Dietary Intervention, Gestational Weight Gain and Gestational Diabetes.

Overweight and Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03191331
• Other study ID #: Dietary intervention1619
• Status: Completed
• Phase: N/A
• Start date: June 6, 2017
• Est. completion date: June 1, 2019

Study information

• Verified date: March 2020
• Source: University of Eastern Finland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: June 1, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Diabetes Mellitus
• Diabetes, Gestational
• Dietary Habits
• Gestational Diabetes
• Gestational Weight Gain
• Overweight
• Overweight and Obesity
• Weight Gain

Intervention

Behavioral:
• Dietary intervention
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.

Locations

Country	Name	City	State
Finland	Neulamäki antenatal care clinic	Kuopio
Finland	Pyörö antenatal care clinic	Kuopio

Sponsors (1)

Lead Sponsor	Collaborator
University of Eastern Finland

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	gestational diabetes mellitus (GDM),	GDM is measured by the result of an oral glucose tolerance test (OGTT)	gestational weeks 12-16
Secondary	eating habits	eating habits are measured by 4 day food records	1st, 2nd and 3rd trimester of pregnancy, gestational weeks
Secondary	eating habits	Eating habits are measured by TFEQ R-18 questionnaire	1st, 2nd and 3rd trimester, gestational weeks
Secondary	Eating habits	Eating habits are measured by Binge Eating Scale (BES)	1st, 2nd and 3rd trimester, gestational weeks