Carbohydrate Counting and DASH Intervention and Pregnancy Outcomes Among Women With Gestational Diabetes
Studying the Effectiveness of Carbohydrate Counting and Dietary Approach to Stop Hypertension Dietary Intervention on Glycemic Control and Maternal and Newborn Health Outcomes Among Jordanian Pregnant Women With Gestational Diabetes
Aperçu de l'étude
Statut
Statut
Les conditions
Les conditions
Intervention / Traitement
Intervention / Traitement
Description détaillée
Type d'étude
Type d'étude
Inscription (Anticipé)
Inscription
Phase
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
Coordonnées de l'étude
- Nom: Sabika S Allehdan, Msc
- Numéro de téléphone: +962799232789
- E-mail: sabika_1986@yahoo.com
Sauvegarde des contacts de l'étude
- Nom: Reema F Tayyem, PhD
- Numéro de téléphone: +962797902535
- E-mail: r_tayyem@yahoo.com
Lieux d'étude
-
-
-
Amman, Jordan, 009626
- Recrutement
- Sabika Allehdan
-
Contact:
- Sabika Allehdan, MSc
- Numéro de téléphone: 799232789
- E-mail: sabika_1986@Yahoo.com
-
-
Critères de participation
Critère d'éligibilité
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Jordanian pregnant women with GDM at 24 -28 gestational weeks.
- Aged 25-40 with no-personal history of type 1 or 2 diabetes, or impaired fasting glucose (Koivusalo et al., 2016).
- Singleton gestation (Louie et al., 2011).
- Absence of chronic diseases such as hypertension, hepatic and kidney disease and cancer, and psychiatric disorder (Ma et al., 2014).
- Absence of the use of medication that influences glucose metabolism, such as continuous therapy with oral corticosteroids (Koivusalo et al., 2016)
- Pregnant women who do not have special dietary requirements (Louie et al., 2011).
Nonsmoker or nonalcoholic drinker during pregnancy (Louie et al., 2011) Well educated and well cooperative, more than 10 years of formal schooling (Ma et al., 2014).
Exclusion Criteria:
- Non- Jordanian pregnant women or Jordanian pregnant women with GDM at <24 or >28 gestational weeks.
- Aged > 40 years with multiple gestation and suspected over-diabetes (Koivusalo et al., 2016).
- Multiple gestations (Louie et al., 2011).
- Presence of chronic diseases, severe psychiatric disorder. Women with the risk factors for placental insufficiency, or history of preeclampsia (Ma et al., 2014; Koivusalo et al., 2016).
- Presence of the use of medication that influences glucose metabolism, such as continuous therapy with oral corticosteroids (Koivusalo et al., 2016)
- Pregnant women who have special dietary requirements (Louie et al., 2011).
- Who smoked or consumed alcohol during pregnancy (Louie et al., 2011)
- Less than 10 years of formal schooling or previous intensive nutrition education or intervention for diabetes (Ma et al., 2014).
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Nombre de bras
Armes et Interventions
Groupe de participants / BrasGroupe de participants / Bras |
Intervention / TraitementIntervention / Traitement |
|---|---|
|
Expérimental: Dietary intervention CHO counting
Carbohydrate counting diet will be prepared according to Kulkarni, (2005).
Tailored diet plans according to patient's food preference, physical activity level and appropriate insulin: Carbohydrates ratio will be prescribed for each participants.
Diets were based on each participants's recommended intakes of energy, protein (15-25%), fat (30-40%) and carbohydrate (40-50%) (Thomas and Gutierrez, 2005; Kleinwechter et al., 2014).
Energy requirement will be determined in the participants' pre-pregnancy weight with adding the extra requirement (450 kcal) due to pregnancy.
The carbohydrate counts will be distributed into three main meals and 3 snacks.
|
Adjusting the quantity and quality of food intake to improve glycemic control, maternal and newborn health outcomes of women with gestational diabetes.
Autres noms:
|
|
Expérimental: Dietary intervention CHO Counting & DASH
The recommended intakes of energy, protein (15-25%), fat (30-40%) and carbohydrate (40-50%) will be similar to that in carbohydrate counting diet which mentioned above.
DASH diet food choices will be inserted in the diet of the participants assigned for the combined diet of DASH and carbohydrate counting.
The emphasis will be more on the fruits and vegetables group (>8 servings/day), whole grains (at least half of the amount of the total servings of cereals; 6-8 servings/day), fat free dairy products (2-3 servings/day), lean meat and plant proteins (0-2 servings/day) and nuts (5-7 servings/week).
From the fat group olive oil will represent the main type of fat (20-25% of total fat %).
Adequate intake of sodium (2000mg) will be applied into participants' diet.
|
Adjusting the quantity and quality of food intake to improve glycemic control, maternal and newborn health outcomes of women with gestational diabetes.
Autres noms:
|
|
Aucune intervention: General Dietary guidlines
the general dietary advice and diet that will be prescribed by hospital for participants
|
Que mesure l'étude ?
