Type 2 diabetes and pre-diabetes Nutritional, Metabolic, Endocrine Type 2 diabetes and pre-diabetes
Conditions
Interventions
Intervention as of 01/10/2018:
Health facilities and their catchment areas are designated as clusters. Clusters are randomized to either a facility-only intervention arm (defined as standard facility-
Sponsors
European Commission
Swedish International Development Agency
Karolinska Institutet Research Foundation Grants for young scientists
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria as of 01/10/2018: 1. Currently residing in, and have resided in their respective communities for at least 6 months prior to enrolment 2. Aged between 30 – 75 years 3. Have no plans of migrating out of the study area over the next 12 months from the date of enrolment 4. Able to provide written informed consent 5. Agree to home visits and follow-up contacts as part of study participation 6. Have not been previously diagnosed with diabetes for longer than 12 months 7. Have a positive confirmatory test of pre-diabetes or diabetes Previous inclusion criteria: 1. Current residents who have resided in their respective communities for at least 6 months prior to enrolment into the study 2. Aged 30 – 75 years 3. Able to provide written informed consent 4. Agree to allow home visits or follow-up contacts as part of participating in the trial 5. Have a positive confirmatory test of pre-diabetes or diabetes following screening or within past 12 months of trial start. In Sweden, this includes high risk of diabetes based on FINDRISC scores. Previous inclusion criteria as of 16/10/2017: 1. Currently residing in, and have resided in their respective communities for at least 6 months prior to enrollment 2. Aged between 30 – 75 years 3. Have no plans of migrating out of the study area over the next 12 months from the date of enrollment 4. Able to provide written informed consent 5. Agree to home visits and follow-up contacts as part of study participation 6. Have not been previously diagnosed with diabetes for longer than 12 months 7. Have a positive confirmatory test of pre-diabetes or diabetes Previous inclusion criteria: 1. Current residents who have resided in their respective communities for at least 6 months prior to enrollment into the study 2. Aged 30 – 75 years 3. Able to provide written informed consent 4. Agree to allow home visits or follow-up contacts as part of participating in the trial 5. Have a positive confirmatory test of pre-diabetes or diabetes following screening or within past 12 months of trial start
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 16/10/2017: 1. Pregnancy 2. Serious mental disability Previous exclusion criteria: 1. Currently known to be pregnant 2. Plans of migrating out of the study area over the next 12 months from the date of enrollment into the study 3. Previous diagnosis of diabetes, 12 months prior to enrollment into the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma glucose, as measured by HbA1c levels between baseline and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence of diabetes as measured by HbA1c levels between baseline and 12 months 2. Incidence of conversion from pre-diabetes state to normal plasma glucose level state as measured by HbA1c levels between baseline and 12 months 3. Adverse events, including hospitalizations due to hypo- or hyperglycemia, morbidity, as measured by self-reported data using interview schedules at month 12 4. Incremental costs to the system related to implementation of the intervention as estimated through costing questionnaire for facility and community components between months 3-10 5. Out-of-pocket expenditure for diabetes – comparison between country sites and change in cost to the individual – through self-reported out-of-pocket expenditure using interview schedules at baseline and 12 months 6. Evaluation of the intervention process through Likert-scaled questionnaires, focusing on treatment satisfaction, knowledge about diabetes, autonomy support, self-efficacy, social support and sources of support, measured at baseline and 12 months 7. Differences between the country sites, in regard to baseline contextual factors relating to infrastructure, guidelines and personnel for prevention and management of diabetes as measured by facility checklist questionnaires between months 3-10 8. Degree of implementation of the intervention elements in each country, and differences between the country sites, through a process evaluation at each site using tracking forms, checklists and qualitative methods between months 2-11 9. Differences between the country sites, and changes within these contexts, as a result of implementing the intervention elements such as stigma towards overweight or obese individuals, security concerns in public spaces, and collaboration between primary care, municipalities and local networks through qualitative methods after 10 months 10. Assessment of the food environment in each site and comparison between the three country sites using a modified EPOCH (Environmental P | — |
Countries
South Africa, Sweden, Uganda
Contacts
Public ContactLinda;Francis Timm;Kasujja
;
Outcome results
None listed