NCT05331586

Brief Summary

Pregnant women with obesity will be invited to participate in structured home-based exercise programme, remotely monitored

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
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

March 3, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 15, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

June 22, 2022

Status Verified

February 1, 2022

Enrollment Period

5 months

First QC Date

March 3, 2022

Last Update Submit

June 20, 2022

Conditions

Pregnancy RelatedObesity, Maternal

Keywords

Obesitypregnancyexercisephysical activitymaternalgestational weight gaingestational diabetes mellitus

Outcome Measures

Primary Outcomes (2)

  • Gestational Weight Gain

    Using portable digital scale (Tantita InnerScan BC-545). Gestational weight gain will be calculated as the difference between maternal weight at last appointment (36-39 gestational weeks) and pre-pregnancy weight.

    At delivery

  • Excessive gestational weight gain

    The adequate gestational weight gain in pregnant women with obesity should not exceed 9kg in entire pregnancy, the values over these thresholds will be considered excessive gestational weight gain.

    At delivery

Secondary Outcomes (6)

  • Low Back Pain

    At first, second and third gestational trimester

  • Subjective Physical Activity assessment

    At first, second and third gestational trimester

  • Objective Physical Activity assessment

    At first, second and third gestational trimester

  • Gestational Diabetes Mellitus

    Second gestational trimester

  • Quality of Life Assessment

    At first, second and third gestational trimester

  • +1 more secondary outcomes

Study Arms (2)

control intervention

NO INTERVENTION

The control group will receive the standard prenatal care in Hospital Center of São Joao (CHUSJ). The standard prenatal care will be regular appointments with obstetrician and midwife nurses, ultrasounds and nutritional appointments. The pregnant women in control group will also receive a pamphlet with the benefits of physical exercise during pregnancy and recommendations for adequate gestational weight gain. Pregnant women in control group will not be discouraged from exercising on their own.

Exercise intervention

EXPERIMENTAL

The exercise group intervention will perform home-based remotely monitored exercise

Behavioral: Remote Exercise

Interventions

Remote ExerciseBEHAVIORAL

The pregnant women will perform a home-based structured exercise programme. The exercise will be remotely monitored since the first gestational trimester until delivery

Exercise intervention

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant women with obesity (BMI ≥ 30 kg/m2) at first gestational trimester

You may not qualify if:

  • pre-pregnancy BMI \< 30 kg/m2;
  • previous bariatric surgery;
  • hemodynamically significant heart disease;
  • restrictive lung disease;
  • incompetent cervix or cerclage;
  • multiple gestation;
  • persistent second- or third-trimester bleeding;
  • placenta previa after 26 weeks of gestation;
  • premature labor during the current pregnancy;
  • ruptured membranes;
  • preeclampsia or pregnancy-induced hypertension;
  • severe anemia;
  • inability to read and understand Portuguese; -\>15 weeks gestation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diana Bernardo

Porto, Portugal

Location

MeSH Terms

Conditions

Pregnancy in ObesityObesityMotor ActivityGestational Weight GainDiabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehaviorWeight GainBody Weight ChangesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2022

First Posted

April 15, 2022

Study Start

July 1, 2022

Primary Completion

December 1, 2022

Study Completion

May 1, 2023

Last Updated

June 22, 2022

Record last verified: 2022-02

Locations

PT(1)