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

NCT01343238 | Completed

• 2 other identifiers: K2009-70X-21091-01-3FAS Dnr: 2006-0339
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

obesity; diet; exercise

Outcome Measures

Primary Outcomes (1)

• Body weight

  Weight loss after 12 weeks intervention

  12 weeks

Secondary Outcomes (1)

• body composition

  12 weeks

Study Arms (4)

Diet

EXPERIMENTAL

12 week diet modification intervention by dietician

Behavioral: Diet

Exercise

EXPERIMENTAL

12 week physical exercise modification intervention by physical therapist

Behavioral: Exercise

Diet and Exercise

EXPERIMENTAL

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

Behavioral: Diet and Exercise

Control

NO INTERVENTION

Standard procedure

Interventions

Diet BEHAVIORAL

12 week diet behavior modification

Diet

Exercise BEHAVIORAL

12 week exercise behavioral intervention

Exercise

Diet and Exercise BEHAVIORAL

12 week diet and exercise behavioral modification intervention

Diet and Exercise

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• prepregnant BMI 25-35
• non smoking, single term birth
• intention to breastfeed exclusively for 6 mo

You may not qualify if:

• Diseases or medication in mother or child

Sponsors & Collaborators

• Göteborg University: lead
• The Swedish Research Council: collaborator
• Swedish Council for Working Life and Social Research: collaborator

Study Sites (1)

The University of Gothenburg

Gothenburg, 40530, Sweden

Location

Related Publications (4)

• 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.

  PMID: 24516621 DERIVED

• 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.

  PMID: 24428802 DERIVED

• 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.

  PMID: 23667649 DERIVED

• 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.

  PMID: 22952179 DERIVED

MeSH Terms

Conditions

Obesity; Motor Activity

Interventions

Diet; Exercise

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Anna Winkvist, PhD

  The Unviersity of Gothenburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2011
• First Posted: April 28, 2011
• Study Start: May 1, 2007
• Primary Completion: August 1, 2010
• Study Completion: June 1, 2011
• Last Updated: September 9, 2016

Record last verified: 2016-09

Locations

SE (1)