Tools For Teen Moms: Reducing Infant Obesity Risk

Infant Obesity Clinical Trial

— TFTM  

Official title:

Tools for Teen Moms: Reducing Infant Obesity Risk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02244424
• Other study ID #: 1R21HDO75974-OIAL
• Status: Completed
• Phase: N/A
• Start date: June 2014
• Est. completion date: September 2016

Study information

• Verified date: March 2019
• Source: Michigan State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 14 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Mothers
• Infant Obesity
• Obesity
• Pediatric Obesity

Intervention

Behavioral:
• Tools for Teen Moms
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.

Locations

Country	Name	City	State
United States	Michigan State University	East Lansing	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Michigan State University

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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