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Completed

NCT Number: NCT03191331

Dietary Intervention, Gestational Weight Gain and Gestational Diabetes.

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.

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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 Overweight and Obesity Pathological Conditions, Signs and Symptoms Pregnancy Complications Signs and Symptoms Urogenital Diseases Weight Gain

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Neulamäki antenatal care clinic, Kuopio, Finland

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About this study

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).

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Dietary intervention

Behavioral

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.

Primary outcomes

  1. gestational weight gain (GWG)

    Time frame: from first to third trimester of pregnancy, gestational weeks

    gestational weight gain from 1st trimester of pregnancy until childbirth, measured at each maternity clinic visit

Secondary outcomes

  1. gestational diabetes mellitus (GDM),

    Time frame: gestational weeks 12-16

    GDM is measured by the result of an oral glucose tolerance test (OGTT)

  2. eating habits

    Time frame: 1st, 2nd and 3rd trimester of pregnancy, gestational weeks

    eating habits are measured by 4 day food records

  3. eating habits

    Time frame: 1st, 2nd and 3rd trimester, gestational weeks

    Eating habits are measured by TFEQ R-18 questionnaire

  4. Eating habits

    Time frame: 1st, 2nd and 3rd trimester, gestational weeks

    Eating habits are measured by Binge Eating Scale (BES)

Sponsors and collaborators

Lead sponsor

University of Eastern Finland

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jun 19, 2017
Registry last updated
Mar 27, 2020

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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