Skip to content

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

Combining Exercise and Diet in Older Adults

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00131105
Enrollment
200
Registered
2005-08-17
Start date
2003-07-31
Completion date
2007-12-31
Last updated
2008-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Behavior, Healthy, Psychological Stress

Keywords

Healthy, Caregivers, Aging

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.

Interventions

Sponsors

National Institute on Aging (NIA)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Increase in aerobic physical activity measured by the Stanford 7-Day Physical Activity Recallbaseline, 4 months, 8 months, and 12 months
decrease in saturated fat measured by the Block food frequency questionnairebaseline, 4 months, 8 months, and 12 months

Secondary

MeasureTime frame
Physical performance on a symptom-limited, graded exercise treadmill testbaseline, 4 months, 8 months, and 12 months
quality of life and psychological questionnaires measuring physical functioningbaseline, 4 months, 8 months, and 12 months
sleepbaseline, 4 months, 8 months, and 12 months
perceived stressbaseline, 4 months, 8 months, and 12 months
depressive symptomsbaseline, 4 months, 8 months, and 12 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026