Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT00131105
Status:
COMPLETED
Last Update Posted:
2008-12-23
First Post:
2005-08-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The TLC2 (Teaching Healthy Lifestyles to Caregivers 2)/CALM (Counseling Advice for Lifestyle Management) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D013315', 'term': 'Stress, Psychological'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-12', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-12-22', 'studyFirstSubmitDate': '2005-08-15', 'studyFirstSubmitQcDate': '2005-08-15', 'lastUpdatePostDateStruct': {'date': '2008-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Increase in aerobic physical activity measured by the Stanford 7-Day Physical Activity Recall', 'timeFrame': 'baseline, 4 months, 8 months, and 12 months'}, {'measure': 'decrease in saturated fat measured by the Block food frequency questionnaire', 'timeFrame': 'baseline, 4 months, 8 months, and 12 months'}], 'secondaryOutcomes': [{'measure': 'Physical performance on a symptom-limited, graded exercise treadmill test', 'timeFrame': 'baseline, 4 months, 8 months, and 12 months'}, {'measure': 'quality of life and psychological questionnaires measuring physical functioning', 'timeFrame': 'baseline, 4 months, 8 months, and 12 months'}, {'measure': 'sleep', 'timeFrame': 'baseline, 4 months, 8 months, and 12 months'}, {'measure': 'perceived stress', 'timeFrame': 'baseline, 4 months, 8 months, and 12 months'}, {'measure': 'depressive symptoms', 'timeFrame': 'baseline, 4 months, 8 months, and 12 months'}]}, 'conditionsModule': {'keywords': ['Healthy', 'Caregivers', 'Aging'], 'conditions': ['Health Behavior', 'Psychological Stress', 'Healthy']}, 'referencesModule': {'references': [{'pmid': '10788729', 'type': 'BACKGROUND', '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.'}, {'pmid': '11773209', 'type': 'BACKGROUND', '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."}, {'pmid': '12021419', 'type': 'BACKGROUND', '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."}, {'pmid': '37816943', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '23609341', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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:\n\n* a 12-month physical activity intervention and a 12-month dietary counseling intervention delivered simultaneously;\n* a 12-month counseling intervention first focusing on physical activity followed by the addition of dietary counseling;\n* a 12-month counseling intervention first focusing on dietary counseling followed by the addition of physical activity counseling; or\n* a 12-month attention-control condition focusing on stress-management skills training.\n\nData 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:\n\n* 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\n* 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women ages 50 and older\n* Current family caregiver\n* Currently experiencing significant psychological stress\n* Free of any medical condition that would limit participation in independent exercise\n* Not currently engaged in a regular pattern of physical conditioning\n* Current dietary pattern includes suboptimal total fat, saturated fat and vegetable and fruit consumption\n* Free of chronic clinical psychopathology\n* Stable on current medications\n* Planning to remain in the geographic area throughout the duration of the trial\n* Able to read and speak English sufficiently to understand protocol materials\n* Able to use the telephone unaided\n* Willing to accept random assignment to any study condition\n\nExclusion Criteria:\n\n* Under the age of 50\n* Currently under treatment for an acute, serious medical condition (e.g. cancer, heart disease, stroke)\n* 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)\n* Dietary patterns meet current recommendations for saturated fat and vegetable and fruit consumption\n* Unstable and/or uncontrolled on medications for chronic medical conditions\n* Unable or unwilling to use a telephone unaided\n* Unwilling to accept random assignment to study condition'}, 'identificationModule': {'nctId': 'NCT00131105', 'briefTitle': 'The TLC2 (Teaching Healthy Lifestyles to Caregivers 2)/CALM (Counseling Advice for Lifestyle Management) Study', 'organization': {'class': 'NIH', 'fullName': 'National Institute on Aging (NIA)'}, 'officialTitle': 'Combining Exercise and Diet in Older Adults', 'orgStudyIdInfo': {'id': 'AG0034'}, 'secondaryIdInfos': [{'id': 'R01AG021010', 'link': 'https://reporter.nih.gov/quickSearch/R01AG021010', 'type': 'NIH'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'The Stanford Active Choices program', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Prevention Research Center', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Abby C. King, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford Prevention Research Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}}}}