- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03244579
Carbohydrate Counting and DASH Intervention and Pregnancy Outcomes Among Women With Gestational Diabetes
November 21, 2018 updated by: 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.
Study Overview
Status
Unknown
Intervention / Treatment
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
Enrollment (Anticipated)
180
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sabika S Allehdan, Msc
- Phone Number: +962799232789
- Email: sabika_1986@yahoo.com
Study Contact Backup
- Name: Reema F Tayyem, PhD
- Phone Number: +962797902535
- Email: r_tayyem@yahoo.com
Study Locations
-
-
-
Amman, Jordan, 009626
- Recruiting
- Sabika Allehdan
-
Contact:
- Sabika Allehdan, MSc
- Phone Number: 799232789
- Email: sabika_1986@Yahoo.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
Adjusting the quantity and quality of food intake to improve glycemic control, maternal and newborn health outcomes of women with gestational diabetes.
Other Names:
|
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.
|
Adjusting the quantity and quality of food intake to improve glycemic control, maternal and newborn health outcomes of women with gestational diabetes.
Other Names:
|
No Intervention: General Dietary guidlines
the general dietary advice and diet that will be prescribed by hospital for participants
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hemoglobin A1c level
Time Frame: one year
|
Hemoglobin A1c% at both baseline and endline of intervention
|
one year
|
Fasting insulin level
Time Frame: one year
|
Fasting insulin level in µIU/mL at both baseline and endline of intervention.
|
one year
|
Fructosamine level
Time Frame: one year
|
fructosamine in µmol/L at both baseline and endline of intervention.
|
one year
|
Total maternal weight gain
Time Frame: one year
|
Total maternal weight gain during pregnancy in kilograms
|
one year
|
Weekly weight gain
Time Frame: one year
|
weight in kilogram will be measured weekly for all participants
|
one year
|
Insulin Therapy
Time Frame: one year
|
Number of participants who need insulin therapy to normalize blood sugar.
|
one year
|
Emergency caesarean section
Time Frame: one year
|
Number of participants who need for emergency caesarean section versus vaginal delivery.
|
one year
|
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).
|
one year
|
Newborn weight
Time Frame: one year
|
The newborn weight in grams
|
one year
|
Newborn Length
Time Frame: one year
|
The new born length in centimeters.
|
one year
|
Newborn head circumference
Time Frame: one year
|
The newborn head circumference in centimeters.
|
one year
|
Hypoglycemic
Time Frame: one year
|
Number of newborn babies who will suffer from hypoglycemia
|
one year
|
Shoulder dystocia
Time Frame: one year
|
Number of newborn babies with shoulder dystocia.
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Reema F Tayyem, PhD, University of Jordan
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 20, 2017
Primary Completion (Anticipated)
August 20, 2019
Study Completion (Anticipated)
October 20, 2019
Study Registration Dates
First Submitted
July 31, 2017
First Submitted That Met QC Criteria
August 6, 2017
First Posted (Actual)
August 9, 2017
Study Record Updates
Last Update Posted (Actual)
November 26, 2018
Last Update Submitted That Met QC Criteria
November 21, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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