Physical ActivityGSDBNCT01110213
Goal Setting and Lifestyle
A study testing Physical activity and Fruit and vegetable in people with Physical Activity and Diet, run by University of Hawaii at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 55 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Diet
- What is being tested?
- Physical activity and Fruit and vegetable
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Aug 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- must be 55 years or older,
- posses a telephone,
- able to give informed consent, and
- commit to a 10 week study.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cancer Research Center of Hawaii / University of Hawaii
Honolulu, Hawaii, 96813
About this study
Official title: 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.
Read the 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.
- Conditions
- Physical Activity, Diet
- Being tested
- Physical activity, Fruit and vegetable
- Keywords
- Aging, physical activity, diet, goal setting
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityBehavioural
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 vegetableBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Physical activity | Experimental | 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. Receives: Behavioral: Physical activity |
| Fruit and vegetable | Experimental | 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. Receives: Behavioral: Fruit and vegetable |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8-weeks
Secondary outcomes (1)
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."
Measured: 8-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2010 (estimated)
- Study startAug 2006
- Primary completionMar 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hawaii
- Sponsor type
- University, hospital or other
- Collaborators
- University of Hawaii Cancer Research Center
- Investigators
- Raheem J Paxton, PhD, Principal investigator, University of Hawaii Cancer Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01110213
- Sponsor's protocol ID
- CHS - 14544
- Acronym
- GSDB
- Status last verified
- Apr 2010
- First submitted
- 21 Apr 2010
- Last updated
- 26 Apr 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Goal Setting and Decisional Balance Applied to Physical Activity and Fruit & Vegetable Consumption
- ClinicalTrials.gov ID
- NCT01110213
- Acronym / sponsor ID
- GSDB / CHS - 14544
- Conditions
- Physical Activity, Diet
- Keywords
- Aging, physical activity, diet, goal setting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of HawaiiUniversity, hospital or other
- Collaborators
- University of Hawaii Cancer Research Center
- Study start
- Aug 2006
- Primary completion
- Mar 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 26 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical activity | Experimental | Behavioral: Physical activityParticipants received individual tailored telephone counseling and group-tailored newsletters encouraging leisure time physical activity. Content was based on goal setting theory and decisional balance. |
| Fruit and vegetable | Experimental | Behavioral: Fruit and vegetableParticipants received individual tailored telephone counseling and group-tailored newsletters encouraging fruit and vegetable intake. Content was based on goal setting theory and decisional balance. |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- must be 55 years or older,
- posses a telephone,
- able to give informed consent, and
- commit to a 10 week study.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activityParticipants received two individually tailored phone calls and two condition specific newsletters encouraging goal setting and weighing the pros and cons for physical activity. | Behavioural | Physical activity |
| Fruit and vegetableParticipants 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. | Behavioural | Fruit and vegetable |
Primary outcome
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.
1 secondary outcome
Goal specificity and difficulty
Time frame: 8-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raheem J Paxton, PhD principal investigator
University of Hawaii Cancer Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity and Fruit and vegetable in people with Physical Activity and Diet, run by University of Hawaii at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leisure Time Physical Activity (time frame: 8-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2010.