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Completed

NCT Number: NCT04690907

Intervention, Dietary, Diabetes, Pregnancy

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.

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Key information

Conditions

Dietary Habits Behavior Behavior, Animal Body Weight Body Weight Changes Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Feeding Behavior Female Urogenital Diseases and Pregnancy Complications Gestational Diabetes Gestational Weight Gain Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pregnancy Complications Signs and Symptoms Urogenital Diseases Weight Gain

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Antenatal maternity care clinics (n=6), Joensuu, Finland

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietary intervention

Behavioral

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

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of Eastern Finland

Other

Registry information

Official study title

Dietary Intervention for Obese Pregnant Women - a Randomized Controlled Trial

Acronym: IDDP

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 31, 2020
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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