Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Avoiding Diabetes After Pregnancy Trial (ADAPT)

14 augustus 2013 bijgewerkt door: 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:

  1. 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.
  2. 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

140

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Maryland
      • Silver Spring, Maryland, Verenigde Staten, 20910
        • Social & Scientific Systems Inc.

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

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)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Weight Reduction Intervention
Gedragsmatig: Weight Reduction Intervention

The weight trial intervention components were:

  • Electronic feedback from the ADAPT interactive obesity treatment approach (iOTA) system, tracking participants' behavior change goals. Participants received feedback either by daily SMS (text messaging) or by weekly IVR (interactive automated calls).
  • Seven behavior change coaching calls, once a month for 6 months, and then one at 7.5 months halfway through the maintenance period.
  • Print mailings/emailings
  • 3 Get Ready e-messages in the four weeks before the weight intervention began
  • Pedometers and program guides. (IVR users received printed activity logs with their program guides.)
  • Access to the ADAPT iOTA website for reviewing their progress and obtaining information on behavior change goals.
Actieve vergelijker: Weight Reduction Control Arm
Gedragsmatig: Weight Reduction Control Arm
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.
Actieve vergelijker: Tested for diabetes
Gedragsmatig: Tested for diabetes
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.
Actieve vergelijker: Not tested for diabetes
Gedragsmatig: Not tested for diabetes
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
For participants in weight group, weight reduction from baseline to 6 months
Tijdsspanne: 6 months
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.
6 months
In testing group, the number of women receiving a diabetes test per ADA Guidelines in the 6-month post-intervention period
Tijdsspanne: 6 months
The number of women who were tested in the 6 months following the intervention was determined from electronic medical records.
6 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Weight intervention participant engagement with the interactive technology-based supports
Tijdsspanne: 9 months
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).
9 months
Success of participants in weight intervention arm in achieving behavior change goals.
Tijdsspanne: 9 months
Information from daily SMS and weekly IVR responses to questions about participants' success in achieving behavior change goals were used to construct achievement scores.
9 months
Weight change from baseline to 9 months
Tijdsspanne: 9 months
Differences were calculated in weights entered on baseline and 9-month surveys for intervention and control arms in the weight group.
9 months
Weight change from 6 to 9 months
Tijdsspanne: 3 months
Difference in weights recorded in 6-month and 9-month questionnaires was calculated for all participants in the weight group.
3 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Social & Scientific Systems Inc.

Medewerkers

Duke University
Harvard Pilgrim Health Care
Harvard Vanguard Medical Associates

Onderzoekers

  • Hoofdonderzoeker: Susan J Griffey, DPh, BSN, Social & Scientific Systems Inc.

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 december 2011

Primaire voltooiing (Werkelijk)

1 maart 2013

Studie voltooiing (Werkelijk)

1 maart 2013

Studieregistratiedata

Eerst ingediend

13 augustus 2013

Eerst ingediend dat voldeed aan de QC-criteria

14 augustus 2013

Eerst geplaatst (Schatting)

15 augustus 2013

Updates van studierecords

Laatste update geplaatst (Schatting)

15 augustus 2013

Laatste update ingediend die voldeed aan QC-criteria

14 augustus 2013

Laatst geverifieerd

1 augustus 2013

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • NDEP-GDM GS10F0381L
  • GS10F0381L (Ander subsidie-/financieringsnummer: GSA)

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren