Clinical trial NCT01343238: Short- and Longterm Effects of Physical Activity and Dietary Restriction Postpartum
Official title: Short- and Longterm Effects of Physical Activity and Dietary Restriction Postpartum on Women's Weight and Body Composition: a Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: obesity
diet
exercise
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: The Swedish Research Council
name: Swedish Council for Working Life and Social Research
First posted: 2011-04-28
Enrollment: 76
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Body weight
timeFrame: 12 weeks
Secondary outcomes:
measure: body composition
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: The University of Gothenburg
Study officials:
affiliation: The Unviersity of Gothenburg
name: Anna Winkvist, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.