Dietary Intervention, Gestational Weight Gain and Gestational Diabetes.

Not Applicable

Completed

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

• Registration Number: NCT03191331
• Lead Sponsor: University of Eastern Finland

Brief Summary

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

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 Timeline

• Study First Submitted: 2017-05-29
• Study Start: 2017-06-06
• Study First Submitted QC: 2017-06-16
• Study First Posted: 2017-06-19
• Primary Completion: 2019-06-01
• Study Completion: 2019-06-01
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-25
• Last Update Posted: 2020-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Dietary intervention	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.

Primary Outcome Measures

Name	Time	Method
gestational weight gain (GWG)	from first to third trimester of pregnancy, gestational weeks	gestational weight gain from 1st trimester of pregnancy until childbirth, measured at each maternity clinic visit

Secondary Outcome Measures

Name	Time	Method
gestational diabetes mellitus (GDM),	gestational weeks 12-16	GDM is measured by the result of an oral glucose tolerance test (OGTT)
Eating habits	1st, 2nd and 3rd trimester, gestational weeks	Eating habits are measured by Binge Eating Scale (BES)
eating habits	1st, 2nd and 3rd trimester, gestational weeks	Eating habits are measured by TFEQ R-18 questionnaire

Trial Locations

Locations (2)

Pyörö antenatal care clinic; 🇫🇮 Kuopio, Finland

Neulamäki antenatal care clinic; 🇫🇮 Kuopio, Finland