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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01110213
Other study ID # CHS - 14544
Secondary ID
Status Completed
Phase N/A
First received April 21, 2010
Last updated April 22, 2010
Start date August 2006
Est. completion date August 2007

Study information

Verified date April 2010
Source University of Hawaii
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 43
Est. completion date August 2007
Est. primary completion date March 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 55 Years to 85 Years
Eligibility Inclusion Criteria:

- must be 55 years or older,

- posses a telephone,

- able to give informed consent, and

- commit to a 10 week study.

Exclusion Criteria:

- currently enrolled in a study promoting physical activity or dietary intake,

- currently exceeding current recommendations for physical activity or F&V intake at baseline, and

- medical conditions contraindicating physical activity or fruit and vegetable consumption.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Physical activity
Participants received two individually tailored phone calls and two condition specific newsletters encouraging goal setting and weighing the pros and cons for physical activity.
Fruit and vegetable
Participants received two individually tailored phone calls and two condition specific newsletters encouraging goal setting and weighing the pros and cons for fruit and vegetable consumption.

Locations

Country Name City State
United States Cancer Research Center of Hawaii / University of Hawaii Honolulu Hawaii

Sponsors (2)

Lead Sponsor Collaborator
University of Hawaii University of Hawaii Cancer Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Leisure Time Physical Activity 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. 8-weeks No
Secondary Goal specificity and difficulty 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." 8-weeks No
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