Dietary Intervention, Gestational Weight Gain and Gestational Diabetes.

Study Overview
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Brief Summary
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The aim of this pilot study is to conduct a dietary intervention for overweight (body maas index BMI≥25) and obese (BMI≥30) pregnant women in two maternity care clinics and explore the effect of the intervention on gestational weight gain and the prevalence of gestational diabetes between the intervention and control groups.

Detailed Description
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Half of the women are allocated to the intervention group and another half for the control group. The intervention group will get written material of healthy diet during pregnancy as well as emphasized nutritional guidance given by public health nurses at each visit in the maternity care clinic. There will also be two group meetings with a dietitian. The control group will get the same written material, but otherwise basic care and guidance at each visit in the maternity care clinics. The collected data of both groups include the information on weight gain, the result of an oral glucose tolerance test and 4 day food records, Three factor eating questionnaire (TFEQ R-18) and Binge Eating Scale (BES).

Official Title
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Intervention Study on Dietary Changes in Relation to Weight Gain and Prevalence of Gestational Diabetes During Pregnancy

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

Intervention / Treatment
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* Behavioral: Dietary intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age less than 35 years BMI 25 or over healthy, no chronic medical conditions singleton pregnancy first trimester of pregnancy at the time of recruitment Exclusion Criteria: Age 35 and older 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
Maximum Age: 35 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: Non-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. Intervention group will receive written material on healthy diet during pregnancy, nutritional guidance given by public health nurses at each maternity care clinic visit and group meeting with dietician x2. | Behavioral: Dietary intervention<br>* Written material on healthy diet during pregnancy, dietary counseling at each maternity clinic visit given by public health nurse, group meeting with a dietician x2.<br>|
| No Intervention: Control group<br>The control group will receive written material on healthy diet during pregnancy, otherwise basic care and guidance 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 1st trimester of pregnancy until childbirth, measured at each maternity clinic visit | from first to third trimester of pregnancy, gestational weeks | 

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) | gestational weeks 12-16 | 
| eating habits | eating habits are measured by 4 day food records | 1st, 2nd and 3rd trimester of pregnancy, gestational weeks | 
| eating habits | Eating habits are measured by TFEQ R-18 questionnaire | 1st, 2nd and 3rd trimester, gestational weeks | 
| Eating habits | Eating habits are measured by Binge Eating Scale (BES) | 1st, 2nd and 3rd trimester, gestational weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dietary intervention, gestational weight gain, gestational diabetes, overweight, obesity