Protocol summary
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Study aim
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Objective: The aim of this study is to determine the effects of the Dietary Approaches to Stop Hypertension (DASH) diet on pregnancy outcomes in gestational diabetes.
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Design
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Study design: Parallel clinical trial. Randomization will be done by the use of computer-generated random numbers.
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Settings and conduct
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Population and sample size: Among patients with gestational diabetes referred to maternity Clinic affiliated to Kashan University of Medical Sciences, 58 patients will be selected according to inclusion and exclusion criteria.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Pregnant women aged 18-40 years diagnosed with GDM at 24-28 weeks' gestation will be included in this study. Exclusion criteria: A previous glucose intolerance/GDM diagnosis, premature preterm rupture of membrane, placenta abruption, pre-eclampsia, requiring to commence insulin therapy during intervention, complete bed rest, hypothyroidism, urinary tract infection, smoking, kidney or liver diseases, taking estrogen therapy.
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Intervention groups
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Intervention group: DASH diet, 6 serving vegetables, 6 serving fruits, rich in fiber and whole grains, daily for 4 weeks.
Control group: Standard diet, 4 serving vegetables, 4 serving fruits, rich in protein, daily for 4 weeks.
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Main outcome variables
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Outcomes: Newborns' weight (primary outcomes) and other pregnancy outcomes (secondary outcome) will be quantified at study baseline and end-of-trial.
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT201212195623N4
Registration date:
2013-02-18, 1391/11/30
Registration timing:
registered_while_recruiting
Last update:
2019-09-25, 1398/07/03
Update count:
1
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Registration date
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2013-02-18, 1391/11/30
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Kashan University of Medical Sciences
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Expected recruitment start date
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2013-02-12, 1391/11/24
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Expected recruitment end date
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2013-03-12, 1391/12/22
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Effects of the Dietary Approaches to Stop Hypertension (DASH) on pregnancy outcomes in gestational diabetes
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Public title
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Effect of diet therapy in treatment of gestational diabetes
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Pregnant women aged 18-40 years
Diagnosed with GDM at 24-28 weeks' gestation
Exclusion criteria:
A previous glucose intolerance/GDM diagnosis
Premature preterm rupture of membrane
Placenta abruption
Pre-eclampsia
Requiring to commence insulin therapy during intervention
Complete bed rest
Hypothyroidism
Urinary tract infection
Smoking
Kidney or liver diseases
Taking estrogen therapy
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Age
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From 18 years old to 40 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
58
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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At study baseline and after stratification for pre-intervention BMI and weeks of gestation, subjects will be randomly divided into two groups to take DASH diet or the standard diet. Randomization will be done by the use of computer-generated random numbers.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2013-02-11, 1391/11/23
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Ethics committee reference number
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29/5/1/4139/پ
Health conditions studied
1
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Description of health condition studied
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Diabetes mellitus in pregnancy
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ICD-10 code
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O24.9
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ICD-10 code description
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Diabetes mellitus in pregnancy, unspecified
Primary outcomes
1
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Description
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Newborns' weight
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Timepoint
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The first 24 h after birth
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Method of measurement
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Scale
Secondary outcomes
1
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Description
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Newborn length
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Timepoint
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The first 24 h after birth
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Method of measurement
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Tape
2
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Description
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Newborn's head circumference
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Timepoint
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The first 24 h after birth
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Method of measurement
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Tape
3
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Description
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Polyhydramnios
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Timepoint
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After the intervention
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Method of measurement
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Sonography
4
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Description
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Apgar score
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Timepoint
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Delivery time
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Method of measurement
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Clinical observation
Intervention groups
1
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Description
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Intervention group: DASH diet, 6 serving vegetables, 6 serving fruits, rich in fiber and whole grains, daily for 4 weeks
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Category
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Other
2
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Description
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Control group: Standard diet, 4 serving vegetables, 4 serving fruits, rich in protein, daily for 4 weeks
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Category
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Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Kashan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available