Clinical Trials Directory

Trials / Completed

CompletedNCT00131105

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

Combining Exercise and Diet in Older Adults

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
200 (actual)
Sponsor
National Institute on Aging (NIA) · NIH
Sex
All
Age
50 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALThe Stanford Active Choices program

Timeline

Start date
2003-07-01
Primary completion
2007-12-01
Completion
2007-12-01
First posted
2005-08-17
Last updated
2008-12-23

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00131105. Inclusion in this directory is not an endorsement.