Intervention, Dietary, Diabetes, Pregnancy

University of Eastern Finland33 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Dietary Habits Obesity Gestational Diabetes Gestational Weight Gain

Interventions

Dietary interventionBEHAVIORAL

Written material on healthy diet during pregnancy and 2 virtual dietary counseling sessions.

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Antenatal maternity care clinics (n=6)

Joensuu, Finland

Antenatal maternity care clinics (n=12)

Kuopio, Finland

Outcomes

Primary Outcomes

Gestational weight gain (GWG)

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

Time frame: immediately after the intervention

Secondary Outcomes

Gestational diabetes mellitus (GDM)

GDM is measured by the result of an oral glucose tolerance test (OGTT)

Time frame: immediately after the intervention

Eating habits I

eating habits are measured by 4 day food records

Time frame: During the intervention up to gestational weeks 36-37

Eating habits II

Eating habits are measured by TFEQ R-18 questionnaire

Time frame: During the intervention up to gestational weeks 37-42

Eating habits III

Eating habits are measured by Binge Eating Scale (BES)

Time frame: During the intervention up to gestational weeks 37-42

Data from ClinicalTrials.gov

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