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

December 22, 2008 updated by: National Institute on Aging (NIA)

Combining Exercise and Diet in Older Adults

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Behavioral: The Stanford Active Choices program

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 Type

Interventional

Enrollment (Actual)

200

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- California
  - Stanford, California, United States, 94305
    - Stanford Prevention Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute on Aging (NIA)

Investigators

Principal Investigator: Abby C. King, PhD, Stanford Prevention Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)