Dietary Intervention, Gestational Weight Gain and Gestational Diabetes.

NCT ID: NCT03191331

Last Updated: 2020-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-06
• Study Completion Date: 2019-06-01

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).

Conditions

Dietary Habits; Gestational Diabetes; Weight Gain; Overweight and Obesity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Dietary intervention

Intervention Type: BEHAVIORAL

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.

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Dietary intervention

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Eastern Finland

OTHER

Sponsor Role: lead

Responsible Party

Reeta Lamminpää

post doctoral researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Reeta Lamminpää, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Eastern Finland, Department of Nursing Science

Locations

Neulamäki antenatal care clinic

Kuopio, , Finland

Pyörö antenatal care clinic

Kuopio, , Finland

Countries

Finland

Other Identifiers

Dietary intervention1619

Identifier Type: -

Identifier Source: org_study_id