Goal Setting and Lifestyle (GSDB)

This study has been completed.
Sponsor:
Collaborator:
University of Hawaii Cancer Research Center
Information provided by:
University of Hawaii
ClinicalTrials.gov Identifier:
NCT01110213
First received: April 21, 2010
Last updated: April 22, 2010
Last verified: April 2010
  Purpose

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.


Condition Intervention
Physical Activity
Diet
Behavioral: Physical activity
Behavioral: Fruit and vegetable

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Goal Setting and Decisional Balance Applied to Physical Activity and Fruit & Vegetable Consumption

Further study details as provided by University of Hawaii:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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."


Enrollment: 43
Study Start Date: August 2006
Study Completion Date: August 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Physical activity
Participants received individual tailored telephone counseling and group-tailored newsletters encouraging leisure time physical activity. Content was based on goal setting theory and decisional balance.
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.
Experimental: Fruit and vegetable
Participants received individual tailored telephone counseling and group-tailored newsletters encouraging fruit and vegetable intake. Content was based on goal setting theory and decisional balance.
Behavioral: 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.

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.

  Eligibility

Ages Eligible for Study:   55 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01110213

Locations
United States, Hawaii
Cancer Research Center of Hawaii / University of Hawaii
Honolulu, Hawaii, United States, 96813
Sponsors and Collaborators
University of Hawaii
University of Hawaii Cancer Research Center
Investigators
Principal Investigator: Raheem J Paxton, PhD University of Hawaii Cancer Research Center
  More Information

No publications provided

Responsible Party: Raheem Paxton, Postdoctoral Fellow, University of Texas M D Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01110213     History of Changes
Other Study ID Numbers: CHS - 14544
Study First Received: April 21, 2010
Last Updated: April 22, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Hawaii:
Aging
physical activity
diet
goal setting

ClinicalTrials.gov processed this record on August 20, 2014