Tools For Teen Moms: Reducing Infant Obesity Risk (TFTM)

March 6, 2019 updated by: Mildred Horodynski, Michigan State University

Tools for Teen Moms: Reducing Infant Obesity Risk

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.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Rapid weight gain during infancy is one of the strongest risk factors for obesity later in childhood. Weight gain in infancy is closely linked with feeding practices. Unhealthy mother-infant feeding practices contribute to rapid and/or excessive infant weight gain. Lower-income, adolescent, first-time mothers are less likely to engage in infant-centered feeding (ICF) which is characterized by maternal responsiveness (MR), healthy feeding styles (FS), and healthy feeding practices (FP). ICF is needed to reduce rapid/excessive weight gain during the first six months of life and to foster infant feeding self-regulation that is associated with healthy growth. ICF is a critical factor in reducing infant obesity risk and later adverse health conditions. Practical early intervention strategies are necessary to promote ICF among adolescent mothers to reduce obesity risk. We propose Baby Dayr, a novel social media intervention platform designed by the investigators which includes cell phone text message reminders, an infant feeding website, and Facebook to increase ICF through daily behavioral challenge activities ("challenges") for this population. Because cell phones permit natural, frequent and non-intrusive contact as they are not time-or-place-dependent, they offer an innovative strategy for intervening with adolescent mothers. However, this approach is untested for its feasibility with this population regarding infant feeding practices. We propose an exploratory, longitudinal, randomized, two-group study design. The three specific aims are: 1) to establish preliminary efficacy of the intervention as assessed by infant growth evaluated pre-intervention, immediately post intervention, and when the infant is six months old; 2) establish preliminary efficacy of the Baby Dayr plus Maternal-Infant Health Program (MIHP) care vs. MIHP care only on infant-centered feeding (MR, FS, and FP) mediated by maternal knowledge and self-efficacy; and 3) establish the feasibility, acceptability, and satisfaction of a social media intervention (Baby Dayr) for low-income adolescent, first-time mothers by assessing: 1) rates of enrollment and completion of daily challenges, 2) acceptability ratings of Baby Dayr; and 3) satisfaction with Baby Dayr. Participants will be randomly assigned to the intervention (Baby Dayr and MIHP) (n = 40) or control group (MIHP care only) (n = 40). The intervention consists of six weeks of daily challenges and will be delivered starting when the infant is four to six weeks old. The study is innovative in its: 1) assessment of ICF to reduce rapid/excessive infant weight gain in the first six months of life with low-income, adolescent, first-time mother-infant dyads, and 2) combination of an infant-centered skill-building, educational, and coaching approach using social media that is accessible and suitable for adolescents. The proposed research is significant in that it will contribute to the science related to ICF and knowledge regarding use of a social media platform in an at-risk population that can lead to reducing the risk of infant obesity. Information gained from this study will be used to refine the intervention for use in a larger-scale, longitudinal, randomized, controlled trial to reduce obesity risk in infants of low-income, adolescent mothers.

Study Type

Interventional

Enrollment (Actual)

164

Phase

  • 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

    • Michigan
      • East Lansing, Michigan, United States, 48824
        • Michigan State University

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

Ages Eligible for Study

14 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tools for Teen Moms Intervention Group
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.
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.
No Intervention: MIHP standard care
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Infant Growth
Time Frame: Baby is less than 2 months; baby is 3 months; baby is 6 months
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

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Mildred A Horodynski, PhD, Michigan State University
  • Principal Investigator: Kami Silk, PhD, Michigan State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

June 1, 2014

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

June 24, 2014

First Submitted That Met QC Criteria

September 16, 2014

First Posted (Estimate)

September 19, 2014

Study Record Updates

Last Update Posted (Actual)

March 8, 2019

Last Update Submitted That Met QC Criteria

March 6, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 1R21HDO75974-OIAL

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.

Clinical Trials on Infant Obesity

Clinical Trials on Tools for Teen Moms

Subscribe