Prevention of Gestational Diabetes Through Lifestyle Modification (RADIEL)

April 15, 2019 updated by: Saila Koivusalo, Helsinki University Central Hospital

Prevention of Gestational Diabetes Through Lifestyle Modification (RADIEL) - a Randomized Controlled Multi-centre Intervention Study

OVERALL OBJECTIVES:

  1. To assess the efficacy of a diet and exercise intervention before and/or during pregnancy in the prevention of GDM and its fetal complications in women with high diabetes risk.
  2. To assess the cost-effectiveness of a diet and exercise intervention in the prevention of GDM from a socio-economic point of view. To find out whether the intervention can be used to reduce health care costs due to GDM and T2DM.
  3. To determine the long-term effectiveness of the above-mentioned lifestyle intervention in the reduction of T2DM incidence among women with prior GDM and their offspring

STUDY SUBJECTS Group 1: Women planning pregnancy with a history of diet/insulin-treated GDM or BMI >30 kg/m2. N= 250 + 250.

Group 2: Women in early pregnancy with a history of diet/insulin-treated GDM or BMI >30 kg/m2. N= 250 + 250

METHOD The Finnish multi-center randomized controlled intervention trial started in the maternity hospitals of Helsinki and Uusimaa District Area 1/2008 and in the South-Karelia Central Hospital in Lappeenranta in 9/2008. 1000 women at high GDM risk will be recruited. Half of the subjects are randomized into the intervention group and the other half act as controls receiving only standard antenatal care in addition to the laboratory tests taken and questionnaires administered by the RADIEL study.

The active intervention arm of the study will be carried out in a structured, standardized manner by diabetes nurses and nutritionists specifically trained for their tasks. The intervention includes:

  1. Structured visits to diabetes nurse every 3 months before and during pregnancy as well as at 6 weeks, 6 and 12 months post partum. Visits include e.g. structured counseling on diet and exercise, setting of specific goals, follow-up of achievements, laboratory tests and measurements
  2. Structured group visits to nutritionist at the moment of enrollment in the study, at the beginning of pregnancy as well as at 6 and 12 months post partum. Additional individual visits are booked if needed.
  3. Services of physical activity advisors are provided by the study subjects' cities of residence free of charge to all who wish to receive extra counseling on exercise. If exercise goals are not met, study subjects book an appointment with the physical activity advisor.

LIFESTYLE TARGETS: 1.Weight: A weight loss of 5-10% before pregnancy if BMI > 25 and/or limited weight gain during the first two trimesters in pregnancy if BMI > 30. 2.Exercise: A minimum of 30 min. of exercise 5 times per week or 50 min. 3 times per week of moderate intensity exercise (Borg 11-15). Daily household and/or transportation physical activity. 3.Diet: Increased intake of vegetables, legumes, fruits and berries, whole grain and fiber, low-fat dairy, vegetable fats; and use of "plate model". Total energy intake: 1600-1800 kcal/day, with 40-50 E% carbohydrates, 30-40 E% fats, 20-25 E% protein.

MEASUREMENTS of maternal variables:

AT THE MOMENT OF ENROLMENT TO THE STUDY, and every 3 months before pregnancy:

(1) Waist circumference, blood pressure, pulse, weight, height (2) i.e. 2-hour OGTT, fP-insulin, fP-glucose, , GHbA1c, lipids, P-hCRP, P-IL-6, S-A1Glypr, leptin. (3) Background questionnaire (4) 15-D-questionnaire: health-related quality of life. (7) Food diary (2+1). Exercise diaries daily for one week.

PREGNANCY At the end of each trimester: (1) The same tests and measurements as in pre-pregnancy period. 2h-OGTT at H10-14 and at H24-28. (2) Questionnaire, 15-D questionnaire, EDPS (=Edinburgh post-partum depression scale) questionnaire for screening mood disorders at H10-13. (4) Food diaries (2+1), and exercise diaries daily for one week at H10-13 and H34-36.

POST PARTUM PERIOD (Groups 1-2) At 6 weeks, 6 and 12 months post partum: (1) The same follow-up tests and measurements as at the beginning. Lipids checked only at 12 months post partum. (2) 2-hour OGTT 6 weeks and 12 months post partum (3) Questionnaires at all visits. (5) Food and exercise diaries at 12 months post partum.

MEASUREMENTS of child's variables at birth

(1) weight (2) height (3) head circumference (4) From delivery records: Mode of delivery, Apgar scores, any perinatal complications, operations, need of neonatal intensive care and length of hospital. (3) Laboratory tests from cord blood.

TIMETABLE Recruitment started in February 2008 and ended in autumn 2011 when about 800 subjects had been recruited to the study. Intervention will continue until 2014 (including pre- and postpartum periods). Long-term follow up of both mothers' and children's cohorts starts in 2014 and has been planned to continue up to 10 years postpartum. Data analysis starts in autumn of 2013 and results will be reported from 2014 onwards in international peer-reviewed journals.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

750

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland
        • Hospital District of Helsinki and Uusimaa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • obese (BMI > 30)
  • previous GDM

Exclusion Criteria:

  • Age < 18 years
  • diabetes before pregnancy
  • medication influencing glucose homeostasis
  • hypertension
  • multiple pregnancy
  • physical disability
  • substance abuse
  • severe psychiatric disorders
  • significant co-operation difficulties

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Lifestyle counseling
Other: Diet and exercise counseling
diet and exercise counseling, setting of specific goals, follow-up of achievements, laboratory tests and measurements
Other Names:
  • Lifestyle intervention
No Intervention: Control, just measurements

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in oral glucose tolerance test at variable time frames
Time Frame: 1) Baseline (group 1= planning a pregnancy; group 2=at gest.week 10-14); 2) at gest.week 10-14 (group 1) and 3) at gest.week 24-28; 4) 6 weeks and 12 months post partum
1) Baseline (group 1= planning a pregnancy; group 2=at gest.week 10-14); 2) at gest.week 10-14 (group 1) and 3) at gest.week 24-28; 4) 6 weeks and 12 months post partum

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in weight at variable time frames
Time Frame: 1) Baseline (group 1= planning a pregnancy; group 2=at gest.week 10-14); 2) at gest.week 10-14 (group 1) and 3) at gest.week 24-28 and 34-36, and 4) 6 weeks, 6 months and 12 months post partum
1) Baseline (group 1= planning a pregnancy; group 2=at gest.week 10-14); 2) at gest.week 10-14 (group 1) and 3) at gest.week 24-28 and 34-36, and 4) 6 weeks, 6 months and 12 months post partum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helsinki University Central Hospital

Collaborators

Provincial Health Services Authority
South Karelia, Social and Health Care District

Investigators

  • Principal Investigator: Saila B Koivusalo, MD, University of Helsinki

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

September 11, 2012

First Submitted That Met QC Criteria

September 28, 2012

First Posted (Estimate)

October 3, 2012

Study Record Updates

Last Update Posted (Actual)

April 16, 2019

Last Update Submitted That Met QC Criteria

April 15, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RADIEL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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