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The Effect of E-Health Management on Gestational Diabetes Control

30. oktober 2018 oppdatert av: Mei-Chen Su, Chang Gung Memorial Hospital

Randomized Controlled Trail of e-Health Management for Women With Prior Gestational Diabetes Mellitus

The purpose of this study was to develop an e-heath management platform(eHMP) for women with high risk of gestational diabetes mellitus (GDM) and to evaluate the longitudinal effects between groups of eHMP intervention.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Background: Women with previous gestational diabetes mellitus are at increased risk for developing type2 diabetes mellitus or metabolic syndrome in their later life. Infants of mothers with GDM are more susceptible to stillbirth and more serious health concerns. With limited time for visits and the predicament of education, applying web-based intervention has become a convenient tool for health management.

Objectives: The approved project aimed to develop an e-heath management platform(eHMP) for women with high risk of gestational diabetes mellitus (GDM) and to evaluate the longitudinal effects between groups of eHMP intervention. The eHMP integrate GDM health care knowledge, self-awareness of health, self-monitoring of health status (i.e., recording weight and measurement data of metabolic syndrome risk factors and monitoring changes in data trends); participation in discussions or browsing forums; healthy lifestyle guidance and counseling; reminder systems, a token system of earning points in exchange for prizes.

Methods: Pregnant women aged 18-45 years with high risk of metabolic syndrome who have a singleton pregnancy, are eligible to participate in this study. Women who agree to participate in the study will be given a participant information sheet and consent form. Participants will be recruited from the Pregnancy diabetes Clinic, at Chang Gung memorial hospital and introduced to the eHMP using the mobile phone in the clinic. Participants will also be given the URL to access to the program and they can learn the modules at home by using their home PCs, mobile phones, or tablets. They were followed up for three times: 28 weeks' gestation, 36-40 weeks' gestation and 6-12 weeks postpartum. SPSS version 20.0 software was used to compile and analyze the research data, including questionnaires and blood test for metabolic index.

Studietype

Intervensjonell

Registrering (Faktiske)

112

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Taiwan
      • Taipei, Taiwan, 10507
        • Chang Gung Memorail Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 45 år (Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

Inclusion Criteria:

Pregnant women (pre-pregnancy body mass index ≧ 24) must meet at least one of the following conditions and agree to be interviewed:

  • Age over 34 years old;
  • Ever had giant infant delivery (weight ≧ 4.5 kg);
  • Previous diagnosed with gestational diabetes ;
  • Family history of diabetes.

Exclusion Criteria:

  • Pre-existing diabetes (types 1 and 2);
  • Unable to write and understand Chinese;
  • Subject has cognitive impairment;
  • Subject has intellectual disability or mental illness;
  • Dependent on medical care (eg, anti-depressants, or any psychiatric medication)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: eHMP experimental group

The experimental group received health management support and counseling,including:

  1. GDM health care knowledge
  2. self-awareness of health
  3. self-monitoring of health status (i.e., recording weight and measurement data of metabolic syndrome risk factors and monitoring changes in data trends)
  4. participation in discussions or browsing forums
  5. healthy lifestyle guidance and counseling
  6. reminder systems
  7. a token system of earning points in exchange for prizes.
Annen: Experimental group
Pregnant women who agree to take part will be assigned to a group: experimental group and control group. The experimental group will received health management support and counseling that were conducted by the researchers through the e-health management platform.
Andre navn:
  • e-Health Management Platform
Ingen inngripen: Control group
only received usual care

