Happy, Healthy, Loved: A Mobile-delivered Breastfeeding Self-efficacy Intervention for First Time Parents (HHL)

July 13, 2023 updated by: OhioHealth
The purpose of this study is to test if a mobile device delivered intervention program can improve breast-feeding self-efficacy in primiparous mothers.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The proposed study will test if a mobile device based intervention program, called "Happy, Healthy, Loved (HHL)", will impact breast feeding rates and breastfeeding self-efficacy when compared to care as usual. Primiparous women and their partners will be randomly assigned to the HHL program or usual care.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
128

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43214
        • OhioHealth

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. primiparous mothers,
  2. living with a partner or spouse,
  3. have an intention to breastfeed their infant for at least 6-weeks postpartum;
  4. whose infant is not in the Neonatal Intensive Care Unit,
  5. have a mobile phone with text message capability,
  6. have no current self-reported depressive episode, and;
  7. English as a primary language

Exclusion Criteria:

  1. mothers who have other biological children,
  2. have infants in the Neonatal Intensive Care Unit,
  3. do not have a mobile phone with text message capabilities,
  4. report current episodes of depression, or are receiving antidepressant treatment or psychotherapy for depression,
  5. have initial study survey that indicates suicide risks (participants who are identified as suicidal ideation at 6 weeks or 6 months will receive further assessment and referral but not be excluded from the program because it may be more harmful and penalizing to remove them from the program if they find it helpful. We will remind the participant that continuing is voluntary and there is no penalty if they wish to discontinue participation)
  6. do not speak, read and write English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Happy, Healthy, Loved
Both parents will complete surveys on a tablet during the postpartum hospital stay. Surveys cover three topic areas related to breast-feeding; modeling and feedback, partner support, and stress coping. For the next 6 weeks participants' will receive 4 personalized text messages per week based on their tablet survey responses. Participants will be asked one yes/no question each week ("still breastfeeding? Text Y for yes, N for no"). Once a "no" response has been received from a participant, all remaining text messages will emphasize coping and partner support rather than breastfeeding.
Behavioral: Happy, Healthy, Loved
A text message based, mobile-device delivered intervention that provides educational information to primiparous mothers and their partners about breast-feeding and coping with stress.
No Intervention: Control
Control group participants will complete surveys on a tablet during the postpartum hospital stay. Surveys cover three topic areas related to breast-feeding; modeling and feedback, partner support, and stress coping. The control group participants will be sent 4 text messages per week for the first 6 weeks, but the content of the texts will be non-breastfeeding related. The content will instead summarize infant development facts.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Breastfeeding Self-Efficacy: Breastfeeding self-efficacy scale short form
Time Frame: 6 weeks postpartum
Breastfeeding self-efficacy scale short form (McCarter-Spaulding & Dennis, 2010)- The Breastfeeding self-efficacy scale short form (BSES-SF) will be used to measure breastfeeding self-efficacy. The scores for this scale range from 1-5, with higher scores indicating greater self-efficacy related to breastfeeding.
6 weeks postpartum
Breastfeeding Self-Efficacy: Breastfeeding self-efficacy scale short form
Time Frame: 6 months postpartum
Breastfeeding self-efficacy scale short form (McCarter-Spaulding & Dennis, 2010)- The Breastfeeding self-efficacy scale short form (BSES-SF) will be used to measure breastfeeding self-efficacy. The scores for this scale range from 1-5, with higher scores indicating greater self-efficacy related to breastfeeding.
6 months postpartum
Breastfeeding Rate
Time Frame: 6 weeks postpartum
Index of breastfeeding status - Women will be asked to identify the level that accurately described their breastfeeding behaviors within the previous 24 hours. Four levels will be reported: exclusive breastfeeding (breast milk only), partial breastfeeding (breast milk and at least 1 bottle of formula per day), token breastfeeding (breast given to comfort baby not for nutrition), and no breastfeeding. Higher values represent more exclusive breastfeeding.
6 weeks postpartum
Breastfeeding Rate
Time Frame: 6 months postpartum
Index of breastfeeding status - Women will be asked to identify the level that accurately described their breastfeeding behaviors within the previous 24 hours. Four levels will be reported: exclusive breastfeeding (breast milk only), partial breastfeeding (breast milk and at least 1 bottle of formula per day), token breastfeeding (breast given to comfort baby not for nutrition), and no breastfeeding. Higher values represent more exclusive breastfeeding.
6 months postpartum