Principaux critères de jugement
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Fasting blood glucose
Délai: one year
|
Fasting blood glucose in mg/dL at 24 -28 weeks of gestation (baseline) and at 36-37) weeks of gestation(endline) of intervention.
|
one year
|
Mesures de résultats secondaires
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Hemoglobin A1c level
Délai: one year
|
Hemoglobin A1c% at both baseline and endline of intervention
|
one year
|
|
Fasting insulin level
Délai: one year
|
Fasting insulin level in µIU/mL at both baseline and endline of intervention.
|
one year
|
|
Fructosamine level
Délai: one year
|
fructosamine in µmol/L at both baseline and endline of intervention.
|
one year
|
|
Total maternal weight gain
Délai: one year
|
Total maternal weight gain during pregnancy in kilograms
|
one year
|
|
Weekly weight gain
Délai: one year
|
weight in kilogram will be measured weekly for all participants
|
one year
|
|
Insulin Therapy
Délai: one year
|
Number of participants who need insulin therapy to normalize blood sugar.
|
one year
|
|
Emergency caesarean section
Délai: one year
|
Number of participants who need for emergency caesarean section versus vaginal delivery.
|
one year
|
|
Pregnancy-induced hypertension
Délai: one year
|
Number of participants with existence of hypertension (defined as a blood pressure of at least 140/90 mmHg on two occasions).
|
one year
|
|
Newborn weight
Délai: one year
|
The newborn weight in grams
|
one year
|
|
Newborn Length
Délai: one year
|
The new born length in centimeters.
|
one year
|
|
Newborn head circumference
Délai: one year
|
The newborn head circumference in centimeters.
|
one year
|
|
Hypoglycemic
Délai: one year
|
Number of newborn babies who will suffer from hypoglycemia
|
one year
|
|
Shoulder dystocia
Délai: one year
|
Number of newborn babies with shoulder dystocia.
|
one year
|
Collaborateurs et enquêteurs
Parrainer
Parrainer
Les enquêteurs
Les enquêteurs
- Directeur d'études: Reema F Tayyem, PhD, University of Jordan
Publications et liens utiles
Publications générales
- Kulkarni DK. Carbohydrate counting: A practical meal-planning option for people with diabetes. Clinical Diabetes 23:120-22, 2005.
- 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. Erratum. Gestational Diabetes Mellitus Can Be Prevented by Lifestyle Intervention: The Finnish Gestational Diabetes Prevention Study (RADIEL). A Randomized Controlled Trial. Diabetes Care 2016;39:24-30. Diabetes Care. 2017 Aug;40(8):1133. doi: 10.2337/dc17-er08a. Epub 2017 Jun 14. No abstract available.
- Ma WJ, Huang ZH, Huang BX, Qi BH, Zhang YJ, Xiao BX, Li YH, Chen L, Zhu HL. Intensive low-glycaemic-load dietary intervention for the management of glycaemia and serum lipids among women with gestational diabetes: a randomized control trial. Public Health Nutr. 2015 Jun;18(8):1506-13. doi: 10.1017/S1368980014001992. Epub 2014 Sep 15.
- Louie JC, Markovic TP, Perera N, Foote D, Petocz P, Ross GP, Brand-Miller JC. A randomized controlled trial investigating the effects of a low-glycemic index diet on pregnancy outcomes in gestational diabetes mellitus. Diabetes Care. 2011 Nov;34(11):2341-6. doi: 10.2337/dc11-0985. Epub 2011 Sep 6.
- Thomas, A. M. and Gutierrez, Y.M. (2005), American Dietetic Association guide to gestational diabetes mellitus. Chicago, IL: American Dietetic Association. Received from http://www.eatright.org/Public/ProductCatalog/ SearchableProducts/104_20728.cfm. Accessed 23 January 2016.
- Kleinwechter H, Schafer-Graf U, Buhrer C, Hoesli I, Kainer F, Kautzky-Willer A, Pawlowski B, Schunck K, Somville T, Sorger M; German Diabetes Association; German Association for Gynaecology and Obstetrics. Gestational diabetes mellitus (GDM) diagnosis, therapy and follow-up care: Practice Guideline of the German Diabetes Association(DDG) and the German Association for Gynaecologyand Obstetrics (DGGG). Exp Clin Endocrinol Diabetes. 2014 Jul;122(7):395-405. doi: 10.1055/s-0034-1366412. Epub 2014 Jul 11. No abstract available.
- Allehdan S, Basha A, Hyassat D, Nabhan M, Qasrawi H, Tayyem R. Effectiveness of carbohydrate counting and Dietary Approach to Stop Hypertension dietary intervention on managing Gestational Diabetes Mellitus among pregnant women who used metformin: A randomized controlled clinical trial. Clin Nutr. 2022 Feb;41(2):384-395. doi: 10.1016/j.clnu.2021.11.039. Epub 2021 Dec 3.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement primaire
Achèvement de l'étude (Anticipé)
Achèvement de l'étude
Dates d'inscription aux études
Première soumission
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Première publication
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour publiée
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
Autres numéros d'identification d'étude
- 2 (Autre identifiant: Instituto Cardiovascular de Buenos Aires)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Dietary Intervention
-
NCT04386278RésiliéMouvement dentaire orthodontique
-
NCT03283072Complété
-
NCT03826394Inconnue
-
NCT07276412RecrutementÉducation à la santé | Gamification dans l'éducation à la santé
-
NCT06289088Actif, ne recrute pasLombalgie, Posturale | Orthèse
-
NCT03991234ComplétéTrouble d'apprentissage des mathématiques | Trouble d'apprentissage de la lecture
-
NCT03849703InconnueCompétences en relations amoureuses | Compétences coparentales
-
NCT00577759ComplétéActivité physique | Habitudes alimentaires | Cesser de fumer
-
NCT04788680ComplétéEndotoxémie | Habitudes alimentaires