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

National Institutes of Health (NIH)

Status and phase

Completed

Phase 2

Conditions

Healthy

Psychological Stress

Health Behavior

Treatments

Behavioral: The Stanford Active Choices program

Study type

Interventional

Funder types

NIH

Identifiers

NCT00131105

R01AG021010 (U.S. NIH Grant/Contract)

AG0034

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 patients

Sex

All

Ages

50+ years old

Volunteers

Accepts Healthy Volunteers

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