Obesity Clinical Trial
— IDDPOfficial title:
Dietary Intervention for Obese Pregnant Women - a Randomized Controlled Trial
Verified date | November 2023 |
Source | University of Eastern Finland |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 33 |
Est. completion date | December 31, 2022 |
Est. primary completion date | October 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Finland | Antenatal maternity care clinics (n=6) | Joensuu | |
Finland | Antenatal maternity care clinics (n=12) | Kuopio |
Lead Sponsor | Collaborator |
---|---|
University of Eastern Finland |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Gestational weight gain (GWG) | gestational weight gain (from pre-pregnancy weight until childbirth), measured at maternity care clinic. | immediately after the intervention | |
Secondary | Gestational diabetes mellitus (GDM) | GDM is measured by the result of an oral glucose tolerance test (OGTT) | immediately after the intervention | |
Secondary | Eating habits I | eating habits are measured by 4 day food records | During the intervention up to gestational weeks 36-37 | |
Secondary | Eating habits II | Eating habits are measured by TFEQ R-18 questionnaire | During the intervention up to gestational weeks 37-42 | |
Secondary | Eating habits III | Eating habits are measured by Binge Eating Scale (BES) | During the intervention up to gestational weeks 37-42 |
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