Obesity, Overweight
Conditions
Keywords
diet, lifestyle
Brief 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.
Interventions
BEHAVIORALDietary Intervention
Sponsors
Göteborg University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
\* BMI at 10 w postpartum \>= 27.0
Exclusion criteria
\*Serious disease in mother or child
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| body weight | 1 and 2 yrs post intervention start |
Secondary
| Measure | Time frame |
|---|---|
| Cost-effectiveness | 1 and 2 years post intervention start |
Other
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life as measured by two validated scales | 1 and 2 yrs after intervention start | Participants fill in EQ-5D, which is a validated scale often used to calculate QoL |
| Reported dietary intake | 1 and 2 yrs post intervention start | Reported dietary intake by 24 hr recall |
| Quality of Life as measured by SF-36 | 1 and 2 years after intervention start | participants fill in SF-36, which is a validated scale, to calculate QoL |
| TLC, Transformative Lifestyle Change | At start and end of intervention | Questions on TLC |
| Physical activity | 1 yr after start of intervention | Step counter worn during 5 days |
Countries
Sweden
Outcome results
None listed