Intervention, Dietary, Diabetes, Pregnancy

Not Applicable

Completed

• Conditions: Gestational Weight Gain; Dietary Habits; Obesity; Gestational Diabetes
• Interventions: Behavioral: Dietary intervention

• Registration Number: NCT04690907
• Lead Sponsor: University of Eastern Finland

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.

Study Timeline

• Study Start: 2020-12-03
• Study First Submitted: 2020-12-03
• Study First Submitted QC: 2020-12-30
• Study First Posted: 2020-12-31
• Primary Completion: 2022-10-31
• Study Completion: 2022-12-31
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 33

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Dietary intervention	Dietary intervention: Written material on healthy diet during pregnancy, 2 virtual dietary counseling sessions given by a dietician. Otherwise basic care and counseling at maternity care clinics.

Primary Outcome Measures

Name	Time	Method
Gestational weight gain (GWG)	immediately after the intervention	gestational weight gain (from pre-pregnancy weight until childbirth), measured at maternity care clinic.

Secondary Outcome Measures

Name	Time	Method
Gestational diabetes mellitus (GDM)	immediately after the intervention	GDM is measured by the result of an oral glucose tolerance test (OGTT)
Eating habits II	During the intervention up to gestational weeks 37-42	Eating habits are measured by TFEQ R-18 questionnaire
Eating habits I	During the intervention up to gestational weeks 36-37	eating habits are measured by 4 day food records
Eating habits III	During the intervention up to gestational weeks 37-42	Eating habits are measured by Binge Eating Scale (BES)

Trial Locations

Locations (2)

Antenatal maternity care clinics (n=6); 🇫🇮 Joensuu, Finland

Antenatal maternity care clinics (n=12); 🇫🇮 Kuopio, Finland