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

Study Overview
=================
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.

Official Title
-----------------
Combining Exercise and Diet in Older Adults

Conditions
-----------------
Health Behavior, Psychological Stress, Healthy

Intervention / Treatment
-----------------
* Behavioral: The Stanford Active Choices program


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: The Stanford Active Choices program|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy, Caregivers, Aging