Maternal Obesity Complicating PregnancyNCT02766426
Cytokine and Body Composition's Changes in Overweight/Obese Women
A study testing Lifestyle change program in people with Maternal Obesity Complicating Pregnancy and Exercise Addiction, run by University of Modena and Reggio Emilia at 1 site in Italy.
Trial summary
Sincev the adipose tissue as been identified as a metabolic active tissue that produces and regulates pro-inflammatory factors, the investigators studied the relationship between cytokine changes and maternal body composition. 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, Exercise Addiction, High-Risk Pregnancy
- What is being tested?
- Lifestyle change program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2015to May 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
- single pregnancy
Who cannot join
- twin pregnancies
- chronic diseases (i.e., diabetes mellitus, chronic hypertension, untreated thyroid diseases)
- dietary supplements or herbal products known to affect body weight
- other medical conditions that might affect body weight
Trial locations and contacts
1 site in 1 country.
Italy1 site
Mother-Infant Department, University of Modena and Reggio Emilia, Italy
Modena, 41124
About this study
Official title: Cytokine and Body Composition's Changes Throughout Pregnancy in Overweight/Obese Women Undergoing an Early Lifestyle Change Program
Sincev the adipose tissue as been identified as a metabolic active tissue that produces and regulates pro-inflammatory factors, the investigators studied the relationship between cytokine changes and maternal body composition.
The investigators evaluated plasmatic pro- and anti-inflammatory cytokines levels in pregnant women with BMI >25 Kg/m^2 undergoing a lifestyle change program, and if this is related with changes in body composition.
Read more
Women enrolled in the study were provided nutritional advices about lifestyle: a proper nutrition and a constant physical activity (30 minutes/day, 3 times/week, according to the American College of Obstetricians and Gynecologists Guidelines) in an integrated counselling with a dietitian and a gynaecologist, both attendant since the enrollment.
Plasma pro- and anti-inflammatory markers were investigated at enrollment (9-12 weeks) and at 36-38 weeks.
Furthermore, the investigators used the bioimpedance analyzer to evaluate changes of body composition (i.e. fat mass and fat free mass) at first and third trimester.
Read the detailed description
Pregnant women, recruited from antenatal clinics, with pre-pregnancy BMI ≥ 25 kg/m2, age >18 years and singleton pregnancy were enrolled within 12th week at the Obstetric Unit of Policlinico Hospital of Modena.
Exclusion criteria were as follows: twin pregnancies, chronic diseases (i.e., diabetes mellitus, chronic hypertension, untreated thyroid diseases) and dietary supplements or herbal products known to affect body weight, other medical conditions that might affect body weight.
At the first visit, an accurate obstetric history, family history, and personal history was collected for the assessment of exclusion criteria. The blood pressure, height and weight were measured, and the BMI is calculated.
Eligible women were given nutritional advices about lifestyle and physical activity, in agreement with the Italian Guidelines for a healthy diet during pregnancy. The diet given comprised 1500 kcal/day and consisted of 3 main meals and 3 snacks (breakfast, snack, lunch, snack, dinner, and evening snack) that corresponds to the baseline metabolism of a pregnant woman. In view of the physical activity program, the dietitian added an amount of 200 kcal/day for obese or 300 kcal/day for overweight women.
The exercise intervention was focused on increasing walking and developing a more active lifestyle (i.e., walking rather than driving for short distances). The recommended exercise prescription for pregnant women was generally consistent with recommendations for the general adult population. All participants were advised to participate in 30 min of moderate intensity activity at least 3 days a week.
Each subject taking part at the study received a 75-g 2-h Oral Glucose Tolerance Test (OGTT) at 16-18 and/or 24-28 weeks. The diagnosis of gestational diabetes mellitus was made for any glucose value exceeding the normal cut-off, as reported by the Guidelines. If OGTT is pathological, women are referred to other health care specialists for further clinical evaluation and/or specific treatment.
Women were scheduled to have a specific follow-up visits for adherence to the program at 16th, 20th, 28th and 36th week also evaluating the fat mass, fat-free mass and total body water through the use of the bioimpedance analyzer.
