Promoting Weight Loss and Stress Reduction in Overweight and Obese Patients With Type 2 Diabetes

NACompletedINTERVENTIONAL
Enrollment

58

Participants

Timeline

Start Date

March 27, 2018

Primary Completion Date

November 18, 2020

Study Completion Date

November 18, 2020

Conditions
Diabetes Mellitus, Type 2Overweight and Obesity
Interventions
BEHAVIORAL

Small change intervention

The small change intervention is a behavioral intervention to help people gradually lose weight by making small changes in their lifestyle. At the beginning of the intervention participants will be met in person to be guided in setting an eating and a physical activity goal. Participants will be then contacted through the phone or met in person weekly for 3 months to check on their adherence to the selected goals and to discuss about facilitators and barriers to goal completion, in order to increase their motivation and problem solving skills. Every weekly contact will last about an hour and will be administered in an individual setting. At each contact selected goals can be revised, changed or another goal can be added based on levels of adherence.

BEHAVIORAL

Well-being intervention

The well-being intervention is a coaching intervention aimed at motivating people in making lifestyle changes by reducing levels of stress through the promotion of psychological well-being. It will consists in 4 weekly sessions to be held before starting the small change intervention. Each session will last about an hour and will be administered in an individual setting.

OTHER

Treatment as usual

The treatment as usual includes any recommendation given to the participants by their physicians, including diet, physical activity, medication and glycemic control instructions.

Trial Locations (2)

26041

Struttura Semplice di Endocrinologia e Metabolismo, Ospedale Oglio Po, Casalmaggiore

47521

Servizio Endocrinologia e Diabetologia, Ospedale Bufalini, Cesena

All Listed Sponsors
lead

Chiara Rafanelli

OTHER

NCT03609463 - Promoting Weight Loss and Stress Reduction in Overweight and Obese Patients With Type 2 Diabetes | Biotech Hunter | Biotech Hunter