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Intervention, Dietary, Diabetes, Pregnancy

NCT ID: NCT04690907

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-03

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Dietary Habits Obesity Gestational Diabetes Gestational Weight Gain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Intervention group and control group.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention group

Dietary intervention: Written material on healthy diet during pregnancy, 2 virtual dietary counseling sessions given by a dietician. Otherwise basic care and counseling at maternity care clinics.

Group Type EXPERIMENTAL

Dietary intervention

Intervention Type BEHAVIORAL

Written material on healthy diet during pregnancy and 2 virtual dietary counseling sessions.

Control group

Written material on healthy diet during pregnancy, otherwise basic care and counseling at maternity care clinics.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Dietary intervention

Written material on healthy diet during pregnancy and 2 virtual dietary counseling sessions.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Eastern Finland

OTHER

Sponsor Role lead

Responsible Party

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Reeta Lamminpää

Post doctoral researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Reeta Lamminpää

Role: PRINCIPAL_INVESTIGATOR

University of Eastern Finland

Locations

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Antenatal maternity care clinics (n=6)

Joensuu, , Finland

Site Status

Antenatal maternity care clinics (n=12)

Kuopio, , Finland

Site Status

Countries

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Finland

Other Identifiers

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031220

Identifier Type: -

Identifier Source: org_study_id