Furthermore, at baseline and at 36-38 week, blood plasma samples were collected in order to investigate: plasma pro- and anti-inflammatory markers related to obesity and to visceral adipose tissue (interferon-γ, interleukin-1α, interleukin-1β, interleukin-2, interleukin-4, interleukin-6, interleukin-8, interleukin-10, interleukin-12p70, and tumor necrosis factor-α).
Data regarding pregnancy and delivery were collected from clinical diaries.
- Conditions
- Maternal Obesity Complicating Pregnancy, Exercise Addiction, High-Risk Pregnancy, Inflammatory Status During Preganancy, Maternal Body Composition
- Being tested
- Lifestyle change program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle change programBehavioural
Women attended a multidisciplinary counseling (by both the dietitian and the gynecologist). They were given nutritional advice about lifestyle and physical activity, in agreement with the Italian Guidelines for a healthy diet during pregnancy. The diet given comprised 1500 kcal/day and consisted of 3 main meals and 3 snacks (breakfast, snack, lunch, snack, dinner, and evening snack) that corresponds to the baseline metabolism of a pregnant woman. In view of the physical activity program, the dietitian added an amount of 200 kcal/day for obese or 300 kcal/day for overweight women.
The exercise intervention was focused on increasing walking and developing a more active lifestyle. The recommendation for physical activity was to perform 30 min of moderate intensity activity at least 3 days a week.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle change intervention | Other | Overweight/obese pregnant women enrolled in a healthy lifestyle change programm Receives: Behavioral: Lifestyle change program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cytokine changes throughout pregnancy in overweight/obese women undergoing a lifestyle change program.
interferon(IFN)-γ, interleukin(IL)-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, and tumor necrosis factor-α plasma levels (pg/ml)
Measured: At baseline, at 36-38 week
Weight changes
Weight at baseline (i.e. enrollment: 9 weeks) and at 36 weeks measured in kg
Measured: At baseline, at 36 weeks
Fat mass changes
Changes in total and visceral (trunk) fat mass (FM) at baseline (i.e. enrollment: 9 weeks), at 36 weeks and calculated as fat changes
Measured: At baseline, at 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2016 (estimated)
- Study startJan 2015
- Primary completionApr 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal Obesity Complicating PregnancyStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Modena and Reggio Emilia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Facchinetti Fabio, University of Modena and Reggio Emilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02766426
- Sponsor's protocol ID
- 136/15
- Status last verified
- Apr 2016
- First submitted
- 14 Apr 2016
- Last updated
- 9 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytokine and Body Composition's Changes Throughout Pregnancy in Overweight/Obese Women Undergoing an Early Lifestyle Change Program
- ClinicalTrials.gov ID
- NCT02766426
- Acronym / sponsor ID
- 136/15
- Conditions
- Maternal Obesity Complicating Pregnancy, Exercise Addiction, High-Risk Pregnancy, Inflammatory Status During Preganancy, Maternal Body Composition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- University of Modena and Reggio EmiliaUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- May 2016
- First posted
- 9 May 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.
Sincev the adipose tissue as been identified as a metabolic active tissue that produces and regulates pro-inflammatory factors, the investigators studied the relationship between cytokine changes and maternal body composition.
The investigators evaluated plasmatic pro- and anti-inflammatory cytokines levels in pregnant women with BMI >25 Kg/m^2 undergoing a lifestyle change program, and if this is related with changes in body composition.
Women enrolled in the study were provided nutritional advices about lifestyle: a proper nutrition and a constant physical activity (30 minutes/day, 3 times/week, according to the American College of Obstetricians and Gynecologists Guidelines) in an integrated counselling with a dietitian and a gynaecologist, both attendant since the enrollment.
Plasma pro- and anti-inflammatory markers were investigated at enrollment (9-12 weeks) and at 36-38 weeks.
Furthermore, the investigators used the bioimpedance analyzer to evaluate changes of body composition (i.e. fat mass and fat free mass) at first and third trimester.
Detailed description
Pregnant women, recruited from antenatal clinics, with pre-pregnancy BMI ≥ 25 kg/m2, age >18 years and singleton pregnancy were enrolled within 12th week at the Obstetric Unit of Policlinico Hospital of Modena.
Exclusion criteria were as follows: twin pregnancies, chronic diseases (i.e., diabetes mellitus, chronic hypertension, untreated thyroid diseases) and dietary supplements or herbal products known to affect body weight, other medical conditions that might affect body weight.
