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

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Behavioral: Exercise; Behavioral: Diet; Behavioral: Diet and Exercise

• Registration Number: NCT01343238
• Lead Sponsor: Göteborg University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05
• Primary Completion: 2010-08
• Study First Submitted: 2011-04-26
• Study First Submitted QC: 2011-04-27
• Study First Posted: 2011-04-28
• Study Completion: 2011-06
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-08
• Last Update Posted: 2016-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 76

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

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Exercise	Exercise	12 week physical exercise modification intervention by physical therapist
Diet	Diet	12 week diet modification intervention by dietician
Diet and Exercise	Diet and Exercise	12 week diet and exercise behavioral modification by dietician and physical therapist

Primary Outcome Measures

Name	Time	Method
Body weight	12 weeks	Weight loss after 12 weeks intervention

Secondary Outcome Measures

Name	Time	Method
body composition	12 weeks	Change in body composition after 12 weeks intervention

Trial Locations

Locations (1)

The University of Gothenburg; 🇸🇪 Gothenburg, Sweden