Skip to content

The DAMA25 study: A physical activity and dietary intervention in young women with breast cancer family history

The DAMA25 study: A non-randomized behavioural intervention to modify physical activity and dietary habits in healthy young women with breast cancer family history with a pre-post evaluation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN54262307
Enrollment
100
Registered
2017-05-18
Start date
2016-01-20
Completion date
Unknown
Last updated
2022-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer Cancer Breast cancer

Interventions

After a baseline visit in which blood samples, anthropometric measurements, dietary and lifestyle information are collected, participants begin dietary and physical activity interventions for 12 month
energy balance, readiness to change. Participant are also invited to 6 practical cooking sessions, led by a professional cook and by a study dietician, in an appropriate facility. Dishes are prepared

Sponsors

Cancer Research and Prevention Institute (ISPO)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Healthy pre-menopausal women aged 25-49 years 2. Residing in the metropolitan Florence area 3. Positive cancer family history assessed in the frame of the Genetic Counselling Service of ISPO (Cancer Research and Prevention Institute)

Exclusion criteria

Exclusion criteria: 1. Post-menopausal status 2. Diabetes and/or other major co-morbidities that could affect the possibility to follow the intervention protocol (major cardiovascular disease, severe hip or knee osteoarthritis) 3. Previous diagnosis of breast cancer or other malignancies

Design outcomes

Secondary

MeasureTime frame
No secondary outcome measures

Primary

MeasureTime frame
1. Consumption of a series of foods (g/day) will be assessed by means of the FFQ specifically developed for the Italian component of the European Prospective Investigation into Cancer and nutrition (EPIC) study at baseline and 12 months 2. Reported physical activity in leisure time both in household and recreational activities (hours /week) is assessed using a lifestyle questionnaire developed for the purpose of this study at baseline and 12 months 3. Weight, waist and hip circumference and body composition (fat mass and fat- free mass) will be measured by trained personnel using a standard protocol at baseline and 12 months

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026