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

Obesity Clinical Trial

— LEVA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01343238
• Other study ID #: K2009-70X-21091-01-3
• Secondary ID: FAS Dnr: 2006-03
• Status: Completed
• Phase: N/A
• First received: April 26, 2011
• Last updated: September 8, 2016
• Start date: May 2007
• Est. completion date: June 2011

Study information

• Verified date: September 2016
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: June 2011
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• Diet
12 week diet behavior modification
• Exercise
12 week exercise behavioral intervention
• Diet and Exercise
12 week diet and exercise behavioral modification intervention

Locations

Country	Name	City	State
Sweden	The University of Gothenburg	Gothenburg

Sponsors (3)

Lead Sponsor	Collaborator
Göteborg University	Swedish Council for Working Life and Social Research, The Swedish Research Council

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight	Weight loss after 12 weeks intervention	12 weeks	No
Secondary	body composition	Change in body composition after 12 weeks intervention	12 weeks	No