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Healthy Bellies - Intervention Program During Pregnancy on Women and Newborn

Primary Purpose

Lifestyle, Physical Activity, Dietary Habits

Status
Unknown status
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
physical exercises classes
Sponsored by
University of Minho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lifestyle focused on measuring Pregnancy, Physical activity, Newborn, Depressive Symptoms, Dietary habits, Healthy lifestyles

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Do not have any medical or obstetric contraindication for physical exercise

Exclusion Criteria:

  • Haemodynamically significant heart disease;
  • restrictive lung disease;
  • incompetent cervix/cerclage;
  • multiple gestation at risk for premature labor;
  • persistent second or third trimester bleeding;
  • placenta praevia after 26 weeks gestation;
  • premature labor during the current pregnancy;
  • ruptured membranes;
  • pregnancy induced hypertension;
  • severe anaemia;
  • unevaluated maternal cardiac arrhythmia;
  • chronic bronchitis;
  • poorly controlled type I diabetes;
  • extreme morbid obesity;
  • extreme underweight (body mass index <12);
  • history of extremely sedentary lifestyle;
  • intrauterine growth restriction in current pregnancy;
  • poorly controlled hypertension/pre-eclampsia;
  • orthopaedic limitations;
  • poorly controlled seizure disorder;
  • poorly controlled thyroid disease; heavy smoker).

Sites / Locations

  • Universidade do Minho

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

The program consists in 3 physical exercise classes, one of them in the pool.

The control group has the basic information through health professionals.

Outcomes

Primary Outcome Measures

Change in physical activity assessed with the "Pregnancy Physical Activity Questionnaire"
Evaluation through "Pregnancy Physical Activity Questionnaire"
Change in Dietary intake assessed with the "Food frequency questionnaire"
Evaluation through "Food frequency questionnaire"
Gestational Weight gain
Values are self-reported by pregnant women
Change in Depressive Symptoms assessed with the "Edinburgh Postnatal Depression Scale"
Evaluation through "Edinburgh Postnatal Depression Scale"
Weight of the baby
Self-reported by participants
Length of the baby
Self-reported by participants

Secondary Outcome Measures

Full Information

First Posted
January 28, 2017
Last Updated
May 6, 2018
Sponsor
University of Minho
Collaborators
Fundação para a Ciência e a Tecnologia, Centro de Investigação em Estudos da Criança, Centro Hospitalar do Alto Ave, Câmara Municipal de Guimarães
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1. Study Identification

Unique Protocol Identification Number
NCT03045237
Brief Title
Healthy Bellies - Intervention Program During Pregnancy on Women and Newborn
Official Title
Sporty Bellies - Intervention Program During Pregnancy on Women and Newborn
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2015 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
August 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Minho
Collaborators
Fundação para a Ciência e a Tecnologia, Centro de Investigação em Estudos da Criança, Centro Hospitalar do Alto Ave, Câmara Municipal de Guimarães

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
"Healthy Bellies" is an intervention program with pregnant women, based on the promotion of healthy lifestyles. It aims to evaluate the impact of the program in the health of both pregnant and newborn. This trial is being conducted with pregnant women, divided into control and intervention group. Are performed 3 assessment periods: 1 - beginning of the program; 2 - postpartum; 3 - 1 month after delivery. The intervention group has a program of 3 weekly physical exercise classes and the control group has the basic information that is usually provided by health professionals. With this program, it is expected to contribute with evidence to the best practice in the field of interventions in pregnancy and improve health outcomes of both pregnant and newborn.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lifestyle, Physical Activity, Dietary Habits, Depressive Symptoms
Keywords
Pregnancy, Physical activity, Newborn, Depressive Symptoms, Dietary habits, Healthy lifestyles

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
410 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
The program consists in 3 physical exercise classes, one of them in the pool.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The control group has the basic information through health professionals.
Intervention Type
Other
Intervention Name(s)
physical exercises classes
Intervention Description
3 physical exercises classes, one of them in the pool.
Primary Outcome Measure Information:
Title
Change in physical activity assessed with the "Pregnancy Physical Activity Questionnaire"
Description
Evaluation through "Pregnancy Physical Activity Questionnaire"
Time Frame
Baseline and 1 month after delivery
Title
Change in Dietary intake assessed with the "Food frequency questionnaire"
Description
Evaluation through "Food frequency questionnaire"
Time Frame
Baseline and 1 month after delivery
Title
Gestational Weight gain
Description
Values are self-reported by pregnant women
Time Frame
1 day after delivery
Title
Change in Depressive Symptoms assessed with the "Edinburgh Postnatal Depression Scale"
Description
Evaluation through "Edinburgh Postnatal Depression Scale"
Time Frame
Baseline, 1 day after delivery and 1 month after delivery
Title
Weight of the baby
Description
Self-reported by participants
Time Frame
1 day after delivery
Title
Length of the baby
Description
Self-reported by participants
Time Frame
1 day after delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Do not have any medical or obstetric contraindication for physical exercise Exclusion Criteria: Haemodynamically significant heart disease; restrictive lung disease; incompetent cervix/cerclage; multiple gestation at risk for premature labor; persistent second or third trimester bleeding; placenta praevia after 26 weeks gestation; premature labor during the current pregnancy; ruptured membranes; pregnancy induced hypertension; severe anaemia; unevaluated maternal cardiac arrhythmia; chronic bronchitis; poorly controlled type I diabetes; extreme morbid obesity; extreme underweight (body mass index <12); history of extremely sedentary lifestyle; intrauterine growth restriction in current pregnancy; poorly controlled hypertension/pre-eclampsia; orthopaedic limitations; poorly controlled seizure disorder; poorly controlled thyroid disease; heavy smoker).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria B Pereira
Organizational Affiliation
University of Minho
Official's Role
Study Director
Facility Information:
Facility Name
Universidade do Minho
City
Braga
Country
Portugal

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Healthy Bellies - Intervention Program During Pregnancy on Women and Newborn

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