NCT02766426

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

April 14, 2016

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 9, 2016

Completed
Last Updated

May 9, 2016

Status Verified

April 1, 2016

Enrollment Period

1.2 years

First QC Date

April 14, 2016

Last Update Submit

May 6, 2016

Conditions

Maternal Obesity Complicating PregnancyExercise AddictionHigh-Risk PregnancyInflammatory Status During PreganancyMaternal Body Composition

Outcome Measures

Primary Outcomes (3)

  • 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)

    At baseline, at 36-38 week

  • Weight changes

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

    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

    At baseline, at 36 weeks

Study Arms (1)

Lifestyle change intervention

OTHER

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

Behavioral: Lifestyle change program

Interventions

Lifestyle change programBEHAVIORAL

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.

Lifestyle change intervention

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age \>18 years
  • single pregnancy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mother-Infant Department, University of Modena and Reggio Emilia, Italy

Modena, 41124, Italy

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairman of Obstetrics and Gynecology Unit

Study Record Dates

First Submitted

April 14, 2016

First Posted

May 9, 2016

Study Start

January 1, 2015

Primary Completion

April 1, 2016

Study Completion

May 1, 2016

Last Updated

May 9, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)