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

Healthy Clinical Trial

Official title:

Combining Exercise and Diet in Older Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00131105
• Other study ID #: AG0034
• Secondary ID: R01AG021010
• Status: Completed
• Phase: Phase 2
• First received: August 15, 2005
• Last updated: December 22, 2008
• Start date: July 2003
• Est. completion date: December 2007

Study information

• Verified date: December 2008
• Source: National Institute on Aging (NIA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Health Behavior
• Healthy
• Psychological Stress
• Stress, Psychological

Intervention

Behavioral:
• The Stanford Active Choices program

Locations

Country	Name	City	State
United States	Stanford Prevention Research Center	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase in aerobic physical activity measured by the Stanford 7-Day Physical Activity Recall		baseline, 4 months, 8 months, and 12 months	No
Primary	decrease in saturated fat measured by the Block food frequency questionnaire		baseline, 4 months, 8 months, and 12 months	No
Secondary	Physical performance on a symptom-limited, graded exercise treadmill test		baseline, 4 months, 8 months, and 12 months	No
Secondary	quality of life and psychological questionnaires measuring physical functioning		baseline, 4 months, 8 months, and 12 months	No
Secondary	sleep		baseline, 4 months, 8 months, and 12 months	No
Secondary	perceived stress		baseline, 4 months, 8 months, and 12 months	No
Secondary	depressive symptoms		baseline, 4 months, 8 months, and 12 months	No