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
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