At the first visit, an accurate obstetric history, family history, and personal history was collected for the assessment of exclusion criteria. The blood pressure, height and weight were measured, and the BMI is calculated.
Eligible women were given nutritional advices about lifestyle and physical activity, in agreement with the Italian Guidelines for a healthy diet during pregnancy. The diet given comprised 1500 kcal/day and consisted of 3 main meals and 3 snacks (breakfast, snack, lunch, snack, dinner, and evening snack) that corresponds to the baseline metabolism of a pregnant woman. In view of the physical activity program, the dietitian added an amount of 200 kcal/day for obese or 300 kcal/day for overweight women.
The exercise intervention was focused on increasing walking and developing a more active lifestyle (i.e., walking rather than driving for short distances). The recommended exercise prescription for pregnant women was generally consistent with recommendations for the general adult population. All participants were advised to participate in 30 min of moderate intensity activity at least 3 days a week.
Each subject taking part at the study received a 75-g 2-h Oral Glucose Tolerance Test (OGTT) at 16-18 and/or 24-28 weeks. The diagnosis of gestational diabetes mellitus was made for any glucose value exceeding the normal cut-off, as reported by the Guidelines. If OGTT is pathological, women are referred to other health care specialists for further clinical evaluation and/or specific treatment.
Women were scheduled to have a specific follow-up visits for adherence to the program at 16th, 20th, 28th and 36th week also evaluating the fat mass, fat-free mass and total body water through the use of the bioimpedance analyzer.
Furthermore, at baseline and at 36-38 week, blood plasma samples were collected in order to investigate: plasma pro- and anti-inflammatory markers related to obesity and to visceral adipose tissue (interferon-γ, interleukin-1α, interleukin-1β, interleukin-2, interleukin-4, interleukin-6, interleukin-8, interleukin-10, interleukin-12p70, and tumor necrosis factor-α).
Data regarding pregnancy and delivery were collected from clinical diaries.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifestyle change intervention | Other | Behavioral: Lifestyle change programOverweight/obese pregnant women enrolled in a healthy lifestyle change programm |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- age >18 years
- single pregnancy
Key exclusion criteria (4 listed)
- twin pregnancies
- chronic diseases (i.e., diabetes mellitus, chronic hypertension, untreated thyroid diseases)
- dietary supplements or herbal products known to affect body weight
- other medical conditions that might affect body weight
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 |
|---|---|---|
| Lifestyle change programWomen attended a multidisciplinary counseling (by both the dietitian and the gynecologist). They were given nutritional advice about lifestyle and physical activity, in agreement with the Italian Guidelines for a healthy diet during pregnancy. The diet given comprised 1500 kcal/day and consisted of 3 main meals and 3 snacks (breakfast, snack, lunch, snack, dinner, and evening snack) that corresponds to the baseline metabolism of a pregnant woman. In view of the physical activity program, the dietitian added an amount of 200 kcal/day for obese or 300 kcal/day for overweight women. The exercise intervention was focused on increasing walking and developing a more active lifestyle. The recommendation for physical activity was to perform 30 min of moderate intensity activity at least 3 days a week. | Behavioural | Lifestyle change intervention |
Primary outcome
Cytokine changes throughout pregnancy in overweight/obese women undergoing a lifestyle change program.
Time frame: At baseline, at 36-38 week
interferon(IFN)-γ, interleukin(IL)-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, and tumor necrosis factor-α plasma levels (pg/ml)
Weight changes
Time frame: At baseline, at 36 weeks
Weight at baseline (i.e. enrollment: 9 weeks) and at 36 weeks measured in kg
Fat mass changes
Time frame: At baseline, at 36 weeks
Changes in total and visceral (trunk) fat mass (FM) at baseline (i.e. enrollment: 9 weeks), at 36 weeks and calculated as fat changes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2016.
- Individual participant dataSharing planned: No
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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 study testing Lifestyle change program in people with Maternal Obesity Complicating Pregnancy and Exercise Addiction, 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 2 inclusion and 4 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 9 May 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?
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?
Cytokine changes throughout pregnancy in overweight/obese women undergoing a lifestyle change program. (time frame: At baseline, at 36-38 week). The study lists 3 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 9 May 2016.