CClinicalTrials.gg
Status unknownNCT02766426Updated May 9, 2016

Cytokine and Body Composition's Changes in Overweight/Obese Women

An interventional study of Lifestyle change program in Maternal Obesity Complicating Pregnancy, Exercise Addiction and High-Risk Pregnancy, sponsored by University of Modena and Reggio Emilia. Status unknown at 1 site in Italy. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-05-09.

Sponsored by University of Modena and Reggio Emilia · Not applicable and Interventional

The sponsor has not verified this record recently (last verified Apr 2016), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
59
Allocation
Not applicable
Ages
18 Years to 40 Years
Sex
Female
01

Study 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.

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.

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.

02

Conditions studied

  • Maternal Obesity Complicating Pregnancy
  • Exercise Addiction
  • High-Risk Pregnancy
  • Inflammatory Status During Preganancy
  • Maternal Body Composition
03

In context

Obesity, Maternal

36 studies on the registry are indexed under Obesity, Maternal; 7 are open to participants now.

This study's planned enrollment of 59 is below the median of 100 across 21 interventional studies indexed under Obesity, Maternal.

Browse Obesity, Maternal studies →

Lead sponsor

University of Modena and Reggio Emilia is the lead sponsor of 61 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • age >18 years
  • single pregnancy

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
59 participants (estimated)

Study arms

  • Other
    Lifestyle change intervention

    Overweight/obese pregnant women enrolled in a healthy lifestyle change programm

    Behavioral: Lifestyle change program

Interventions

  • BehavioralLifestyle change program

    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.

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: At baseline, at 36-38 week

  2. Weight changes

    Weight at baseline (i.e. enrollment: 9 weeks) and at 36 weeks measured in kg

    Time frame: At baseline, at 36 weeks

  3. 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

    Time frame: At baseline, at 36 weeks

07

Study locations

1 site
  • Mother-Infant Department, University of Modena and Reggio Emilia, Italy
    Modena, 41124, Italy
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 9, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02766426
Lead sponsor
University of Modena and Reggio Emilia
Responsible party
Prof. Facchinetti Fabio (Chairman of Obstetrics and Gynecology Unit, University of Modena and Reggio Emilia) — Principal investigator
First posted
May 9, 2016
Start date
Jan 2015
Primary completion
Apr 2016
Completion
May 2016
Last update
May 9, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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