Short- and Longterm Effects of Physical Activity and Dietary Restriction Postpartum (LEVA)

Göteborg University

Status: Completed

Conditions: Obesity

Treatments: Behavioral: Diet and Exercise; Behavioral: Exercise; Behavioral: Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT01343238

K2009-70X-21091-01-3

FAS Dnr: 2006-0339 (Other Grant/Funding Number)

Details and patient eligibility

About

The study will investigate whether physical exercise, or dietary restrictions, or a combination of both, among overweight and obese postpartum women lead to a significantly larger reduction in weight in a longer perspective, compared to similar women not receiving the intervention. The study also will investigate the effects on body composition, cardiovascular fitness, blood lipids, insulin levels and inflammation markers. In total, 68 women with pre-pregnancy BMI 25 - 34.9 will be randomized at 10 wk postpartum into: (1) physical exercise, (2) dietary restrictions, (3) physical exercise + dietary restrictions and (4) control group. The intervention lasts for 12 wk and longterm effects are measured 1 yr after trial initiation. To date only studies showing short term (12 wk) effects exist. Our study is the first to include four intervention groups, so that separate effects of physical activity and dietary restriction and their interaction, can be assessed. Further, the investigators will estimate effects on body composition taking body water into account and estimate total energy expenditure with higher precision than previously. Overweight and obesity is an escalating problem in Sweden. Sustainable weight reduction programs are urgently needed. During the postpartum period, women may be motivated to lose weight. Information aimed at promoting life style changes among overweight and obese women could in a longer perspective be integrated in the regular maternal health care in Sweden.

Enrollment: 76 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• prepregnant BMI 25-35
• non smoking, single term birth
• intention to breastfeed exclusively for 6 mo

Exclusion criteria

• Diseases or medication in mother or child

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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76 participants in 4 patient groups

Diet

Experimental group

Description:

12 week diet modification intervention by dietician

Treatment:

Behavioral: Diet

Exercise

Experimental group

Description:

12 week physical exercise modification intervention by physical therapist

Treatment:

Behavioral: Exercise

Diet and Exercise

Experimental group

Description:

12 week diet and exercise behavioral modification by dietician and physical therapist

Treatment:

Behavioral: Diet and Exercise

Control

No Intervention group

Description:

Standard procedure