## Protocol Section
### Identification Module
**NCT ID:** NCT06430853

**Acronym:** PIP

**Brief Title:** Psychobiological Interventions in Pregnancy

**Official Title:** Psychobiological Effects of Lifestyle Interventions in Pregnancy

#### Organization Study ID Info
**ID:** IRB-74741
#### Organization
**Class:** OTHER
**Full Name:** Stanford University
### Status Module
#### Completion Date
**Date:** 2027-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2027-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-09

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

#### Lead Sponsor

**Class:** OTHER

**Name:** Stanford University

#### Responsible Party

**Investigator Affiliation:** Stanford University

**Investigator Full Name:** Danielle Panelli

**Investigator Title:** Instructor of Obstetrics and Gynecology

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This randomized control trial will evaluate whether a physical activity intervention can improve mental health and biologic markers of stress in pregnant people with depressive or anxiety symptoms. The study will enroll participants if they are presenting for prenatal care at Stanford Children's Health Obstetrics Clinic with a singleton gestation.

### Conditions Module

**Conditions:**

- Pregnancy Complications

- Mental Health Issue

- Depression, Anxiety

- Pregnancy, High Risk

- Biological Clock Disturbance

**Keywords:**

- Pregnancy

- Stress

- Mental health

- Depression

- Anxiety

- Telomeres

- Cortisol

- Physical activity

- Exercise

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 88

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants will wear an Actigraph accelerometer watch, but not be given a step count goal, between 20 and 37 weeks of gestation. They will receive monthly text reminders to wear their watch as much as possible.

**Intervention Names:**

- Device: Actigraph watch

**Label:** Usual step count

**Type:** PLACEBO_COMPARATOR

#### Arm Group 2

**Description:** Participants will be given a daily step count goal of 9,000 steps per day based on the Actigraph watch, between 20 and 37 weeks of gestation. They will receive monthly text reminders reminding them of the step count goal and offering ways to achieve this goal.

**Intervention Names:**

- Behavioral: Step count goal

- Device: Actigraph watch

**Label:** Step count goal

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Step count goal

**Description:** The step count goal will be discussed at the beginning of the study, and participants will be able to see their step count on the Actigraph watch to facilitate achieving this goal. All participants will receive monthly reminders that are tailored for their intervention arm.

**Name:** Step count goal

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Step count goal

- Usual step count

**Description:** Both groups will wear the watch. Adherence will be assessed via step counts from accelerometer watch.

**Name:** Actigraph watch

**Other Names:**

- Actigraph GT9X Link Accelerometer

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** The mean within person change in EPDS score between randomization and the end of the study will be compared between the 2 arms. The EPDS is a 10-question validated measure with a score range of 0-30 for depression and/or anxiety screening in pregnancy that has been translated into many languages. A score of \>=10 has been shown to be consistent with depressive symptoms.

**Measure:** Change in Edinburgh Postpartum Depression Scale (EPDS) Score

**Time Frame:** Randomization around 20 weeks gestation and end of study (around 37 weeks gestation).

#### Secondary Outcomes

**Description:** The mean within person change in Edinburgh Postpartum Depression Anxiety Subscale score between randomization and the end of the study will be compared between the 2 arms. The three-question anxiety subscale on the EPDS (EPDS 3A) has a score range between 0-9, and a score \>=5 has been shown to be consistent with anxiety symptoms.

**Measure:** Change in EPDS Anxiety Subscale Score

**Time Frame:** Randomization around 20 weeks gestation and end of study (around 37 weeks)

**Description:** Mean within person change in STAI score between randomization and the end of the study will be compared between the 2 arms. The STAI is 40 questions, and the score ranges from 40 to 160. A STAI score \>=80 has been shown to be consistent with anxiety symptoms.

**Measure:** Change in State-Trait Anxiety Inventory (STAI) Score

**Time Frame:** Randomization around 20 weeks gestation and end of study (around 37 weeks)

**Description:** Maternal leukocyte telomere length will be measured from saliva samples and analyzed via quantitative PCR. Mean within-person change in leukocyte telomere length will be compared between the two arms.

**Measure:** Change in leukocyte telomere length

**Time Frame:** Randomization around 20 weeks and end of study (around 37 weeks)

**Description:** Maternal hair cortisol level will be measured from consecutive segments of hair strands. Mean within-person change in hair cortisol level will be compared between the two arms.

**Measure:** Change in hair cortisol level

**Time Frame:** Randomization around 20 weeks and end of study (around 37 weeks)

**Description:** Frequency of pregnancy complications including hypertensive disorders, diabetes, fetal growth restriction, placental abruption, preterm birth, or stillbirth will be abstracted from the medical record

**Measure:** Frequency of pregnancy complications

**Time Frame:** 6 weeks postpartum

**Description:** Frequency of neonatal complications including NICU admission, 5-minute Apgar \<7, low birthweight, need for mechanical ventilation, or neonatal demise will be abstracted from the medical record

**Measure:** Frequency of neonatal complications

**Time Frame:** 6 weeks postpartum

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Able to read and write in English or Spanish
* Presenting for a prenatal visit with a viable singleton gestation (no known lethal fetal anomaly or plan for pregnancy termination) between 18 and 20 weeks 0 days
* Any history of depression or anxiety, defined as: 1) documented depression or anxiety in the medical record within the preceding 2 years; 2) baseline EPDS score \>=10 at intake prenatal visit; 3) baseline EPDS anxiety subscale 3A score \>=5

Exclusion Criteria:

* Known allergy to steel or rubber
* Contraindication to physical activity such as a pre-existing cardiovascular condition or arrhythmia
* Plan to relocate and/or deliver at another institution
* Concurrent severe mental illness (diagnosis of bipolar disorder or schizophrenia)

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Stanford

**Country:** United States

**Facility:** Stanford University

**State:** California

**Zip:** 94305

#### Overall Officials

**Official 1:**

**Affiliation:** Stanford University

**Name:** Danielle M Panelli, MD, MS

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001526

- Term: Behavioral Symptoms

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000009422

- Term: Nervous System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

### Condition Browse Module - Browse Leaves

- ID: M7058

- Name: Depression

- Relevance: HIGH

- As Found: Depression

- ID: M4324

- Name: Anxiety Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7061

- Name: Depressive Disorder

- Relevance: LOW

- As Found: Unknown

- ID: M22703

- Name: Chronobiology Disorders

- Relevance: HIGH

- As Found: Biological Clock Disturbance

- ID: M14127

- Name: Pregnancy Complications

- Relevance: HIGH

- As Found: Pregnancy Complications

- ID: M4818

- Name: Behavioral Symptoms

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000021081

- Term: Chronobiology Disorders

- ID: D000011248

- Term: Pregnancy Complications

- ID: D000003863

- Term: Depression

### Intervention Browse Module - Browse Branches

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M9912

- Name: Hydrocortisone

- Relevance: LOW

- As Found: Unknown

- ID: M155245

- Name: Hydrocortisone 17-butyrate 21-propionate

- Relevance: LOW

- As Found: Unknown

- ID: M228609

- Name: Hydrocortisone acetate

- Relevance: LOW

- As Found: Unknown

- ID: M263259

- Name: Hydrocortisone hemisuccinate

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
