NCT01949558

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 24, 2013

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

September 19, 2019

Status Verified

September 1, 2019

Enrollment Period

4.8 years

First QC Date

September 20, 2013

Last Update Submit

September 17, 2019

Conditions

OverweightObesity

Keywords

dietlifestyle

Outcome Measures

Primary Outcomes (1)

  • body weight

    1 and 2 yrs post intervention start

Secondary Outcomes (1)

  • Cost-effectiveness

    1 and 2 years post intervention start

Other Outcomes (5)

  • Reported dietary intake

    1 and 2 yrs post intervention start

  • Physical activity

    1 yr after start of intervention

  • Quality of Life as measured by two validated scales

    1 and 2 yrs after intervention start

  • +2 more other outcomes

Study Arms (2)

Control group

NO INTERVENTION

The control group receives a brochure on healthy dietary habits according to regular care.

Dietary intervention

EXPERIMENTAL

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

Interventions

Dietary InterventionBEHAVIORAL
Dietary intervention

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

  • \*Serious disease in mother or child

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Närhälsan Majorna

Gothenburg, 41458, Sweden

Location

Antenatal and child care

Lerum, 44325, Sweden

Location

Related Publications (2)

  • 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.

    PMID: 30621673DERIVED

  • 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.

    PMID: 27413127DERIVED

MeSH Terms

Conditions

OverweightObesity

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2013

First Posted

September 24, 2013

Study Start

December 1, 2012

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

September 19, 2019

Record last verified: 2019-09

Locations

SE(2)