NCT04125914Active, not recruiting
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
Source: ClinicalTrials.gov · Last updated 6 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 384 (estimated)
- First submitted
- 6 May 2019
- Start date
- 26 Jan 2017
- Primary completion date
- 30 Apr 2028
- Lead sponsor
- M.D. Anderson Cancer Center
- Diseases
- Ovarian cancer
- NCT number
- NCT04125914
What you commit to
- Study type: Interventional
- Planned participants: 384
- From 26 Jan 2017 to the primary completion date, 30 Apr 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently receiving radiation therapy or cytotoxic chemotherapy.
- Within 3 months of major surgery.
Other illness
- HEALTH4CPC only: Persons diagnosed with any invasive cancer excluding non-melanoma skin cancer.
- HEALTH4CPC only: Patient at high risk for cancer.
Other
- Unable to walk without crutches, walker, cane, or other assistive device.
- Women who are pregnant or nursing (by self-report).
- Does not live in the United States.
- HEALTH4CPC only: Participated in the HEALTH 4 MD Anderson pilot study (protocol 2014-0230).
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| M D Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.