Maternal Obesity Complicating Pregnancy, Birth,or PuerperiumNCT02750774
An Early-customized Low Glycaemic-index (GI) Diet Prevents LGA Babies in Overweight/Obese Pregnant Women
A study testing Low-glycemic index group in people with Maternal Obesity Complicating Pregnancy, Birth,or Puerperium and Gestational Diabetes Mellitus, run by University of Modena and Reggio Emilia at 1 site in Italy.
Trial summary
High pre-pregnancy body mass index (BMI) and excessive gestational weight gain (GWG) are associated with many unfavourable maternal and neonatal outcomes. Adherence to lifestyle recommendations could be a major determinant of the efficacy on preventing unfavorable outcomes, namely among overweight/obese women. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal Obesity Complicating Pregnancy, Birth,or Puerperium, Gestational Diabetes Mellitus, Birthweight
- What is being tested?
- Low-glycemic index group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- age >18 years
- singleton pregnancy
- BMI >= 25 kg/m2
Who cannot join
- Chronic diseases including diabetes mellitus (first trimester glycosuria> 100 mg/dl or fasting plasma glucose ≥126 mg/dL or random glycemia ≥ 200 mg/dL) and hypertension
- Previous GDM
- Medical conditions or dietary supplements that might affect the body weight (i.e., thyroid diseases)
- Previous bariatric surgery
- Smoking habits
- Contraindications to exercise
- Intent to deliver outside our hospital
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Mother-Infant Department, University of Modena and Reggio Emilia, Italy
Modena, 41124
Fabio Fachhinetti, MD, 0039 0594222512, facchi@unimore.it
Elisabetta Petrella, MD
About this study
Official title: A Customized Low Glycaemic-index (GI) Diet, Introduced at First Trimester of Pregnancy by Both Gynecologist and Dietitian, Prevents Large for Gestational Age (LGA) Newborns in Overweight/Obese Pregnant Women
High pre-pregnancy body mass index (BMI) and excessive gestational weight gain (GWG) are associated with many unfavourable maternal and neonatal outcomes.
Adherence to lifestyle recommendations could be a major determinant of the efficacy on preventing unfavorable outcomes, namely among overweight/obese women. Previous studies investigated adherence to specific dietary patterns and their effect on pregnancy outcomes; however, no study has investigated adherence among overweight/obese pregnant women and its effect on the onset of several maternal-neonatal outcomes.
This study aimed to determine whether the prescription of a lifestyle program, consisting of a customized low-glycemic index (GI) diet and a physical activity program, in overweight and obese women could affect the occurrence LGA babies. It also aimed to determine whether this kind of prescription influences the adherence to healthier eating habits, and how this, in turn, can influence the occurrence LGA.
Read the detailed description
High pre-pregnancy BMI and excessive GWG are associated with many unfavourable maternal and neonatal outcomes and are independent risk factors for gestational diabetes mellitus (GDM) and large for gestatiola age (LGA) babies. Overweight/obese women should be counselled regarding their body weight before conception; however, most women have access to obstetricians only when they are pregnant. The Institute of Medicine (IOM) revised the guidelines of recommended GWG according to the BMI; however, only a minority of women succeed in reaching the recommended GWG. Among the interventions aimed at preventing excessive GWG, few have demonstrated efficacy in high-risk populations; the principal issues are population heterogeneity, the interventional methods, and the timing of the interventional programs. Additionally, lifestyle interventions did not have a substantial effect on other clinical outcomes. Dietary advice to prevent gestational diabetes mellitus (GDM) appears to be beneficial in general, although the results are overly heterogeneous. A systematic review concerning exercise alone demonstrated no effect on preventing GDM, whereas another study showed only a slight protective effect. The reports evaluating the efficacy of diverse approaches (exercise, diet, lifestyle interventions, dietary supplements) to prevent GDM are of poor quality. Adherence to lifestyle recommendations could be a major determinant of their efficacy, specifically among overweight/obese women. Previous studies investigated adherence to specific dietary patterns and their effect on pregnancy outcomes; however, no study has investigated adherence among overweight/obese pregnant women and its effect on the onset of GDM. Nowadays, there are insufficient evidences for recommend a specific diet in preventing LGA babies.
This study aimed to determine whether the prescription of an early lifestyle program, consisting of a low-glycemic index (GI) caloric restriction and physical activity (PA), in overweight and obese women could affect the occurrence of LGA newborns. It also aimed to determine whether this kind of prescription influences the adherence to healthier eating habits, and how this, in turn, can influence the occurrence of LGA babies.
