Short- and Longterm Effects of Physical Activity and Dietary Restriction Postpartum (LEVA)

This study has been completed.
Sponsor:
Collaborators:
The Swedish Research Council
Swedish Council for Working Life and Social Research
Information provided by (Responsible Party):
Göteborg University
ClinicalTrials.gov Identifier:
NCT01343238
First received: April 26, 2011
Last updated: August 29, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Obesity
Behavioral: Diet
Behavioral: Exercise
Behavioral: Diet and Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Short- and Longterm Effects of Physical Activity and Dietary Restriction Postpartum on Women's Weight and Body Composition: a Randomized Study

Resource links provided by NLM:


Further study details as provided by Göteborg University:

Primary Outcome Measures:
  • Body weight [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Weight loss after 12 weeks intervention


Secondary Outcome Measures:
  • body composition [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change in body composition after 12 weeks intervention


Enrollment: 76
Study Start Date: May 2007
Study Completion Date: June 2011
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diet
12 week diet modification intervention by dietician
Behavioral: Diet
12 week diet behavior modification
Experimental: Exercise
12 week physical exercise modification intervention by physical therapist
Behavioral: Exercise
12 week exercise behavioral intervention
Experimental: Diet and Exercise
12 week diet and exercise behavioral modification by dietician and physical therapist
Behavioral: Diet and Exercise
12 week diet and exercise behavioral modification intervention
No Intervention: Control
Standard procedure

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01343238

Locations
Sweden
The University of Gothenburg
Gothenburg, Sweden, 40530
Sponsors and Collaborators
Göteborg University
The Swedish Research Council
Swedish Council for Working Life and Social Research
Investigators
Principal Investigator: Anna Winkvist, PhD The Unviersity of Gothenburg
  More Information

No publications provided by Göteborg University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT01343238     History of Changes
Other Study ID Numbers: K2009-70X-21091-01-3, FAS Dnr: 2006-0339
Study First Received: April 26, 2011
Last Updated: August 29, 2012
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Göteborg University:
obesity
diet
exercise

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014