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Completed

NCT Number: NCT01506310

Efficacy of Behavioral Therapy and Exercise in Gestational Diabetes Mellitus (GDM)

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.

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Key information

Conditions

Birth-weight Birth Weight Body Weight Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Pregnancy Complications Signs and Symptoms Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

University of Turin

Turin, Italy, 10126

About this study

Women with gestational diabetes (GDM) are at increased risk of adverse pregnancy and neonatal outcomes. It is estimated that most women diagnosed with GDM can achieve targeted glycemic goals with nutrition therapy alone. A moderate exercise is recommended to lower serum glucose and to improve insulin sensitivity. Despite this, few reports examine the effect of exercise on glucose intolerance during pregnancy. Furthermore, no trial on the efficacy of behavioral treatment in women with GDM is available.

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Behavioral therapy

Behavioral

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.

Exercise

Other

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

Behavioral therapy and exercise

Other

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

Primary outcomes

  1. Serum fasting glucose values.

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

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

Secondary outcomes

  1. Serum fasting insulin values

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

    To investigate changes from baseline in serum fasting insulin values in each arm.

  2. The need for insulin therapy

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

    The need for insulin therapy in each arm

  3. The number of Cesarean sections

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

    The number of Cesarean sections in each arm

  4. The mean birth-weight of newborns

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

    The mean birth-weight of newborns in each arm

Sponsors and collaborators

Lead sponsor

University of Turin, Italy

Other

Registry information

Official study title

Randomized Comparative Trial on the Efficacy of Behavioral Therapy, Exercise and Their Combination in Gestational Diabetes Mellitus (GDM).

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jan 10, 2012
Registry last updated
Jan 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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