Effect of Exercise Training on Breastmilk Composition (MILKSHAKE)

Norwegian University of Science and Technology

Status: Enrolling

Conditions: Obesity

Treatments: Behavioral: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT05488964

479236

Details and patient eligibility

About

The aim of this trial is to investigate whether regular endurance exercise during the lactation period will influence breastmilk composition among individuals with overweight/obesity, and secondarily to assess if such changes impact the growth and health of the infants.

Enrollment: 62 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female
• Aged 18 years or older
• Body mass index ≥ 25 kg/m2 pre-pregnancy and/or BMI ≥ 28 kg/m2 postpartum
• Given birth to a singleton term (after 37 weeks + 0 days) baby
• 6-7 weeks postpartum at time of inclusion
• Exclusively breastfeeding the baby (no other foods are given) and intend to continue this practice for ≥ 8 weeks at inclusion
• Understands oral and written Norwegian

Exclusion criteria

• On-going pregnancy
• Known type 1 or type 2 diabetes
• Known cardiovascular disease
• High intensity exercise more than twice weekly the last three months before inclusion and/or an intention to start regular endurance training within the next 8 weeks at baseline

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

Exercise

Experimental group

Description:

Regular endurance training for 8 weeks

Treatment:

Behavioral: Exercise

Control

No Intervention group

Description:

Habitual living for 8 weeks