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Coping Behavior
Time Frame: 6 weeks postpartum
Brief Coping Orientation to Problems Experienced (COPE) - This 28-item validated scale derived from a previously published measure showing reliability and convergent validity with several established coping measures will be used to identify coping strategies consistent with cognitive-behavioral skills. The scale assesses frequency with which a person uses coping strategies rated on a scale of 1-4. The higher the number indicates a higher frequency.
6 weeks postpartum
Coping Behavior
Time Frame: 6 months postpartum
Brief Coping Orientation to Problems Experienced (COPE) - This 28-item validated scale derived from a previously published measure showing reliability and convergent validity with several established coping measures will be used to identify coping strategies consistent with cognitive-behavioral skills. The scale assesses frequency with which a person uses coping strategies rated on a scale of 1-4. The higher the number indicates a higher frequency.
6 months postpartum
Postpartum Partner Support
Time Frame: 6 weeks postpartum
Postpartum Partner Support Scale (PPSS) - The PPSS is a 24-item self-report instrument to assess partner postpartum-specific support. Items are rated on a 4-point Likert-type scale (responses from 1-4) to produce a total score ranging from 24 to 96, with higher scores indicating higher levels of postpartum partner support.
6 weeks postpartum
Partner Support
Time Frame: 6 weeks postpartum
Social Provisions Checklist - This is a 30-item measure of perceived support from the co-parent. The scale covers six provisions of support: guidance, reliable alliance, reassurance of worth, attachment, social integration, and opportunity for nurturance. All items are rated on a 5-point scale for a total score of between 30-120, with higher scores indicating higher levels of support.
6 weeks postpartum
Postpartum Partner Support
Time Frame: 6 months postpartum
Postpartum Partner Support Scale (PPSS) - The PPSS is a 24-item self-report instrument to assess partner postpartum-specific support. Items are rated on a 4-point Likert-type scale (responses from 1-4) to produce a total score ranging from 24 to 96, with higher scores indicating higher levels of postpartum partner support.
6 months postpartum
Partner Support
Time Frame: 6 months postpartum
Social Provisions Checklist - This is a 30-item measure of perceived support from the co-parent. The scale covers six provisions of support: guidance, reliable alliance, reassurance of worth, attachment, social integration, and opportunity for nurturance. All items are rated on a 5-point scale for a total score of between 30-120, with higher scores indicating higher levels of support.
6 months postpartum
Hair Cortisol
Time Frame: 0-2 days postpartum
A small amount (15-30 mg) of hair from the posterior vertex of the head will be collected. Hair strands will then be cut into 3 cm segments, which based on human scalp hair grows at approximately 1 cm per month, so each of the 3 cm samples will index cortisol output during the three trimesters of pregnancy. If hair is less than 9 cm long, the analysis will include only the number of 3 cm segments available. The wash procedure and steroid extraction will be undertaken using high performance liquid chromatography-mass spectrometry. Additionally, mothers will be asked about their hair histories to use as covariates in analysis along with hair sample. Hair histories include questions related to hair color, salon treatments, sunlight exposure, use of hair products, medications, creams, and hair pieces, style and indoor tanning habits.
0-2 days postpartum
Sleep Quality (hair cortisol covariate): Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 0-2 days postpartum
Pittsburgh Sleep Quality Index (PSQI) - This scale assesses sleep quality, which is a covariate of hair cortisol and mood. The PSQI is well-established questionnaire for assessing sleep quality, duration and disturbances. Items range from 0-3, with high scores indicating greater sleep disturbance.
0-2 days postpartum
Postnatal Depression
Time Frame: 0-2 days postpartum
Edinburgh Postnatal Depression Scale (EPDS) - The EPDS is a well-validated 10-item self-report depression screening tool, in which endorsement of each item is based on how women feel during the previous 7 days. Possible scores range from 0 to 30, with high scores reflecting more depressive symptoms.
0-2 days postpartum
Postnatal Depression
Time Frame: 6 weeks postpartum
Edinburgh Postnatal Depression Scale (EPDS) - The EPDS is a well-validated 10-item self-report depression screening tool, in which endorsement of each item is based on how women feel during the previous 7 days. Possible scores range from 0 to 30, with high scores reflecting more depressive symptoms.
6 weeks postpartum
Postnatal Depression
