The TLC2 (Teaching Healthy Lifestyles to Caregivers 2)/CALM (Counseling Advice for Lifestyle Management) Study
NCT ID: NCT00131105
Last Updated: 2008-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
200 participants
INTERVENTIONAL
2003-07-31
2007-12-31
Brief Summary
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Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Interventions
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The Stanford Active Choices program
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
50 Years
ALL
Yes
Sponsors
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National Institute on Aging (NIA)
NIH
Principal Investigators
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Abby C. King, PhD
Role: PRINCIPAL_INVESTIGATOR
Stanford Prevention Research Center
Locations
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Stanford Prevention Research Center
Stanford, California, United States
Countries
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References
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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. doi: 10.1016/s0749-3797(00)00117-3.
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. doi: 10.1093/gerona/57.1.m26.
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. doi: 10.1097/00006842-200205000-00010.
Patel ML, Rodriguez Espinosa P, King AC. Moderators of a Diet and Physical Activity Intervention: who Responds Best to Sequential vs. Simultaneous Approaches. Int J Behav Med. 2025 Feb;32(1):80-91. doi: 10.1007/s12529-023-10223-9. Epub 2023 Oct 10.
King AC, Castro CM, Buman MP, Hekler EB, Urizar GG Jr, Ahn DK. Behavioral impacts of sequentially versus simultaneously delivered dietary plus physical activity interventions: the CALM trial. Ann Behav Med. 2013 Oct;46(2):157-68. doi: 10.1007/s12160-013-9501-y.
Other Identifiers
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AG0034
Identifier Type: -
Identifier Source: org_study_id