Here is the design of a clinical trial:

Official Title: HOME DM-BAT: Home-based Diabetes-Modified Behavioral Activation Treatment for Low Income Seniors With T2DM

Included conditions:
- Type 2 Diabetes

Study Armgroups:
- {'label': 'Home DM-BAT Intervention', 'type': 'EXPERIMENTAL', 'description': 'A trained nurse educator will deliver the manualized Home DM-BAT intervention. Subjects will receive 8-weekly sessions of behavioral activation and monthly booster sessions from months 3-12 via telephone.', 'interventionNames': ['Behavioral: Home DM-BAT']}
- {'label': 'Control Group (GHE+ST)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients randomized to the control group will receive in-home 8-weekly sessions of combined general health education (GHE) and supportive therapy (ST) and monthly booster sessions from months 3-12 via telephone.', 'interventionNames': ['Behavioral: Supportive Therapy (Control)']}

Interventions:
- {'type': 'BEHAVIORAL', 'name': 'Supportive Therapy (Control)', 'description': 'Description: 8-weekly sessions of in-home, supportive therapy and monthly booster sessions from months 3-12 via telephone.', 'armGroupLabels': ['Control Group (GHE+ST)']}
- {'type': 'BEHAVIORAL', 'name': 'Home DM-BAT', 'description': 'Description: 8-weekly sessions of in-home, culturally-modified, manualized diabetes-modified, behavioral activation treatment (Home DM-BAT) and monthly booster sessions from months 3-12 via telephone.', 'armGroupLabels': ['Home DM-BAT Intervention']}

Primary Outcomes:
- {'measure': 'Glycemic control (HbA1c)', 'description': 'About 10cc of blood will be drawn by trained phlebotomists and sent to the lab for HbA1c.', 'timeFrame': 'Change in baseline HbA1c at 12 months post intervention follow-up'}
- {'measure': 'Systolic and Diastolic Blood Pressure', 'description': 'Blood pressure readings will be obtained using automated BP monitors (OMRON IntelliSenseTM HEM-907XL). The device will be programmed to take 3 readings at 2-minute intervals, and give an average of the 3 BP readings.', 'timeFrame': 'Change in baseline blood pressure at 12 months post intervention follow-up'}
- {'measure': 'LDL-Cholesterol', 'description': 'About 10cc of blood will be drawn by trained phlebotomists and sent to the lab for LDL-Cholesterol.', 'timeFrame': 'Change in baseline cholesterol at 12 months post intervention follow-up'}

Please estimate the sample size based on the assumption: 
Significance level alpha=0.05 (two-tailed), 4 repeated measures for each participant, correlation between repeated measures rho ranging from 0.5 to 0.7, 20% increase in sample size to account for missing information and ITT analysis dilution effect.
Sample size and power
        For comparing the difference in outcome means for Home DM-BAT versus GHE/ST in an individually randomized design, measured at baseline and 3, 6, 9, and 12 months, with 80 participants per group, there will be 85% power to detect a standardized effect size ranging from 0.34 to 0.39 for the primary endpoint at 12 months [assuming levels of significance alpha=0.05 (two-tailed); 4 repeated measures for each participant; the correlation between repeated measures, rho, ranging from 0.5 to 0.7. Using the following pooled standard deviations from previous studies: 1.8 percentage point for HbA1c, 19.9 mmHg for SBP, 20.0 mmHg for LDL, and 12 points for SF-12, we will be able to detect raw differences (raw effect sizes) of approximately 0.61 to 0.70 percentage points in HbA1c, 6.77 to 7.77 mmHg in SBP, 6.8 to 7.8 mg/DL in LDL, and 4.08â4.68 points for SF-12 between the Home-DMBAT and GHE/ST groups. With 80% power, the standardized effect sizes that can be detected range from 0.32 to 0.36 for the given assumptions. The corresponding raw effect sizes are HbA1c (0.57 to 0.66 percentage points), SBP (6.33 to 7.27 mmHg), LDL (6.36 to 7.30 mg/DL), and SF-12 (3.82 to 4.38 points). To account for missing information in the ITT sample and the dilution effect of ITT analyses, we increase the sample size by 20% to achieve a final ITT sample size of 100 participants randomized 1:1 to each treatment group (total N=200 randomized participants).