Overweight and ObesityPRALIMAPCINeCONCT05399407
PRALIMAP-CINeCO: Comparison of Health E-coaching Versus Referral to the Usual Care System
A study testing Health e-coaching in people with Overweight and Obesity, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
This study involves young adults from the PRALIMAP-INES trial and student volunteers from the University of Lorraine, who are overweight or obese. For young adults from the PRALIMAP-INES trial, the proposed research is a continuation of the PRALIMAP-CINeCO research (part 1). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Health e-coaching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 384 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jan 2023to 9 Jan 2025
- 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
- Among the young adults who agreed to participate in follow-up visit (T3) in the PRALIMAP-CINeCO trial (Part 1), the inclusion criteria for the inclusion criteria for the proposed research are as follows:
- Person having received complete information on the organization of the research and not and who did not object to their participation and to the use of their data to participate and to use their data
- Have agreed to complete the pre-test questionnaire prior to/at the follow-up visit (T3)
- Have agreed to the anthropometric measurements without invasive intervention performed at the follow-up visit (Q3)
- Have a BMI greater than 25kg/m² (Cole et al. 2000) or a percentage of body fat mass greater than or equal to 20% for men and greater than or equal to 33% for women, depending on age and greater than or equal to 33% for women and not receiving medical medical care for this situation
- Agree to participate in the follow-up
Show all 20Show fewer
- Accepting the health e-coaching/orientation to routine care
- Affiliated to a social security system or beneficiary of such a system
- Reside in France
- Among the students who agreed to participate, through the Student Health Service of the University of Lorraine, the inclusion criteria for the proposed research are as follows:
- Person having received complete information on the organization of the research and not and who did not object to their participation and to the use of their data to participate and to use their data
- Have agreed to complete the pre-test questionnaire prior to/at the follow-up visit (T0)
- Have agreed to the anthropometric measurements without invasive intervention performed at the follow-up visit (T0)
- Have a BMI greater than 25kg/m² (Cole et al. 2000) or a percentage of body fat mass greater than or equal to 20% for men and greater than or equal to 33% for women, depending on age and greater than or equal to 33% for women and not receiving medical medical care for this situation
- Agree to participate in the follow-up
- Accepting the health e-coaching/orientation to routine care
- Affiliated to a social security system or beneficiary of such a system
- Reside in France
- Be of legal age (18 years or older)
- Be a student at the Université de Lorraine
Who cannot join
- If the follow-up visit n°3 (T3) during the PRALIMAP-CINeCO trial (1st part) or the inclusion visit (T0 for University of Lorraine students), was completed, the non-inclusion criteria for the referral of young adults young adults (health e-coaching/current care) are as follows:
- Do not feel the need for coaching
- Be already being treated for overweight by a health professional specializing in the treatment of specialized in the treatment of overweight and obesity or a specialized specialized medical structure/service
- Do not agree to participate in the continuation of PRALIMAP-CINeCO
- Major person under a legal protection measure (guardianship, curatorship, safeguard of justice)
- Persons deprived of liberty by a judicial or administrative decision administrative decision Persons under psychiatric care in accordance with Articles L. 3212-1 and L. 3213-1 of the Public Health Code
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHRU de Nancy
Nancy, 54000
Yacoubou OMOROU, 0383859303, Y.OMOROU@chru-nancy.fr
About this study
Official title: Randomized Controlled Trial PRALIMAP-CINeCO: Comparison of Health E-coaching Versus Referral to the Usual Care System for Overweight and Obese Young Adults
This study involves young adults from the PRALIMAP-INES trial and student volunteers from the University of Lorraine, who are overweight or obese.
For young adults from the PRALIMAP-INES trial, the proposed research is a continuation of the PRALIMAP-CINeCO research (part 1).
Read more
For students at the University of Lorraine, the proposed research is aimed at volunteer students who are overweight or obese, via the University of Lorraine's Student Health Service (SSE).
Young adults and overweight or obese students not receiving medical care at the time of the inclusion visit (4th measurement time for PRALIMAP-INES participants and 1st time for others) will be offered the chance to take part in a randomized trial comparing the acceptability of health e-coaching versus referral to standard care.
Experimental group: health e-coaching Control group: usual care system
Primary objective : To determine the effectiveness of an e-health coaching intervention using new technologies that promotes changes in eating and physical activity behavior in overweight and obese young adults aged 20, an intervention targeting the development of autonomous self-regulation.
Secondary objectives :
- Determine the acceptability of health e-coaching: acceptability of new technologies (container), acceptability of personalized health e-coaching (content).
- Determine the effectiveness of health e-coaching on the criteria of corpulence (BMI; body composition), changes in eating behaviors (TCA), emotion management skills and social interaction skills.
- Evaluate the benefit of health e-coaching alone or combined with the previous intervention received in the PRALIMAP-INÈS trial on primary and secondary endpoints.
