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

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ClinicalTrials.gov Identifier: NCT03244579
Recruitment Status : Recruiting
First Posted : August 9, 2017
Last Update Posted : November 26, 2018
Sponsor:
Information provided by (Responsible Party):
Sabika Salem Allehdan, University of Jordan

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Gestational Diabetes Mellitus With Baby Delivered Behavioral: Dietary Intervention Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 20, 2017
Estimated Primary Completion Date : August 20, 2019
Estimated Study Completion Date : October 20, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Behavioral: Dietary Intervention
Adjusting the quantity and quality of food intake to improve glycemic control, maternal and newborn health outcomes of women with gestational diabetes.
Other Name: diet therpy

Experimental: 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.
Behavioral: Dietary Intervention
Adjusting the quantity and quality of food intake to improve glycemic control, maternal and newborn health outcomes of women with gestational diabetes.
Other Name: diet therpy

No Intervention: General Dietary guidlines
the general dietary advice and diet that will be prescribed by hospital for participants



Primary Outcome Measures :
  1. Fasting blood glucose [ Time Frame: 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.


Secondary Outcome Measures :
  1. Hemoglobin A1c level [ Time Frame: one year ]
    Hemoglobin A1c% at both baseline and endline of intervention

  2. Fasting insulin level [ Time Frame: one year ]
    Fasting insulin level in µIU/mL at both baseline and endline of intervention.

  3. Fructosamine level [ Time Frame: one year ]
    fructosamine in µmol/L at both baseline and endline of intervention.

  4. Total maternal weight gain [ Time Frame: one year ]
    Total maternal weight gain during pregnancy in kilograms

  5. Weekly weight gain [ Time Frame: one year ]
    weight in kilogram will be measured weekly for all participants

  6. Insulin Therapy [ Time Frame: one year ]
    Number of participants who need insulin therapy to normalize blood sugar.

  7. Emergency caesarean section [ Time Frame: one year ]
    Number of participants who need for emergency caesarean section versus vaginal delivery.

  8. Pregnancy-induced hypertension [ Time Frame: one year ]
    Number of participants with existence of hypertension (defined as a blood pressure of at least 140/90 mmHg on two occasions).

  9. Newborn weight [ Time Frame: one year ]
    The newborn weight in grams

  10. Newborn Length [ Time Frame: one year ]
    The new born length in centimeters.

  11. Newborn head circumference [ Time Frame: one year ]
    The newborn head circumference in centimeters.

  12. Hypoglycemic [ Time Frame: one year ]
    Number of newborn babies who will suffer from hypoglycemia

  13. Shoulder dystocia [ Time Frame: one year ]
    Number of newborn babies with shoulder dystocia.



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Ages Eligible for Study:   25 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03244579


Contacts
Contact: Sabika S Allehdan, Msc +962799232789 sabika_1986@yahoo.com
Contact: Reema F Tayyem, PhD +962797902535 r_tayyem@yahoo.com

Locations
Jordan
Sabika Allehdan Recruiting
Amman, Jordan, 009626
Contact: Sabika Allehdan, MSc    799232789    sabika_1986@Yahoo.com   
Sponsors and Collaborators
University of Jordan
Investigators
Study Director: Reema F Tayyem, PhD University of Jordan

Publications:
Kulkarni DK. Carbohydrate counting: A practical meal-planning option for people with diabetes. Clinical Diabetes 23:120-22, 2005.
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.

Responsible Party: Sabika Salem Allehdan, Principal Investigator, University of Jordan
ClinicalTrials.gov Identifier: NCT03244579     History of Changes
Other Study ID Numbers: 2
First Posted: August 9, 2017    Key Record Dates
Last Update Posted: November 26, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications