Postpartum DepressionNCT04146025
Nurtured in Nature
A study testing Nature Coach Intervention in people with Postpartum Depression and Pregnancy Related, run by University of Pennsylvania at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Depression, Pregnancy Related, Environmental Exposure
- What is being tested?
- Nature Coach Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2019to 27 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Leveraging Urban Nature, Behavioral Economics, and Mobile Platforms to Prevent Postpartum Depression
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.
Read the 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.
- Being tested
- Nature Coach Intervention
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nature Coach InterventionBehavioural
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Nature Coach Intervention | Experimental | The Nature Coach Intervention consists of 3 components - home visit, text message follow up, and goal feedback. Receives: Behavioral: Nature Coach Intervention |
| Control Group | No intervention | Education only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Green space use
This will be measured using Global Positioning System (GPS) data to see the amount of time spent in green space.
Measured: 3 months
Secondary outcomes (2)
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.
Measured: 3 months
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2019
- Study start12 Sep 2019
- Primary completion24 Feb 2020
- Study completion27 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum DepressionStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eugenia South, MD MS, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04146025
- Sponsor's protocol ID
- 833693
- Status last verified
- Nov 2020
- First submitted
- 2 Oct 2019
- Last updated
- 24 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging Urban Nature, Behavioral Economics, and Mobile Platforms to Prevent Postpartum Depression
- ClinicalTrials.gov ID
- NCT04146025
- Acronym / sponsor ID
- 833693
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 12 Sep 2019 (actual)
- Primary completion
- 24 Feb 2020 (actual)
- Study completion
- 27 Mar 2020 (actual)
- First posted
- 31 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nature Coach Intervention | Experimental | Behavioral: Nature Coach InterventionThe Nature Coach Intervention consists of 3 components - home visit, text message follow up, and goal feedback. |
| Control Group | No intervention | –Education only |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years old and older
- Delivery of a living child
- Ambulatory
- Live in West or Southwest Philadelphia
- Have a smart phone
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nature Coach Intervention1. 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. 2. 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. 3. 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. | Behavioural | Nature Coach Intervention |
Primary outcome
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.
2 secondary outcomes
Prevention of postpartum depression
Time frame: 3 months
Improvement in general well-being
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eugenia South, MD MS principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nature Coach Intervention in people with Postpartum Depression and Pregnancy Related, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Green space use (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2020.