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Carbohydrate Counting and DASH Intervention and Pregnancy Outcomes Among Women With Gestational Diabetes

21. november 2018 opdateret af: Sabika Salem Allehdan, University of Jordan

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

Study is an interventional clinical trial. Pregnant women (aged 25-40 years) diagnosed with GDM (by a 75-g oral glucose tolerance test at 24-28 weeks' gestation) will be recruited conveniently from Obstetrics and Gynecology clinic at the Jordan University Hospital and National Center for Diabetes, Endocrinology and Genetics, Amman, Jordan. A sample of 180 pregnant women with GDM (60 women who do not use insulin and hypoglycemia medications, 60 women who are treated with metformin, 60 women who are treated with insulin), who will meet the inclusion criteria and will be agreed to participate will be centrally randomized to follow carbohydrate counting dietary intervention, carbohydrate counting and DASH dietary intervention, and control dietary intervention.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The main objective of this study is to compare the effect of carbohydrate counting, carbohydrate counting and DASH diet dietary interventions and a general dietary intervention on glycemic control, maternal and neonatal outcomes among Jordanian pregnant women with GDM. Eligibility criteria to be enrolled in the study will be being Jordanian pregnant women with GDM at 24 -28 gestational weeks, aged between 25 to 40 with no-personal history of type 1 or 2 diabetes, or impaired fasting glucose, or chronic diseases and singleton gestation. DASH diet; and the third group will follow the diet prescribed by the hospital for GDM. The duration of intervention will extend from 24-28 gestational weeks until delivery, which will be usually 12-14 weeks later. The glycemic controls outcomes are testing fasting blood glucose, HbA1C, insulin and fructosamine at baseline and at end of intervention for three dietary interventions. While maternal outcomes are total maternal weight gain (kg), need for emergency caesarean section, the presence or absence of pregnancy-induced hypertension and preeclampsia. The new born birth weight, length and head circumference, the presence or absence of hypoglycemia and shoulder dystocia are the newborn outcomes.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

180

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Jordan
      • Amman, Jordan, 009626
        • Rekruttering
        • Sabika Allehdan
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

25 år til 40 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

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).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: Dietary Intervention
Adjusting the quantity and quality of food intake to improve glycemic control, maternal and newborn health outcomes of women with gestational diabetes.
Andre navne:
  • diet therpy
Eksperimentel: 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.
Adfærdsmæssigt: Dietary Intervention
Adjusting the quantity and quality of food intake to improve glycemic control, maternal and newborn health outcomes of women with gestational diabetes.
Andre navne:
  • diet therpy
Ingen indgriben: General Dietary guidlines
the general dietary advice and diet that will be prescribed by hospital for participants

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Fasting blood glucose
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Hemoglobin A1c level
Tidsramme: one year
Hemoglobin A1c% at both baseline and endline of intervention
one year
Fasting insulin level
Tidsramme: one year
Fasting insulin level in µIU/mL at both baseline and endline of intervention.
one year
Fructosamine level
Tidsramme: one year
fructosamine in µmol/L at both baseline and endline of intervention.
one year
Total maternal weight gain
Tidsramme: one year
Total maternal weight gain during pregnancy in kilograms
one year
Weekly weight gain
Tidsramme: one year
weight in kilogram will be measured weekly for all participants
one year
Insulin Therapy
Tidsramme: one year
Number of participants who need insulin therapy to normalize blood sugar.
one year
Emergency caesarean section
Tidsramme: one year
Number of participants who need for emergency caesarean section versus vaginal delivery.
one year
Pregnancy-induced hypertension
Tidsramme: 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
Tidsramme: one year
The newborn weight in grams
one year
Newborn Length
Tidsramme: one year
The new born length in centimeters.
one year
Newborn head circumference
Tidsramme: one year
The newborn head circumference in centimeters.
one year
Hypoglycemic
Tidsramme: one year
Number of newborn babies who will suffer from hypoglycemia
one year
Shoulder dystocia
Tidsramme: one year
Number of newborn babies with shoulder dystocia.
one year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Jordan

Efterforskere

  • Studieleder: Reema F Tayyem, PhD, University of Jordan

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

20. august 2017

Primær færdiggørelse (Forventet)

20. august 2019

Studieafslutning (Forventet)

20. oktober 2019

Datoer for studieregistrering

Først indsendt

31. juli 2017

Først indsendt, der opfyldte QC-kriterier

6. august 2017

Først opslået (Faktiske)

9. august 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. november 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. november 2018

Sidst verificeret

1. november 2018

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2 (Anden identifikator: Instituto Cardiovascular de Buenos Aires)

Plan for individuelle deltagerdata (IPD)

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