Dietary Intervention, Gestational Weight Gain and Gestational Diabetes.

N/ACompletedNCT03191331

University of Eastern Finland13 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Dietary Habits Gestational Diabetes Weight Gain Overweight and Obesity

Interventions

Dietary interventionBEHAVIORAL

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Neulamäki antenatal care clinic

Kuopio, Finland

Pyörö antenatal care clinic

Kuopio, Finland

Outcomes

Primary Outcomes

gestational weight gain (GWG)

gestational weight gain from 1st trimester of pregnancy until childbirth, measured at each maternity clinic visit

Time frame: from first to third trimester of pregnancy, gestational weeks

Secondary Outcomes

gestational diabetes mellitus (GDM),

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

Time frame: gestational weeks 12-16

eating habits

eating habits are measured by 4 day food records

Time frame: 1st, 2nd and 3rd trimester of pregnancy, gestational weeks

eating habits

Eating habits are measured by TFEQ R-18 questionnaire

Time frame: 1st, 2nd and 3rd trimester, gestational weeks

Eating habits

Eating habits are measured by Binge Eating Scale (BES)

Time frame: 1st, 2nd and 3rd trimester, gestational weeks

Data from ClinicalTrials.gov

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