The TLC2 (Teaching Healthy Lifestyles to Caregivers 2)/CALM (Counseling Advice for Lifestyle Management) Study

• Increase in aerobic physical activity measured by the Stanford 7-Day Physical Activity Recall [ Time Frame: baseline, 4 months, 8 months, and 12 months ] [ Designated as safety issue: No ]
  
• decrease in saturated fat measured by the Block food frequency questionnaire [ Time Frame: baseline, 4 months, 8 months, and 12 months ] [ Designated as safety issue: No ]
  

• Physical performance on a symptom-limited, graded exercise treadmill test [ Time Frame: baseline, 4 months, 8 months, and 12 months ] [ Designated as safety issue: No ]
  
• quality of life and psychological questionnaires measuring physical functioning [ Time Frame: baseline, 4 months, 8 months, and 12 months ] [ Designated as safety issue: No ]
  
• sleep [ Time Frame: baseline, 4 months, 8 months, and 12 months ] [ Designated as safety issue: No ]
  
• perceived stress [ Time Frame: baseline, 4 months, 8 months, and 12 months ] [ Designated as safety issue: No ]
  
• depressive symptoms [ Time Frame: baseline, 4 months, 8 months, and 12 months ] [ Designated as safety issue: No ]
  

This study combines elements of two previous studies--Teaching Healthy Lifestyles for Caregivers (TLC2) and Counseling Advice for Lifestyle Management (CALM)--to compare exercise and diet interventions in caregivers and non-caregivers. Two hundred and forty healthy men and women ages 50 and older, half caregivers and half non-caregivers, will be randomly assigned to one of four conditions:

• a 12-month physical activity intervention and a 12-month dietary counseling intervention delivered simultaneously;
• a 12-month counseling intervention first focusing on physical activity followed by the addition of dietary counseling;
• a 12-month counseling intervention first focusing on dietary counseling followed by the addition of physical activity counseling; or
• a 12-month attention-control condition focusing on stress-management skills training.

Data on physical activity participation, saturated fat consumption, and related quality of life indicators (e.g., improved physical functioning, fitness, sleep, and psychological well-being) will be collected at baseline, 4 months, 8 months, and 12 months post-test. The primary hypotheses are:

• participants assigned to the physical activity and dietary counseling conditions will show greater improvements in physical activity participation and saturated fat consumption at 12 months compared to the attention-control condition; and
• participants in the sequentially-delivered counseling interventions will show greater improvements in physical activity and saturated fat consumption compared to participants in the simultaneously-delivered interventions.