Clinical Trials Directory

Trials / Completed

CompletedNCT01343238

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
76 (actual)
Sponsor
Göteborg University · Academic / Other
Sex
Female
Age
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALDiet12 week diet behavior modification
BEHAVIORALExercise12 week exercise behavioral intervention
BEHAVIORALDiet and Exercise12 week diet and exercise behavioral modification intervention

Timeline

Start date
2007-05-01
Primary completion
2010-08-01
Completion
2011-06-01
First posted
2011-04-28
Last updated
2016-09-09

Locations

1 site across 1 country: Sweden

Source: ClinicalTrials.gov record NCT01343238. Inclusion in this directory is not an endorsement.