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

This study is currently recruiting patients.
Verified by National Institute on Aging (NIA) August 2005

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
Aging
Health behavior
Psychological Stress
 Behavior: The Stanford Active Choices program
Phase II

MedlinePlus related topics:  Stress

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: 
Primary Outcomes: 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 Outcomes: Physical performance on a symptom-limited, graded exercise treadmill test; quality of life and psychological questionnaires measuring physical functioning; sleep; perceived stress; depressive symptoms
Expected Total Enrollment:  240

Study start: July 2003;  Expected completion: December 2008
Last follow-up: December 2007;  Data entry closure: December 2007

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: 1) a 12-month physical activity intervention and a 12-month dietary counseling intervention delivered simultaneously; 2) a 12-month counseling intervention first focusing on physical activity followed by the addition of dietary counseling; 3) a 12-month counseling intervention first focusing on dietary counseling followed by the addition of physical activity counseling; or 4) 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: 1) 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 2) 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 above,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00131105


California
      Stanford Prevention Research Center, Stanford,  California,  94305,  United States; Recruiting
Cynthia Castro, PhD  650-498-7281    cynthia.castro@stanford.edu 
Leslie Pruitt, PhD  650-725-5318    LAPruitt@stanford.edu 

Study chairs or principal investigators

Abby C. King, PhD,  Principal Investigator,  Stanford Prevention Research Center   

More Information

Publications

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.

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.

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.

Study ID Numbers:  AG0034; R01AG021010
Last Updated:  August 16, 2005
Record first received:  August 15, 2005
ClinicalTrials.gov Identifier:  NCT00131105
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-08-23

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