type 2 diabetes mellitus
Conditions
Interventions
* Notifications for reminding the participants of entering their data (reaching
goals, moti-vation, self-efficacy, mood)
* Provide support via
Subjects in the study groups (NDC-only, NDC+app, and NDC-only/app-only) will
take part in the NDC intervention program, a 20-week community-based walking
event in which weekly group walks are organi
* Generate a personalized recommendation for lifestyle (e.g. a dietary
pattern). Sub-jects may be recommended one or more of these dietary pattern
based on their T2DM pathophysiology and medication
* Assess current food and diet related habits
* Advice the user in achieving the recommended lifestyle, tuned to the
individual health data and current dietary behaviour of the user
* Set personal lifestyle goals as first step towards achieving a healthy diet
* Monitor the achievements in lifestyle change
Sponsors
TNO
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Diagnosed with type 2 diabetes mellitus * Digitally skilled (able to work with computers for filling in questionnaires) * Proficient in Dutch * Willing to complete the National Diabetes Challenge program * Willing to comply with all study procedures * Able and willing to sign the informed consent form Only for the people in the NDC+app-group and the NDC-only/app-only group, the following inclusion criterion also applies: * In possession of an Android (v.4.4 or higher) or iOS (v.9 or higher) smartphone rokken
Exclusion criteria
Exclusion criteria: * On holidays for more than three weeks during the NDC program * Planned surgery during the entire study period (including follow-up) * Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The study parameters mainly consist of questionnaires and anthropometric data. Clinical chemistry data will be collected subjects in the NDC+app and the NDC-only group. For participants in the NDC+app group and NDC-only/app-only group, data will also be collected via the IRIS-app. * For the NDC-only and NDC+app groups, all measurements, except the use of and user evaluation of the IRIS-app, will be performed at baseline, post-intervention (t=20 weeks), and after the follow-up period (t=30 weeks). * For the NDC-only/app-only group, the measurements will take place at the Festival day (anthropomorphic data), and in the week afterwards (questionnaires; t=20 weeks), and after the follow-up period (t=30 weeks). All of the following questionnaires will be self-administered, and can be filled in by participants via an online portal at home. Participants will be asked to fill in the questionnaires at baseline (t=0), post-intervention (t=20 weeks) and follow-up (t=30 weeks). Quality of life (F1-b) Quality of life is measured using the WHO (Five) Well-being Index (WHO-5; Hajos et al., 2012). The participants are asked to indicate for five statements which answer best reflects how they felt the past two weeks. Dietary behavior (F1-d) Dietary intake will be estimated using the online tool Eetscore (Division of Human Nutrition, Wageningen University and Research, www.eetscore.nl). The Eetscore evaluates to what extent individual food consumption patterns comply with food-based dietary guidelines, i.e. Dutch Healthy Diet index 2015 (Looman et al. unpublished). For different components of the food based dietary guidelines a score will be given ranging from 1 (non-compliant) to 10 (fully compliant). In this study we both the total score and the individual components (e.g. fruits, vegetables, whole grain products, dairy, fish, fats & oils, red meat, etc.) will be used. Physical activity behavior (F1-b) The Short QUestionnaire to ASses Health enhancing ph | — |
Secondary
| Measure | Time frame |
|---|---|
| Parameters related to the IRIS-app (NDC+App and NDC-only/app only groups) Participants in the NDC+app- and the NDC-only/app-only groups will also collect data via their use of the IRIS-app. During the *onboarding* (first use of the app), data will be entered by the participant on their demography (age, gender, length, weight), their health status (HbA1c, glucose, cholesterol, blood pressure) and medication use. Also, data are collected on dietary intake, personal goals, self-efficacy, motivation, and mood. Finally, compliance with the app will be assessed by registering the use of the app (number of data-points, duration of use, response to notifications, etc.), as well as via a self-evaluation questionnaire (see below). Clinical parameters As a measure of T2DM related health status, HbA1c, fasting glucose, c-peptide, cholesterol (total, HDL and LDL) and triglycerides will be measured from venous blood samples at baseline, (t=0), post-intervention (t=20 weeks) and follow-up (t=30 weeks) for participants in the NDC-only and NDC+app group. Changes in these parameters over time, as well as differences between the two study groups and control will be assessed. Anthropometric measurements For participants in the NDC+app and NDC-only group length, body weight and waist and hip circumference will be measured by the GP or GP*s assistant at baseline, (t=0). Body weight and waist & hip circumference will be repeated post-intervention (t=20 weeks) and after follow-up (t=30 weeks). BMI will be calculated from length and body weight. Subjects in the NDC-only/app-only group will undergo anthropometric measurements during the Festival Day (t=20 weeks) by a TNO researcher, and after follow up (t=30 weeks) by a GP or GP*s assistant. Changes in these parameters over time, as well as differences between the study groups and control will be assessed. Questionnaires All of the following questionnaires will be self-administered, and can be filled in by parti | — |
Countries
Netherlands
Outcome results
None listed