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Intervention, Dietary, Diabetes, Pregnancy (IDDP)

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ClinicalTrials.gov Identifier: NCT04690907
Recruitment Status : Recruiting
First Posted : December 31, 2020
Last Update Posted : December 31, 2020
Sponsor:
Information provided by (Responsible Party):
Reeta Lamminpää, University of Eastern Finland

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Dietary Habits Obesity Gestational Diabetes Gestational Weight Gain Behavioral: Dietary intervention Not Applicable

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Intervention group and control group.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Dietary Intervention for Obese Pregnant Women - a Randomized Controlled Trial
Actual Study Start Date : December 3, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Behavioral: Dietary intervention
Written material on healthy diet during pregnancy and 2 virtual dietary counseling sessions.
No Intervention: Control group
Written material on healthy diet during pregnancy, otherwise basic care and counseling at maternity care clinics.


Outcome Measures
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Primary Outcome Measures :
  1. Gestational weight gain (GWG) [ Time Frame: immediately after the intervention ]
    gestational weight gain (from pre-pregnancy weight until childbirth), measured at maternity care clinic.


Secondary Outcome Measures :
  1. Gestational diabetes mellitus (GDM) [ Time Frame: immediately after the intervention ]
    GDM is measured by the result of an oral glucose tolerance test (OGTT)

  2. Eating habits I [ Time Frame: During the intervention up to gestational weeks 36-37 ]
    eating habits are measured by 4 day food records

  3. Eating habits II [ Time Frame: During the intervention up to gestational weeks 37-42 ]
    Eating habits are measured by TFEQ R-18 questionnaire

  4. Eating habits III [ Time Frame: During the intervention up to gestational weeks 37-42 ]
    Eating habits are measured by Binge Eating Scale (BES)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Females because of pregnancy
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04690907


Contacts
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Contact: Reeta Lamminpää +358403552240 reeta.lampinen@uef.fi
Contact: Krista Liljeström +358505984514 krista.liljestrom@uef.fi

Locations
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Finland
Antenatal maternity care clinics (n=6) Recruiting
Joensuu, Finland
Principal Investigator: Reeta Lamminpää         
Antenatal maternity care clinics (n=12) Recruiting
Kuopio, Finland
Principal Investigator: Reeta Lamminpää         
Sponsors and Collaborators
University of Eastern Finland
Investigators
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Principal Investigator: Reeta Lamminpää University of Eastern Finland
More Information
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Responsible Party: Reeta Lamminpää, Post doctoral researcher, University of Eastern Finland
ClinicalTrials.gov Identifier: NCT04690907    
Other Study ID Numbers: 031220
First Posted: December 31, 2020    Key Record Dates
Last Update Posted: December 31, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes, Gestational
Weight Gain
Gestational Weight Gain
Pregnancy Complications
Diabetes Mellitus
 Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Body Weight Changes
Body Weight