Biobehavioral Bases & Management of Metabolic Syndrome (CHARMS)
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      The metabolic syndrome is increasingly being recognized as a major threat to good health -
      especially cardiovascular health - and its frequency appears to be increasing in relation to
      the current epidemic of obesity. The objective of this study is to determine whether a
      program of enhanced lifestyle intervention can, compared to standard care, reduce the
      frequency and severity of the metabolic syndrome as assessed by clinical, metabolic,
      inflammatory and vascular outcome measures. EC will consist of a 17-session structured,
      lifestyle intervention plan, directed at achieving weight reduction and increasing physical
      activity change through education, behavior modification and stress management, and conducted
      in groups. It will comprise a 3-month Core Curriculum of 8 sessions, followed by a
      Maintenance phase with 9 monthly sessions delivered by lifestyle counselors, experienced in
      breaking through barriers in working with socioeconomically disadvantaged members of minority
      groups. All participants will have baseline, 6-monthly and 1-year assessments. This project,
      Project 2, entitled Community Health Approaches to Reducing Risk in the Metabolic Syndrome
      (CHARMS), seeks to study psychosocial and behavioral (lifestyle) variables that may
      contribute to the progression or amelioration of atherosclerotic processes underlying the
      pathogenesis of coronary heart disease (CHD).
    

Detailed description: 
      The metabolic syndrome is increasingly being recognized as a major threat to good health -
      especially cardiovascular health - and its frequency appears to be increasing in relation to
      the current epidemic of obesity. The objective of this study is to determine whether a
      program of enhanced lifestyle intervention can, compared to standard care, reduce the
      frequency and severity of the metabolic syndrome as assessed by clinical, metabolic,
      inflammatory and vascular outcome measures. The project will compare the effects of Enhanced
      Care (EC) in 112 patients (80 completers) to Standard Care (SC) in 112 patients (80
      completers) over a 12-month period. Following 3 run-in sessions given to both SC and EC
      participants, eligible subjects randomized to SC will receive lifestyle modification advice
      as recommended management of the metabolic syndrome and this will be administered at the
      baseline and the 6 month assessment visits. EC will consist of a 17-session structured,
      lifestyle intervention plan, directed at achieving weight reduction and increasing physical
      activity change through education, behavior modification and stress management, and conducted
      in groups. It will comprise a 3-month Core Curriculum of 8 sessions, followed by a
      Maintenance phase with 9 monthly sessions delivered by lifestyle counselors, experienced in
      breaking through barriers in working with socioeconomically disadvantaged members of minority
      groups. All participants will have baseline, 6-monthly and 1-year assessments. This project,
      Project 2, entitled Community Health Approaches to Reducing Risk in the Metabolic Syndrome
      (CHARMS), seeks to study psychosocial and behavioral (lifestyle) variables that may
      contribute to the progression or amelioration of atherosclerotic processes underlying the
      pathogenesis of coronary heart disease (CHD). Outcome variables will include measures of
      glycemic control/insulin resistance and/or dyslipidemia, oxidative stress, inflammation and
      overt manifestations of disease.
    

Intervention name(s): CHARMS
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Metabolic syndrome