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Completed

NCT Number: NCT01343238

Short- and Longterm Effects of Physical Activity and Dietary Restriction Postpartum

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.

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The University of Gothenburg

Gothenburg, 40530, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diet

Behavioral

12 week diet behavior modification

Exercise

Behavioral

12 week exercise behavioral intervention

Diet and Exercise

Behavioral

12 week diet and exercise behavioral modification intervention

Primary outcomes

  1. Body weight

    Time frame: 12 weeks

    Weight loss after 12 weeks intervention

Secondary outcomes

  1. body composition

    Time frame: 12 weeks

    Change in body composition after 12 weeks intervention

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Collaborators

  • Swedish Council for Working Life and Social Research
  • The Swedish Research Council

Registry information

Official study title

Short- and Longterm Effects of Physical Activity and Dietary Restriction Postpartum on Women's Weight and Body Composition: a Randomized Study

Acronym: LEVA

Important dates

Study start
2007
Primary completion
2010
Study completion
2011
First posted
Apr 28, 2011
Registry last updated
Sep 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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