Trial document




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  DRKS00012996

Trial Description

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Title

Test Triangle - Multicenter randomized pilot study to test a smartphone-based lifestyle intervention for women who had gestational diabetes

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Trial Acronym

Test Triangle

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URL of the Trial

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Brief Summary in Lay Language

Gestational diabetes is a transient metabolic disturbance during pregnancy and indicates a risk of future, permanent type 2 diabetes. A healthy lifestyle can reduce this risk. In this study, we test a newly developed smartphone app that is meant to help women who had gestational diabetes adopt a healthy lifestyle.

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Brief Summary in Scientific Language

Gestational diabetes indicates a high risk of future permanent type 2 diabetes. The prevalence of type 2 diabetes 10 years after gestational diabetes is 20 to 70 percent.

Lifestyle interventions can contribute to the prevention of type 2 diabetes. Women, who had gestational diabetes can benefit from lifestyle change, but are difficult to reach by conventional counseling programs.

We developed the smartphone app ‘Triangle’ to deliver a lifestyle intervention program specifically designed for women who recently had gestational diabetes. The app was already evaluated in a small user study and was modified based on this user feedback.

In this study, we will now compare the app-based intervention with standard care (a single counseling session) in a multicenter, randomized trial. The primary endpoint is the achievement of pre-defined nutrition, exercise and body weight targets after 6 months.

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Organizational Data

  •   DRKS00012996
  •   2017/09/11
  •   [---]*
  •   yes
  •   Approved
  •   17-311, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
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Secondary IDs

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Health Condition or Problem studied

  •   O24.4 -  Diabetes mellitus arising in pregnancy
  •   E11.9 -  Type 2 diabetes mellitus; Without complications
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Interventions/Observational Groups

  •   6 months lifestyle intervention via the smartphone app 'Triangle'
  •   one-time written and in-person lifestyle counseling (standard of care)
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   assessor, data analyst
  •   Active control (effective treament of control group)
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Proportion of study participants reaching 3 or more of the 5 DPP (Diabetes Prevention Program) lifestyle aims at the final study visit, 6-8 months after randomization

(1. moderate or high intensity exercise ≥150 minutes per week;
2. ≥15g fiber intake per 1000 kcal;
3. ≤30% energy from fat;
4. ≤10% energy from saturated fat;
5. for baseline BMI ≥23 weight at follow-up ≤95% of baseline, for baseline BMI 20-22,9 weight at follow-up ≤100% of baseline, for baseline BMI <20 weight at follow-up ≤105% of baseline)

instruments: 4 days diet protocols, IPAQ physical activity questionnaire
Analysis: Intention to treat (all randomized participants with V2 data); per protocol 1 (only those participants from the intervention Group, who started to actively use the app); per protocol 2 (only those participants from per protocol 1, who continued to actively use the app throughout the 6 months intervention period)

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Secondary Outcome

change of AUC glucose (oGTT - oral glucose tolerance test) baseline to follow-up (6-8 months after randomization); change of ISI (Matsuda insulin sensitivity index) baseline to follow-up; change of DI (disposition index) baseline to follow-up; change of BMI (body mass index) baseline to follow-up (stratified analysis for baseline BMI <≥ 23); change of VO2peak baseline to follow-up (ergospirometry); change of body fat mass baseline to follow-up (bioimpedance measurement); change of psychologic wellbeing and perceived stress level baseline to follow-up (instruments: WHO-5 and PSS-10 questionnaires)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • other 
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Recruitment

  •   Actual
  •   2017/09/20
  •   64
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   50   Years
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Additional Inclusion Criteria

Physician-validated diagnosis of gestational diabetes in a pregnancy 3 to 18 months ago; Early post-partum phase completed; No post-partal restrictions on physical activity; Uses iPhone 5 or newer; Fluent in German

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Exclusion Criteria

Age less than 18 years; Current pregnancy or pregnancy planned for the next 6 months; Cardiopulmonary disease precluding exercise Intervention; Orthopedic disease precluding exercise Intervention; Gastrointestinal disease precluding dietary Intervention; Psychiatric disease requiring Treatment; Other disease precluding lifestyle intervention (decision of responsible study physician after discussion with main study center); Inpatient hospital treatment planned for the next 6 months; Alcohol or substance abuse; Other lifestyle intervention program (ongoing or planned for the next 6 months); Diagnosis of diabetes or use of glucose-lowering medication

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Addresses

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    • Klinikum der Universität München, Campus Innenstadt
    • Lindwurmstraße 2a
    • 81337  München
    • Germany
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    • Klinikum der Universität MünchenMedizinische Klinik 4Diabetes Research Group
    • Mr.  PD Dr. med.  Andreas  Lechner 
    • Ziemssenstr. 1
    • 80336  München
    • Germany
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    • Klinikum der Universität MünchenMedizinische Klinik 4Diabetes Research Group
    • Mr.  PD Dr. med.  Andreas  Lechner 
    • Ziemssenstr. 1
    • 80336  München
    • Germany
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Sources of Monetary or Material Support

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    • Deutsches Zentrum für Diabetesforschung
    • 85764  Neuherberg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2019/06/03
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.