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OverweightLIVNCT01949558

Randomized Controlled Trial of Lifestyle Intervention Postpartum in Primary Health Care

A study testing Dietary Intervention in people with Overweight and Obesity, run by Göteborg University at 2 sites in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Any age, women only
Conditions the study is for
Overweight, Obesity
What is being tested?
Dietary Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
2 sitesSweden
Study dates
Dec 2012to Sep 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • Serious disease in mother or child

Trial locations and contacts

2 sites in 1 country.

Sweden2 sites

  • Närhälsan Majorna

    Gothenburg, 41458

  • Antenatal and child care

    Lerum, 44325

Other trials in Sweden

About this study

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

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.

Conditions
Overweight, Obesity
Keywords
diet, lifestyle
Medical subject headings
Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01949558
Study groupRoleWhat they receive
Control groupNo interventionThe control group receives a brochure on healthy dietary habits according to regular care.
Dietary interventionExperimental12 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.
Receives: Behavioral: Dietary Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. body weight

    Measured: 1 and 2 yrs post intervention start

Secondary outcomes (1)

  1. Cost-effectiveness

    Measured: 1 and 2 years post intervention start

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2013 (estimated)
  2. Study startDec 2012
  3. Primary completionSep 2017
  4. Study completionSep 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01949558
Sponsor's protocol ID
LIV 2011-0193
Other IDs
FORTE LIV
Acronym
LIV
Status last verified
Sep 2019
First submitted
20 Sep 2013
Last updated
19 Sep 2019
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 30621673

  • 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.

    PubMed 27413127

Questions about this trial

What is this clinical trial studying?

A study testing Dietary Intervention in people with Overweight and Obesity, run by Göteborg University at 2 sites in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

body weight (time frame: 1 and 2 yrs post intervention start). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01949558, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2019.

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