Randomized Controlled Trial of Lifestyle Intervention Postpartum in Primary Health Care (LIV)

September 17, 2019 updated by: Göteborg University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Gothenburg, Sweden, 41458
        • Närhälsan Majorna
      • Lerum, Sweden, 44325
        • Antenatal and child care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria * BMI at 10 w postpartum >= 27.0

Exclusion Criteria

*Serious disease in mother or child

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
The control group receives a brochure on healthy dietary habits according to regular care.
Experimental: Dietary intervention
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.
Behavioral: Dietary Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
body weight
Time Frame: 1 and 2 yrs post intervention start
1 and 2 yrs post intervention start

Secondary Outcome Measures

Outcome Measure
Time Frame
Cost-effectiveness
Time Frame: 1 and 2 years post intervention start
1 and 2 years post intervention start

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reported dietary intake
Time Frame: 1 and 2 yrs post intervention start
Reported dietary intake by 24 hr recall
1 and 2 yrs post intervention start
Physical activity
Time Frame: 1 yr after start of intervention
Step counter worn during 5 days
1 yr after start of intervention
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
1 and 2 yrs after intervention start
TLC, Transformative Lifestyle Change
Time Frame: At start and end of intervention
Questions on TLC
At start and end of intervention
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
1 and 2 years after intervention start

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Göteborg University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

September 20, 2013

First Submitted That Met QC Criteria

September 20, 2013

First Posted (Estimate)

September 24, 2013

Study Record Updates

Last Update Posted (Actual)

September 19, 2019

Last Update Submitted That Met QC Criteria

September 17, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LIV 2011-0193
  • FORTE LIV (Other Grant/Funding Number: FORTE)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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