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Clinical Trials/NCT03191331
NCT03191331
Completed
Not Applicable

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

University of Eastern Finland2 sites in 1 country13 target enrollmentJune 6, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dietary Habits
Sponsor
University of Eastern Finland
Enrollment
13
Locations
2
Primary Endpoint
gestational weight gain (GWG)
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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.

Detailed Description

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).

Registry
clinicaltrials.gov
Start Date
June 6, 2017
End Date
June 1, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Reeta Lamminpää

post doctoral researcher

University of Eastern Finland

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • gestational diabetes mellitus (GDM),(gestational weeks 12-16)
  • Eating habits(1st, 2nd and 3rd trimester, gestational weeks)
  • eating habits(1st, 2nd and 3rd trimester, gestational weeks)

Study Sites (2)

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