NCT Number: NCT01949558
Randomized Controlled Trial of Lifestyle Intervention Postpartum in Primary Health Care
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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Notify MeKey information
Conditions
Sex eligibility
Female
Study type
Interventional
Phase
Not applicable
Primary location
Närhälsan Majorna, Gothenburg, Sweden
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
* BMI at 10 w postpartum >= 27.0
Exclusion criteria
*Serious disease in mother or child
Treatment and study plan
Primary outcomes
-
body weight
Time frame: 1 and 2 yrs post intervention start
Secondary outcomes
-
Cost-effectiveness
Time frame: 1 and 2 years post intervention start
Other outcomes
-
Reported dietary intake
Time frame: 1 and 2 yrs post intervention start
Reported dietary intake by 24 hr recall
-
Physical activity
Time frame: 1 yr after start of intervention
Step counter worn during 5 days
-
Quality of Life as measured by two validated scales
Time frame: 1 and 2 yrs after intervention start
Participants fill in EQ-5D, which is a validated scale often used to calculate QoL
-
TLC, Transformative Lifestyle Change
Time frame: At start and end of intervention
Questions on TLC
-
Quality of Life as measured by SF-36
Time frame: 1 and 2 years after intervention start
participants fill in SF-36, which is a validated scale, to calculate QoL
Sponsors and collaborators
Lead sponsor
Göteborg University
Other
Registry information
Official study 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
Acronym: LIV
Important dates
- Study start
- 2012
- Primary completion
- 2017
- Study completion
- 2017
- First posted
- Sep 24, 2013
- Registry last updated
- Sep 19, 2019
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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