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

• Register: ISRCTN
• Last refreshed on: 24 October 2022
• Main ID: ISRCTN54262307
• Date of registration: 18/05/2017
• Prospective Registration: No
• Primary sponsor: Cancer Research and Prevention Institute (ISPO)
• Public title: The DAMA25 study: A physical activity and dietary intervention in young women with breast cancer family history
• Scientific title: 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
• Date of first enrolment: 20/01/2016
• Target sample size: 100
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN54262307
• Study type: Interventional
• Study design: Non-randomised interventional study (Prevention)
• Phase: Not Applicable

Countries of recruitment

Italy

Contacts

• Name: Giovanna Masala

Key inclusion & exclusion 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:
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


Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Breast cancer
Cancer
Breast cancer

Intervention(s)

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 months.
Dietary Intervention: Participant are asked to consume a diet mainly based on plant food, with a low glycaemic load, low in saturated and trans-fats and alcohol, and rich in antioxidants. The requested dietary changes are individually discussed. An integrated approach includes individual and group sessions and cooking classes. Study participants are invited to participate to 2 group sessions about: diet, lifestyle and disease prevention; nutritional value of foods; 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 according to specifically designed recipes and then consumed at the end of session. Participants are encouraged to use study recipes as frequently as possible.

Physical activity (PA) intervention: Participants aim to increase moderate daily activities, accounting for 3-5.9 metabolic equivalent (MET) hours/day, such as walking, biking, swimming, ballroom dancing, to be combined with a more strenuous activity. The intervention is based on individual and group training, including practical sessions. The goal is to reach at least 1hour/day of a moderate plus at least 1 hour/week of a more strenuous activity. These aims are discussed and specifically adapted to each participant’s lifestyle. Activities can be split in two daily sessions (e.g. 30 minutes walking at moderate pace +30 minutes fast dancing).
Study participants are invited to participate to 2

Primary Outcome(s)

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

Secondary Outcome(s)

No secondary outcome measures

Secondary ID(s)

N/A

Source(s) of Monetary Support

Corri La Vita ONLUS

Ethics review

Status:
Approval date:
Contact:

Ethics committee of the Local Health Authority, Florence, 30/11/2015.

Results

• Results available: Yes
• Date Completed: 17/11/2017