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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04146025
Other study ID # 833693
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 12, 2019
Est. completion date March 27, 2020

Study information

Verified date November 2020
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date March 27, 2020
Est. primary completion date February 24, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Intervention

Behavioral:
Nature Coach Intervention
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.

Locations

Country Name City State
United States University of Pennsylvania Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Green space use This will be measured using Global Positioning System (GPS) data to see the amount of time spent in green space. 3 months
Secondary 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.
3 months
Secondary 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. 3 months
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