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Health BehaviorPhase 2NCT00131105

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

A Phase 2 study testing The Stanford Active Choices program in people with Health Behavior and Psychological Stress, run by National Institute on Aging (NIA) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and olderHealthy volunteers can take part
Conditions the study is for
Health Behavior, Psychological Stress, Healthy
What is being tested?
The Stanford Active Choices program
How many people
200 participants
Where
1 siteUnited States
Study dates
Jul 2003to Dec 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 12Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Stanford Prevention Research Center

    Stanford, California, 94305

Other trials in United States

About this study

Official title: 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.

Read the 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.
Being tested
The Stanford Active Choices program
Keywords
Healthy, Caregivers, Aging
Medical subject headings
Health Behavior, Stress, Psychological

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The Stanford Active Choices programBehavioural

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Increase in aerobic physical activity measured by the Stanford 7-Day Physical Activity Recall

    Measured: baseline, 4 months, 8 months, and 12 months

  2. decrease in saturated fat measured by the Block food frequency questionnaire

    Measured: baseline, 4 months, 8 months, and 12 months

Secondary outcomes (5)

  1. Physical performance on a symptom-limited, graded exercise treadmill test

    Measured: baseline, 4 months, 8 months, and 12 months

  2. quality of life and psychological questionnaires measuring physical functioning

    Measured: baseline, 4 months, 8 months, and 12 months

  3. sleep

    Measured: baseline, 4 months, 8 months, and 12 months

  4. perceived stress

    Measured: baseline, 4 months, 8 months, and 12 months

  5. depressive symptoms

    Measured: baseline, 4 months, 8 months, and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2005 (estimated)
  2. Study startJul 2003
  3. Primary completionDec 2007
  4. Study completionDec 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00131105
Sponsor's protocol ID
AG0034
Other IDs
R01AG021010
Status last verified
Dec 2008
First submitted
15 Aug 2005
Last updated
23 Dec 2008
Results posted
No

Publications

  • 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.

    PubMed 10788729

  • 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.

    PubMed 11773209

  • 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.

    PubMed 12021419

  • Patel ML, Rodriguez Espinosa P, King AC. Moderators of a Diet and Physical Activity Intervention: who Responds Best to Sequential vs. Simultaneous Approaches. Int J Behav Med. 2025 Feb;32(1):80-91. doi: 10.1007/s12529-023-10223-9. Epub 2023 Oct 10.

    PubMed 37816943

  • 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.

    PubMed 23609341

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing The Stanford Active Choices program in people with Health Behavior and Psychological Stress, run by National Institute on Aging (NIA) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Increase in aerobic physical activity measured by the Stanford 7-Day Physical Activity Recall (time frame: baseline, 4 months, 8 months, and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00131105, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2008.

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