- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03191331
Dietary Intervention, Gestational Weight Gain and Gestational Diabetes.
March 25, 2020 updated by: Reeta Lamminpää, University of Eastern Finland
Intervention Study on Dietary Changes in Relation to Weight Gain and Prevalence of Gestational Diabetes During Pregnancy
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.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
13
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Kuopio, Finland
- Neulamäki antenatal care clinic
-
Kuopio, Finland
- Pyörö antenatal care clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
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.
|
Written material on healthy diet during pregnancy, dietary counseling at each maternity clinic visit given by public health nurse, group meeting with a dietician x2.
|
No Intervention: Control group
The control group will receive written material on healthy diet during pregnancy, otherwise basic care and guidance at maternity care clinics.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
from first to third trimester of pregnancy, gestational weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
gestational diabetes mellitus (GDM),
Time Frame: gestational weeks 12-16
|
GDM is measured by the result of an oral glucose tolerance test (OGTT)
|
gestational weeks 12-16
|
eating habits
Time Frame: 1st, 2nd and 3rd trimester of pregnancy, gestational weeks
|
eating habits are measured by 4 day food records
|
1st, 2nd and 3rd trimester of pregnancy, gestational weeks
|
eating habits
Time Frame: 1st, 2nd and 3rd trimester, gestational weeks
|
Eating habits are measured by TFEQ R-18 questionnaire
|
1st, 2nd and 3rd trimester, gestational weeks
|
Eating habits
Time Frame: 1st, 2nd and 3rd trimester, gestational weeks
|
Eating habits are measured by Binge Eating Scale (BES)
|
1st, 2nd and 3rd trimester, gestational weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Reeta Lamminpää, PhD, University of Eastern Finland, Department of Nursing Science
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 6, 2017
Primary Completion (Actual)
June 1, 2019
Study Completion (Actual)
June 1, 2019
Study Registration Dates
First Submitted
May 29, 2017
First Submitted That Met QC Criteria
June 16, 2017
First Posted (Actual)
June 19, 2017
Study Record Updates
Last Update Posted (Actual)
March 27, 2020
Last Update Submitted That Met QC Criteria
March 25, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Dietary intervention1619
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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