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

Phase 2

Completed

• Conditions: Health Behavior; Psychological Stress; Healthy

• Registration Number: NCT00131105
• Lead Sponsor: National Institute on Aging (NIA)

Brief 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.

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.

Study Timeline

• Study Start: 2003-07
• Study First Submitted: 2005-08-15
• Study First Submitted QC: 2005-08-15
• Study First Posted: 2005-08-17
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2008-12
• Last Update Submitted: 2008-12-22
• Last Update Posted: 2008-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Increase in aerobic physical activity measured by the Stanford 7-Day Physical Activity Recall	baseline, 4 months, 8 months, and 12 months
decrease in saturated fat measured by the Block food frequency questionnaire	baseline, 4 months, 8 months, and 12 months

Secondary Outcome Measures

Name	Time	Method
Physical performance on a symptom-limited, graded exercise treadmill test	baseline, 4 months, 8 months, and 12 months
quality of life and psychological questionnaires measuring physical functioning	baseline, 4 months, 8 months, and 12 months
sleep	baseline, 4 months, 8 months, and 12 months
perceived stress	baseline, 4 months, 8 months, and 12 months
depressive symptoms	baseline, 4 months, 8 months, and 12 months

Trial Locations

Locations (1)

Stanford Prevention Research Center; 🇺🇸 Stanford, California, United States