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The TLC2 (Teaching Healthy Lifestyles to Caregivers 2)/CALM (Counseling Advice for Lifestyle Management) Study
This study has been completed.
Study NCT00131105   Information provided by National Institute on Aging (NIA)
First Received: August 15, 2005   Last Updated: December 22, 2008   History of Changes

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
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP