by self-report). * Currently receiving radiation therapy or cytotoxic chemotherapy. * Within 3 months of major surgery. * Does not live in the United States. * HEALTH4CPC only: Persons diagnosed with any invasive cancer excluding non-melanoma skin cancer. * HEALTH4CPC only: Patient at high risk for cancer. * HEALTH4CPC only: Participated in the HEALTH 4 MD Anderson pilot study (protocol 2014-0230).
References
Publications (0)
Data not yet available
No reference posted for this study.