Goal Setting and Lifestyle

Physical Activity Clinical Trial

— GSDB  

Official title:

Goal Setting and Decisional Balance Applied to Physical Activity and Fruit & Vegetable Consumption

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01110213
• Other study ID #: CHS - 14544
• 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

• Diet
• Physical Activity

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