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

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.

Inclusion criteria

• Men and women ages 50 and older
• Current family caregiver
• Currently experiencing significant psychological stress
• Free of any medical condition that would limit participation in independent exercise
• Not currently engaged in a regular pattern of physical conditioning
• Current dietary pattern includes suboptimal total fat, saturated fat and vegetable and fruit consumption
• Free of chronic clinical psychopathology
• Stable on current medications
• Planning to remain in the geographic area throughout the duration of the trial
• Able to read and speak English sufficiently to understand protocol materials
• Able to use the telephone unaided
• Willing to accept random assignment to any study condition

Exclusion criteria

• Under the age of 50
• Currently under treatment for an acute, serious medical condition (e.g. cancer, heart disease, stroke)
• Physically active on a regular basis (i.e. performing more than 60 minutes per week of aerobic physical activity of at least a moderate intensity)
• Dietary patterns meet current recommendations for saturated fat and vegetable and fruit consumption
• Unstable and/or uncontrolled on medications for chronic medical conditions
• Unable or unwilling to use a telephone unaided
• Unwilling to accept random assignment to study condition