Time Frame: 6 months postpartum
Edinburgh Postnatal Depression Scale (EPDS) - The EPDS is a well-validated 10-item self-report depression screening tool, in which endorsement of each item is based on how women feel during the previous 7 days. Possible scores range from 0 to 30, with high scores reflecting more depressive symptoms.
6 months postpartum
Depression, Anxiety, Stress
Time Frame: 0-2 days postpartum
Depression Anxiety and Stress Scales (DASS-21) - The DASS-21 will be used to measure the unique symptoms of each state. There is normative data for the scale. Scores range from 0-63, with higher scores indicating more severe depression, anxiety, and stress.
0-2 days postpartum
Depression, Anxiety, Stress
Time Frame: 6 weeks postpartum
Depression Anxiety and Stress Scales (DASS-21) - The DASS-21 will be used to measure the unique symptoms of each state. There is normative data for the scale. Scores range from 0-63, with higher scores indicating more severe depression, anxiety, and stress.
6 weeks postpartum
Depression, Anxiety, Stress
Time Frame: 6 months postpartum
Depression Anxiety and Stress Scales (DASS-21) - The DASS-21 will be used to measure the unique symptoms of each state. There is normative data for the scale. Scores range from 0-63, with higher scores indicating more severe depression, anxiety, and stress.
6 months postpartum
Mood
Time Frame: 0-2 days postpartum
Maternal Mood Screener (Munoz, 1988) - The mood screener questions were adapted from the Diagnostic Interview Schedule and assesses lifetime and current major depressive episode. Positive endorsement of 5 out of 9 depression symptoms present for at least two weeks screens positive for possible major depressive episode. The screener is a self-report checklist using the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria that has shown high concordance with the Structured Clinical Interview for DSM-IV (SCID-IV), the gold standard diagnostic interview for depression.
0-2 days postpartum
Mood
Time Frame: 6 weeks postpartum
Maternal Mood Screener (Munoz, 1988) - The mood screener questions were adapted from the Diagnostic Interview Schedule and assesses lifetime and current major depressive episode. Positive endorsement of 5 out of 9 depression symptoms present for at least two weeks screens positive for possible major depressive episode. The screener is a self-report checklist using the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria that has shown high concordance with the Structured Clinical Interview for DSM-IV (SCID-IV), the gold standard diagnostic interview for depression.
6 weeks postpartum
Mood
Time Frame: 6 months postpartum
Maternal Mood Screener (Munoz, 1988) - The mood screener questions were adapted from the Diagnostic Interview Schedule and assesses lifetime and current major depressive episode. Positive endorsement of 5 out of 9 depression symptoms present for at least two weeks screens positive for possible major depressive episode. The screener is a self-report checklist using DSM-IV criteria that has shown high concordance with the SCID-IV, the gold standard diagnostic interview for depression.
6 months postpartum

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Acceptability: Happy Healthy Loved Acceptability Scale
Time Frame: 6 weeks postpartum
Happy Healthy Loved Acceptability Scale - The investigators developed a list of 11 questions designed to assess participant satisfaction with the program on a scale of 1 (strongly disagree) to 5 (strongly agree). Open ended responses for participants to suggest alterations to the program are included as well.
6 weeks postpartum
Acceptability: Happy Healthy Loved Acceptability Scale
Time Frame: 6 months postpartum
Happy Healthy Loved Acceptability Scale - The investigators developed a list of 11 questions designed to assess participant satisfaction with the program on a scale of 1 (strongly disagree) to 5 (strongly agree). Open ended responses for participants to suggest alterations to the program are included as well.
6 months postpartum
Adherence
Time Frame: 6 months postpartum
Adherence will be measured by the percentage of text messages recorded as opened by participants, as well as the percentage of weekly breastfeeding check-in texts participants respond to with a yes, or no response.
6 months postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
OhioHealth

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Claremont McKenna College
Denison University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marie Cooper, RN, OhioHealth

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 26, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 24, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 8, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1296284

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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