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

Study Overview
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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.

Official Title
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Short- and Longterm Effects of Physical Activity and Dietary Restriction Postpartum on Women's Weight and Body Composition: a Randomized Study

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Diet
* Behavioral: Exercise
* Behavioral: Diet and Exercise


Participation Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diet<br>12 week diet modification intervention by dietician | Behavioral: Diet<br>* 12 week diet behavior modification<br>|
| Experimental: Exercise<br>12 week physical exercise modification intervention by physical therapist | Behavioral: Exercise<br>* 12 week exercise behavioral intervention<br>|
| Experimental: Diet and Exercise<br>12 week diet and exercise behavioral modification by dietician and physical therapist | Behavioral: Diet and Exercise<br>* 12 week diet and exercise behavioral modification intervention<br>|
| No Intervention: Control<br>Standard procedure | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight | Weight loss after 12 weeks intervention | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body composition | Change in body composition after 12 weeks intervention | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, diet, exercise