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Dietary Intervention, Gestational Weight Gain and Gestational Diabetes.

Primary Purpose

Dietary Habits, Gestational Diabetes, Weight Gain

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Dietary intervention
Sponsored by
University of Eastern Finland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dietary Habits focused on measuring dietary intervention, gestational weight gain, gestational diabetes, overweight, obesity

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Neulamäki antenatal care clinic
  • Pyörö antenatal care clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

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.

The control group will receive written material on healthy diet during pregnancy, otherwise basic care and guidance at maternity care clinics.

Outcomes

Primary Outcome Measures

gestational weight gain (GWG)
gestational weight gain from 1st trimester of pregnancy until childbirth, measured at each maternity clinic visit

Secondary Outcome Measures

gestational diabetes mellitus (GDM),
GDM is measured by the result of an oral glucose tolerance test (OGTT)
eating habits
eating habits are measured by 4 day food records
eating habits
Eating habits are measured by TFEQ R-18 questionnaire
Eating habits
Eating habits are measured by Binge Eating Scale (BES)

Full Information

First Posted
May 29, 2017
Last Updated
March 25, 2020
Sponsor
University of Eastern Finland
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1. Study Identification

Unique Protocol Identification Number
NCT03191331
Brief Title
Dietary Intervention, Gestational Weight Gain and Gestational Diabetes.
Official Title
Intervention Study on Dietary Changes in Relation to Weight Gain and Prevalence of Gestational Diabetes During Pregnancy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
June 6, 2017 (Actual)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
June 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Eastern Finland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dietary Habits, Gestational Diabetes, Weight Gain, Overweight and Obesity
Keywords
dietary intervention, gestational weight gain, gestational diabetes, overweight, obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
intervention group and control group.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group will receive written material on healthy diet during pregnancy, otherwise basic care and guidance at maternity care clinics.
Intervention Type
Behavioral
Intervention Name(s)
Dietary intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
gestational weight gain (GWG)
Description
gestational weight gain from 1st trimester of pregnancy until childbirth, measured at each maternity clinic visit
Time Frame
from first to third trimester of pregnancy, gestational weeks
Secondary Outcome Measure Information:
Title
gestational diabetes mellitus (GDM),
Description
GDM is measured by the result of an oral glucose tolerance test (OGTT)
Time Frame
gestational weeks 12-16
Title
eating habits
Description
eating habits are measured by 4 day food records
Time Frame
1st, 2nd and 3rd trimester of pregnancy, gestational weeks
Title
eating habits
Description
Eating habits are measured by TFEQ R-18 questionnaire
Time Frame
1st, 2nd and 3rd trimester, gestational weeks
Title
Eating habits
Description
Eating habits are measured by Binge Eating Scale (BES)
Time Frame
1st, 2nd and 3rd trimester, gestational weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Eligibility is based on gender
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reeta Lamminpää, PhD
Organizational Affiliation
University of Eastern Finland, Department of Nursing Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neulamäki antenatal care clinic
City
Kuopio
Country
Finland
Facility Name
Pyörö antenatal care clinic
City
Kuopio
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Dietary Intervention, Gestational Weight Gain and Gestational Diabetes.

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