O24.4 E11.9
Conditions
Interventions
Group 1: 6 months lifestyle intervention via the smartphone app 'Triangle'
Group 2: one-time written and in-person lifestyle counseling (standard of care)
Sponsors
Klinikum der Universität München, Campus Innenstadt
Eligibility
Sex/Gender
Female
Age
18 Years to 50 Years
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Germany
Contacts
Public ContactAndreas Lechner
Klinikum der Universität MünchenMedizinische Klinik 4Diabetes Research Group
Outcome results
None listed