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- Essai clinique NCT03080064
Health Coach Intervention Pilot Study (AHA)
Supporting Healthful Lifestyles During Pregnancy: A Health Coach Intervention Pilot Study
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
<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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Massachusetts
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Boston, Massachusetts, États-Unis, 02215
- Harvard Pilgrim Health Care Institute
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Satisfaction with the health coach intervention as assessed by surveys
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Marie-France Hivert, MD, MMSc, Harvard Pilgrim Health Care Institute
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- PH000523C
- 14CRP20490354 (Autre subvention/numéro de financement: American Heart Association)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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