- Conditions
- Maternal Obesity Complicating Pregnancy, Birth,or Puerperium, Gestational Diabetes Mellitus, Birthweight, Large for Gestational Age (LGA), Caloric Restriction, Lifestyle Intervention
- Being tested
- Low-glycemic index group, Standard Care Group
- Medical subject headings
- Diabetes, Gestational, Birth Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-glycemic index groupBehavioural
The dietary intervention consisted of the prescription of a Mediterranean style, low-glycaemic, low-fat, exchange diet (3 main meals and 3 snacks) with a total intake of 1500 kcal/day. In light of the PA, the dietitian adds 200 kcal/day for obese, 300 kcal/day for overweight women. The diet had a target macronutrient composition of 55% carbohydrates (80% complex carbohydrates with a low glycaemic index and 20% simple carbohydrates), 20% protein (50% animal and 50% vegetable) and 25% fat (12% mono-unsaturated, 7% polyunsaturated and 6% saturated) with moderately low saturated fat levels. The daily intake of carbohydrates was at least 225 g/day. The exercise intervention was focused on developing a more active lifestyle. The PA prescription is consistent with recommendations by the ACOG and ACSM for pregnant women. The "talk test" (being able to maintain a conversation during activity) was suggested to monitor the exercise intensity.
Standard Care GroupOther
Women randomized to the Standard Care Group received general information about healthy lifestyle during pregnancy, according to the Guidelines
| Study group | Role | What they receive |
|---|---|---|
| Low-Glycemic Index Group | Experimental | Women in the low- glycaemic index group received a dietary intervention based on 3 main meals and 3 snacks, with a precise macronutrient composition, and a physical activity counseling according to the ACOG and ACSM recommendations. Receives: Behavioral: Low-glycemic index group |
| Standard Care Group | Other | Women in the Standard Care Group received a simple nutritional booklet regarding lifestyle, which was in agreement with the Italian Guidelines for a healthy diet during pregnancy that included general advice regarding food consumption and physical activity. Receives: Other: Standard Care Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Large-for-gestational-age (LGA) occurrence
LGA babies were defined if birthweight centile was ≥ 90°, and it was measured at delivery
Measured: At delivery
Gestational Diabetes Mellitus (GDM) occurrence
The diagnosis of GDM was made for any glucose value exceeding the normal cut-off, according to the Guidelines
Measured: At 24-26 weeks
Secondary outcomes (4)
Gestational Weight Gain (GWG)
Excessive GWG is related to unfavorable pregnancy outcomes. Weight gain is measured at each follow-up visit, at delivery and 3 months after delivery in both groups, to evaluate possible effects of the intervention.
Measured: At baseline, at 16, 20, 28 and 36 weeks, at delivery and 3 months after delivery
Pre-term Birth (PTB)
Both spontaneous and medically indicated preterm births are associated with obesity. We recorded cases of preterm birth, if it was spontaneous or not and the eventual indication.
Measured: At delivery
Neonatal hypoglycemia
Altered maternal glucose metabolism is associated with neonatal hypoglicemia
Measured: Within 24 hours after delivery
Neonatal Intensive Care Unit (NICU) admission
Maternal overweight and obesity are related to higher prevalence of neonatal complications
Measured: Within 24 hours after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2016 (estimated)
- Study startDec 2015
- Primary completionJul 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal Obesity Complicating Pregnancy, Birth,or PuerperiumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Modena and Reggio Emilia
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Elisabetta Petrella
- Responsible party
- Principal investigator, Prof. Facchinetti Fabio, University of Modena and Reggio Emilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02750774
- Sponsor's protocol ID
- Pratica CE 136/15
- Status last verified
- Apr 2016
- First submitted
- 14 Apr 2016
- Last updated
- 26 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Customized Low Glycaemic-index (GI) Diet, Introduced at First Trimester of Pregnancy by Both Gynecologist and Dietitian, Prevents Large for Gestational Age (LGA) Newborns in Overweight/Obese Pregnant Women
- ClinicalTrials.gov ID
- NCT02750774
- Acronym / sponsor ID
- Pratica CE 136/15
- Conditions
- Maternal Obesity Complicating Pregnancy, Birth,or Puerperium, Gestational Diabetes Mellitus, Birthweight, Large for Gestational Age (LGA), Caloric Restriction, Lifestyle Intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Modena and Reggio EmiliaUniversity, hospital or other
- Collaborators
- Dr. Elisabetta Petrella
- Study start
- Dec 2015
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 26 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
High pre-pregnancy body mass index (BMI) and excessive gestational weight gain (GWG) are associated with many unfavourable maternal and neonatal outcomes.
Adherence to lifestyle recommendations could be a major determinant of the efficacy on preventing unfavorable outcomes, namely among overweight/obese women. Previous studies investigated adherence to specific dietary patterns and their effect on pregnancy outcomes; however, no study has investigated adherence among overweight/obese pregnant women and its effect on the onset of several maternal-neonatal outcomes.
This study aimed to determine whether the prescription of a lifestyle program, consisting of a customized low-glycemic index (GI) diet and a physical activity program, in overweight and obese women could affect the occurrence LGA babies. It also aimed to determine whether this kind of prescription influences the adherence to healthier eating habits, and how this, in turn, can influence the occurrence LGA.
