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

Measured as the acceptance rate (total number of participants enrolled out of the total number of eligible candidates approached).

Measured as drop-out rates (total number of participants who withdraw out of the total number enrolled).

Measured as total number of sessions attended and number of weeks needed to complete the intervention. Semi-structured interviews will be conducted to estimate patients' satisfaction and provide data on optimal timing, dosing, and delivery.

Measured by the Symptoms Questionnaire (SQ), a 92-item self-rating scale with yes/no responses (or true/false for some questions to avoid double-negative statements) divided into four domains: anxiety, depression, somatic, and anger-hostility.

Each domain is further divided into two sub-scales: one sub-scale with 17 symptom questions and one sub-scale with 6 questions that are antonyms of some of the symptom questions in order to measure well-being.

A response of yes/true for a symptom question gives 1 point, and a response of no/false for a well-being question gives 1 point for a score ranging from 0-17 for each symptom sub-scale and 0-6 for each well-being sub-scale, where a higher score indicates greater distress. If the well-being score is calculated separately the raw score can be subtracted from 6 for a score ranging from 0-6, where a higher score indicates greater well-being.

Measured by the Psychosocial Index (PSI), a 55-item self-rating scale divided into five domains:

Sociodemographic and clinical data: 12 questions including routine medical and demographic information. Stress: 17 yes/no questions with a score from 0-17. A higher score indicates greater stress. Well-being: 6 yes/no questions with a score from 0-6. A higher score indicates greater psychological well-being. Psychological distress: 15 four-point questions from 0-3, with a total score from 0-45. A higher score indicates greater psychological distress. 4 questions referring to sleep may be scored separately. Abnormal illness behavior: 3 four-point questions from 0-3, with a total score from 0-9. A higher score indicates more severe abnormal illness behavior. Quality of life: 1 four-point question, with a score from 0 to 4. A higher score indicates a higher quality of life. Psychological well-being and quality of life scores can be summed for a global well-being score from 0-10.

Measured by the Psychological Well-Being scale (PWB), a 42-question self-rating scale for the assessment of 6 dimensions: self-acceptance, positive relations with others, autonomy, environmental mastery, purpose in life and personal growth. Each of the 42 six-point response questions are given a score from 1-6, with questions phrased in the negative reversed (e.g. 1 to 6, 6 to 1). The total score in each dimension ranges from 7-42, and all the dimensions scores are summed to give a final total ranging from 42-252, with higher scores indicating greater psychological well-being.

Measured in kg.

Measured by the Diagnostic Criteria for Psychosomatic Research - Revised (DCPR-R), which uses a semi-structured interview of yes/no questions (DCPR-R SSI) to assess for the presence of 14 different psychosomatic syndromes. The prevalence will be reported as a within-population mean for each of the 14 syndromes described by the DCPR-R.

Hemoglobin A1C levels will be obtained from patients' medical record.

Abdominal circumference will be measured in centimeters with a tape ruler.

Measured by the GOSPEL questionnaire, a 32-item self-rating instrument for the assessment of physical activity levels, eating habits, and stress tailored to the dietary variation among Italian adults:

Seven 4-point items regarding physical activity with a total score from 0 (least active) to 20 (most active).

Ten 4-point items regarding diet based on frequency of consumption, with scores summed to obtain a Mediterranean diet score from 0 (worst) to 30 (best).

Three 4-point items on eating habits summed for a score ranging from 0 (worst habits) to 9 (best habits).

Diet and eating habits are summed to give a total diet score from 0 (worst) to 39 (best).

Seven 4-point items regarding stress management summed for a total score from 0 (optimal management) to 21 (inadequate management).

Four 4-point items on family risk behaviors with a score ranging from 0 (least risky) to 4 (most risky).

One 4-point item on family support scored from 0 (least support) to 3 (most support).

Measured by the Dutch Eating Behavior Questionnaire (DEB-Q), a 33-item self-rating instrument for the assessment of restrained (10 items), emotional (13 items), and external (10 items) eating behavior. Each item ranges from 1 (never) to 5 (very often), with higher scores indicating greater endorsement of the particular eating behavior, and thus a greater propensity to behavior associated with increased BMI. The mean score from each of the three sub-scales is reported.

Measured by the Goal Related Weight Questionnaire (GRWQ). The first section consists of 4 items and assesses the respondent's dream weight, happy weight, acceptable weight, and disappointed weight in kilograms. The respondent also writes the most important changes they hope to see following weight loss in one free-response question. The second section consists of 21 items asking the respondent to rate how they expect weight loss to impact various aspects of their psychosocial and health-related functioning, with each item scored from 1 (extremely negative) to 10 (extremely positive).

Measured by the 12-item Short Form Survey (SF-12), a 12-item self-rating scale for the assessment of physical and mental health comprising 8 domains: physical functioning, role-physical, bodily pain, general health, energy/fatigue, social functioning, role-emotional, mental health, and change in health. The weighted means of the 8 domains are calculated to develop two composite scores (Physical Health and Mental Health) ranging from 0 to 100, where 0 indicates the lowest level of health and 100 indicates the highest level of health.