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Clinical Trials/NCT03191331
NCT03191331CompletedNot 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 enrollmentStarted: June 6, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
13
Locations
2
Primary Endpoint
gestational weight gain (GWG)

Study 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).

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 35 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Intervention group

Experimental

Dietary intervention. Intervention group will receive written material on healthy diet during pregnancy, nutritional guidance given by public health nurses at each maternity care clinic visit and group meeting with dietician x2.

Intervention: Dietary intervention (Behavioral)

Control group

No Intervention

The control group will receive written material on healthy diet during pregnancy, otherwise basic care and guidance at maternity care clinics.

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

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

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Reeta Lamminpää

post doctoral researcher

University of Eastern Finland

Study Sites (2)

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