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CompletedNCT04690907IDDPUpdated Nov 29, 2023

Intervention, Dietary, Diabetes, Pregnancy

An interventional study of Dietary intervention in Dietary Habits, Obesity and Gestational Diabetes, sponsored by University of Eastern Finland. Completed at 2 sites in Finland. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-29.

Sponsored by University of Eastern Finland · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
33
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Dietary Habits
  • Obesity
  • Gestational Diabetes
  • Gestational Weight Gain
03

In context

Diabetes, Gestational

842 studies on the registry are indexed under Diabetes, Gestational; 198 are open to participants now.

This study's enrollment of 33 is below the median of 110 across 550 interventional studies indexed under Diabetes, Gestational.

Browse Diabetes, Gestational studies →

Lead sponsor

University of Eastern Finland is the lead sponsor of 51 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • BMI less than 25
  • chronic medical conditions
  • multiple pregnancy
  • pregnancy at second or third trimester at the time of recruitment
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
33 participants (actual)

Study arms

  • 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

  • No intervention
    Control group

    Written material on healthy diet during pregnancy, otherwise basic care and counseling at maternity care clinics.

Interventions

  • BehavioralDietary intervention

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

06

What researchers measure

Primary outcomes

  1. Gestational weight gain (GWG)

    gestational weight gain (from pre-pregnancy weight until childbirth), measured at maternity care clinic.

    Time frame: immediately after the intervention

Secondary outcomes

  1. Gestational diabetes mellitus (GDM)

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

    Time frame: immediately after the intervention

  2. Eating habits I

    eating habits are measured by 4 day food records

    Time frame: During the intervention up to gestational weeks 36-37

  3. Eating habits II

    Eating habits are measured by TFEQ R-18 questionnaire

    Time frame: During the intervention up to gestational weeks 37-42

  4. Eating habits III

    Eating habits are measured by Binge Eating Scale (BES)

    Time frame: During the intervention up to gestational weeks 37-42

07

Study locations

2 sites
  • Antenatal maternity care clinics (n=6)
    Joensuu, Finland
  • Antenatal maternity care clinics (n=12)
    Kuopio, Finland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 29, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04690907
Lead sponsor
University of Eastern Finland
Responsible party
Reeta Lamminpää (Post doctoral researcher, University of Eastern Finland) — Principal investigator
First posted
Dec 31, 2020
Start date
Dec 3, 2020
Primary completion
Oct 31, 2022
Completion
Dec 31, 2022
Last update
Nov 29, 2023

Study contacts

Reeta Lamminpää
principal investigator · University of Eastern Finland

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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