Behavior ChangeNCT00810173
Phone Call in Type 2 Diabetes Patient
A study testing phone call support in people with Behavior Change, run by University of Sao Paulo.
Trial summary
To assay the influence of personality profile to promote behavior change adherence for physical activity using a pedometer. The investigators also studied the metabolic profile, diagnosis of depression, intention to change behavior, physical activity referred and the quality of life. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Behavior Change
- What is being tested?
- phone call support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to Oct 2008
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- to assign written informed consent
- to have a phone call number
- to agree to use a pedometer for 6 weeks to be able to write the data concerning their number of steps per day
Who cannot join
- don´t agree to assign written informed consent
- don´t have phone number
- don´t have conditions to answer all the questionnaire
- don´t agree to use pedometer for 6 weeks
About this study
Official title: Phone Call as an Intervention for Improving Walking Practice in Type 2 Diabetes: Influence of Personality Profile in This Response
To assay the influence of personality profile to promote behavior change adherence for physical activity using a pedometer. The investigators also studied the metabolic profile, diagnosis of depression, intention to change behavior, physical activity referred and the quality of life. Casuistic and Methods: a randomized "quasi-experimental" enrolling 48 T2DM patients using a pedometer for 6 weeks. The intervention group received phone calls stimulating them to increase their walking activity. The control group received only one telephone call to explain pedometer use. The investigators also analyzed the personality profile, quality of life, and metabolic and anthropometric indexes.
- Conditions
- Behavior Change
- Being tested
- phone call support
- Keywords
- type 2 diabetes, physical activity, behavior change, profile personality, phone call support
- Medical subject headings
- Diabetes Mellitus, Type 2, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phone call supportBehavioural
Also called couselling to behavior change
The intervention group received a phone call support for 6 weeks to incentive to increase the number of steps/day.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | This group received call phone support to incentive the increase of the number of steps during 6 weeks Receives: Behavioral: phone call support |
| 2 | No intervention | This group just received a pedometer to register the number of steps for 6 weeks but this group don´t received a phone call. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2008 (estimated)
- Study startJan 2008
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavior ChangeStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00810173
- Sponsor's protocol ID
- Fonseca-Guedes
- Status last verified
- Dec 2008
- First submitted
- 16 Dec 2008
- Last updated
- 17 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phone Call as an Intervention for Improving Walking Practice in Type 2 Diabetes: Influence of Personality Profile in This Response
- ClinicalTrials.gov ID
- NCT00810173
- Acronym / sponsor ID
- Fonseca-Guedes
- Conditions
- Behavior Change
- Keywords
- type 2 diabetes, physical activity, behavior change, profile personality, phone call support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 17 Dec 2008 (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.
To assay the influence of personality profile to promote behavior change adherence for physical activity using a pedometer. The investigators also studied the metabolic profile, diagnosis of depression, intention to change behavior, physical activity referred and the quality of life. Casuistic and Methods: a randomized "quasi-experimental" enrolling 48 T2DM patients using a pedometer for 6 weeks. The intervention group received phone calls stimulating them to increase their walking activity. The control group received only one telephone call to explain pedometer use. The investigators also analyzed the personality profile, quality of life, and metabolic and anthropometric indexes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: phone call supportThis group received call phone support to incentive the increase of the number of steps during 6 weeks |
| 2 | No intervention | –This group just received a pedometer to register the number of steps for 6 weeks but this group don´t received a phone call. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- to assign written informed consent
- to have a phone call number
- to agree to use a pedometer for 6 weeks to be able to write the data concerning their number of steps per day
Key exclusion criteria (4 listed)
- don´t agree to assign written informed consent
- don´t have phone number
- don´t have conditions to answer all the questionnaire
- don´t agree to use pedometer for 6 weeks
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 |
|---|---|---|
| phone call supportAlso: couselling to behavior changeThe intervention group received a phone call support for 6 weeks to incentive to increase the number of steps/day. | Behavioural | 1 |
Primary outcome
Not reported in the source record.
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 17 Dec 2008.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing phone call support in people with Behavior Change, run by University of Sao Paulo.
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 3 inclusion and 4 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 17 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
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.
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 17 Dec 2008.