- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02244424
Tools For Teen Moms: Reducing Infant Obesity Risk (TFTM)
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Michigan
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East Lansing, Michigan, Forente stater, 48824
- Michigan State University
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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.
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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.
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Ingen inngripen: 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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Change in Infant Growth
Tidsramme: Baby is less than 2 months; baby is 3 months; baby is 6 months
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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.
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Baby is less than 2 months; baby is 3 months; baby is 6 months
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Mildred A Horodynski, PhD, Michigan State University
- Hovedetterforsker: Kami Silk, PhD, Michigan State University
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1R21HDO75974-OIAL
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