NCT03307733

Brief Summary

A physical activity feasibility randomised control trial for pregnant, obese women.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2016

Shorter than P25 for not_applicable

Status
completed

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

September 1, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 12, 2017

Completed
Last Updated

October 12, 2017

Status Verified

October 1, 2017

Enrollment Period

10 months

First QC Date

August 23, 2017

Last Update Submit

October 6, 2017

Conditions

Maternal Obesity Complicating PregnancyMaternal Obesity Complicating Childbirth

Outcome Measures

Primary Outcomes (4)

  • Recruitment

    Recruitment rate will be calculated by simple descriptive statistics. (number of participants approached vs. number of participants that agree to take part)

    5 weeks

  • Compliance

    Compliance to the study procedures will be calculated by simple descriptive. statistics

    5 weeks

  • Attrition

    Drop out rate will be calculated by simple descriptive statistics.

    5 weeks

  • Adherence rates

    Adherence to Fitbit will be measured daily.

    5 weeks

Secondary Outcomes (6)

  • Gestational Weight Gain

    5 weeks

  • gestational diabetes status

    26 weeks

  • Pregnancy and Birth outcomes

    9 months

  • C-section

    9 months

  • Birth weight

    At delivery ( 9 months roughly)

  • +1 more secondary outcomes

Study Arms (2)

Control Group

NO INTERVENTION

Control group received usual care plus a blinded Fitbit pedometer.

Intervention

ACTIVE COMPARATOR

Intervention group received a Fitbit pedometer with individualised physical activity targets and behaviour change techniques which were delivered via a closed Facebook group

Behavioral: walking and behavour change techniques

Interventions

walking and behavour change techniquesBEHAVIORAL

a Fitbit pedometer with individualised step targets and partaking in a closed Facebook group

Intervention

Eligibility Criteria

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

You may qualify if:

  • pregnant 11-14 weeks gestation
  • BMI \>30kg/m2
  • No known risks or complications
  • Able to walk

You may not qualify if:

  • High risk of miscarriage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Walking

Intervention Hierarchy (Ancestors)

LocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
It is difficult to mask in these type of interventions.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Feasibility Randomized Control Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2017

First Posted

October 12, 2017

Study Start

September 1, 2016

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

October 12, 2017

Record last verified: 2017-10