Intervention, Dietary, Diabetes, Pregnancy

NCT04690907 | Completed

• 1 other identifier: 031220
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 2

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.

Conditions

Dietary Habits; Obesity; Gestational Diabetes; Gestational Weight Gain

Outcome Measures

Primary Outcomes (1)

• Gestational weight gain (GWG)

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

  immediately after the intervention

Secondary Outcomes (4)

• Gestational diabetes mellitus (GDM)

  immediately after the intervention

• Eating habits I

  During the intervention up to gestational weeks 36-37

• Eating habits II

  During the intervention up to gestational weeks 37-42

• Eating habits III

  During the intervention up to gestational weeks 37-42

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Behavioral: Dietary intervention

Control group

NO INTERVENTION

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

Interventions

Dietary intervention BEHAVIORAL

Written material on healthy diet during pregnancy and 2 virtual dietary counseling sessions.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Females because of pregnancy
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• BMI less than 25
• chronic medical conditions
• multiple pregnancy
• pregnancy at second or third trimester at the time of recruitment

Sponsors & Collaborators

• University of Eastern Finland: lead

Study Sites (2)

Antenatal maternity care clinics (n=6)

Joensuu, Finland

Location

Antenatal maternity care clinics (n=12)

Kuopio, Finland

Location

MeSH Terms

Conditions

Feeding Behavior; Obesity; Diabetes, Gestational; Gestational Weight Gain

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Weight Gain; Body Weight Changes

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Reeta Lamminpää

  University of Eastern Finland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post doctoral researcher

Model Details: Intervention group and control group.

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: December 31, 2020
• Study Start: December 3, 2020
• Primary Completion: October 31, 2022
• Study Completion: December 31, 2022
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

FI (2)