Clinical trial NCT01949558: Randomized Controlled Trial of Lifestyle Intervention Postpartum in Primary Health Care
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Keywords: diet
lifestyle
Lead sponsor: Göteborg University
Sponsor class: OTHER
First posted: 2013-09-24
Enrollment: 110
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria \* BMI at 10 w postpartum \>= 27.0

Exclusion Criteria

\*Serious disease in mother or child

Primary outcomes:
measure: body weight
timeFrame: 1 and 2 yrs post intervention start
Secondary outcomes:
measure: Cost-effectiveness
timeFrame: 1 and 2 years post intervention start
Other outcomes:
measure: Reported dietary intake
timeFrame: 1 and 2 yrs post intervention start
measure: Physical activity
timeFrame: 1 yr after start of intervention
measure: Quality of Life as measured by two validated scales
timeFrame: 1 and 2 yrs after intervention start
measure: TLC, Transformative Lifestyle Change
timeFrame: At start and end of intervention
measure: Quality of Life as measured by SF-36
timeFrame: 1 and 2 years after intervention start
Locations:
city: Gothenburg
country: Sweden
facility: Närhälsan Majorna
city: Lerum
country: Sweden
facility: Antenatal and child care
Study officials:
References:
citation: 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.
citation: 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.