Biobehavioral Bases & Management of Type 2 Diabetes (CALM-D)
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|ClinicalTrials.gov Identifier: NCT01739205|
Recruitment Status : Completed
First Posted : December 3, 2012
Last Update Posted : December 3, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes and Depression||Behavioral: CALM-D Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||114 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Biobehavioral Bases & Management of Type 2 Diabetes|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||November 2011|
|Actual Study Completion Date :||November 2011|
Experimental: Lifestyle counseling
CALM-D Intervention Session Topic Weekly
Behavioral: CALM-D Intervention
Participants (Pts) randomized to the lifestyle intervention received a yr long, 17 session intervention. Pts were asked to wear a pedometer and record their food intake for at least the week prior to each session. The first 4 sessions were delivered weekly, followed by 4 sessions delivered biweekly and finally 9 sessions delivered monthly. Each session was approximately 1-2 hrs. At the beginning of each session anthropometric, physical activity and dietary data were collected. Participants were lead in a 5 min deep breathing exercise before the didactic portion of the session began. Sessions targeted a broad range of material related to diet, physical activity, and psychosocial well-being. Participants were given homework assignments to incorporate covered material into their daily lives. Participants randomized to the intervention arm received follow-up assessments at 6 and 12 months post randomization.
- Weight loss [ Time Frame: 6-12 months ]The objectives of the intervention are for participants to: a) lose 7% of their weight through healthy eating; (b) do 2.5 hrs of brisk, physical activity each wk (e.g., walk briskly for 30 min 5x per week); (c) manage stress better (e.g., through coping strategies; deep breathing); and (d) always take their medication.
- Inflammation [ Time Frame: 6-12 months ]Secondary outcomes will include: (a) glucose tolerance, (b) insulin resistance, (c) inflammation, (d) fibrinolysis, (e) lipid profile, (f) oxidative stress, (g) endothelial function, (h) resting blood pressure, (i) cardiac and vascular function, (j) cardiac morphology, (k) psychosocial functioning, and (l) health quality of life.
- Other outcomes [ Time Frame: 6-12 months ]Secondary outcomes will include: (a) glucose tolerance, (b) insulin resistance, (c) inflammation, (d) fibrinolysis, (e) lipid profile, (f) oxidative stress, (g) endothelial function, (h) resting blood pressure, (i) cardiac and vascular function, (j) cardiac morphology, (k) psychosocial functioning, and (l) health quality of life.