ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  Related Studies  
The TLC2 (Teaching Healthy Lifestyles to Caregivers 2)/CALM (Counseling Advice for Lifestyle Management) Study

This study is ongoing, but not recruiting participants.

Sponsored by: National Institute on Aging (NIA)
Information provided by: National Institute on Aging (NIA)
ClinicalTrials.gov Identifier: NCT00131105
  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 II

MedlinePlus related topics:   Caregivers    Exercise and Physical Fitness    Healthy Living    Stress   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   Combining Exercise and Diet in Older Adults

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
  • decrease in saturated fat measured by the Block food frequency questionnaire

Secondary Outcome Measures:
  • Physical performance on a symptom-limited, graded exercise treadmill test
  • quality of life and psychological questionnaires measuring physical functioning
  • sleep
  • perceived stress
  • depressive symptoms

Estimated Enrollment:   240
Study Start Date:   July 2003
Estimated Study Completion Date:   December 2007

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    
  More Information

Counseling Advice for Lifestyle Management (the CALM study)  This link exits the ClinicalTrials.gov site
 
Teaching Healthy Lifestyles for Caregivers (TLC2)  This link exits the ClinicalTrials.gov site
 

Publications:

Study ID Numbers:   AG0034, R01AG021010
First Received:   August 15, 2005
Last Updated:   January 24, 2007
ClinicalTrials.gov Identifier:   NCT00131105
Health Authority:   United States: Federal Government

Keywords provided by National Institute on Aging (NIA):
Healthy  
Caregivers  
Aging  

Study placed in the following topic categories:
Stress, Psychological
Stress
Healthy
Behavioral Symptoms

ClinicalTrials.gov processed this record on July 18, 2008




Links to all studies - primarily for crawlers