NCT03191331

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2017

Completed
8 days until next milestone

Study Start

First participant enrolled

June 6, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 19, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

March 27, 2020

Status Verified

March 1, 2020

Enrollment Period

2 years

First QC Date

May 29, 2017

Last Update Submit

March 25, 2020

Conditions

Dietary HabitsGestational DiabetesWeight GainOverweight and Obesity

Keywords

dietary interventiongestational weight gaingestational diabetesoverweightobesity

Outcome Measures

Primary Outcomes (1)

  • gestational weight gain (GWG)

    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 Outcomes (4)

  • gestational diabetes mellitus (GDM),

    gestational weeks 12-16

  • eating habits

    1st, 2nd and 3rd trimester of pregnancy, gestational weeks

  • eating habits

    1st, 2nd and 3rd trimester, gestational weeks

  • Eating habits

    1st, 2nd and 3rd trimester, gestational weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Behavioral: Dietary intervention

Control group

NO INTERVENTION

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

Interventions

Dietary interventionBEHAVIORAL

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 group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsEligibility is based on gender
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Age 35 and older
  • BMI less than 25
  • chronic medical conditions
  • multiple pregnancy
  • pregnancy at second or third trimester at the time of recruitment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Neulamäki antenatal care clinic

Kuopio, Finland

Location

Pyörö antenatal care clinic

Kuopio, Finland

Location

MeSH Terms

Conditions

Feeding BehaviorDiabetes, GestationalWeight GainOverweightObesityGestational Weight Gain

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Behavior, AnimalBehaviorPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionNutrition Disorders

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeutics

Study Officials

  • Reeta Lamminpää, PhD

    University of Eastern Finland, Department of Nursing Science

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: intervention group and control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
post doctoral researcher

Study Record Dates

First Submitted

May 29, 2017

First Posted

June 19, 2017

Study Start

June 6, 2017

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

March 27, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

FI(2)