Skip to content

Intervention, Dietary, Diabetes, Pregnancy

Dietary Intervention for Obese Pregnant Women - a Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04690907
Acronym
IDDP
Enrollment
33
Registered
2020-12-31
Start date
2020-12-03
Completion date
2022-12-31
Last updated
2023-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dietary Habits, Gestational Diabetes, Gestational Weight Gain, Obesity

Brief 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.

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.

Interventions

BEHAVIORALDietary intervention

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

Sponsors

University of Eastern Finland
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Intervention group and control group.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
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

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

Design outcomes

Primary

MeasureTime frameDescription
Gestational weight gain (GWG)immediately after the interventiongestational weight gain (from pre-pregnancy weight until childbirth), measured at maternity care clinic.

Secondary

MeasureTime frameDescription
Gestational diabetes mellitus (GDM)immediately after the interventionGDM is measured by the result of an oral glucose tolerance test (OGTT)
Eating habits IDuring the intervention up to gestational weeks 36-37eating habits are measured by 4 day food records
Eating habits IIDuring the intervention up to gestational weeks 37-42Eating habits are measured by TFEQ R-18 questionnaire
Eating habits IIIDuring the intervention up to gestational weeks 37-42Eating habits are measured by Binge Eating Scale (BES)

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026