Intervention, Dietary, Diabetes, Pregnancy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Dietary Intervention for Obese Pregnant Women - a Randomized Controlled Trial

Conditions
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Dietary Habits, Obesity, Gestational Diabetes, Gestational Weight Gain

Intervention / Treatment
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* Behavioral: Dietary intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Intervention group and control group.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>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. | Behavioral: Dietary intervention<br>* Written material on healthy diet during pregnancy and 2 virtual dietary counseling sessions.<br>|
| No Intervention: Control group<br>Written material on healthy diet during pregnancy, otherwise basic care and counseling at maternity care clinics. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational weight gain (GWG) | gestational weight gain (from pre-pregnancy weight until childbirth), measured at maternity care clinic. | immediately after the intervention | 

Secondary Outcome Measures

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