- Evaluate and compare participation in a health promotion program over two life periods (adolescence and young adulthood) for young adults from the PRALIMAP-INÈS trial.
- Evaluate the effectiveness of health e-coaching (reinforcement of autonomous self-regulation and changes in eating behaviors and physical activity practices/time spent sitting) according to the dose of intervention received by young adults (received-treatment analysis).
- Determine the cost-efficiency and cost-utility ratios by means of a medico-economic evaluation based on the incremental cost of the e-coaching intervention in relation to the usual care offered by the health care system (ICER: Incremental Cost-Effectiveness Ratio).
- Conditions
- Overweight and Obesity
- Being tested
- Health e-coaching
- Keywords
- E-coaching, Usual Care System, young adults
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health e-coachingOther
Management of overweight / obesity
| Study group | Role | What they receive |
|---|---|---|
| Experimental group: health e-coaching | Experimental | * Personalised and secure access to the health e-coaching platform for 12 months.
* Follow-up by professionals who are specialized in the subject matter (at a distance): a psychologist, a dietician and a teacher of adapted physical activity.
* Personalised activities offered to each young adult throughout their follow-up: synchronous and asynchronous activities (video, animation, quizzes, etc.), individual and collective on different themes (expression of emotions, my weight and me, eating well to start with, my image and me, making choices, my way of moving, etc.). The personalisation of the activities will be done in consultation between the professionals and the young adult according to the needs expressed and identified. Receives: Other: Health e-coaching |
| Control group: Usual Care System | No intervention | Control group : - Referral to health professionals in the health care system and, in priority, to the GP declared by the young adult. - Transmission of the data collected during follow-up visit No. 3 / 0 (T3/T0) to the GP with relay for the implementation of a care plan. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of the corpulence determined from the body mass index [BMI]
Body Mass Index (BMI) indicates the ratio between your weight and your height in meters squared (kg/m^2)
Measured: Before and after intervention, an average of 1 year
Change of the eating behaviors
Diet, tobacco and alcohol consumption (food frequency questionnaire)
Measured: Before and after intervention, an average of 1 year
Change of the physical activity practices
Physical activity and sedentary behaviour (GPAQ)
Measured: Before and after intervention, an average of 1 year
Change of the Self-regulatory skills
Adaptation strategy (BriefCOPE)
Measured: Before and after intervention, an average of 1 year
Change of the Self Efficacy Diet
TESQ-E (Self-Efficacy Diet Questionnaire)
Measured: Before and after intervention, an average of 1 year
Secondary outcomes (3)
Level of satisfaction
Satisfaction questionnaire
Measured: Study completion, an average of 1 year
Change of the level of quality of Life
Questionnaire EQ-5D-5L
Measured: Before and after intervention, an average of 1 year
Change of the Knowledge on nutrition and physical activity
Questionnaire of knowledge on nutrition and physical activity
Measured: Before and after intervention, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start9 Jan 2023
- Primary completion9 Jan 2025 (estimated)
- Study completion9 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental group: health e-coaching Control group: standard care
- Masking
- None (open label)
- Enrolment
- 384 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lorraine, Cnam-ISTNA
- Responsible party
- Principal investigator, Yacoubou OMOROU, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05399407
- Sponsor's protocol ID
- 2021PI178
- Acronym
- PRALIMAPCINeCO
- Status last verified
- Oct 2023
- First submitted
- 3 May 2022
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial PRALIMAP-CINeCO: Comparison of Health E-coaching Versus Referral to the Usual Care System for Overweight and Obese Young Adults
- ClinicalTrials.gov ID
- NCT05399407
- Acronym / sponsor ID
- PRALIMAPCINeCO / 2021PI178
- Conditions
- Overweight and Obesity
- Keywords
- E-coaching, Usual Care System, young adults
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 384 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- University of Lorraine, Cnam-ISTNA
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 9 Jan 2025 (estimated)
- Study completion
- 9 Jan 2025 (estimated)
- First posted
- 1 Jun 2022 (actual)
- 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.
This study involves young adults from the PRALIMAP-INES trial and student volunteers from the University of Lorraine, who are overweight or obese.
For young adults from the PRALIMAP-INES trial, the proposed research is a continuation of the PRALIMAP-CINeCO research (part 1).
For students at the University of Lorraine, the proposed research is aimed at volunteer students who are overweight or obese, via the University of Lorraine's Student Health Service (SSE).
Young adults and overweight or obese students not receiving medical care at the time of the inclusion visit (4th measurement time for PRALIMAP-INES participants and 1st time for others) will be offered the chance to take part in a randomized trial comparing the acceptability of health e-coaching versus referral to standard care.
Experimental group: health e-coaching Control group: usual care system
Primary objective : To determine the effectiveness of an e-health coaching intervention using new technologies that promotes changes in eating and physical activity behavior in overweight and obese young adults aged 20, an intervention targeting the development of autonomous self-regulation.
