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Biobehavioral Bases & Management of Type 2 Diabetes (CALM-D)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Neil Schneiderman, University of Miami
ClinicalTrials.gov Identifier:
NCT01739205
First received: November 27, 2012
Last updated: November 30, 2012
Last verified: November 2012
History of Changes
  Purpose

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 Intervention
Type 2 Diabetes and Depression
 Behavioral: CALM-D Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Biobehavioral Bases & Management of Type 2 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Miami:

Primary Outcome Measures:
  • Weight loss [ Time Frame: 6-12 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Inflammation [ Time Frame: 6-12 months ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Other outcomes [ Time Frame: 6-12 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 114
Study Start Date: January 2008
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lifestyle counseling

CALM-D Intervention Session Topic Weekly

  1. I Welcome to the CALM-D Program. Getting Started Being Active, Losing Weight and Managing Stress
  2. I Negative Thoughts and Emotions
  3. G Where's the Fat?/Three Ways to Eat Less Fat
  4. G Taking Your Medications/Stress and You Bi weekly
  5. G Move Those Muscles/Being Active: A Way of Life
  6. G Challenging and Changing Negative Thoughts
  7. G Healthy Eating
  8. G Problem Solving Monthly
  9. G Four Keys to Healthy Eating Out
  10. G Social Support/Communication
  11. G Take Charge of What's Around You/Tip the Calorie Balance
  12. G The Slippery Slope of Lifestyle Change
  13. G Jump Start Your Activity Plan
  14. G Assertiveness/Make Social Cues Work for You.
  15. G You Can Manage Stress
  16. G Life Goals
  17. G Ways to Stay Motivated Abbreviations: I = Individual session; G = Group session
 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.

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  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes
  • Major depression
  • Overweight (BMI≥27 kg/m2)
  • 18-70 years

Exclusion Criteria:

  • Non-diabetics or Type 1 diabetes
  • Not depressed
  • Other psychosis
  • Normal weight
  • Age <18 or >70
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Neil Schneiderman, Professor, University of Miami
ClinicalTrials.gov Identifier: NCT01739205     History of Changes
Other Study ID Numbers: HL 36588-P1
Study First Received: November 27, 2012
Last Updated: November 30, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Miami:
Type 2 diabetes and depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Diabetes Mellitus
Diabetes Mellitus, Type 2
Behavioral Symptoms
 Mood Disorders
Mental Disorders
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 17, 2013