search
Back to results

Intervention, Dietary, Diabetes, Pregnancy (IDDP)

Primary Purpose

Dietary Habits, Obesity, Gestational Diabetes

Status
Active
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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Antenatal maternity care clinics (n=6)
  • Antenatal maternity care clinics (n=12)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

Dietary intervention: Written material on healthy diet during pregnancy, 2 virtual dietary counseling sessions given by a dietician. Otherwise basic care and counseling at maternity care clinics.

Written material on healthy diet during pregnancy, otherwise basic care and counseling at maternity care clinics.

Outcomes

Primary Outcome Measures

Gestational weight gain (GWG)
gestational weight gain (from pre-pregnancy weight until childbirth), measured at maternity care clinic.

Secondary Outcome Measures

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

Full Information

First Posted
December 3, 2020
Last Updated
December 2, 2022
Sponsor
University of Eastern Finland
search

1. Study Identification

Unique Protocol Identification Number
NCT04690907
Brief Title
Intervention, Dietary, Diabetes, Pregnancy
Acronym
IDDP
Official Title
Dietary Intervention for Obese Pregnant Women - a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 3, 2020 (Actual)
Primary Completion Date
October 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Anticipated)

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dietary Habits, Obesity, Gestational Diabetes, Gestational Weight Gain

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
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Dietary intervention: Written material on healthy diet during pregnancy, 2 virtual dietary counseling sessions given by a dietician. Otherwise basic care and counseling at maternity care clinics.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Written material on healthy diet during pregnancy, otherwise basic care and counseling at maternity care clinics.
Intervention Type
Behavioral
Intervention Name(s)
Dietary intervention
Intervention Description
Written material on healthy diet during pregnancy and 2 virtual dietary counseling sessions.
Primary Outcome Measure Information:
Title
Gestational weight gain (GWG)
Description
gestational weight gain (from pre-pregnancy weight until childbirth), measured at maternity care clinic.
Time Frame
immediately after the intervention
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
immediately after the intervention
Title
Eating habits I
Description
eating habits are measured by 4 day food records
Time Frame
During the intervention up to gestational weeks 36-37
Title
Eating habits II
Description
Eating habits are measured by TFEQ R-18 questionnaire
Time Frame
During the intervention up to gestational weeks 37-42
Title
Eating habits III
Description
Eating habits are measured by Binge Eating Scale (BES)
Time Frame
During the intervention up to gestational weeks 37-42

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Females because of pregnancy
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reeta Lamminpää
Organizational Affiliation
University of Eastern Finland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Antenatal maternity care clinics (n=6)
City
Joensuu
Country
Finland
Facility Name
Antenatal maternity care clinics (n=12)
City
Kuopio
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Intervention, Dietary, Diabetes, Pregnancy

We'll reach out to this number within 24 hrs