Avoiding Diabetes After Pregnancy Trial (ADAPT)
14 août 2013 mis à jour par: Social & Scientific Systems Inc.
Increasing Adoption of Early Intervention to Prevent Diabetes After Gestational Diabetes Mellitus
The Avoiding Diabetes After Pregnancy Trial (ADAPT) study was designed to test the effectiveness of interventions that potentially increase the adoption of Diabetes Prevention Program (DPP) elements by women who had a pregnancy with gestational diabetes mellitus (GDM).
The study was conducted as an integrated trial with two separate arms: one to facilitate weight reduction and the other to increase diabetes testing.
There were two hypotheses:
- Women in the testing intervention will be more likely to have received a diabetes test within the 6 months post-intervention than women in the control group.
- Women in the weight reduction intervention will have lost more weight at the 6-month and 9-month follow-up than women in the control group.
The primary study aim was to determine the efficacy of a system of interactive technology-based supports to prompt women with a history of gestational diabetes to take steps to prevent diabetes. The secondary aims were focused on women's engagement:
- To evaluate the impact of the weight reduction intervention in terms of participant engagement with the interactive technology-based supports.
- To evaluate changes in the women's perception of their personal diabetes risk following after exposure to information about diabetes risk following a pregnancy with GDM.
- To identify the determinants and motivators of and barriers to diabetes testing in the 6- to 12-week postpartum period and thereafter, using the Health Belief model to guide the study.
There was an additional secondary aim involving metformin:
- To evaluate the impact of the diabetes risk reduction intervention in terms of women seeking out their physician's advice on metformin treatment and receiving a metformin prescription, if appropriate.
Aperçu de l'étude
Statut
Complété
Les conditions
Type d'étude
Interventionnel
Inscription (Réel)
140
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Maryland
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Silver Spring, Maryland, États-Unis, 20910
- Social & Scientific Systems Inc.
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Femelle
La description
Inclusion Criteria:
General
- History of GDM in the previous 6 months to 4.5 years
- Access to the internet and text messages or phone messages
- Current patient of Harvard Vanguard Medical Associates
- 18 years of age or older
- Able to read in English
Weight Reduction Group
- Overweight or obese
- Capable of performing moderate physical activity
Diabetes Testing Group
- Had not competed a diabetes test (OGTT or fasting blood sugar at 6-12 weeks postpartum or OGTT, fasting blood sugar or hemoglobin A1c after 12 weeks postpartum)
Exclusion Criteria:
General:
- Diabetes diagnosis
- Psychotic disorder diagnosis
- Enrolled in a research study
Weight Reduction Group
- Taking prescription medications for weight loss
- Engaged in a formal weight reduction program
Diabetes Testing Group
- History of postpartum OGTT, fasting plasma glucose or hemoglobin A1c (after 6 weeks postpartum)
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Weight Reduction Intervention
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The weight trial intervention components were:
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Comparateur actif: Weight Reduction Control Arm
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Participants received an initial brochure about managing diabetes risk, a digital scale to use in entering their weights in online questionnaires, and monthly emailed wellness messages unrelated to diabetes.
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Comparateur actif: Tested for diabetes
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Due to small numbers in this group, the planned intervention was changed to a mixed-mode study, using baseline and follow-up self-administered questionnaires and semi-structured questionnaires administered to a sub-sample of those tested for diabetes to identify factors differentiating the behavior of women who had and had not been tested for diabetes following a pregnancy with gestational diabetes mellitus.
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Comparateur actif: Not tested for diabetes
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Due to small numbers in this group, the planned intervention was changed to a mixed-mode study, using baseline and follow-up self-administered questionnaires and semi-structured questionnaires administered to a subsample of those not tested for diabetes to identify factors differentiating the behavior of women who had and had not been tested for diabetes following a pregnancy with gestational diabetes mellitus.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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For participants in weight group, weight reduction from baseline to 6 months
Délai: 6 months
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Participants reported their weights online at baseline, 3 months, 6 months, and 9 months, and the difference in weight from baseline to 6 months was the primary measure of the intervention's success.
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6 months
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In testing group, the number of women receiving a diabetes test per ADA Guidelines in the 6-month post-intervention period
Délai: 6 months
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The number of women who were tested in the 6 months following the intervention was determined from electronic medical records.
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6 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Weight intervention participant engagement with the interactive technology-based supports
Délai: 9 months
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Measured by separate scores for taking part in behavioral support (coaching calls) and electronic feedback (women responding on goal performance via daily text messaging (SMS)or weekly IVR, chosen by the participant).
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9 months
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Success of participants in weight intervention arm in achieving behavior change goals.
Délai: 9 months
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Information from daily SMS and weekly IVR responses to questions about participants' success in achieving behavior change goals were used to construct achievement scores.
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9 months
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Weight change from baseline to 9 months
Délai: 9 months
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Differences were calculated in weights entered on baseline and 9-month surveys for intervention and control arms in the weight group.
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9 months
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Weight change from 6 to 9 months
Délai: 3 months
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Difference in weights recorded in 6-month and 9-month questionnaires was calculated for all participants in the weight group.
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3 months
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Susan J Griffey, DPh, BSN, Social & Scientific Systems Inc.
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 décembre 2011
Achèvement primaire (Réel)
1 mars 2013
Achèvement de l'étude (Réel)
1 mars 2013
Dates d'inscription aux études
Première soumission
13 août 2013
Première soumission répondant aux critères de contrôle qualité
14 août 2013
Première publication (Estimation)
15 août 2013
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
15 août 2013
Dernière mise à jour soumise répondant aux critères de contrôle qualité
14 août 2013
Dernière vérification
1 août 2013
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- NDEP-GDM GS10F0381L
- GS10F0381L (Autre subvention/numéro de financement: GSA)
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