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

Primary Purpose

Adolescent Mothers, Infant Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tools for Teen Moms
Sponsored by
Michigan State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Adolescent Mothers focused on measuring Infant, Obesity, Adolescent, Social media, Prevention

Eligibility Criteria

14 Years - 19 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Michigan State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Tools for Teen Moms Intervention Group

MIHP standard care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 24, 2014
Last Updated
March 6, 2019
Sponsor
Michigan State University
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1. Study Identification

Unique Protocol Identification Number
NCT02244424
Brief Title
Tools For Teen Moms: Reducing Infant Obesity Risk
Acronym
TFTM
Official Title
Tools for Teen Moms: Reducing Infant Obesity Risk
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Michigan State University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Mothers, Infant Obesity
Keywords
Infant, Obesity, Adolescent, Social media, Prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
164 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tools for Teen Moms Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
MIHP standard care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Tools for Teen Moms
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Infant Growth
Description
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.
Time Frame
Baby is less than 2 months; baby is 3 months; baby is 6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mildred A Horodynski, PhD
Organizational Affiliation
Michigan State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kami Silk, PhD
Organizational Affiliation
Michigan State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michigan State University
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48824
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25604090
Citation
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.
Results Reference
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Tools For Teen Moms: Reducing Infant Obesity Risk

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