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

Primary Purpose

Health Behavior, Psychological Stress, Healthy

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
The Stanford Active Choices program
Sponsored by
National Institute on Aging (NIA)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Health Behavior focused on measuring Healthy, Caregivers, Aging

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Stanford Prevention Research Center

Outcomes

Primary Outcome Measures

Increase in aerobic physical activity measured by the Stanford 7-Day Physical Activity Recall
decrease in saturated fat measured by the Block food frequency questionnaire

Secondary Outcome Measures

Physical performance on a symptom-limited, graded exercise treadmill test
quality of life and psychological questionnaires measuring physical functioning
sleep
perceived stress
depressive symptoms

Full Information

First Posted
August 15, 2005
Last Updated
December 22, 2008
Sponsor
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT00131105
Brief Title
The TLC2 (Teaching Healthy Lifestyles to Caregivers 2)/CALM (Counseling Advice for Lifestyle Management) Study
Official Title
Combining Exercise and Diet in Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Aging (NIA)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Health Behavior, Psychological Stress, Healthy
Keywords
Healthy, Caregivers, Aging

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
The Stanford Active Choices program
Primary Outcome Measure Information:
Title
Increase in aerobic physical activity measured by the Stanford 7-Day Physical Activity Recall
Time Frame
baseline, 4 months, 8 months, and 12 months
Title
decrease in saturated fat measured by the Block food frequency questionnaire
Time Frame
baseline, 4 months, 8 months, and 12 months
Secondary Outcome Measure Information:
Title
Physical performance on a symptom-limited, graded exercise treadmill test
Time Frame
baseline, 4 months, 8 months, and 12 months
Title
quality of life and psychological questionnaires measuring physical functioning
Time Frame
baseline, 4 months, 8 months, and 12 months
Title
sleep
Time Frame
baseline, 4 months, 8 months, and 12 months
Title
perceived stress
Time Frame
baseline, 4 months, 8 months, and 12 months
Title
depressive symptoms
Time Frame
baseline, 4 months, 8 months, and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abby C. King, PhD
Organizational Affiliation
Stanford Prevention Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Prevention Research Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
10788729
Citation
Wilcox S, King AC, Castro C, Bortz W. Do changes in physical activity lead to dietary changes in middle and old age? Am J Prev Med. 2000 May;18(4):276-83. doi: 10.1016/s0749-3797(00)00117-3.
Results Reference
background
PubMed Identifier
11773209
Citation
King AC, Baumann K, O'Sullivan P, Wilcox S, Castro C. Effects of moderate-intensity exercise on physiological, behavioral, and emotional responses to family caregiving: a randomized controlled trial. J Gerontol A Biol Sci Med Sci. 2002 Jan;57(1):M26-36. doi: 10.1093/gerona/57.1.m26.
Results Reference
background
PubMed Identifier
12021419
Citation
Castro CM, Wilcox S, O'Sullivan P, Baumann K, King AC. An exercise program for women who are caring for relatives with dementia. Psychosom Med. 2002 May-Jun;64(3):458-68. doi: 10.1097/00006842-200205000-00010.
Results Reference
background
PubMed Identifier
23609341
Citation
King AC, Castro CM, Buman MP, Hekler EB, Urizar GG Jr, Ahn DK. Behavioral impacts of sequentially versus simultaneously delivered dietary plus physical activity interventions: the CALM trial. Ann Behav Med. 2013 Oct;46(2):157-68. doi: 10.1007/s12160-013-9501-y.
Results Reference
derived

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

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