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

NCT ID: NCT01343238

Last Updated: 2016-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2011-06-30

Brief Summary

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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

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Diet

12 week diet modification intervention by dietician

Group Type EXPERIMENTAL

Diet

Intervention Type BEHAVIORAL

12 week diet behavior modification

Exercise

12 week physical exercise modification intervention by physical therapist

Group Type EXPERIMENTAL

Exercise

Intervention Type BEHAVIORAL

12 week exercise behavioral intervention

Diet and Exercise

12 week diet and exercise behavioral modification by dietician and physical therapist

Group Type EXPERIMENTAL

Diet and Exercise

Intervention Type BEHAVIORAL

12 week diet and exercise behavioral modification intervention

Control

Standard procedure

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Diet

12 week diet behavior modification

Intervention Type BEHAVIORAL

Exercise

12 week exercise behavioral intervention

Intervention Type BEHAVIORAL

Diet and Exercise

12 week diet and exercise behavioral modification intervention

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The Swedish Research Council

OTHER_GOV

Sponsor Role collaborator

Swedish Council for Working Life and Social Research

OTHER

Sponsor Role collaborator

Göteborg University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anna Winkvist, PhD

Role: PRINCIPAL_INVESTIGATOR

The Unviersity of Gothenburg

Locations

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The University of Gothenburg

Gothenburg, , Sweden

Site Status

Countries

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Sweden

References

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Brekke HK, Bertz F, Rasmussen KM, Bosaeus I, Ellegard L, Winkvist A. Diet and exercise interventions among overweight and obese lactating women: randomized trial of effects on cardiovascular risk factors. PLoS One. 2014 Feb 7;9(2):e88250. doi: 10.1371/journal.pone.0088250. eCollection 2014.

Reference Type DERIVED
PMID: 24516621 (View on PubMed)

Hagberg LA, Brekke HK, Bertz F, Winkvist A. Cost-utility analysis of a randomized controlled weight loss trial among lactating overweight/obese women. BMC Public Health. 2014 Jan 15;14:38. doi: 10.1186/1471-2458-14-38.

Reference Type DERIVED
PMID: 24428802 (View on PubMed)

Winkvist A, Bertz F, Ellegard L, Bosaeus I, Brekke HK. Metabolic risk profile among overweight and obese lactating women in Sweden. PLoS One. 2013 May 7;8(5):e63629. doi: 10.1371/journal.pone.0063629. Print 2013.

Reference Type DERIVED
PMID: 23667649 (View on PubMed)

Bertz F, Brekke HK, Ellegard L, Rasmussen KM, Wennergren M, Winkvist A. Diet and exercise weight-loss trial in lactating overweight and obese women. Am J Clin Nutr. 2012 Oct;96(4):698-705. doi: 10.3945/ajcn.112.040196. Epub 2012 Sep 5.

Reference Type DERIVED
PMID: 22952179 (View on PubMed)

Other Identifiers

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FAS Dnr: 2006-0339

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

K2009-70X-21091-01-3

Identifier Type: -

Identifier Source: org_study_id

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