Secondary objectives :
- Determine the acceptability of health e-coaching: acceptability of new technologies (container), acceptability of personalized health e-coaching (content).
- Determine the effectiveness of health e-coaching on the criteria of corpulence (BMI; body composition), changes in eating behaviors (TCA), emotion management skills and social interaction skills.
- Evaluate the benefit of health e-coaching alone or combined with the previous intervention received in the PRALIMAP-INÈS trial on primary and secondary endpoints.
- Evaluate and compare participation in a health promotion program over two life periods (adolescence and young adulthood) for young adults from the PRALIMAP-INÈS trial.
- Evaluate the effectiveness of health e-coaching (reinforcement of autonomous self-regulation and changes in eating behaviors and physical activity practices/time spent sitting) according to the dose of intervention received by young adults (received-treatment analysis).
- Determine the cost-efficiency and cost-utility ratios by means of a medico-economic evaluation based on the incremental cost of the e-coaching intervention in relation to the usual care offered by the health care system (ICER: Incremental Cost-Effectiveness Ratio).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Experimental group: health e-coaching Control group: standard care
| Arm | Type | Receives |
|---|---|---|
| Experimental group: health e-coaching | Experimental | Other: Health e-coaching* Personalised and secure access to the health e-coaching platform for 12 months. * Follow-up by professionals who are specialized in the subject matter (at a distance): a psychologist, a dietician and a teacher of adapted physical activity. * Personalised activities offered to each young adult throughout their follow-up: synchronous and asynchronous activities (video, animation, quizzes, etc.), individual and collective on different themes (expression of emotions, my weight and me, eating well to start with, my image and me, making choices, my way of moving, etc.). The personalisation of the activities will be done in consultation between the professionals and the young adult according to the needs expressed and identified. |
| Control group: Usual Care System | No intervention | –Control group : - Referral to health professionals in the health care system and, in priority, to the GP declared by the young adult. - Transmission of the data collected during follow-up visit No. 3 / 0 (T3/T0) to the GP with relay for the implementation of a care plan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Among the young adults who agreed to participate in follow-up visit (T3) in the PRALIMAP-CINeCO trial (Part 1), the inclusion criteria for the inclusion criteria for the proposed research are as follows:
- Person having received complete information on the organization of the research and not and who did not object to their participation and to the use of their data to participate and to use their data
- Have agreed to complete the pre-test questionnaire prior to/at the follow-up visit (T3)
- Have agreed to the anthropometric measurements without invasive intervention performed at the follow-up visit (Q3)
- Have a BMI greater than 25kg/m² (Cole et al. 2000) or a percentage of body fat mass greater than or equal to 20% for men and greater than or equal to 33% for women, depending on age and greater than or equal to 33% for women and not receiving medical medical care for this situation
Key exclusion criteria (6 listed)
- If the follow-up visit n°3 (T3) during the PRALIMAP-CINeCO trial (1st part) or the inclusion visit (T0 for University of Lorraine students), was completed, the non-inclusion criteria for the referral of young adults young adults (health e-coaching/current care) are as follows:
- Do not feel the need for coaching
- Be already being treated for overweight by a health professional specializing in the treatment of specialized in the treatment of overweight and obesity or a specialized specialized medical structure/service
- Do not agree to participate in the continuation of PRALIMAP-CINeCO
- Major person under a legal protection measure (guardianship, curatorship, safeguard of justice)
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 |
|---|---|---|
| Health e-coachingManagement of overweight / obesity | Other | Experimental group: health e-coaching |
Primary outcome
Evolution of the corpulence determined from the body mass index [BMI]
Time frame: Before and after intervention, an average of 1 year
Body Mass Index (BMI) indicates the ratio between your weight and your height in meters squared (kg/m^2)
Change of the eating behaviors
Time frame: Before and after intervention, an average of 1 year
Diet, tobacco and alcohol consumption (food frequency questionnaire)
Change of the physical activity practices
Time frame: Before and after intervention, an average of 1 year
Physical activity and sedentary behaviour (GPAQ)
Change of the Self-regulatory skills
Time frame: Before and after intervention, an average of 1 year
Adaptation strategy (BriefCOPE)
Change of the Self Efficacy Diet
Time frame: Before and after intervention, an average of 1 year
TESQ-E (Self-Efficacy Diet Questionnaire)
3 secondary outcomes
Level of satisfaction
Time frame: Study completion, an average of 1 year
Change of the level of quality of Life
Time frame: Before and after intervention, an average of 1 year
Change of the Knowledge on nutrition and physical activity
Time frame: Before and after intervention, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health e-coaching in people with Overweight and Obesity, run by Central Hospital, Nancy, France 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 20 inclusion and 6 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 5 Oct 2023. 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 Yacoubou OMOROU (0383859303, Y.OMOROU@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of the corpulence determined from the body mass index [BMI] (time frame: Before and after intervention, an average of 1 year). The study lists 5 primary outcomes in all. 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 5 Oct 2023.