NCT01506310

Brief Summary

The purpose of the study is to test whether four lifestyle intervention programs (diet alone; diet and behavioral therapy, diet and exercise, diet and behavioral therapy and exercise), delivered to women with GDM during 24-26 weeks of gestational age will help women to improve their metabolic pattern, and decrease the incidence of adverse maternal and neonatal outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2009

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

December 26, 2011

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 10, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

January 23, 2013

Status Verified

January 1, 2013

Enrollment Period

2.7 years

First QC Date

December 26, 2011

Last Update Submit

January 22, 2013

Conditions

Birth-weight

Keywords

gestational diabetes mellitusfasting glucoseinsulin resistancebirth-weightGlucose valuesInsulin concentrationsCesarean sections

Outcome Measures

Primary Outcomes (1)

  • Serum fasting glucose values.

    To investigate changes from baseline in serum fasting glucose values in each arm with a 2x2 factorial design.

    Fasting glucose will be measured at recruitment (24 weeks of gestation) and at the end of follow-up (38 weeks of gestation)

Secondary Outcomes (4)

  • Serum fasting insulin values

    At recruitment (at 24 weeks of gestation) and at the end of follow-up (38 weeks of gestation)

  • The need for insulin therapy

    At recruitment and at the end of follow-up (38 weeks)

  • The number of Cesarean sections

    From recruitment until the date of delivery, either natural or by Caesarean section, assessed up to 42 weeks

  • The mean birth-weight of newborns

    From recruitment until the date of delivery, assessed up to 42 weeks

Study Arms (4)

Diet alone

NO INTERVENTION

Behavioral therapy

EXPERIMENTAL
Behavioral: Behavioral therapy

Exercise

EXPERIMENTAL
Other: Exercise

Behavioral therapy and exercise

EXPERIMENTAL
Other: Behavioral therapy and exercise

Interventions

Behavioral therapyBEHAVIORAL

General written dietary recommendations (about cooking, lowering sugar intake, reducing salt intake, reducing beverages and food with added sugars) and written options for dining out. A brief written guide on behavior change.

Behavioral therapy
ExerciseOTHER

The exercise groups will be advised to walk at least 20-minute a day.

Exercise
Behavioral therapy and exerciseOTHER

General written dietary recommendations (about cooking, lowering fat intake, reducing salt intake, reducing beverages and food with added sugars) and written options for dining out. Written recommendations for physical activity A brief written guide on behavior change

Behavioral therapy and exercise

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Gestational age between 24 and 26 weeks
  • Diagnosis of GDM at the 75g oral glucose tolerance test (OGTT)
  • Singleton pregnancy

You may not qualify if:

  • Body mass index \> 40 or \< 12kg/m2
  • Any known diseases (pre-existing diabetes mellitus, cardiovascular diseases, liver/kidney diseases, cancers, arterial hypertension)
  • Patients on any drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Turin

Turin, Italy, 10126, Italy

Location

Related Publications (1)

  • Bo S, Gambino R, Menato G, Canil S, Ponzo V, Pinach S, Durazzo M, Ghigo E, Cassader M, Musso G. Isoleucine-to-methionine substitution at residue 148 variant of PNPLA3 gene and metabolic outcomes in gestational diabetes. Am J Clin Nutr. 2015 Feb;101(2):310-8. doi: 10.3945/ajcn.114.095125. Epub 2014 Dec 17.

    PMID: 25646328DERIVED

Related Links

MeSH Terms

Conditions

Birth WeightDiabetes, GestationalInsulin Resistance

Interventions

Behavior TherapyExercise

Condition Hierarchy (Ancestors)

Body WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and ActivitiesMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, MD, Professor Assistant, Department of Internal Medicine

Study Record Dates

First Submitted

December 26, 2011

First Posted

January 10, 2012

Study Start

July 1, 2009

Primary Completion

March 1, 2012

Study Completion

June 1, 2012

Last Updated

January 23, 2013

Record last verified: 2013-01

Locations

IT(1)