Dietary Intervention for Obese Pregnant Women - a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 33
- Locations
- 2
- Primary Endpoint
- Gestational weight gain (GWG)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
- •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: immediately after the intervention
gestational weight gain (from pre-pregnancy weight until childbirth), measured at maternity care clinic.
Secondary Outcomes
- Gestational diabetes mellitus (GDM)(immediately after the intervention)
- Eating habits II(During the intervention up to gestational weeks 37-42)
- Eating habits I(During the intervention up to gestational weeks 36-37)
- Eating habits III(During the intervention up to gestational weeks 37-42)
Investigators
Reeta Lamminpää
Post doctoral researcher
University of Eastern Finland