- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03080064
Health Coach Intervention Pilot Study (AHA)
Supporting Healthful Lifestyles During Pregnancy: A Health Coach Intervention Pilot Study
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
<Health Coach Intervention > The investigators connected participants at enrollment (median gestation of 12.5 weeks, IQR: 11-15) with a trained health coach who called participants every 2-3 weeks until 36 weeks of gestation. During these phone calls, health coaches helped participants adopt and maintain new healthful lifestyle behaviors that were evidence-based, simple, and easy to track. Goals aimed to promote appropriate gestational weight gain and covered several domains including diet, physical activity, screen time, and sleep.
During the first call, health coaches invited participants to prioritize these goals according to their level of self-efficacy, readiness to change, preferences, and values. Throughout the intervention, health coaches used principles of motivational interviewing that relied on a patient-centered approach to enhance readiness to change by exploring ambivalence and resistance to change. In addition to setting personal goals, health coaches also presented optimal goals for ideal cardiovascular health.
During follow-up calls, health coaches monitored progress and helped adjust goals when necessary (e.g. too many goals, or the goal was too ambitious). Health coaches also addressed barriers and potential solutions with participants, and helped them target higher goal settings or select novel goals when participants attained them. Health coaches sent emails or text messages depending on participant preferences to check-in about progress toward goals or clinical appointments between calls. Research staff (including an MD) met weekly with health coaches to review their conversations with participants, and to address any medical issues to ensure that it would be reported to the primary care provider obstetric team if appropriate.
<Study Design and Sample> Participants completed baseline (N=30) and follow-up (N=26) surveys at the end of the intervention as well as follow-up phone interviews (N=18). Surveys collected information on demographics, attitudes related to weight status and pregnancy, opinions about the intervention, and included food frequency questions . Interviews followed a guide of open-ended questions to determine insights on what helped achieve goals, motivation, opinions of the health coach intervention, and areas for improvement. One study staff member, who has experience with qualitative data collection, conducted all of the individual interviews. This study was approved by the Harvard Pilgrim Health Care Human Studies Committee.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Massachusetts
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Boston, Massachusetts, Forente stater, 02215
- Harvard Pilgrim Health Care Institute
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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:
- pregnant (less than 16 weeks of gestation),
- overweight or obese (pre-pregnancy BMI≥25 kg/m2),
- 18 years of age or older,
- English speaking,
- planned to remain at the same obstetrics clinic for the duration of their pregnancies.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Health Coach Intervention
The investigators connected participants at enrollment (median gestation of 12.5 weeks, IQR: 11-15) with a trained health coach who called participants every 2-3 weeks until 36 weeks of gestation.
During these phone calls, health coaches helped participants adopt and maintain new healthful lifestyle behaviors that were evidence-based, simple, and easy to track.
Goals aimed to promote appropriate gestational weight gain and covered several domains including diet, physical activity, screen time, and sleep.
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Please see arm description.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Satisfaction with the health coach intervention as assessed by surveys
Tidsramme: From enrollment until the end of the intervention at 36 weeks of gestation.
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The investigators assessed the feasibility and acceptability of a remote health coach intervention to promote healthful lifestyle behaviors among overweight pregnant women using baseline and follow-up surveys.
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From enrollment until the end of the intervention at 36 weeks of gestation.
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Satisfaction with the health coach intervention as assessed by phone interviews
Tidsramme: From enrollment until the end of the intervention at 36 weeks of gestation.
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Using an interview guide, the investigators assessed the feasibility and acceptability of a remote health coach intervention to promote healthful lifestyle behaviors among overweight pregnant women.
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From enrollment until the end of the intervention at 36 weeks of gestation.
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Marie-France Hivert, MD, MMSc, Harvard Pilgrim Health Care Institute
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
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
Andre studie-ID-numre
- PH000523C
- 14CRP20490354 (Annet stipend/finansieringsnummer: American Heart Association)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
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