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Healthy Bellies - Intervention Program During Pregnancy on Women and Newborn

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03045237
Recruitment Status : Active, not recruiting
First Posted : February 7, 2017
Last Update Posted : May 8, 2018
Sponsor:
Collaborators:
Fundação para a Ciência e a Tecnologia
Centro de Investigação em Estudos da Criança
Centro Hospitalar do Alto Ave
Câmara Municipal de Guimarães
Information provided by (Responsible Party):
Ana Isabel Teixeira Jesus Silva, University of Minho

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.

Condition or disease Intervention/treatment Phase
Lifestyle Physical Activity Dietary Habits Depressive Symptoms Other: physical exercises classes Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 410 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Sporty Bellies - Intervention Program During Pregnancy on Women and Newborn
Actual Study Start Date : November 1, 2015
Actual Primary Completion Date : December 31, 2017
Estimated Study Completion Date : August 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention Group
The program consists in 3 physical exercise classes, one of them in the pool.
Other: physical exercises classes
3 physical exercises classes, one of them in the pool.

No Intervention: Control Group
The control group has the basic information through health professionals.



Primary Outcome Measures :
  1. Change in physical activity assessed with the "Pregnancy Physical Activity Questionnaire" [ Time Frame: Baseline and 1 month after delivery ]
    Evaluation through "Pregnancy Physical Activity Questionnaire"

  2. Change in Dietary intake assessed with the "Food frequency questionnaire" [ Time Frame: Baseline and 1 month after delivery ]
    Evaluation through "Food frequency questionnaire"

  3. Gestational Weight gain [ Time Frame: 1 day after delivery ]
    Values are self-reported by pregnant women

  4. Change in Depressive Symptoms assessed with the "Edinburgh Postnatal Depression Scale" [ Time Frame: Baseline, 1 day after delivery and 1 month after delivery ]
    Evaluation through "Edinburgh Postnatal Depression Scale"

  5. Weight of the baby [ Time Frame: 1 day after delivery ]
    Self-reported by participants

  6. Length of the baby [ Time Frame: 1 day after delivery ]
    Self-reported by participants



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03045237


Locations
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Portugal
Universidade do Minho
Braga, Portugal
Sponsors and Collaborators
University of Minho
Fundação para a Ciência e a Tecnologia
Centro de Investigação em Estudos da Criança
Centro Hospitalar do Alto Ave
Câmara Municipal de Guimarães
Investigators
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Study Director: Maria B Pereira University of Minho

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Responsible Party: Ana Isabel Teixeira Jesus Silva, PhD Student, University of Minho
ClinicalTrials.gov Identifier: NCT03045237    
Other Study ID Numbers: Healthy Bellies
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ana Isabel Teixeira Jesus Silva, University of Minho:
Pregnancy
Physical activity
Newborn
Depressive Symptoms
Dietary habits
Healthy lifestyles
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms