Goal Setting and Lifestyle (GSDB)
| Tracking Information | |||||
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| First Received Date ICMJE | April 21, 2010 | ||||
| Last Updated Date | April 22, 2010 | ||||
| Start Date ICMJE | August 2006 | ||||
| Primary Completion Date | March 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Leisure Time Physical Activity [ Time Frame: 8-weeks ] [ Designated as safety issue: No ] Physical Activity was measured using an adaptation of the Godin Leisure-Time Exercise Questionnaire. Participants reported how many times during an average week they participated in mild (i.e., takes minimal effort), moderate (i.e., increases your heart and breathing rate a little), and strenuous activity (i.e., caused one's heart to beat rapidly) for at least 30 minutes at a time. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01110213 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Goal specificity and difficulty [ Time Frame: 8-weeks ] [ Designated as safety issue: No ] Goal Specificity and Difficulty. Four items were created for each concept: (1) "The goals I set for number times I will [eat F&V or exercise] in a week are," (2) "the goals I set for the type of [F&V or exercise] I will [eat or do] in a week are," (3) "the goals I set for the [amount or duration] of [F&V or exercise] I get in a week are," and (4) "the goals I set for intensity of my exercise sessions within a week are." |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Goal Setting and Lifestyle | ||||
| Official Title ICMJE | Goal Setting and Decisional Balance Applied to Physical Activity and Fruit & Vegetable Consumption | ||||
| Brief Summary | The primary aim of this feasibility study is to determine if a theory-based lifestyle intervention consisting of telephone counseling is associated with improvements in physical activity and dietary intake. |
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| Detailed Description | Goal setting has become an integral part of physical activity and dietary interventions; however, few studies have examined the theoretical constructs that drive goal-setting theory. To address the limitations and gaps in the literature, we designed an 8-week health behavior intervention for a racially and ethnically diverse sample of older adults. The primary aim of this study was to determine whether older adults randomized to a goal-setting intervention for physical activity or fruit and vegetable (F&V) intake would make significant improvements in physical activity or F&V intake. The secondary aim of this study was to determine whether participating in goal-setting interventions was associated with changes in theoretical constructs related to goal-setting. We hypothesized that older adults assigned to the physical activity condition would significantly increase metabolic minutes (MET-minutes) of physical activity from baseline to follow-up and that participants assigned to the F&V intake condition would significantly increase mean servings of F&V. In addition, we hypothesized that mean scores of goal specificity, difficulty, effort, commitment, persistence, barrier self-efficacy, and task self-efficacy would significantly increase from baseline to follow-up for both groups. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
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| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 43 | ||||
| Completion Date | August 2007 | ||||
| Primary Completion Date | March 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 55 Years to 85 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01110213 | ||||
| Other Study ID Numbers ICMJE | CHS - 14544 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Raheem Paxton, Postdoctoral Fellow, University of Texas M D Anderson Cancer Center | ||||
| Study Sponsor ICMJE | University of Hawaii | ||||
| Collaborators ICMJE | University of Hawaii Cancer Research Center | ||||
| Investigators ICMJE |
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| Information Provided By | University of Hawaii | ||||
| Verification Date | April 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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