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| ID | Type | Description | Link |
|---|---|---|---|
| FORTE LIV | Other Grant/Funding Number | FORTE |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | The control group receives a brochure on healthy dietary habits according to regular care. | |
| Dietary intervention | Experimental | 12 week individual intervention based on a cognitive behavioral approach. It includes dietary restriction under guidance by a dietitian. Thereafter monthly follow-up takes place via email during the following 9 mo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary Intervention | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| body weight | 1 and 2 yrs post intervention start |
| Measure | Description | Time Frame |
|---|---|---|
| Cost-effectiveness | 1 and 2 years post intervention start |
| Measure | Description | Time Frame |
|---|---|---|
| Reported dietary intake | Reported dietary intake by 24 hr recall | 1 and 2 yrs post intervention start |
| Physical activity | Step counter worn during 5 days |
Inclusion Criteria * BMI at 10 w postpartum >= 27.0
Exclusion Criteria
*Serious disease in mother or child
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Närhälsan Majorna | Gothenburg | 41458 | Sweden | |||
| Antenatal and child care |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30621673 | Derived | Hagberg L, Winkvist A, Brekke HK, Bertz F, Hellebo Johansson E, Huseinovic E. Cost-effectiveness and quality of life of a diet intervention postpartum: 2-year results from a randomized controlled trial. BMC Public Health. 2019 Jan 8;19(1):38. doi: 10.1186/s12889-018-6356-y. | |
| 27413127 | Derived | Huseinovic E, Bertz F, Leu Agelii M, Hellebo Johansson E, Winkvist A, Brekke HK. Effectiveness of a weight loss intervention in postpartum women: results from a randomized controlled trial in primary health care. Am J Clin Nutr. 2016 Aug;104(2):362-70. doi: 10.3945/ajcn.116.135673. Epub 2016 Jul 13. |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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| 1 yr after start of intervention |
| Quality of Life as measured by two validated scales | Participants fill in EQ-5D, which is a validated scale often used to calculate QoL | 1 and 2 yrs after intervention start |
| TLC, Transformative Lifestyle Change | Questions on TLC | At start and end of intervention |
| Quality of Life as measured by SF-36 | participants fill in SF-36, which is a validated scale, to calculate QoL | 1 and 2 years after intervention start |
| Lerum |
| 44325 |
| Sweden |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |