Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study aims to evaluate the effectiveness and cost-utility of an intervention based on the social prescription of health assets to modify lifestyles and reduce blood glucose values in prediabetic patients in primary care nursing consultations.
Multicentre, controlled and randomized (two different branches) clinical trial with 18 months of follow-up will be performed. The intervention group will receive a social prescription of health assets related to the practice of physical activity and healthy eating patterns in primary care nursing consultation.
No pragmatic clinical trial evaluating the effectiveness of prevention interventions has been performed to date. Social prescription is a useful health promotion strategy that facilitates the continuity of individual care. This randomized controlled trial aims to evaluate the effectiveness and cost-utility of an intervention based on the social prescription of health assets to modify lifestyles and reduce blood glucose values in prediabetic patients in primary care nursing consultations. Additional aims are to describe and assess barriers, motivations, and attitudes of patients with low adherence to the intervention and their association with social class and gender.
Methods: Multicentre, controlled and randomized (two different branches) clinical trial with 18 months of follow-up will be performed. The randomization unit will be the primary healthcare center. The study will be conducted by nurses in 12 primary health care centers (PHC) of Mallorca in Spain that will be included and randomly allocated to intervention or control groups. Furthermore, the intervention will be delivered at the PHC level, which is considered the unit of analysis. At least 232 patients (116 per branch) will be recruited. Participants will be aged 25 to 75 years with altered fasting glucose levels (100-125 mg/dl) or with glycosylated hemoglobin (HbA1c) between 5.7 and 6.4%. The intervention will be carried out at three levels: community, group and individually. The intervention group will receive a social prescription of health assets related to the practice of physical activity and healthy eating patterns in primary care nursing consultation for 8 sessions during 12 months of follow-up. The Control group will follow the usual care recommendations. Data will be collected at baseline, 6, 12 and 18 months. Glycaemia, HbA1c, BMI and waist circumference will be measured, as well as the Mediterranean diet adherence (PREDIMED), the physical activity (IPAQ), the cardiovascular risk (REGICOR equation), the quality of life (EuroQoL-5D), the social class, gender, and financial costs.
.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | The intervention will be carried out by primary care nurses over eight visits: baseline visit and follow-up visits which take place 15 days, 1, 2, 4, 6, 9, and 12 months after baseline with a final visit evaluation at 18 months. The intervention will be based on the social prescription of health assets related to the practice of physical activity and a healthy eating pattern to modify lifestyles in people with prediabetes. The content of the intervention proposed is based on the NHS and it will be carried out at three levels (individual, group and community) to facilitate the patient empowerment and promotion of healthy lifestyles with a positive orientation using the community resources. |
|
| Control | No Intervention | The Control group will receive routine standard care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention | Behavioral | Social prescription of health assets related to the practice of physical activity and a healthy eating pattern to modify lifestyles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glucosa level | The primary outcome will be the percentage of participants reducing at least 4 mg/dl of FPG | 18 month |
| Measure | Description | Time Frame |
|---|---|---|
| Reversion to normal glucose | Percentage of patients who reverse to normal glucose levels | 18 month |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aina M Yanez, PhD | Contact | +34 971172914 | aina.yanez@uib.es | |
| Miquel Bennasar, PhD | Contact | +34 971172367 | miquel.bennasar@uib.es |
| Name | Affiliation | Role |
|---|---|---|
| Miquel Bennasar, PhD | University of balearic islands | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D004700 | Endocrine System Diseases |