Relaxation Intervention to Improve Newborn Growth and Maternal Well-being

NCT07774793 | Not Yet Recruiting DMC

• 1 other identifier: 1R21HD117269
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if listening to a relaxation audiorecording during breastfeeding improves breastfeeding and infant outcomes and maternal well-being in a low-income country setting. The main questions it aims to answer are:

• Does listening to a relaxation audiorecording during breastfeeding improve infant growth?
• Does listening to a relaxation audiorecording during breastfeeding reduce maternal stress and anxiety? Researchers will compare listening to an audiorecording on a digital recording device to receiving the digital recording device without an audiorecording to see if relaxation audiorecordings work to improve breastfeeding, infant growth and maternal well-being. Participants will:
• Listen to an audiorecording twice daily while breastfeeding for 12 weeks
• Have study visits at 1, 2, 4 and 12 weeks for checkups and tests
• Let us know what they think of the audiorecording

Conditions

Well-Being, Psychological; Breastfeeding; Low Birth Weight; Undernutrition

Keywords

relaxation; audiorecording; breastfeeding; well-being; maternal-child health

Outcome Measures

Primary Outcomes (1)

• Change in weight-for-age z-score (WAZ)

  Weight will be measured with the Seca 334 Infant Scale (Seca Inc., Wandsbek, Germany), which is portable for study visits at home or in hospital or clinic and is accurate to 5 grams. WAZ will be calculated from measured weight using the World Health Organization (WHO) Anthro Survey Analyser. Change in WAZ will be calculated by subtracting WAZ at birth from WAZ at 12 weeks of age.

  From birth through 12 weeks of age

Secondary Outcomes (13)

• Breastfeeding frequency

  1, 2, 4 and 12 weeks of age

• Any infant dietary intake other than human milk since last study visit

  1, 2, 4 and 12 weeks of age

• Milk transfer

  1, 2, 4 and 12 weeks of age

• Maternal stress

  1, 2, 4 and 12 weeks of age

• Maternal anxiety

  2, 4 and 12 weeks after birth

Study Arms (2)

Relaxation Audiorecording

EXPERIMENTAL

Listening to a relaxation audiorecording twice daily on a digital audio device while breastfeeding

Behavioral: Relaxation audiorecording

Control audio device

PLACEBO COMPARATOR

Digital audio device without a relaxation audiorecording

Behavioral: Control audio device without relaxation audiorecording

Interventions

Relaxation audiorecording BEHAVIORAL

This intervention will be an audiorecording on a digital audio device consisting of 15 minutes of relaxing messages supportive of breastfeeding.

Relaxation Audiorecording

Control audio device without relaxation audiorecording BEHAVIORAL

Participants in the control group will receive a digital audio device that does not have a relaxation audiorecording

Control audio device

Eligibility Criteria

• Age: 0 Days+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Newborn low birth weight (LBW) (birth weight \< 2500 grams)
• Newborn birth weight \>= 1800 g
• Newborn admitted to Neonatal Intensive Care Unit (NICU)
• Newborn in stable condition without WHO danger signs
• Newborn age \<24 hours old
• Breastfeeding initiated
• Residence in the catchment area

You may not qualify if:

• Twins and other multiples
• Newborn respiratory support or WHO danger signs
• Newborn with major congenital anomaly or expected surgery
• Contraindications to or unable to breastfeed
• Mother with hearing impairment
• Unable to speak Luganda

Sponsors & Collaborators

• Makerere University: collaborator
• Cornell University: collaborator
• University of California, San Francisco: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Makerere University School of Public Health

Kampala, Uganda

Location

Related Publications (5)

• Levene I, Mohd Shukri NH, O'Brien F, Quigley MA, Fewtrell M. Relaxation Therapy and Human Milk Feeding Outcomes: A Systematic Review and Meta-Analysis. JAMA Pediatr. 2024 Jun 1;178(6):567-576. doi: 10.1001/jamapediatrics.2024.0814.

  PMID: 38709505 BACKGROUND

• Mohd Shukri NH, Wells J, Eaton S, Mukhtar F, Petelin A, Jenko-Praznikar Z, Fewtrell M. Randomized controlled trial investigating the effects of a breastfeeding relaxation intervention on maternal psychological state, breast milk outcomes, and infant behavior and growth. Am J Clin Nutr. 2019 Jul 1;110(1):121-130. doi: 10.1093/ajcn/nqz033.

  PMID: 31161202 BACKGROUND

• Dib S, Wells JCK, Eaton S, Fewtrell M. A Breastfeeding Relaxation Intervention Promotes Growth in Late Preterm and Early Term Infants: Results from a Randomized Controlled Trial. Nutrients. 2022 Nov 27;14(23):5041. doi: 10.3390/nu14235041.

  PMID: 36501071 BACKGROUND

• Kaggwa MM, Najjuka SM, Bongomin F, Mamun MA, Griffiths MD. Prevalence of depression in Uganda: A systematic review and meta-analysis. PLoS One. 2022 Oct 20;17(10):e0276552. doi: 10.1371/journal.pone.0276552. eCollection 2022.

  PMID: 36264962 BACKGROUND

• Roddy Mitchell A, Gordon H, Atkinson J, Lindquist A, Walker SP, Middleton A, Tong S, Hastie R. Prevalence of Perinatal Anxiety and Related Disorders in Low- and Middle-Income Countries: A Systematic Review and Meta-Analysis. JAMA Netw Open. 2023 Nov 1;6(11):e2343711. doi: 10.1001/jamanetworkopen.2023.43711.

  PMID: 37976063 BACKGROUND

MeSH Terms

Conditions

Psychological Well-Being; Breast Feeding; Malnutrition

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Feeding Behavior; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Valerie Flaherman, MD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Victoria Nankabirwa, PhD, MBBCh

  Makerere University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Victoria Laleau, MS

CONTACT

415-502-6266; victoria.laleau@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: August 19, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: August 19, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)