- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04146025
Nurtured in Nature
Leveraging Urban Nature, Behavioral Economics, and Mobile Platforms to Prevent Postpartum Depression
Study Overview
Status
Intervention / Treatment
Detailed Description
Postpartum depression (PPD), characterized by feelings of sadness, irritability, and fatigue following the birth of a child, occurs in 10-15% of women. PPD peaks within the first 2-3 months following delivery, but can occur anytime in the first year, representing one of the most common complications of childbearing. The consequences go beyond impaired functioning for the woman, and include harmful effects on the cognitive and emotional development of the woman's infant. Despite this, many women are undiagnosed and do not get adequate treatment.
Living near and spending time in green space is associated with a host of mental health benefits, including reduced depression and improved well-being. Research has shown that women who live near more green space have improved birth outcomes such as higher birthweight infants.
Despite the growing body of evidence linking nature with improved mental health, spending time in green space is not a standard health promoting tool to address mental illness. Behavioral economics concepts have been used successfully in promoting other preventative health behaviors such as physical activity and healthy eating.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18 years old and older
- Delivery of a living child
- Ambulatory
- Live in West or Southwest Philadelphia
- Have a smart phone
- Able to understand and respond to an oral interview in English
Exclusion Criteria:
- Baby in Neonatal Intensive Care Unit
- Mother has not been in Intensive Care Unit pre/post-delivery
- Gestational age less than 37 weeks
- Department of Human Services involvement
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Nature Coach Intervention
The Nature Coach Intervention consists of 3 components - home visit, text message follow up, and goal feedback.
|
|
No Intervention: Control Group
Education only
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Green space use
Time Frame: 3 months
|
This will be measured using Global Positioning System (GPS) data to see the amount of time spent in green space.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevention of postpartum depression
Time Frame: 3 months
|
This will be measured using the Edinburgh Postnatal Depression Scale. The Edinburgh Postnatal Depression Scale is a 10-statement scale that was developed to identify women who may have postpartum depression. Each answer is given a score of 0 to 3.The maximum score is 30 Questions 1, 2, & 4 are scored 0, 1, 2 or 3 with the first choice option scored as a 0 and the last choice option scored as 3. Questions 3, 5-10 are reverse scored, with the first choice option scored as a 3 and the last choice option scored as a 0. A score of 10 or more suggests that minor or major depression may be present. |
3 months
|
Improvement in general well-being
Time Frame: 3 months
|
This will be measured using the World Health Organization-5 (WHO-5) Well-being Index.
The WHO-5 Well-Being Index is a questionnaire that measures current mental well-being,with the time frame being the previous two weeks.This is five items rated on 6-point Likert scale (All of the time, Most of the time, More than half the time, Less than half the time, Some of the time, At no time).
The raw score is calculated by totaling the figures of the five answers.
The raw score ranges from 0 to 25, 0 representing worst possible and 25 representing best possible quality of life.
|
3 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 833693
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Postpartum Depression
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR); Women's Health Research Institute...CompletedPostpartum Depression | Perinatal Disorder | Postpartum Disorder | Perinatal Depression | Postpartum Anxiety | Postnatal DepressionCanada
-
University of CoimbraEnrolling by invitationPostPartum DepressionPortugal
-
University of MinnesotaNational Institute of Mental Health (NIMH)Completed
-
Sage TherapeuticsCompletedSevere Postpartum DepressionUnited States
-
Women's College HospitalCanadian Institutes of Health Research (CIHR); Michael Garron HospitalCompletedPostpartum Depression | Postpartum Anxiety | Postpartum Blues | Postpartum Mood DisorderCanada
-
Gazi UniversityCompletedPostpartum Depression | Postpartum AdaptationTurkey
-
British Columbia Children's HospitalActive, not recruiting
-
University of RochesterMae Stone Goode FoundationCompletedPostpartum Depression | Postpartum AnxietyUnited States
-
Hacettepe UniversityCompletedQuality of Life | Postpartum Depression | Nursing Caries | Nurse's Role | Postpartum Disorder | Postpartum AnxietyTurkey
Clinical Trials on Nature Coach Intervention
-
University of PennsylvaniaAmerican Heart Association; Pennsylvania Horticultural Society; United States... and other collaboratorsCompletedHealth, Subjective | Health Behavior | Environmental ExposureUnited States
-
University of CalgaryAlzheimer's AssociationRecruitingAlzheimer Disease | Mild Dementia | Moderate DementiaCanada
-
Charlotte TateUniversity of California, San FranciscoRecruitingStress, Psychological | Stress Reaction | Telomere ShorteningUnited States
-
University of OuluNot yet recruitingPain | Anxiety | Fear | SatisfactionFinland
-
University of OuluOulu University HospitalRecruitingPain | Stress | Anxiety | Fear of Childbirth | Childbirth ExperienceFinland
-
Universitaire Ziekenhuizen KU LeuvenCompleted
-
Hospital Israelita Albert EinsteinBeneficência Portuguesa de São PauloNot yet recruiting
-
Wake Forest University Health SciencesNational Heart, Lung, and Blood Institute (NHLBI)Recruiting
-
East Carolina UniversityVidant Medical CenterCompletedMedication AdherenceUnited States
-
Vladimíra DostálováBarcelona Institute for Global HealthRecruiting