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
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | The 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.