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| Descriptive Information Fields | |||||
| Brief Title † | The TLC2 (Teaching Healthy Lifestyles to Caregivers 2)/CALM (Counseling Advice for Lifestyle Management) Study | ||||
| Official Title † | Combining Exercise and Diet in Older Adults | ||||
| Brief Summary | 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. |
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| Detailed Description | 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:
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:
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| Study Phase | Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Primary Outcome Measure † | 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 |
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| Secondary Outcome Measure † | Physical performance on a symptom-limited, graded exercise treadmill test quality of life and psychological questionnaires measuring physical functioning sleep perceived stress depressive symptoms |
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| Condition † | Health Behavior Psychological Stress Healthy |
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| Intervention † | Behavioral: The Stanford Active Choices program | ||||
| MEDLINE PMIDs | 10788729, 11773209, 12021419 | ||||
| Links | Counseling Advice for Lifestyle Management (the CALM study) ![]() Teaching Healthy Lifestyles for Caregivers (TLC2)  ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Active, not recruiting | ||||
| Enrollment † | 240 | ||||
| Start Date † | July 2003 | ||||
| Completion Date | December 2007 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 50 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00131105 | ||||
| Organization ID | AG0034 | ||||
| Secondary IDs †† | R01AG021010 | ||||
| Study Sponsor † | National Institute on Aging (NIA) | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | National Institute on Aging (NIA) | ||||
| Verification Date | January 2007 | ||||
| First Received Date † | August 15, 2005 | ||||
| Last Updated Date | January 24, 2007 | ||||