NCT04264910

Brief Summary

The purpose of this study is to determine the feasibility of using a consumer-based mindfulness app, Calm, to reduce stress during pregnancy. Women will be randomly assigned to an intervention group (i.e., Calm) or standard care group and asked to participate in at least 10 minutes of daily meditation for the duration of their pregnancy (i.e., 12-weeks' gestation up to date of birth). Aim #1: Determine the feasibility (acceptability and demand) of using the Calm app at least 10-minutes per day for the duration of pregnancy (i.e., 12-weeks' gestation up to date of birth). Acceptability will be measured with an investigator-developed satisfaction survey. Demand will be measured using time spent in meditation and meditations used (tracked by Calm). For the intervention group, the benchmarks will be as follows:

  1. 1.Acceptability (i.e., satisfaction) 70% (n=34) of participants will report a 75% satisfaction,
  2. 2.Demand (i.e., time spent in meditation and meditations used,) 70% (n=34) of participants will adhere to ≥75% of prescribed meditation using Calm.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
97

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

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

November 1, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2020

Completed
29 days until next milestone

First Posted

Study publicly available on registry

February 11, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

July 19, 2022

Status Verified

July 1, 2022

Enrollment Period

1.7 years

First QC Date

January 13, 2020

Last Update Submit

July 18, 2022

Conditions

Pregnant Women

Outcome Measures

Primary Outcomes (2)

  • Feasibility: Acceptability

    Acceptability will be measured with an investigator developed survey

    Two weeks after delivery of baby

  • Feasibility: Demand (Time spent in meditation and meditations used)

    Demand will be gathered using meditation app usage data and defined as at least 70% of intervention group will adhere to at 75% of prescribed meditation

    At birth/delivery

Secondary Outcomes (1)

  • Perceived Stress of Participant

    baseline, 16, 20, 24, 28, 32, and 36 weeks' gestation, two weeks after delivery of baby

Other Outcomes (4)

  • Age of Birth

    At delivery

  • Fetal Weight

    At delivery

  • APGAR score

    At delivery

  • +1 more other outcomes

Study Arms (2)

Calm Meditation

EXPERIMENTAL

Participants (n=49) will be provided free access to and asked to register for the consumer-based mobile meditation app on their phone. Participants (n=49) will then receive an email containing 28 weeks of free access to Calm. Participants (n=49) will be asked to use Calm at least 10 minutes per day and encouraged to use it as much as they would like during the intervention. This prescription mimics how a new, paying member would use the app (full exposure with autonomy).

Behavioral: Calm App

Control

NO INTERVENTION

The control group will be asked to maintain normal activity and refrain from using Calm meditation app.

Interventions

Calm AppBEHAVIORAL

Calm is a subscription-based meditation app which provides guided meditations, sleep stories, soundscapes and calming music. Calm offers 7 Days of Calm for those new to meditation, the daily Calm, a meditation posted daily and a library of unique 10-12 minute meditations with topics related to acceptance, anxiety, self-compassion, and physical pain (to name a few).

Calm Meditation

Eligibility Criteria

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

You may qualify if:

  • women 12-16 weeks pregnant
  • years of age
  • English speaking
  • not currently on steroid therapy
  • willing to download the Calm app to their smartphone,
  • have not practiced meditation or mindful movement more than 60 minutes a month in the past six months
  • willing to be randomized to one of two groups.

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arizona Biomedical Collaborative

Phoenix, Arizona, 85004, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2020

First Posted

February 11, 2020

Study Start

November 1, 2019

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

July 19, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)