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

Primary Purpose

Gestational Diabetes Mellitus With Baby Delivered

Status
Unknown status
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
Dietary Intervention
Sponsored by
University of Jordan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gestational Diabetes Mellitus With Baby Delivered

Eligibility Criteria

25 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

  • Sabika AllehdanRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Dietary intervention CHO counting

Dietary intervention CHO Counting & DASH

General Dietary guidlines

Arm Description

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.

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.

the general dietary advice and diet that will be prescribed by hospital for participants

Outcomes

Primary Outcome Measures

Fasting blood glucose
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

Hemoglobin A1c level
Hemoglobin A1c% at both baseline and endline of intervention
Fasting insulin level
Fasting insulin level in µIU/mL at both baseline and endline of intervention.
Fructosamine level
fructosamine in µmol/L at both baseline and endline of intervention.
Total maternal weight gain
Total maternal weight gain during pregnancy in kilograms
Weekly weight gain
weight in kilogram will be measured weekly for all participants
Insulin Therapy
Number of participants who need insulin therapy to normalize blood sugar.
Emergency caesarean section
Number of participants who need for emergency caesarean section versus vaginal delivery.
Pregnancy-induced hypertension
Number of participants with existence of hypertension (defined as a blood pressure of at least 140/90 mmHg on two occasions).
Newborn weight
The newborn weight in grams
Newborn Length
The new born length in centimeters.
Newborn head circumference
The newborn head circumference in centimeters.
Hypoglycemic
Number of newborn babies who will suffer from hypoglycemia
Shoulder dystocia
Number of newborn babies with shoulder dystocia.

Full Information

First Posted
July 31, 2017
Last Updated
November 21, 2018
Sponsor
University of Jordan
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1. Study Identification

Unique Protocol Identification Number
NCT03244579
Brief Title
Carbohydrate Counting and DASH Intervention and Pregnancy Outcomes Among Women With Gestational Diabetes
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 20, 2017 (Actual)
Primary Completion Date
August 20, 2019 (Anticipated)
Study Completion Date
October 20, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jordan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes Mellitus With Baby Delivered

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dietary intervention CHO counting
Arm Type
Experimental
Arm Description
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.
Arm Title
Dietary intervention CHO Counting & DASH
Arm Type
Experimental
Arm Description
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.
Arm Title
General Dietary guidlines
Arm Type
No Intervention
Arm Description
the general dietary advice and diet that will be prescribed by hospital for participants
Intervention Type
Behavioral
Intervention Name(s)
Dietary Intervention
Other Intervention Name(s)
diet therpy
Intervention Description
Adjusting the quantity and quality of food intake to improve glycemic control, maternal and newborn health outcomes of women with gestational diabetes.
Primary Outcome Measure Information:
Title
Fasting blood glucose
Description
Fasting blood glucose in mg/dL at 24 -28 weeks of gestation (baseline) and at 36-37) weeks of gestation(endline) of intervention.
Time Frame
one year
Secondary Outcome Measure Information:
Title
Hemoglobin A1c level
Description
Hemoglobin A1c% at both baseline and endline of intervention
Time Frame
one year
Title
Fasting insulin level
Description
Fasting insulin level in µIU/mL at both baseline and endline of intervention.
Time Frame
one year
Title
Fructosamine level
Description
fructosamine in µmol/L at both baseline and endline of intervention.
Time Frame
one year
Title
Total maternal weight gain
Description
Total maternal weight gain during pregnancy in kilograms
Time Frame
one year
Title
Weekly weight gain
Description
weight in kilogram will be measured weekly for all participants
Time Frame
one year
Title
Insulin Therapy
Description
Number of participants who need insulin therapy to normalize blood sugar.
Time Frame
one year
Title
Emergency caesarean section
Description
Number of participants who need for emergency caesarean section versus vaginal delivery.
Time Frame
one year
Title
Pregnancy-induced hypertension
Description
Number of participants with existence of hypertension (defined as a blood pressure of at least 140/90 mmHg on two occasions).
Time Frame
one year
Title
Newborn weight
Description
The newborn weight in grams
Time Frame
one year
Title
Newborn Length
Description
The new born length in centimeters.
Time Frame
one year
Title
Newborn head circumference
Description
The newborn head circumference in centimeters.
Time Frame
one year
Title
Hypoglycemic
Description
Number of newborn babies who will suffer from hypoglycemia
Time Frame
one year
Title
Shoulder dystocia
Description
Number of newborn babies with shoulder dystocia.
Time Frame
one year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sabika S Allehdan, Msc
Phone
+962799232789
Email
sabika_1986@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Reema F Tayyem, PhD
Phone
+962797902535
Email
r_tayyem@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reema F Tayyem, PhD
Organizational Affiliation
University of Jordan
Official's Role
Study Director
Facility Information:
Facility Name
Sabika Allehdan
City
Amman
ZIP/Postal Code
009626
Country
Jordan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabika Allehdan, MSc
Phone
799232789
Email
sabika_1986@Yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
Citation
Kulkarni DK. Carbohydrate counting: A practical meal-planning option for people with diabetes. Clinical Diabetes 23:120-22, 2005.
Results Reference
background
PubMed Identifier
28615238
Citation
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.
Results Reference
background
PubMed Identifier
25222105
Citation
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.
Results Reference
background
PubMed Identifier
21900148
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
25014091
Citation
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.
Results Reference
background
PubMed Identifier
34999333
Citation
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.
Results Reference
derived

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

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