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Clinical Trials/NCT04690907
NCT04690907
Completed
N/A

Dietary Intervention for Obese Pregnant Women - a Randomized Controlled Trial

University of Eastern Finland2 sites in 1 country33 target enrollmentDecember 3, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Dietary Habits
Sponsor
University of Eastern Finland
Enrollment
33
Locations
2
Primary Endpoint
Gestational weight gain (GWG)
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The aim of this rct -study is to explore the effect of a dietary intervention for overweight (body maas index BMI≥25) and obese (BMI≥30) pregnant women on gestational weight gain and the prevalence of gestational diabetes.

Detailed Description

Pregnant women are recruited for the study from 18 maternity care clinics in Northern Savo and Northern Karelia area. The participants will be randomized into intervention and control groups. All the participants will have access to the study web-pages, which includes written material of healthy diet during pregnancy as well as all the study material (4 day food records, Three factor eating questionnaire (TFEQ R-18) and Binge Eating Scale (BES)). In addition, intervention group will get two virtual dietary counseling sessions by a dietician. The information on participants' gestational weight gain and the result of oral glucose tolerance tests will be collected by the public health nurses after birth.

Registry
clinicaltrials.gov
Start Date
December 3, 2020
End Date
December 31, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Reeta Lamminpää

Post doctoral researcher

University of Eastern Finland

Eligibility Criteria

Inclusion Criteria

  • BMI 25 or higher
  • healthy, no chronic medical conditions that can prevent participating to the study
  • singleton pregnancy
  • first trimester of pregnancy at the time of recruitment

Exclusion Criteria

  • BMI less than 25
  • chronic medical conditions
  • multiple pregnancy
  • pregnancy at second or third trimester at the time of recruitment

Outcomes

Primary Outcomes

Gestational weight gain (GWG)

Time Frame: immediately after the intervention

gestational weight gain (from pre-pregnancy weight until childbirth), measured at maternity care clinic.

Secondary Outcomes

  • Gestational diabetes mellitus (GDM)(immediately after the intervention)
  • Eating habits II(During the intervention up to gestational weeks 37-42)
  • Eating habits I(During the intervention up to gestational weeks 36-37)
  • Eating habits III(During the intervention up to gestational weeks 37-42)

Study Sites (2)

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