## Protocol Section
### Identification Module
**NCT ID:** NCT02519179

**Acronym:** OBS-II

**Brief Title:** Influence of Bottle-Type of Infant Feeding Behavior

#### Organization Study ID Info
**ID:** 00000
#### Organization
**Class:** OTHER
**Full Name:** California Polytechnic State University-San Luis Obispo
### Status Module
#### Completion Date
**Date:** 2018-08

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2018-10-09

**Type:** ACTUAL

**Last Update Submit Date:** 2018-10-08

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2017-09

**Type:** ACTUAL

#### Start Date
**Date:** 2015-06

**Type:** ACTUAL

**Status Verified Date:** 2018-01

#### Study First Post Date
**Date:** 2015-08-10
**Type:** ESTIMATED
**Study First Submit Date:** 2015-08-05
**Study First Submit QC Date:** 2015-08-06
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** California Polytechnic State University-San Luis Obispo

#### Responsible Party

**Investigator Affiliation:** California Polytechnic State University-San Luis Obispo

**Investigator Full Name:** Alison Ventura

**Investigator Title:** Assistant Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The objective this research is to conduct a within-subject, experimental study that will describe mothers' feeding practices during typical bottle-feeding conditions and will examine whether removal of visual cues related to the amount of milk/formula in the bottle will alter these feeding practices. The investigators hypothesize that mothers will show higher levels of infant-directed feeding practices and lower levels of mother-directed feeding practices when using opaque, weighted bottles compared to when using standard, clear bottles. The investigators also hypothesize that infants will consume less breast milk or formula when fed from opaque, weighted bottles compared to when fed from standard, clear bottles.

### Conditions Module

**Conditions:**

- Bottle Feeding

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

**Intervention Model Description:** This is a within-subject study; mothers are observed during both feeding conditions.

##### Masking Info

**Masking:** NONE

**Primary Purpose:** BASIC_SCIENCE

#### Enrollment Info

**Count:** 48

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** This is a within-subject experiment; mothers will be asked to feed their infants from a clear, conventional bottle during one visit and an opaque, weighted bottle during the other visit. Order of conditions will be counterbalanced.

**Intervention Names:**

- Behavioral: Opaque, weighted bottle

- Behavioral: Clear, conventional bottle

**Label:** Conventional vs. Opaque, Weighted Bottle

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Conventional vs. Opaque, Weighted Bottle

**Description:** This is the experimental condition; mothers will be asked to feed their infants from an opaque, weighted bottle.

**Name:** Opaque, weighted bottle

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Conventional vs. Opaque, Weighted Bottle

**Description:** This is the control condition; mothers will be asked to feed their infants from a clear, conventional bottle.

**Name:** Clear, conventional bottle

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** Infant intake within a feeding (mL) assessed by weighing the bottle before and after a feeding.

**Measure:** Infant intake

**Time Frame:** 3-hour period

**Description:** Maternal responsiveness to infant cues during a feeding assessed by Nursing Child Assessment Satellite Training Parent-Child Interaction Feeding Scale.

**Measure:** Maternal responsiveness

**Time Frame:** 3-hour period

#### Secondary Outcomes

**Description:** Maternal perception/acceptance of the bottles during a feeding assessed through a mixed methods interview.

**Measure:** Maternal acceptance/perception of intervention

**Time Frame:** 3-hour period

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Mothers must be 18 years or older
* Infants must be between 0-6 months of age
* Infants must be prior to the introduction of solid foods

Exclusion Criteria:

* Preterm birth
* Medical conditions that interfere with feeding

**Healthy Volunteers:** True

**Maximum Age:** 6 Months

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** San Luis Obispo

**Country:** United States

**Facility:** California Polytechnic State University

**State:** California

**Zip:** 93401

#### Overall Officials

**Official 1:**

**Affiliation:** Assistant Professor

**Name:** Alison K Ventura, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Ventura AK, Pollack Golen R. A pilot study comparing opaque, weighted bottles with conventional, clear bottles for infant feeding. Appetite. 2015 Feb;85:178-84. doi: 10.1016/j.appet.2014.11.028. Epub 2014 Nov 28.

**PMID:** 25445988

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24
