- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Michigan
-
East Lansing, Michigan, Förenta staterna, 48824
- Michigan State University
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
|
Inget ingripande: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Infant Growth
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Mildred A Horodynski, PhD, Michigan State University
- Huvudutredare: Kami Silk, PhD, Michigan State University
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 1R21HDO75974-OIAL
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .