Please select the outcome measures that correspond to the clinical trial below.
Title: Biobehavioral Bases & Management of Type 2 Diabetes
Brief Summary: The major objective of this project is to determine if compared to Standard Care (SC), a Community Approach to Lifestyle Modification for Diabetes (CALM-D) program including diet, exercise and coping skills training, can decrease depression, weight and HbA1c and improve medication adherence in low income, primarily Black and Latino/Hispanic, depressed, overweight, Type 2 diabetic patients seen in a large, comprehensive, community health center. Type 2 diabetes is a major risk factor for coronary heart disease (CHD). Obesity, poor glycemic control, depression, low socioeconomic status (SES) and being a member of a racial/ethnic minority group all increase this risk.

The project will compare 100 CALM-D and 100 SC participants. Following 3 run-in sessions assessment sessions to determine eligibility, given to both SC and CALM-D participants, SC patients will be treated in accordance with ADA Clinical Practice Guidelines (2005) and also assessed by project staff at baseline, 6 months and 1 year. The CALM-D participants will receive 2 individual stress management and lifestyle sessions followed by 2 weekly group sessions. Then 4 bi-weekly sessions will be followed by 9 monthly sessions for a total of 17 sessions. Secondary objectives of the project are to determine if compared to SC, CALM-D can improve glucose tolerance to challenge, insulin resistance, oxidative stress, inflammation, procoagulation, lipid profile, endothelial function resting blood pressure, cardiac and vascular function, cardiac morphology, psychosocial functioning and health quality of life. As many of the participants will already have been prescribed aspirin, statins, oral hypoglycemics and other medications, an important objective of the project will be to assess the extent to which improved adherence to medications - a goal of the CALM-D program - can account for improved intervention effects.


Options:
A: Recruitment Feasibility: Percent of Participants Screened Eligible (6 months); Recruitment Feasibility: Percent of Participants Enrolled (6 months); MBCT Feasibility: Percent of Participants Retained (6 months); Mindfulness Based Cognitive Therapy (MBCT) Feasibility: Percent of Participants Adherent to Treatment (6 months); Mindfulness Based Cognitive Therapy (MBCT) Feasibility: Percent of Participants Adherent to Home Practice (6 months); Control Group Feasibility: Percent of Participants Retained (6 months); Control Group Feasibility: Percent of Participants Adherent to Treatment (6 months); Control Group Feasibility: Percent of Participants Adherent to Home Practice (6 months); Videoconferencing Feasibility: Number of Sessions Missed Due to Technical Problems (6 months); Blood Spot Feasibility: Percent of Blood Spot Samples Submitted at Baseline (At Baseline (Month 0)); Blood Spot Feasibility: Percent of Blood Spot Samples Submitted at Post-intervention (At Post Intervention (Month 3)); Mindfulness Based Cognitive Therapy (MBCT) Acceptability: Ratings of Intervention Satisfaction (At post intervention (Month 3)); Mindfulness Based Cognitive Therapy (MBCT) Acceptability: Percent of Participants Who Plan to Continue Using the Skills (6 months); Mindfulness Based Cognitive Therapy (MBCT) Acceptability: Percent of Participants Who Would Recommend the Program (6 months); Control Group Acceptability: Ratings of Intervention Satisfaction (6 months); Control Group Acceptability: Percent of Participants Who Plan to Continue Using the Skills (6 months); Control Group Acceptability: Percent of Participants Who Would Recommend the Program (6 months); Videoconferencing Acceptability: Ratings of Videoconferencing Satisfaction (6 months); Blood Spot Acceptability: Blood Spot Collection Ease (6 months); Blood Spot Acceptability: Blood Spot Collection Comfort (6 months)
B: Change in depressive symptoms as a result of intervention effects (Baseline, 3, 6 and 12 months); Change in intervention effects on depressive symptoms moderated by perceived stigma (Baseline, 3, 6, and 12 months); Change in intervention effects on depressive symptoms moderated by sex (Baseline, 3, 6, and 12 months)
C: Weight loss (6-12 months)
D: Depression and Well-being Improvements After Cognitive-Behavioral Therapy and Well-Being Therapy as Assessed by Changes in Clinical Interview for Depression, Compared to Clinical Management (Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up); Depression and Well-being Improvements After Cognitive-Behavioral Therapy and Well-Being Therapy as Assessed by Changes in Symptom Questionnaire ("Anxiety" Subscale), Compared to Clinical Management (Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up); Depression and Well-being Improvements After Cognitive-behavioral Therapy and Well-Being Therapy Assessed by Changes in Psychological Well-Being Scales ("Autonomy" Dimension), Compared to Clinical Management (Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up); Depression and Well-being Improvements After Cognitive-Behavioral Therapy and Well-Being Therapy as Assessed by Changes in Symptom Questionnaire ("Depression" Subscale), Compared to Clinical Management (Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up); Depression and Well-being Improvements After Cognitive-Behavioral Therapy and Well-Being Therapy as Assessed by Changes in Symptom Questionnaire ("Somatization" Subscale), Compared to Clinical Management (Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up); Depression and Well-being Improvements After Cognitive-Behavioral Therapy and Well-Being Therapy as Assessed by Changes in Symptom Questionnaire ("Hostility" Subscale), Compared to Clinical Management (Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up); Depression and Well-being Improvements After Cognitive-behavioral Therapy and Well-Being Therapy Assessed by Changes in Psychological Well-Being Scales ("Environmental Mastery" Dimension), Compared to Clinical Management (Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up); Depression and Well-being Improvements After Cognitive-behavioral Therapy and Well-Being Therapy Assessed by Changes in Psychological Well-Being Scales ("Personal Growth" Dimension), Compared to Clinical Management (Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up); Depression and Well-being Improvements After Cognitive-behavioral Therapy and Well-Being Therapy Assessed by Changes in Psychological Well-Being Scales ("Positive Relations" Dimension), Compared to Clinical Management (Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up); Depression and Well-being Improvements After Cognitive-behavioral Therapy and Well-Being Therapy Assessed by Changes in Psychological Well-Being Scales ("Purpose in Life" Dimension), Compared to Clinical Management (Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up); Depression and Well-being Improvements After Cognitive-behavioral Therapy and Well-Being Therapy Assessed by Changes in Psychological Well-Being Scales ("Self-acceptance" Dimension), Compared to Clinical Management (Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up)

Answer: C