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Nurtured in Nature

Primary Purpose

Postpartum Depression, Pregnancy Related, Environmental Exposure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nature Coach Intervention
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postpartum Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Nature Coach Intervention

Control Group

Arm Description

The Nature Coach Intervention consists of 3 components - home visit, text message follow up, and goal feedback.

Education only

Outcomes

Primary Outcome Measures

Green space use
This will be measured using Global Positioning System (GPS) data to see the amount of time spent in green space.

Secondary Outcome Measures

Prevention of postpartum depression
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.
Improvement in general well-being
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.

Full Information

First Posted
October 2, 2019
Last Updated
November 23, 2020
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT04146025
Brief Title
Nurtured in Nature
Official Title
Leveraging Urban Nature, Behavioral Economics, and Mobile Platforms to Prevent Postpartum Depression
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
September 12, 2019 (Actual)
Primary Completion Date
February 24, 2020 (Actual)
Study Completion Date
March 27, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators pilot test a Nature Coach Intervention in a population of postpartum women, to increase the amount of time people spend outside in local nature, with the goal of preventing postpartum depression.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Depression, Pregnancy Related, Environmental Exposure

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nature Coach Intervention
Arm Type
Experimental
Arm Description
The Nature Coach Intervention consists of 3 components - home visit, text message follow up, and goal feedback.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Education only
Intervention Type
Behavioral
Intervention Name(s)
Nature Coach Intervention
Intervention Description
Home visit. During the 1-hour home visit, the coach will (a) provide education about the health benefits of nature, (b) identify nearby nature targets for the participant to visit, (c) complete a pre-commitment contract based on individualized weekly nature goals, and (d) brainstorm barriers and solutions to reaching the goals. Personalized weekly text messages. Texts will serve as reminders of goals set with the Nature Coach, as well as encouragement to meet the goals. The context of text messages with change slightly based on individual participants, the goals they set, and the barriers they identify. Goal feedback- At the end of each week, participants will receive a progression badge via text message that shows the amount of days and time they spent in nature, and how this matched up to the goal set with the Nature Coach.
Primary Outcome Measure Information:
Title
Green space use
Description
This will be measured using Global Positioning System (GPS) data to see the amount of time spent in green space.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Prevention of postpartum depression
Description
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.
Time Frame
3 months
Title
Improvement in general well-being
Description
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.
Time Frame
3 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Postpartum women living in West and South West Philadelphia
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eugenia South, MD MS
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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