Trials / Completed
CompletedNCT01949558
Randomized Controlled Trial of Lifestyle Intervention Postpartum in Primary Health Care
From Efficacy to Effectiveness: Randomized Controlled Trial of Lifestyle Intervention Postpartum Among Overweight and Obese Women Within Primary Health Care in the Vastra Gotaland Region
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 110 (actual)
- Sponsor
- Göteborg University · Academic / Other
- Sex
- Female
- Age
- —
- Healthy volunteers
- Not accepted
Summary
Chronic diseases such as overweight and cardiovascular diseases represent important threats to women's health. Pregnancy and lactation are associated with changes in weight, body composition and lipid metabolism and affect the risk of developing these chronic illnesses. Our group has conducted a randomized clinical trial (LEVA) to evaluate overweight/obese women's ability to make longterm lifestyle changes during the postpartum (pp) period, under ideal study conditions. Physiological mechanisms for weight reduction were investigated with precise methodology. However, effectiveness studies under different conditions are crucial for the development of effective programs for the Primary Health Care sector. Hence, the interest for translational research that brings results from clinical trials to the Primary Health Care sector has increased. The aim of this effectiveness-study is to investigate if dietary restrictions pp lead to significantly greater weight reduction among overweight/obese women, compared to no intervention, in a longterm perspective. In total 106 women will be recruited 10 wk pp and randomized into 1) control group; 2) dietary restrictions in individualized intervention during 12 wks. One and two years pp long term effects are evaluated. Positive results may be integrated into usual practice after the study ends.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Dietary Intervention |
Timeline
- Start date
- 2012-12-01
- Primary completion
- 2017-09-01
- Completion
- 2017-09-01
- First posted
- 2013-09-24
- Last updated
- 2019-09-19
Locations
2 sites across 1 country: Sweden
Source: ClinicalTrials.gov record NCT01949558. Inclusion in this directory is not an endorsement.