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change of Triglyceride Level
Tidsramme: Change from Baseline at 6-12 weeks after delivery
Blood sampling was performed in the fasting state. Normal triglyceride was <150 mg/dl; ≥150mg/dl was abnormal
Change from Baseline at 6-12 weeks after delivery
Change of Fasting Blood Glucose (FBG) Level
Tidsramme: Change from Baseline at 6-12 weeks after delivery
Blood sampling was performed in the fasting state. Normal FBG was < 100 mg/dl; ≥100mg/dl was abnormal
Change from Baseline at 6-12 weeks after delivery
Change of high-density lipoprotein cholesterol (HDL) level
Tidsramme: Change from Baseline at 6-12 weeks after delivery
Blood sampling was performed in the fasting state. Normal HDL was ≥50 mg/dl; <50mg/dl was abnormal
Change from Baseline at 6-12 weeks after delivery
Change of Cholesterol level
Tidsramme: Change from Baseline at 6-12 weeks after delivery
Blood sampling was performed in the fasting state. Normal Cholesterol was < 200 mg/dl; ≥200mg/dl was abnormal
Change from Baseline at 6-12 weeks after delivery
Change of systolic blood pressure
Tidsramme: Change from Baseline at 6-12 weeks after delivery
Normal systolic blood pressure was <130mmHg; ≥130mmHg was abnormal. Blood pressure was measured at the right arm twice after a 10-min rest in the supine position by using a calibrated sphygmomanometer and averaged.
Change from Baseline at 6-12 weeks after delivery
Change of diastolic blood pressure
Tidsramme: Change from Baseline at 6-12 weeks after delivery
Normal diastolic blood pressure was <85mmHg; ≥85mmHg was abnormal. Blood pressure was measured at the right arm twice after a 10-min rest in the supine position by using a calibrated sphygmomanometer and averaged.
Change from Baseline at 6-12 weeks after delivery
Change of body weight
Tidsramme: Change from Baseline at 6-12 weeks after delivery
Women's weight following as assessed using calibrated digital scales
Change from Baseline at 6-12 weeks after delivery
Newborn baby weight
Tidsramme: at birth
Newborn baby weight in normal range (>2500g - <4500g) - dichotomous outcome Yes/No assessed using calibrated digital scales.
at birth

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change of Pregnancy Physical Activity Assessment
Tidsramme: Change from Baseline at 6-12 weeks after delivery
There are 12 items in this questionnaire, including two dimensions: exercise and inactivity. Exercise dimension contained four items to assess the type of physical activity, intensity, duration, frequency during pregnancy. At least 3 days per week, and each time at least 20-30 minutes, counted as regular exercise (dichotomous outcome Yes/No assessed). Inactivity dimension contained 8 items, dichotomous outcome Yes/No assessed (score 0-8), higher values represent an inactivity lifestyle.
Change from Baseline at 6-12 weeks after delivery
Change of Dietary Behavioral Characteristics Scale
Tidsramme: Change from Baseline at 6-12 weeks after delivery
The instrument is 17-item Likert-type self-report instrument, used a 5-point response format to obtain data regarding the frequency of reported behaviors (never, rarely, sometimes, usually, always). It including two dimensions and each scale range as: balanced diet (5 items, scale range 5-25) and diet control behavior (12 items, scale range 12-60). Higher values represent a better maternal dietary patterns during pregnancy.
Change from Baseline at 6-12 weeks after delivery
Change of Health Promotion Scale
Tidsramme: Change from Baseline at 6-12 weeks after delivery
The instrument is 40-item Likert-type self-report instrument, used a 5-point response format to obtain data regarding the frequency of reported behaviors (never, rarely, sometimes, usually, always). It including six dimensions and each scale range as: social-support (6 items, scale range 6-30), life-appreciation (8 items, scale range 8-40), health-responsibility (8 items, scale range 8-40), stress-management (9 items, scale range 9-45), nutritional behaviors (5 items, scale range 5-25) and exercise behaviors (4 items, scale range 4-20). The total score was 40 to 200, higher values represent a better health promotion lifestyle.
Change from Baseline at 6-12 weeks after delivery

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Chang Gung Memorial Hospital

Etterforskere

  • Hovedetterforsker: Mei-Chen Su, Dr., Chang Gung Memorial Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

5. januar 2017

Primær fullføring (Faktiske)

28. februar 2018

Studiet fullført (Faktiske)

28. februar 2018

Datoer for studieregistrering

Først innsendt

29. oktober 2018

Først innsendt som oppfylte QC-kriteriene

30. oktober 2018

Først lagt ut (Faktiske)

1. november 2018

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

1. november 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. oktober 2018

Sist bekreftet

1. oktober 2018

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 105-4129C

Plan for individuelle deltakerdata (IPD)

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NEI

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Studerer et amerikansk FDA-regulert medikamentprodukt

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Nei

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