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The TLC2 (Teaching Healthy Lifestyles to Caregivers 2)/CALM (Counseling Advice for Lifestyle Management) Study

This study has been completed.
Sponsor:
Information provided by:
National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:
NCT00131105
First received: August 15, 2005
Last updated: December 22, 2008
Last verified: December 2008
  Purpose

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
Health Behavior
Psychological Stress
Healthy
Behavioral: The Stanford Active Choices program
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Combining Exercise and Diet in Older Adults

Resource links provided by NLM:


Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 200
Study Start Date: July 2003
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
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:

  • 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.
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00131105

Locations
United States, California
Stanford Prevention Research Center
Stanford, California, United States, 94305
Sponsors and Collaborators
Investigators
Principal Investigator: Abby C. King, PhD Stanford Prevention Research Center