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OpenTrials
Completed

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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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Närhälsan Majorna, Gothenburg, Sweden

Loading trial locations.

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

Dietary intervention

Behavioral

Primary outcomes

  1. body weight

    Time frame: 1 and 2 yrs post intervention start

Secondary outcomes

  1. Cost-effectiveness

    Time frame: 1 and 2 years post intervention start

Other outcomes

  1. Reported dietary intake

    Time frame: 1 and 2 yrs post intervention start

    Reported dietary intake by 24 hr recall

  2. Physical activity

    Time frame: 1 yr after start of intervention

    Step counter worn during 5 days

  3. 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

  4. TLC, Transformative Lifestyle Change

    Time frame: At start and end of intervention

    Questions on TLC

  5. 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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