NCT02244424

Brief Summary

The purpose of this social media group randomized trial (GRT) is to test the feasibility of our Baby Dayr for Teen Moms intervention to increase maternal responsiveness to infant cues and implement healthy feeding practices through development of a healthy feeding style. Aim 1: Evaluate the feasibility and acceptability of the Baby Dayr intervention administered to the target population as it relates to their acceptance and satisfaction with the content, format, delivery, and use of social media. Aim 2: Explore efficacy of the Baby Dayr intervention administered to adolescent mothers of infants 4 months of age or less as assessed by maternal responsiveness, feeding style, and feeding practices evaluated at the completion of the intervention using self-report methods.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
164

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

June 24, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 19, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

March 8, 2019

Completed
Last Updated

March 8, 2019

Status Verified

March 1, 2019

Enrollment Period

2.3 years

First QC Date

June 24, 2014

Results QC Date

May 30, 2017

Last Update Submit

March 6, 2019

Conditions

Keywords

InfantObesityAdolescentSocial mediaPrevention

Outcome Measures

Primary Outcomes (1)

  • Change in Infant Growth

    Recumbent infant length (inches) and weight (pounds/ounces) measured at three separate time points. While recumbent infant length was collected in inches and weight collected in pounds/ounces, these measures were converted into z-score measurements for the outcome measurement of change in infant growth. Standardized weight scores are measures of relative weight adjusted for child age and sex. The z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. A z-score of 0 is equal to the mean. Negative numbers indicated weight values lower than the mean and the positive numbers indicate weight values higher than the mean.

    Baby is less than 2 months; baby is 3 months; baby is 6 months

Study Arms (2)

Tools for Teen Moms Intervention Group

EXPERIMENTAL

Tools for Teen Moms intervention group will receive daily challenges focusing on: 1) Maternal-Infant Feeding Interaction; and 2) Feeding Practices Challenges. The challenges will cycle through a pre-determined schedule where they are automatically updated each day at midnight. Participants will have a 24-hour period to complete each challenge. The intervention will provide a new daily challenge over six weeks, a time frame selected to provide participants with enough opportunities to form the habit of visiting the website daily. Participants will continue to receive usual MIHP care during the intervention.

Behavioral: Tools for Teen Moms

MIHP standard care

NO INTERVENTION

MIHP care consists of voluntary home visits: one week postpartum, at six weeks, and six months, and on-going as needed provided by a RN, licensed social worker, RD, infant mental health specialist and/or paraprofessional. Content includes a flexible plan of care with visits based on identified domains for both the mother and the infant.

Interventions

The Tools for Teen Moms intervention is a novel social media intervention platform designed by the investigators which includes cell phone text message reminders, and infant feeding website, and Facebook to increase infant-centered feeding through daily behavioral challenge activities ("challenges") for this population. The intervention consists of 6 weeks of daily challenges and will be delivered within the infant's first 6 months of life.

Tools for Teen Moms Intervention Group

Eligibility Criteria

Age14 Years - 19 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Self-identified, English-speaking
  • Low-income, adolescent
  • First-time mothers between the ages of 14 and 19
  • With daily web access and access to a cell phone that includes text messaging capabilities
  • Family income ≤ 185% of federal poverty
  • Term birth (37≤42 weeks, 2500≤3750 grams birth weight)
  • Mothers and infants with no special nutrients or feeding needs
  • Infants less than six weeks old at study enrollment who have not started eating solid foods
  • Adolescent mothers must be a primary caretaker of the infant who feeds her infant at least once a day, and who is willing to participate in a six-week intervention with data collection at three defined time points (T1, T2, and T3)

You may not qualify if:

  • Male caregivers
  • Mothers and infants with diagnosed feeding/eating disorders
  • Significant perinatal or postnatal complications
  • Post partum depression or other mental health problems
  • Adolescent mothers who do not share in the feeding responsibility of their infants
  • Adolescents without daily web access nor a cell phone with text messaging capabilities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Michigan State University

East Lansing, Michigan, 48824, United States

Location

Related Publications (1)

  • Horodynski MA, Silk K, Hsieh G, Hoffman A, Robson M. Tools for teen moms to reduce infant obesity: a randomized clinical trial. BMC Public Health. 2015 Jan 21;15:22. doi: 10.1186/s12889-015-1345-x.

    PMID: 25604090BACKGROUND

MeSH Terms

Conditions

Pediatric ObesityObesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Mildred A. Horodynski
Organization
Michigan State University, College of Nursing

Study Officials

  • Mildred A Horodynski, PhD

    Michigan State University

    PRINCIPAL INVESTIGATOR
  • Kami Silk, PhD

    Michigan State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 24, 2014

First Posted

September 19, 2014

Study Start

June 1, 2014

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

March 8, 2019

Results First Posted

March 8, 2019

Record last verified: 2019-03

Locations