- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01110213
Goal Setting and Lifestyle (GSDB)
April 22, 2010 updated by: University of Hawaii
Goal Setting and Decisional Balance Applied to Physical Activity and Fruit & Vegetable Consumption
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
43
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hawaii
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Honolulu, Hawaii, United States, 96813
- Cancer Research Center of Hawaii / University of Hawaii
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Leisure Time Physical Activity
Time Frame: 8-weeks
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Goal specificity and difficulty
Time Frame: 8-weeks
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Raheem J Paxton, PhD, University of Hawaii Cancer Research Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2006
Primary Completion (Actual)
March 1, 2007
Study Completion (Actual)
August 1, 2007
Study Registration Dates
First Submitted
April 21, 2010
First Submitted That Met QC Criteria
April 22, 2010
First Posted (Estimate)
April 26, 2010
Study Record Updates
Last Update Posted (Estimate)
April 26, 2010
Last Update Submitted That Met QC Criteria
April 22, 2010
Last Verified
April 1, 2010
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CHS - 14544
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Physical Activity
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Muğla Sıtkı Koçman UniversityEge UniversityCompletedPhysical Activity | Physical Activity Behavior | Physical Activity LevelsTurkey
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Istinye UniversityCompletedPhysical Activity | Youth | Physical Activity Barriers | Physical Activity FacilitatorsTurkey
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University of ManitobaResearch ManitobaCompletedPhysical Activity | Physical Activity Self-Definition
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Odense University HospitalUniversity of Southern DenmarkRecruitingQuality of Life | Physical Activity | Physical Disability | Physical Function | ParticipationDenmark
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Firat UniversityNot yet recruitingUniversity Students | Physical Activity Level | Postural Awareness | Physical Activity AttitudeTurkey
-
Assistance Publique - Hôpitaux de ParisTerminatedPhysical Activity | Physical DisabilityFrance
Clinical Trials on Physical activity
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Zohra Institute of Health SciencesCompletedPhysical Activity and StressPakistan
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Health Education Research Foundation (HERF)CompletedQuality of LifePakistan
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Centre Hospitalier Universitaire DijonWithdrawn
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Fundacion para la Investigacion y Formacion en...CompletedImpaired CognitionSpain
-
Universidad Santo TomasEmory University; Universidad Pública de Navarra; Universidad de Granada; University... and other collaboratorsCompletedObesity | Lipid Metabolism Disorders | Mental Health Wellness 1 | Body Composition, Beneficial | Metabolic Syndrome X
-
University of NottinghamBiotechnology and Biological Sciences Research CouncilRecruitingMetabolic Syndrome | Sedentary Behavior | Age-related Cognitive Decline | Age-Related SarcopeniaUnited Kingdom
-
Upper Alsace UniversityUniversity Hospital, Strasbourg, France; Centre Hospitalier Universitaire de... and other collaboratorsRecruitingQuality of Life | EndometriosisFrance
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Cardenal Herrera UniversityCompleted
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Istituti Clinici Scientifici Maugeri SpACompleted
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Assaf-Harofeh Medical CenterBen-Gurion University of the NegevUnknown