| August 15, 2005 |
| December 22, 2008 |
| July 2003 |
| December 2007 (final data collection date for primary outcome measure) |
- 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 ]
|
- 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
|
| Complete list of historical versions of study NCT00131105 on ClinicalTrials.gov Archive Site |
- 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 ]
|
- Physical performance on a symptom-limited, graded exercise treadmill test
- quality of life and psychological questionnaires measuring physical functioning
- sleep
- perceived stress
- depressive symptoms
|
| |
| The TLC2 (Teaching Healthy Lifestyles to Caregivers 2)/CALM (Counseling Advice for Lifestyle Management) Study |
| Combining Exercise and Diet in Older Adults |
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. |
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.
|
| Phase II |
| Interventional |
| Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
- Health Behavior
- Psychological Stress
- Healthy
|
| Behavioral: The Stanford Active Choices program |
| |
- Wilcox S, King AC, Castro C, Bortz W. Do changes in physical activity lead to dietary changes in middle and old age? Am J Prev Med. 2000 May;18(4):276-83.
- King AC, Baumann K, O'Sullivan P, Wilcox S, Castro C. Effects of moderate-intensity exercise on physiological, behavioral, and emotional responses to family caregiving: a randomized controlled trial. J Gerontol A Biol Sci Med Sci. 2002 Jan;57(1):M26-36.
- Castro CM, Wilcox S, O'Sullivan P, Baumann K, King AC. An exercise program for women who are caring for relatives with dementia. Psychosom Med. 2002 May-Jun;64(3):458-68.
|
| |
| Completed |
| 200 |
| December 2007 |
| December 2007 (final data collection date for primary outcome measure) |
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
|
| Both |
| 50 Years and older |
| Yes |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00131105 |
|
| AG0034, R01AG021010 |
| National Institute on Aging (NIA) |
|
| Principal Investigator: |
Abby C. King, PhD |
Stanford Prevention Research Center |
|
|
| National Institute on Aging (NIA) |
| December 2008 |