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Clinical Trials/NCT01343238
NCT01343238
Completed
Not Applicable

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

Göteborg University1 site in 1 country76 target enrollmentMay 2007
ConditionsObesity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
Göteborg University
Enrollment
76
Locations
1
Primary Endpoint
Body weight
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
May 2007
End Date
June 2011
Last Updated
9 years ago
Study Type
Interventional
Study Design
Factorial
Sex
Female

Investigators

Sponsor
Göteborg University
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Body weight

Time Frame: 12 weeks

Weight loss after 12 weeks intervention

Secondary Outcomes

  • body composition(12 weeks)

Study Sites (1)

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