ObesityNCT03484637
Response Evolution Chart
An observational study of Obesity and Overweight, run by BiomediKcal at 1 site in Colombia.
Trial summary
This study evaluates patient response to a motivation evolution chart for a medical-nutrition intervention as a continuation of a previous study: adherence to an overweight and obesity treatment available at: https://www.ncbi.nlm.nih.gov/pubmed/25101227 Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight, Motivation
- What is being tested?
- Lifestyle-medicine intervention
- How many people
- 110 participants
- Where
- 1 siteColombia
- Study dates
- 14 Oct 2016to 24 Mar 2018
- How long will I take part?
- 16 Weeks
- Phase
- Observational
- 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Overweight and obese participants who consulted a medical nutrition clinic
Who may be able to join
- Voluntary assistance
- Clinical diagnosis of overweight
- Clinical diagnosis of obesity
- Patient desire to improve their aesthetic image and health status
Who cannot join
- This study does not consider patients who tried a diet to lose weight in the previous month or earlier
Trial locations and contacts
1 site in 1 country.
Colombia1 site
BiomediKcal - Advanced Medical Nutrition & Lifestyle Center
Barranquilla, Atlántico, 080020
About this study
Official title: Adherence to an Overweight and Obesity Treatment: the Evolution Chart
This study evaluates patient response to a motivation evolution chart for a medical-nutrition intervention as a continuation of a previous study: adherence to an overweight and obesity treatment available at: https://www.ncbi.nlm.nih.gov/pubmed/25101227
- Conditions
- Obesity, Overweight, Motivation, Adherence, Patient
- Being tested
- Lifestyle-medicine intervention
- Keywords
- motivation, Treatment adherence, Waist circumference, obesity, overweight
- Medical subject headings
- Obesity, Overweight, Patient Compliance, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle-medicine interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle-medicine intervention | Photographic follow-up every 4 weeks Receives: Other: Lifestyle-medicine intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution registration by photograph
To register Body Image of patients regarding results to a medical nutrition treatment
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2018
- Study start14 Oct 2016
- Primary completion15 Sep 2017
- Study completion24 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
- Target duration
- 16 Weeks
Sponsor and investigators
- Lead sponsor
- BiomediKcal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03484637
- Sponsor's protocol ID
- BCE25318
- Status last verified
- Mar 2018
- First submitted
- 25 Mar 2018
- Last updated
- 2 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kuzmar IE, Cortes-Castell E, Rizo M. Effectiveness of telenutrition in a women's weight loss program. PeerJ. 2015 Feb 3;3:e748. doi: 10.7717/peerj.748. eCollection 2015.
PubMed 25674363Kuzmar I, Cortes E, Rizo M. Age group, menarche and regularity of menstrual cycles as efficiency predictors in the treatment of overweight. Nutr Hosp. 2014 Oct 30;31(2):637-41. doi: 10.3305/nh.2015.31.2.7501.
PubMed 25617544Kuzmar I, Rizo M, Cortes-Castell E. Adherence to an overweight and obesity treatment: how to motivate a patient? PeerJ. 2014 Jul 29;2:e495. doi: 10.7717/peerj.495. eCollection 2014.
PubMed 25101227
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence to an Overweight and Obesity Treatment: the Evolution Chart
- ClinicalTrials.gov ID
- NCT03484637
- Acronym / sponsor ID
- BCE25318
- Conditions
- Obesity, Overweight, Motivation, Adherence, Patient
- Keywords
- motivation, Treatment adherence, Waist circumference, obesity, overweight
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- BiomediKcalUniversity, hospital or other
- Study start
- 14 Oct 2016 (actual)
- Primary completion
- 15 Sep 2017 (actual)
- Study completion
- 24 Mar 2018 (actual)
- First posted
- 2 Apr 2018 (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 evaluates patient response to a motivation evolution chart for a medical-nutrition intervention as a continuation of a previous study: adherence to an overweight and obesity treatment available at: https://www.ncbi.nlm.nih.gov/pubmed/25101227
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 16 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifestyle-medicine intervention | – | Other: Lifestyle-medicine interventionPhotographic follow-up every 4 weeks |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Overweight and obese participants who consulted a medical nutrition clinic
Key inclusion criteria (4 listed)
- Voluntary assistance
- Clinical diagnosis of overweight
- Clinical diagnosis of obesity
- Patient desire to improve their aesthetic image and health status
Key exclusion criteria (1 listed)
- This study does not consider patients who tried a diet to lose weight in the previous month or earlier
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 |
|---|---|---|
| Lifestyle-medicine intervention | Other | Lifestyle-medicine intervention |
Primary outcome
Evolution registration by photograph
Time frame: 16 weeks
To register Body Image of patients regarding results to a medical nutrition treatment
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 2 Apr 2018.
- Background: PubMed 25674363Kuzmar IE, Cortes-Castell E, Rizo M. Effectiveness of telenutrition in a women's weight loss program. PeerJ. 2015 Feb 3;3:e748. doi: 10.7717/peerj.748. eCollection 2015.
- Background: PubMed 25617544Kuzmar I, Cortes E, Rizo M. Age group, menarche and regularity of menstrual cycles as efficiency predictors in the treatment of overweight. Nutr Hosp. 2014 Oct 30;31(2):637-41. doi: 10.3305/nh.2015.31.2.7501.
- Results publication: PubMed 25101227Kuzmar I, Rizo M, Cortes-Castell E. Adherence to an overweight and obesity treatment: how to motivate a patient? PeerJ. 2014 Jul 29;2:e495. doi: 10.7717/peerj.495. eCollection 2014.
- Organization siteLink provided by the sponsor.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Overweight, run by BiomediKcal at 1 site in Colombia.
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 1 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 2 Apr 2018. 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 Colombia. 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?
Evolution registration by photograph (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03484637, which also lists 3 linked publications.
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 2 Apr 2018; AzTrials last refreshed its copy on 31 Oct 2026.