Detailed description
High pre-pregnancy BMI and excessive GWG are associated with many unfavourable maternal and neonatal outcomes and are independent risk factors for gestational diabetes mellitus (GDM) and large for gestatiola age (LGA) babies. Overweight/obese women should be counselled regarding their body weight before conception; however, most women have access to obstetricians only when they are pregnant. The Institute of Medicine (IOM) revised the guidelines of recommended GWG according to the BMI; however, only a minority of women succeed in reaching the recommended GWG. Among the interventions aimed at preventing excessive GWG, few have demonstrated efficacy in high-risk populations; the principal issues are population heterogeneity, the interventional methods, and the timing of the interventional programs. Additionally, lifestyle interventions did not have a substantial effect on other clinical outcomes. Dietary advice to prevent gestational diabetes mellitus (GDM) appears to be beneficial in general, although the results are overly heterogeneous. A systematic review concerning exercise alone demonstrated no effect on preventing GDM, whereas another study showed only a slight protective effect. The reports evaluating the efficacy of diverse approaches (exercise, diet, lifestyle interventions, dietary supplements) to prevent GDM are of poor quality. Adherence to lifestyle recommendations could be a major determinant of their efficacy, specifically among overweight/obese women. Previous studies investigated adherence to specific dietary patterns and their effect on pregnancy outcomes; however, no study has investigated adherence among overweight/obese pregnant women and its effect on the onset of GDM. Nowadays, there are insufficient evidences for recommend a specific diet in preventing LGA babies.
This study aimed to determine whether the prescription of an early lifestyle program, consisting of a low-glycemic index (GI) caloric restriction and physical activity (PA), in overweight and obese women could affect the occurrence of LGA newborns. It also aimed to determine whether this kind of prescription influences the adherence to healthier eating habits, and how this, in turn, can influence the occurrence of LGA babies.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-Glycemic Index Group | Experimental | Behavioral: Low-glycemic index groupWomen in the low- glycaemic index group received a dietary intervention based on 3 main meals and 3 snacks, with a precise macronutrient composition, and a physical activity counseling according to the ACOG and ACSM recommendations. |
| Standard Care Group | Other | Other: Standard Care GroupWomen in the Standard Care Group received a simple nutritional booklet regarding lifestyle, which was in agreement with the Italian Guidelines for a healthy diet during pregnancy that included general advice regarding food consumption and physical activity. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age >18 years
- singleton pregnancy
- BMI >= 25 kg/m2
Key exclusion criteria (7 listed)
- Chronic diseases including diabetes mellitus (first trimester glycosuria> 100 mg/dl or fasting plasma glucose ≥126 mg/dL or random glycemia ≥ 200 mg/dL) and hypertension
- Previous GDM
- Medical conditions or dietary supplements that might affect the body weight (i.e., thyroid diseases)
- Previous bariatric surgery
- Smoking habits
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-glycemic index groupThe dietary intervention consisted of the prescription of a Mediterranean style, low-glycaemic, low-fat, exchange diet (3 main meals and 3 snacks) with a total intake of 1500 kcal/day. In light of the PA, the dietitian adds 200 kcal/day for obese, 300 kcal/day for overweight women. The diet had a target macronutrient composition of 55% carbohydrates (80% complex carbohydrates with a low glycaemic index and 20% simple carbohydrates), 20% protein (50% animal and 50% vegetable) and 25% fat (12% mono-unsaturated, 7% polyunsaturated and 6% saturated) with moderately low saturated fat levels. The daily intake of carbohydrates was at least 225 g/day. The exercise intervention was focused on developing a more active lifestyle. The PA prescription is consistent with recommendations by the ACOG and ACSM for pregnant women. The "talk test" (being able to maintain a conversation during activity) was suggested to monitor the exercise intensity. | Behavioural | Low-Glycemic Index Group |
| Standard Care GroupWomen randomized to the Standard Care Group received general information about healthy lifestyle during pregnancy, according to the Guidelines | Other | Standard Care Group |
Primary outcome
Large-for-gestational-age (LGA) occurrence
Time frame: At delivery
LGA babies were defined if birthweight centile was ≥ 90°, and it was measured at delivery
Gestational Diabetes Mellitus (GDM) occurrence
Time frame: At 24-26 weeks
The diagnosis of GDM was made for any glucose value exceeding the normal cut-off, according to the Guidelines
4 secondary outcomes
Gestational Weight Gain (GWG)
Time frame: At baseline, at 16, 20, 28 and 36 weeks, at delivery and 3 months after delivery
Pre-term Birth (PTB)
Time frame: At delivery
Neonatal hypoglycemia
Time frame: Within 24 hours after delivery
Neonatal Intensive Care Unit (NICU) admission
Time frame: Within 24 hours after delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2016.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mother-Infant Department, University of Modena and Reggio Emilia, Italy
Modena, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-glycemic index group in people with Maternal Obesity Complicating Pregnancy, Birth,or Puerperium and Gestational Diabetes Mellitus, run by University of Modena and Reggio Emilia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Large-for-gestational-age (LGA) occurrence (time frame: At delivery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2016.