Randomized Controlled Trial of Lifestyle Intervention Postpartum in Primary Health Care

Obesity Clinical Trial

— LIV  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01949558
• Other study ID #: LIV 2011-0193
• Secondary ID: FORTE LIV
• Status: Completed
• Phase: N/A
• Start date: December 2012
• Est. completion date: September 2017

Study information

• Verified date: September 2019
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria * BMI at 10 w postpartum >= 27.0

Exclusion Criteria

*Serious disease in mother or child

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Behavioral:
• Dietary Intervention

Locations

Country	Name	City	State
Sweden	Närhälsan Majorna	Gothenburg
Sweden	Antenatal and child care	Lerum

Sponsors (1)

Lead Sponsor	Collaborator
Göteborg University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Reported dietary intake	Reported dietary intake by 24 hr recall	1 and 2 yrs post intervention start
Other	Physical activity	Step counter worn during 5 days	1 yr after start of intervention
Other	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
Other	TLC, Transformative Lifestyle Change	Questions on TLC	At start and end of intervention
Other	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
Primary	body weight		1 and 2 yrs post intervention start
Secondary	Cost-effectiveness		1 and 2 years post intervention start