Randomized Controlled Trial of Lifestyle Intervention Postpartum in Primary Health Care (LIV)

Göteborg University

Status: Completed

Conditions: Overweight; Obesity

Treatments: Behavioral: Dietary Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT01949558

LIV 2011-0193

FORTE LIV (Other Grant/Funding Number)

Details and patient eligibility

About

Chronic diseases such as overweight and cardiovascular diseases represent important threats to women's health. Pregnancy and lactation are associated with changes in weight, body composition and lipid metabolism and affect the risk of developing these chronic illnesses. Our group has conducted a randomized clinical trial (LEVA) to evaluate overweight/obese women's ability to make longterm lifestyle changes during the postpartum (pp) period, under ideal study conditions. Physiological mechanisms for weight reduction were investigated with precise methodology. However, effectiveness studies under different conditions are crucial for the development of effective programs for the Primary Health Care sector. Hence, the interest for translational research that brings results from clinical trials to the Primary Health Care sector has increased. The aim of this effectiveness-study is to investigate if dietary restrictions pp lead to significantly greater weight reduction among overweight/obese women, compared to no intervention, in a longterm perspective. In total 106 women will be recruited 10 wk pp and randomized into 1) control group; 2) dietary restrictions in individualized intervention during 12 wks. One and two years pp long term effects are evaluated. Positive results may be integrated into usual practice after the study ends.

Enrollment: 110 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria * BMI at 10 w postpartum >= 27.0

Exclusion Criteria

*Serious disease in mother or child

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

Control group

No Intervention group

Description:

The control group receives a brochure on healthy dietary habits according to regular care.

Dietary intervention

Experimental group

Description:

12 week individual intervention based on a cognitive behavioral approach. It includes dietary restriction under guidance by a dietitian. Thereafter monthly follow-up takes place via email during the following 9 mo.

Treatment:

Behavioral: Dietary Intervention