Breast FeedingHHLNCT04578925
Happy, Healthy, Loved: A Mobile-delivered Breastfeeding Self-efficacy Intervention for First Time Parents
A study testing Happy, Healthy, Loved in people with Breast Feeding, run by OhioHealth at 1 site in United States.
Trial summary
The purpose of this study is to test if a mobile device delivered intervention program can improve breast-feeding self-efficacy in primiparous mothers. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Feeding
- What is being tested?
- Happy, Healthy, Loved
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2020to 1 Mar 2023
- 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
- primiparous mothers,
- living with a partner or spouse,
- have an intention to breastfeed their infant for at least 6-weeks postpartum;
- whose infant is not in the Neonatal Intensive Care Unit,
- have a mobile phone with text message capability,
- have no current self-reported depressive episode, and;
- English as a primary language
Who cannot join
- mothers who have other biological children,
- have infants in the Neonatal Intensive Care Unit,
- do not have a mobile phone with text message capabilities,
- report current episodes of depression, or are receiving antidepressant treatment or psychotherapy for depression,
- 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)
- do not speak, read and write English
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to test if a mobile device delivered intervention program can improve breast-feeding self-efficacy in primiparous mothers.
Read the 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.
- Conditions
- Breast Feeding
- Being tested
- Happy, Healthy, Loved
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Happy, Healthy, LovedBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Happy, Healthy, Loved | Experimental | 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. Receives: Behavioral: Happy, Healthy, Loved |
| Control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Breastfeeding Self-Efficacy: Breastfeeding self-efficacy scale short form
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.
Measured: 6 weeks postpartum
Breastfeeding Self-Efficacy: Breastfeeding self-efficacy scale short form
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.
Measured: 6 months postpartum
Breastfeeding Rate
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.
Measured: 6 weeks postpartum
Breastfeeding Rate
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.
Measured: 6 months postpartum
Secondary outcomes (17)
Coping Behavior
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.
Measured: 6 weeks postpartum
Coping Behavior
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.
Measured: 6 months postpartum
Postpartum Partner Support
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.
Measured: 6 weeks postpartum
Partner Support
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.
Measured: 6 weeks postpartum
Postpartum Partner Support
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.
Measured: 6 months postpartum
Partner Support
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.
Measured: 6 months postpartum
Hair Cortisol
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.
Measured: 0-2 days postpartum
Sleep Quality (hair cortisol covariate): Pittsburgh Sleep Quality Index (PSQI)
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.
Measured: 0-2 days postpartum
Postnatal Depression
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.
Measured: 0-2 days postpartum
Postnatal Depression
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.
Measured: 6 weeks postpartum
Postnatal Depression
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.
Measured: 6 months postpartum
Depression, Anxiety, Stress
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.
Measured: 0-2 days postpartum
Depression, Anxiety, Stress
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.
Measured: 6 weeks postpartum
Depression, Anxiety, Stress
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.
Measured: 6 months postpartum
Mood
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.
Measured: 0-2 days postpartum
Mood
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.
Measured: 6 weeks postpartum
Mood
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.
Measured: 6 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start1 Oct 2020
- Primary completion26 Sep 2022
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast FeedingStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Mother partner pairs will be randomly assigned to the HHL program or care as usual.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- OhioHealth
- Sponsor type
- University, hospital or other
- Collaborators
- Denison University, Claremont McKenna College
- Responsible party
- Sponsor
- Investigators
- Marie Cooper, RN, Principal investigator, OhioHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04578925
- Sponsor's protocol ID
- 1296284
- Acronym
- HHL
- Status last verified
- Jul 2023
- First submitted
- 24 Jul 2020
- Last updated
- 14 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Henshaw E, Cooper M, Wood T, Krishna S, Lockhart M, Doan S. A randomized controlled trial of the Happy, Healthy, Loved personalized text-message program for new parent couples: impact on breastfeeding self-efficacy and mood. BMC Pregnancy Childbirth. 2024 Jul 26;24(1):506. doi: 10.1186/s12884-024-06684-9.
PubMed 39060974
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Happy, Healthy, Loved: A Mobile-delivered Breastfeeding Self-efficacy Intervention for First Time Parents
- ClinicalTrials.gov ID
- NCT04578925
- Acronym / sponsor ID
- HHL / 1296284
- Conditions
- Breast Feeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- OhioHealthUniversity, hospital or other
- Collaborators
- Denison University, Claremont McKenna College
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 26 Sep 2022 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 8 Oct 2020 (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 purpose of this study is to test if a mobile device delivered intervention program can improve breast-feeding self-efficacy in primiparous mothers.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Mother partner pairs will be randomly assigned to the HHL program or care as usual.
| Arm | Type | Receives |
|---|---|---|
| Happy, Healthy, Loved | Experimental | Behavioral: Happy, Healthy, LovedBoth 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. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- primiparous mothers,
- living with a partner or spouse,
- have an intention to breastfeed their infant for at least 6-weeks postpartum;
- whose infant is not in the Neonatal Intensive Care Unit,
- have a mobile phone with text message capability,
Key exclusion criteria (6 listed)
- mothers who have other biological children,
- have infants in the Neonatal Intensive Care Unit,
- do not have a mobile phone with text message capabilities,
- report current episodes of depression, or are receiving antidepressant treatment or psychotherapy for depression,
- 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)
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 |
|---|---|---|
| Happy, Healthy, LovedA text message based, mobile-device delivered intervention that provides educational information to primiparous mothers and their partners about breast-feeding and coping with stress. | Behavioural | Happy, Healthy, Loved |
Primary outcome
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.
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.
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.
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.
17 secondary outcomes
Coping Behavior
Time frame: 6 weeks postpartum
Coping Behavior
Time frame: 6 months postpartum
Postpartum Partner Support
Time frame: 6 weeks postpartum
Partner Support
Time frame: 6 weeks postpartum
Postpartum Partner Support
Time frame: 6 months postpartum
Partner Support
Time frame: 6 months postpartum
Hair Cortisol
Time frame: 0-2 days postpartum
Sleep Quality (hair cortisol covariate): Pittsburgh Sleep Quality Index (PSQI)
Time frame: 0-2 days postpartum
Postnatal Depression
Time frame: 0-2 days postpartum
Postnatal Depression
Time frame: 6 weeks postpartum
Postnatal Depression
Time frame: 6 months postpartum
Depression, Anxiety, Stress
Time frame: 0-2 days postpartum
Depression, Anxiety, Stress
Time frame: 6 weeks postpartum
Depression, Anxiety, Stress
Time frame: 6 months postpartum
Mood
Time frame: 0-2 days postpartum
Mood
Time frame: 6 weeks postpartum
Mood
Time frame: 6 months postpartum
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 14 Jul 2023.
- Derived from this study: PubMed 39060974Henshaw E, Cooper M, Wood T, Krishna S, Lockhart M, Doan S. A randomized controlled trial of the Happy, Healthy, Loved personalized text-message program for new parent couples: impact on breastfeeding self-efficacy and mood. BMC Pregnancy Childbirth. 2024 Jul 26;24(1):506. doi: 10.1186/s12884-024-06684-9.
- 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.
Marie Cooper, RN principal investigator
OhioHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Happy, Healthy, Loved in people with Breast Feeding, run by OhioHealth 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 7 inclusion and 6 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 14 Jul 2023. 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?
Breastfeeding Self-Efficacy: Breastfeeding self-efficacy scale short form (time frame: 6 weeks postpartum). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04578925, which also lists 1 linked publication.
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 14 Jul 2023.