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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diet alone | No Intervention | ||
| Behavioral therapy | Experimental |
| |
| Exercise | Experimental |
| |
| Behavioral therapy and exercise | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Serum fasting insulin values | To investigate changes from baseline in serum fasting insulin values in each arm. | At recruitment (at 24 weeks of gestation) and at the end of follow-up (38 weeks of gestation) |
| The need for insulin therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Turin | Turin | Italy | 10126 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25646328 | Derived | 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. |
| Label | URL |
|---|---|
| site for randomization | View source |
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| ID | Term |
|---|---|
| D001724 | Birth Weight |
| D016640 | Diabetes, Gestational |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011248 | Pregnancy Complications |
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| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D009043 | Motor Activity |
| D009068 | Movement |
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| 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 |
|
The need for insulin therapy in each arm
| At recruitment and at the end of follow-up (38 weeks) |
| The number of Cesarean sections | The number of Cesarean sections in each arm | From recruitment until the date of delivery, either natural or by Caesarean section, assessed up to 42 weeks |
| The mean birth-weight of newborns | The mean birth-weight of newborns in each arm | From recruitment until the date of delivery, assessed up to 42 weeks |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |
| D009142 |
| Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |