The purpose of this study is to evaluate the effects of a 12-month telephone-supervised, home-based physical activity and dietary intervention, conducted in either a sequential or simultaneous fashion, on improving physical activity and dietary patterns in a high-stress population.

Condition	Intervention	Phase
Aging Health behavior Psychological Stress	Behavior: The Stanford Active Choices program	Phase II

Further Study Details: 

Primary Outcomes: Increase in aerobic physical activity measured by the Stanford 7-Day Physical Activity Recall; decrease in saturated fat measured by the Block food frequency questionnaire
Secondary Outcomes: Physical performance on a symptom-limited, graded exercise treadmill test; quality of life and psychological questionnaires measuring physical functioning; sleep; perceived stress; depressive symptoms
Expected Total Enrollment:  240

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: 1) a 12-month physical activity intervention and a 12-month dietary counseling intervention delivered simultaneously; 2) a 12-month counseling intervention first focusing on physical activity followed by the addition of dietary counseling; 3) a 12-month counseling intervention first focusing on dietary counseling followed by the addition of physical activity counseling; or 4) 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: 1) 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 2) 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.

Ages Eligible for Study:  50 Years and above,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00131105

California
      Stanford Prevention Research Center, Stanford,  California,  94305,  United States; Recruiting

Study chairs or principal investigators

Abby C. King, PhD,  Principal Investigator,  Stanford Prevention Research Center   

Study ID Numbers:  AG0034; R01AG021010
Last Updated:  August 16, 2005
Record first received:  August 15, 2005
ClinicalTrials.gov Identifier:  NCT00131105
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-08-23