- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03382132
momHealth: Multiple Health Behavior Change Intervention in Teen Pregnancy & Parenting Using Mobile Technology (momHealth)
1. september 2020 opdateret af: University of Kansas Medical Center
The purpose of this study is to find out if information and support provided with a mobile-delivered (via iPad) momHealth Teen Pregnancy Program can promote healthy choices and behaviors during and after pregnancy.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This is a RCT to pilot test an innovative multiple health behavior intervention to influence three areas of health for pregnant and parenting adolescents: breastfeeding, healthy eating/active living, and depression prevention.
Intervention and control groups will be compared in the main outcomes of the study (see 4.2.c. and 4.3).
Beginning in the last eight weeks of pregnancy and extending to one month after giving birth, we use mobile health technology (e.g., iPad minis) to deliver multi-media educational modules, text-messaging, virtual home visits with professionals using secure televideo, and real-time peer group support over televideo.
At birth, five weeks, and three months after giving birth, effectiveness of the program outcomes will be assessed and compared to a usual care control group and include breastfeeding/infant-feeding practices; healthy eating and physical activity; and depressive symptoms.
This is the first known study to address these multiple behaviors simultaneously with pregnant and parenting adolescent women.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
78
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Kansas
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Kansas City, Kansas, Forenede Stater, 66160
- University of Kansas Medical Center
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
15 år til 20 år (Barn, Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
Inclusion Criteria:
- Pregnant females
- English-speaking
- Giving birth to first child
- Intending to keep the newborn
- Access to a telephone
- 27-31 weeks gestation
- Low-risk pregnancy
Exclusion Criteria:
- Multiple gestation pregnancy
- High-risk pregnancy
- Women with active untreated mental health conditions such as affective disorder, substance use disorder, anxiety disorder (excluding simple phobia), or psychosis
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: momHealth
Participants will receive support and information via the momHealth program.
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Mobile health program delivered via an iPad.
Program delivers information and support related to breastfeeding education, Ten Steps of the Baby Friendly Hospital Initiative, healthy eating and active living topics, and depression prevention information.
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Aktiv komparator: Control
Participants will receive the normal support they would normally receive if they were not in a study.
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Participants will receive standard health care via their prenatal provider, including routine prenatal education and postpartum support.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Duration of breastfeeding
Tidsramme: Month 3
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Number of days out to 3 months postpartum of any breastfeeding.
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Month 3
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Consumption of "red" foods per day
Tidsramme: Change from Baseline to Month 3
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Measure will be assessed using the Automated Self-Administered 24-hour Recall™ (ASA24™).
Participants will provide information on food eaten through an online site and accessed with an individualized link.
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Change from Baseline to Month 3
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Minutes of moderate to vigorous physical activity per week
Tidsramme: Change from Baseline to Month 3
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Measure will be assessed using ActiGraph Physical Activity Monitors.
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Change from Baseline to Month 3
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Change in depressive symptoms
Tidsramme: Month 3
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Assessed using the Edinburgh Postnatal Depression Scale (EPDS), a 10-item questionnaire.
Each question response is coded from 0 to 3. Scores can range from a minimum of 0 to a maximum of 30.
A score of 10 or greater detects a major depressive disorder with sensitivity.
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Month 3
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Rate of any and exclusive breastfeeding
Tidsramme: Month 3
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Self-report data on breastfeeding continuation, either wholly or partially, out to 3 months postpartum.
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Month 3
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Karen Wambach, PhD, University of Kansas Medical Center
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
20. september 2017
Primær færdiggørelse (Faktiske)
25. maj 2020
Studieafslutning (Faktiske)
30. august 2020
Datoer for studieregistrering
Først indsendt
13. december 2017
Først indsendt, der opfyldte QC-kriterier
18. december 2017
Først opslået (Faktiske)
22. december 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
3. september 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. september 2020
Sidst verificeret
1. september 2020
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- STUDY00141254
- R21HD088913-01A1 (U.S. NIH-bevilling/kontrakt)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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