Birth-weightPhase 3NCT01506310
Efficacy of Behavioral Therapy and Exercise in Gestational Diabetes Mellitus (GDM)
A Phase 3 study testing Behavioral therapy, Exercise and Behavioral therapy and exercise in people with Birth-weight, run by University of Turin, Italy at 1 site in Italy.
Trial summary
The purpose of the study is to test whether four lifestyle intervention programs (diet alone; diet and behavioral therapy, diet and exercise, diet and behavioral therapy and exercise), delivered to women with GDM during 24-26 weeks of gestational age will help women to improve their metabolic pattern, and decrease the… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Birth-weight
- What is being tested?
- Behavioral therapy, Exercise and Behavioral therapy and exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2009to Jun 2012
- Phase
- Phase 3
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Gestational age between 24 and 26 weeks
- Diagnosis of GDM at the 75g oral glucose tolerance test (OGTT)
- Singleton pregnancy
Who cannot join
- Body mass index > 40 or < 12kg/m2
- Any known diseases (pre-existing diabetes mellitus, cardiovascular diseases, liver/kidney diseases, cancers, arterial hypertension)
- Patients on any drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Comparative Trial on the Efficacy of Behavioral Therapy, Exercise and Their Combination in Gestational Diabetes Mellitus (GDM).
The purpose of the study is to test whether four lifestyle intervention programs (diet alone; diet and behavioral therapy, diet and exercise, diet and behavioral therapy and exercise), delivered to women with GDM during 24-26 weeks of gestational age will help women to improve their metabolic pattern, and decrease the incidence of adverse maternal and neonatal outcomes.
Read the detailed description
Women with gestational diabetes (GDM) are at increased risk of adverse pregnancy and neonatal outcomes. It is estimated that most women diagnosed with GDM can achieve targeted glycemic goals with nutrition therapy alone. A moderate exercise is recommended to lower serum glucose and to improve insulin sensitivity. Despite this, few reports examine the effect of exercise on glucose intolerance during pregnancy. Furthermore, no trial on the efficacy of behavioral treatment in women with GDM is available.
The purpose of the study is to test whether four lifestyle intervention programs (diet alone; diet and behavioral therapy, diet and exercise, diet and behavioral therapy and exercise), delivered to women with GDM during 24-26 weeks of gestational age will help women to improve their metabolic pattern, and decrease the incidence of adverse maternal and neonatal outcomes.
- Conditions
- Birth-weight
- Being tested
- Behavioral therapy, Exercise, Behavioral therapy and exercise
- Keywords
- gestational diabetes mellitus, fasting glucose, insulin resistance, birth-weight, Glucose values, Insulin concentrations, Cesarean sections
- Medical subject headings
- Birth Weight, Diabetes, Gestational, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral therapyBehavioural
General written dietary recommendations (about cooking, lowering sugar intake, reducing salt intake, reducing beverages and food with added sugars) and written options for dining out. A brief written guide on behavior change.
ExerciseOther
The exercise groups will be advised to walk at least 20-minute a day.
Behavioral therapy and exerciseOther
General written dietary recommendations (about cooking, lowering fat intake, reducing salt intake, reducing beverages and food with added sugars) and written options for dining out.
Written recommendations for physical activity A brief written guide on behavior change
| Study group | Role | What they receive |
|---|---|---|
| Diet alone | No intervention | Not described |
| Behavioral therapy | Experimental | Not described Receives: Behavioral: Behavioral therapy |
| Exercise | Experimental | Not described Receives: Other: Exercise |
| Behavioral therapy and exercise | Experimental | Not described Receives: Other: Behavioral therapy and exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum fasting glucose values.
To investigate changes from baseline in serum fasting glucose values in each arm with a 2x2 factorial design.
Measured: Fasting glucose will be measured at recruitment (24 weeks of gestation) and at the end of follow-up (38 weeks of gestation)
Secondary outcomes (4)
Serum fasting insulin values
To investigate changes from baseline in serum fasting insulin values in each arm.
Measured: At recruitment (at 24 weeks of gestation) and at the end of follow-up (38 weeks of gestation)
The need for insulin therapy
The need for insulin therapy in each arm
Measured: At recruitment and at the end of follow-up (38 weeks)
The number of Cesarean sections
The number of Cesarean sections in each arm
Measured: From recruitment until the date of delivery, either natural or by Caesarean section, assessed up to 42 weeks
The mean birth-weight of newborns
The mean birth-weight of newborns in each arm
Measured: From recruitment until the date of delivery, assessed up to 42 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2012 (estimated)
- Study startJul 2009
- Primary completionMar 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Birth-weightStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simona Bo, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01506310
- Sponsor's protocol ID
- sbo2010
- Status last verified
- Jan 2013
- First submitted
- 26 Dec 2011
- Last updated
- 23 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Bo S, Gambino R, Menato G, Canil S, Ponzo V, Pinach S, Durazzo M, Ghigo E, Cassader M, Musso G. Isoleucine-to-methionine substitution at residue 148 variant of PNPLA3 gene and metabolic outcomes in gestational diabetes. Am J Clin Nutr. 2015 Feb;101(2):310-8. doi: 10.3945/ajcn.114.095125. Epub 2014 Dec 17.
PubMed 25646328
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparative Trial on the Efficacy of Behavioral Therapy, Exercise and Their Combination in Gestational Diabetes Mellitus (GDM).
- ClinicalTrials.gov ID
- NCT01506310
- Acronym / sponsor ID
- sbo2010
- Conditions
- Birth-weight
- Keywords
- gestational diabetes mellitus, fasting glucose, insulin resistance, birth-weight, Glucose values, Insulin concentrations, Cesarean sections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Mar 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 10 Jan 2012 (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.
The purpose of the study is to test whether four lifestyle intervention programs (diet alone; diet and behavioral therapy, diet and exercise, diet and behavioral therapy and exercise), delivered to women with GDM during 24-26 weeks of gestational age will help women to improve their metabolic pattern, and decrease the incidence of adverse maternal and neonatal outcomes.
Detailed description
Women with gestational diabetes (GDM) are at increased risk of adverse pregnancy and neonatal outcomes. It is estimated that most women diagnosed with GDM can achieve targeted glycemic goals with nutrition therapy alone. A moderate exercise is recommended to lower serum glucose and to improve insulin sensitivity. Despite this, few reports examine the effect of exercise on glucose intolerance during pregnancy. Furthermore, no trial on the efficacy of behavioral treatment in women with GDM is available.
The purpose of the study is to test whether four lifestyle intervention programs (diet alone; diet and behavioral therapy, diet and exercise, diet and behavioral therapy and exercise), delivered to women with GDM during 24-26 weeks of gestational age will help women to improve their metabolic pattern, and decrease the incidence of adverse maternal and neonatal outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Diet alone | No intervention | – |
| Behavioral therapy | Experimental | Behavioral: Behavioral therapy |
| Exercise | Experimental | Other: Exercise |
| Behavioral therapy and exercise | Experimental | Other: Behavioral therapy and exercise |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Gestational age between 24 and 26 weeks
- Diagnosis of GDM at the 75g oral glucose tolerance test (OGTT)
- Singleton pregnancy
Key exclusion criteria (3 listed)
- Body mass index > 40 or < 12kg/m2
- Any known diseases (pre-existing diabetes mellitus, cardiovascular diseases, liver/kidney diseases, cancers, arterial hypertension)
- Patients on any drugs
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 |
|---|---|---|
| Behavioral therapyGeneral written dietary recommendations (about cooking, lowering sugar intake, reducing salt intake, reducing beverages and food with added sugars) and written options for dining out. A brief written guide on behavior change. | Behavioural | Behavioral therapy |
| ExerciseThe exercise groups will be advised to walk at least 20-minute a day. | Other | Exercise |
| Behavioral therapy and exerciseGeneral written dietary recommendations (about cooking, lowering fat intake, reducing salt intake, reducing beverages and food with added sugars) and written options for dining out. Written recommendations for physical activity A brief written guide on behavior change | Other | Behavioral therapy and exercise |
Primary outcome
Serum fasting glucose values.
Time frame: Fasting glucose will be measured at recruitment (24 weeks of gestation) and at the end of follow-up (38 weeks of gestation)
To investigate changes from baseline in serum fasting glucose values in each arm with a 2x2 factorial design.
4 secondary outcomes
Serum fasting insulin values
Time frame: At recruitment (at 24 weeks of gestation) and at the end of follow-up (38 weeks of gestation)
The need for insulin therapy
Time frame: At recruitment and at the end of follow-up (38 weeks)
The number of Cesarean sections
Time frame: From recruitment until the date of delivery, either natural or by Caesarean section, assessed up to 42 weeks
The mean birth-weight of newborns
Time frame: From recruitment until the date of delivery, assessed up to 42 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2013.
- Derived from this study: PubMed 25646328Bo S, Gambino R, Menato G, Canil S, Ponzo V, Pinach S, Durazzo M, Ghigo E, Cassader M, Musso G. Isoleucine-to-methionine substitution at residue 148 variant of PNPLA3 gene and metabolic outcomes in gestational diabetes. Am J Clin Nutr. 2015 Feb;101(2):310-8. doi: 10.3945/ajcn.114.095125. Epub 2014 Dec 17.
- site for randomizationLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Behavioral therapy, Exercise and Behavioral therapy and exercise in people with Birth-weight, run by University of Turin, Italy 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 3 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: finished, as of the sponsor's last update on 23 Jan 2013. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum fasting glucose values. (time frame: Fasting glucose will be measured at recruitment (24 weeks of gestation) and at the end of follow-up (38 weeks of gestation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01506310, which also lists 1 linked publication.
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 23 Jan 2013.