Prevention of Gestational Diabetes Through Lifestyle Modification

NCT01698385 | Completed DMC

• 1 other identifier: RADIEL
• Study Type: interventional
• Target: 750
• Locations: 1 country
• Sites: 1

Brief Summary

OVERALL OBJECTIVES:

1. 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. 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. 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
4. 4.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
5. 5.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.
6. 6.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.

Conditions

Gestational Diabetes

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in oral glucose tolerance test at variable time frames

  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 Outcomes (1)

• Change from Baseline in weight at variable time frames

  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

Study Arms (2)

Lifestyle counseling

ACTIVE COMPARATOR

Other: Diet and exercise counseling

Control, just measurements

NO INTERVENTION

Interventions

Diet and exercise counseling OTHER

diet and exercise counseling, setting of specific goals, follow-up of achievements, laboratory tests and measurements

Also known as: Lifestyle intervention

Lifestyle counseling

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• obese (BMI \> 30)
• previous GDM

You may not qualify if:

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

Sponsors & Collaborators

• Helsinki University Central Hospital: lead
• Provincial Health Services Authority British Columbia: collaborator
• South Karelia, Social and Health Care District: collaborator

Study Sites (1)

Hospital District of Helsinki and Uusimaa

Helsinki, Finland

Location

Related Publications (10)

• Blanco Sequeiros E, Tuomaala AK, Tabassum R, Bergman PH, Koivusalo SB, Huvinen E. Early ascending growth is associated with maternal lipoprotein profile during mid and late pregnancy and in cord blood. Int J Obes (Lond). 2023 Nov;47(11):1081-1087. doi: 10.1038/s41366-023-01361-x. Epub 2023 Aug 17.

  PMID: 37592059 DERIVED

• Huvinen E, Lahti J, Klemetti MM, Bergman PH, Raikkonen K, Orho-Melander M, Laivuori H, Koivusalo SB. Genetic risk of type 2 diabetes modifies the effects of a lifestyle intervention aimed at the prevention of gestational and postpartum diabetes. Diabetologia. 2022 Aug;65(8):1291-1301. doi: 10.1007/s00125-022-05712-7. Epub 2022 Apr 30.

  PMID: 35501401 DERIVED

• Huvinen E, Tuomaala AK, Bergman PH, Meinila J, Tammelin T, Kulmala J, Engberg E, Koivusalo SB. Ascending Growth is Associated with Offspring Adiposity in Pregnancies Complicated with Obesity or Gestational Diabetes. J Clin Endocrinol Metab. 2021 Apr 23;106(5):e1993-e2004. doi: 10.1210/clinem/dgaa979.

  PMID: 33524144 DERIVED

• Huvinen E, Engberg E, Meinila J, Tammelin T, Kulmala J, Heinonen K, Bergman P, Stach-Lempinen B, Koivusalo S. Lifestyle and glycemic health 5 years postpartum in obese and non-obese high diabetes risk women. Acta Diabetol. 2020 Dec;57(12):1453-1462. doi: 10.1007/s00592-020-01553-1. Epub 2020 Jul 25.

  PMID: 32712801 DERIVED

• Valkama AJ, Meinila J, Koivusalo S, Lindstrom J, Rono K, Stach-Lempinen B, Kautiainen H, Eriksson JG. The effect of pre-pregnancy lifestyle counselling on food intakes and association between food intakes and gestational diabetes in high-risk women: results from a randomised controlled trial. J Hum Nutr Diet. 2018 Jun;31(3):301-305. doi: 10.1111/jhn.12547. Epub 2018 Feb 7.

  PMID: 29468749 DERIVED

• Huvinen E, Eriksson JG, Koivusalo SB, Grotenfelt N, Tiitinen A, Stach-Lempinen B, Rono K. Heterogeneity of gestational diabetes (GDM) and long-term risk of diabetes and metabolic syndrome: findings from the RADIEL study follow-up. Acta Diabetol. 2018 May;55(5):493-501. doi: 10.1007/s00592-018-1118-y. Epub 2018 Feb 19.

  PMID: 29460080 DERIVED

• Huvinen E, Koivusalo SB, Meinila J, Valkama A, Tiitinen A, Rono K, Stach-Lempinen B, Eriksson JG. Effects of a Lifestyle Intervention During Pregnancy and First Postpartum Year: Findings From the RADIEL Study. J Clin Endocrinol Metab. 2018 Apr 1;103(4):1669-1677. doi: 10.1210/jc.2017-02477.

  PMID: 29409025 DERIVED

• Koivusalo SB, Rono K, Klemetti MM, Roine RP, Lindstrom J, Erkkola M, Kaaja RJ, Poyhonen-Alho M, Tiitinen A, Huvinen E, Andersson S, Laivuori H, Valkama A, Meinila J, Kautiainen H, Eriksson JG, Stach-Lempinen B. Gestational Diabetes Mellitus Can Be Prevented by Lifestyle Intervention: The Finnish Gestational Diabetes Prevention Study (RADIEL): A Randomized Controlled Trial. Diabetes Care. 2016 Jan;39(1):24-30. doi: 10.2337/dc15-0511. Epub 2015 Jul 29.

  PMID: 26223239 DERIVED

• Miettinen HE, Rono K, Koivusalo S, Stach-Lempinen B, Poyhonen-Alho M, Eriksson JG, Hiltunen TP, Gylling H. Elevated serum squalene and cholesterol synthesis markers in pregnant obese women with gestational diabetes mellitus. J Lipid Res. 2014 Dec;55(12):2644-54. doi: 10.1194/jlr.P049510. Epub 2014 Oct 9.

  PMID: 25301963 DERIVED

• Rono K, Stach-Lempinen B, Klemetti MM, Kaaja RJ, Poyhonen-Alho M, Eriksson JG, Koivusalo SB; RADIEL group. Prevention of gestational diabetes through lifestyle intervention: study design and methods of a Finnish randomized controlled multicenter trial (RADIEL). BMC Pregnancy Childbirth. 2014 Feb 14;14:70. doi: 10.1186/1471-2393-14-70.

  PMID: 24524674 DERIVED

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Diet

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Saila B Koivusalo, MD

  University of Helsinki

  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: MD PhD

Study Record Dates

• First Submitted: September 11, 2012
• First Posted: October 3, 2012
• Study Start: February 1, 2008
• Primary Completion: January 1, 2014
• Study Completion: February 1, 2014
• Last Updated: April 16, 2019

Record last verified: 2019-04

Locations

FI (1)