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The main objective is to evaluate the effect of therapeutic exercise program on blood glucose regulation in women with gestational diabetes mellitus (GDM) who are assigned to diet-and-exercise, compared to diet only (usual treatment). The primary outcome is the need for insulin treatment in the two groups.
In women with gestational diabetes, light to moderate daily physical activity may a useful therapeutic approach to improve the control of glycaemia and decrease the need for prescription of insulin. Increased physical activity in pregnant women with gestational diabetes is expected to decrease the mother and child morbidity associated with gestational diabetes, but also to improve the general health status of the mother and the child.
The objectives of this randomized trial are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise + diet | Experimental | Exercise intervention: During the first session a standardized exercise prescription will be discussed with the participant. The exercise program will be of a moderate intensity, at less than 140 heart beats/min (which corresponds to 60% of the calculated maximum heart rate (HRmax) or 50% maximum oxygen volume (VO2max) ). A session of 30 to 60 minutes/week will be organised.
This is in addition to the diet (see below, control group) |
|
| Diet only | No Intervention | Participants will receive diet counselling according to their characteristics. The usual recommendation is to have a fractioned normocaloric diet (unless the dietician identify a grossly hypercaloric diet), with low fat and increase in fibers content. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Behavioral | Once per week, participants will be enrolled in supervised group exercise intervention. They will be encouraged in walking 45 minutes per day |
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| Measure | Description | Time Frame |
|---|---|---|
| Prescription of insulin during the follow-up | The primary outcome will include any amount (dosage) of insulin and any frequency of injection. Prescription of insulin is considered when glycaemia is above 5.3 mmol/L fasting and/or above 8.0 at 1 hour after the meal. | From inclusion in the study (randomization usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery, usually 38 to 41 weeks of gestation). It is impossible in our context to give a specific time point. |
| Measure | Description | Time Frame |
|---|---|---|
| Control of glycemia | 4 times per day, participants will check their blood sugar level. The investigators will record these blood sugar levels and consider as normal if below 5.3 mmol/L fasting and below 8.0 at 1 hour after the meal. Suboptimal glycemic control will be defined as 2 or more glycemia above these target values; good control will be defined as less than 2 values above the thresholds. The variable "good glycemic control" will be coded "yes" if the above criteria (<2 abnormal values) are met, and "no" otherwise (>=2 abnormal values) |
| Measure | Description | Time Frame |
|---|---|---|
| Timing of insulin treatment | To better understand the effect of the intervention on the primary outcome, prescription of insulin), the investigators will compare between groups: Time between randomization and insulin prescription (days) | From inclusion in the study (randomization usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michel Boulvain | University Hospital, Geneva | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39343942 | Derived | Boulvain M, Othenin-Girard V, Jornayvaz FR, Kayser B. Impact of an exercise program combined with dietary advice on avoiding insulin prescription in women with gestational diabetes: a randomized controlled trial. Diabetol Metab Syndr. 2024 Sep 30;16(1):238. doi: 10.1186/s13098-024-01470-1. |
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Meta-analysis with the Cochrane Collaboration, if individual patient data are needed
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| From inclusion in the study (randomization usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery). |
| Compliance with the exercise (in the exercise group only) | Satisfactory compliance will be defined as walking at least 5000 steps/day 5 days a week and attending at 50% or more of the weekly supervised exercise program. The variable "compliance" will be coded "yes" if both the above criteria are met, and "no" otherwise | From inclusion in the study (randomization usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery). |
| Gestational age at start of insulin treatment | the investigators will compare between groups: Gestational age at start of insulin treatment (weeks) (mean ± SD) | From inclusion in the study (randomization usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery). |
| Dosage of long-acting insulin | Maximal dose of long-acting insulin per day (mean ± SD) | From inclusion in the study (randomization usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery). |
| Dosage of short-acting insulin | Maximal dose of short-acting insulin per day (mean ± SD) | usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery). |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |