Intervention, Dietary, Diabetes, Pregnancy

Obesity Clinical Trial

— IDDP  

Official title:

Dietary Intervention for Obese Pregnant Women - a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04690907
• Other study ID #: 031220
• Status: Completed
• Phase: N/A
• Start date: December 3, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: November 2023
• Source: University of Eastern Finland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Dietary intervention
Written material on healthy diet during pregnancy and 2 virtual dietary counseling sessions.

Locations

Country	Name	City	State
Finland	Antenatal maternity care clinics (n=6)	Joensuu
Finland	Antenatal maternity care clinics (n=12)	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 pre-pregnancy weight until childbirth), measured at maternity care clinic.	immediately after the intervention
Secondary	Gestational diabetes mellitus (GDM)	GDM is measured by the result of an oral glucose tolerance test (OGTT)	immediately after the intervention
Secondary	Eating habits I	eating habits are measured by 4 day food records	During the intervention up to gestational weeks 36-37
Secondary	Eating habits II	Eating habits are measured by TFEQ R-18 questionnaire	During the intervention up to gestational weeks 37-42
Secondary	Eating habits III	Eating habits are measured by Binge Eating Scale (BES)	During the intervention up to gestational weeks 37-42