Promoting Weight Loss and Stress Reduction in Overweight and Obese Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2; Overweight and Obesity
MeSH terms: Diabetes Mellitus; Overweight; Diabetes Mellitus, Type 2; Weight Loss
Study type: Interventional

Summary: 
      This is a feasibility and acceptability study of a 16-month single-blind randomized
      controlled trial (RCT) designed to test the initial effectiveness of a well-being and small
      lifestyle changes intervention aimed at promoting weight loss and stress reduction in
      overweight and obese patients with type 2 diabetes. Primary goals of this study are to 1)
      evaluate study feasibility and patient acceptability, 2) develop a tailored protocol of a
      behavioral intervention for overweight or obese patients with type 2 diabetes that takes
      stress and well-being into consideration, 3) evaluate appropriateness of research procedures
      and measures, 4) examine effect size estimates of key outcomes to provide essential data to
      inform a larger efficacy trial, 5) determine whether clinically significant improvements
      occurred in any key outcomes.
    

Detailed description: 
      Overweight and obese patients with type 2 diabetes will be recruited at 2 different diabetes
      clinics. Physicians will screen every patient attending to each clinic during the enrollment
      period for the presence of main eligibility criteria. Those patients who appear to be
      eligible will be introduced to the study and referred to a researcher for a more in-depth
      screening evaluation. Eligible patients who are interested in participating in the study will
      be asked to sign the informed consent. Consecutive patients will be randomly assigned in a
      1:1 ratio to an experimental group or a control group. During the first month, participants
      in the experimental group will receive a well-being promoting intervention in adjunction to
      the treatment as usual (TAU), while those in the control group will be asked to follow the
      TAU. In the following 3 months participants in both groups will receive the small change
      intervention in adjunction to the the TAU. All in person sessions of the intervention will
      take place in an office of both the 2 diabetes clinics involved. Data about psychological and
      clinical variables will be collected for each participant through questionnaires and
      interviews at baseline, at post-intervention, and at 6 and 12 months of follow-up.
      Participants' weight will be measured at each assessment point using a scale. Medical charts
      will be accessed to collect further data about physiological parameters, treatment received
      and medical history.
    

Intervention name(s): Small change intervention; Well-being intervention; Treatment as usual
Intervention type(s): Behavioral; Behavioral; Other
Intervention description(s): 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.; 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.; The treatment as usual includes any recommendation given to the participants by their physicians, including diet, physical activity, medication and glycemic control instructions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: diabetes; overweight; obesity; well-being; behavioral; small change; weight loss