Type 2 DiabetesAPADIAB-ESPOIRNCT02733302
Hope Theory as Ability Determinant to Permanently Change the Adapted Physical Activity (APA) in Type 2 Diabetic Patients
A study testing Hope theory in people with Type 2 Diabetes, run by University Hospital, Angers at 1 site in France.
Trial summary
The control of diabetes is related both to food, treatment but also to physical activity. Despite these recommendations and these positive findings, patients are always sedentary because of brakes in the practice of a regular physical activity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Hope theory
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteFrance
- Study dates
- 4 Apr 2016to Sep 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major Topic
- Type 2 Diabetic Topic
- Inactive Topic
- Subject of CHU ANGERS hospitalized for a week Diab'Equilibre, Diabetology Service
- Subject participating in the service of the APA program
- Subject who understands and reads French
- Subject has given its consent to participate signed the protocol
Who cannot join
- Removing the participation of consent;
- Severe heart failure
- Severe respiratory failure
- Bone metastases
Trial locations and contacts
1 site in 1 country.
DUBOIS Séverine, PhD contact
France1 site, 1 recruiting
- Recruiting
UHAngers
Angers, 49933
Séverine DUBOIS, PhD
Séverine DUBOIS, PhD
About this study
The control of diabetes is related both to food, treatment but also to physical activity. Despite these recommendations and these positive findings, patients are always sedentary because of brakes in the practice of a regular physical activity.
It is therefore interesting to consider the representations of patients and particularly on the way of establishment in order to reach a goal. The Hope Theory highlights the hope as the sum of the will and means that an individual has to achieve its goals. Will be discussed in this study to identify a relationship between the level of hope for patients and their ability to permanently change their behavior in regular physical activity as part of the goals set during the week of therapeutic education patient.
- Conditions
- Type 2 Diabetes
- Being tested
- Hope theory
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hope theoryBehavioural
Adapted Physical Activity
| Study group | Role | What they receive |
|---|---|---|
| Hope theory | Experimental | Not described Receives: Behavioral: Hope theory |
What is being measured
The primary outcome is the main question the study is designed to answer.
IPAQ-SF questionnaire for measure of Physical Activity
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2016 (estimated)
- Study start4 Apr 2016
- Primary completionAug 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02733302
- Sponsor's protocol ID
- 2015-A01815-44
- Acronym
- APADIAB-ESPOIR
- Status last verified
- Oct 2017
- First submitted
- 30 Mar 2016
- Last updated
- 1 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hope Theory as Ability Determinant to Permanently Change the Adapted Physical Activity (APA) in Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT02733302
- Acronym / sponsor ID
- APADIAB-ESPOIR / 2015-A01815-44
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 4 Apr 2016 (actual)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 11 Apr 2016 (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 control of diabetes is related both to food, treatment but also to physical activity. Despite these recommendations and these positive findings, patients are always sedentary because of brakes in the practice of a regular physical activity.
It is therefore interesting to consider the representations of patients and particularly on the way of establishment in order to reach a goal. The Hope Theory highlights the hope as the sum of the will and means that an individual has to achieve its goals. Will be discussed in this study to identify a relationship between the level of hope for patients and their ability to permanently change their behavior in regular physical activity as part of the goals set during the week of therapeutic education patient.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hope theory | Experimental | Behavioral: Hope theory |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Major Topic
- Type 2 Diabetic Topic
- Inactive Topic
- Subject of CHU ANGERS hospitalized for a week Diab'Equilibre, Diabetology Service
- Subject participating in the service of the APA program
Key exclusion criteria (4 listed)
- Removing the participation of consent;
- Severe heart failure
- Severe respiratory failure
- Bone metastases
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 |
|---|---|---|
| Hope theoryAdapted Physical Activity | Behavioural | Hope theory |
Primary outcome
IPAQ-SF questionnaire for measure of Physical Activity
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2017.
Related trials for Type 2 Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
DUBOIS Séverine, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hope theory in people with Type 2 Diabetes, run by University Hospital, Angers at 1 site in France.
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 7 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: status not confirmed, as of the sponsor's last update on 1 Nov 2017. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact DUBOIS Séverine, PhD (sedubois@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IPAQ-SF questionnaire for measure of Physical Activity (time frame: 6 month). 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 1 Nov 2017.