Overweight and ObesityCOGNI-OBNCT03749772
Cognitive Therapy Plus Dietary Intervention for Obesity Treatment
A study testing Cognitive Training in people with Overweight and Obesity, run by Universidad Católica San Antonio de Murcia.
Trial summary
This randomized clinical trial was carried out from January 2017 to December 2017 at the facilities of the Catholic University of Murcia. Written informed consent was required from each patient. The protocols of the present clinical trial follow the CONSORT standards. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Cognitive Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2016to 28 Feb 2017
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Present a BMI> 27 kg / m2, and want to be part of the study voluntarily
Who cannot join
- subjects with diabetes mellitus type 2
- subjects with a history of a cardiovascular event (acute myocardial infarction, intermittent claudication, etc.)
- subjects with kidney or liver failure or some other significant pathology (cancer)
- subjects under pharmacological treatment that could affect body weight (corticoids, thyroxine, etc.)
- subjects who were on a diet or had been on a diet at least 6 months before their participation in the study were also excluded.
About this study
Official title: Effectiveness of a Cognitive Training Therapy for Overweight/Obesity Treatment: A Randomized Clinical Trial.
This randomized clinical trial was carried out from January 2017 to December 2017 at the facilities of the Catholic University of Murcia. Written informed consent was required from each patient. The protocols of the present clinical trial follow the CONSORT standards. To measure the impact of cognitive training on weight loss in overweight / obese subjects, a double-blind study (de facto masking) was designed.
Both the participants and the statistical assessors were unaware of the study hypothesis. Participants were unaware of treatments and possible assignments between groups, and only those subjects who were randomly assigned to the cognitive training group were informed that such training was part of dietary therapy.
Read more
The principal investigator of the present study (J.J.H.M.) carried out the randomization, with the assistance of the Microsoft Excell program, with the help of a macro designed in Visual Basic® for that purpose.
The randomization divided the subjects into two groups, as they were treated with a hypocaloric diet plus 12 nutrition education sessions (CONTROL group) or a group that were treated with a hypocaloric diet plus 12 sessions of cognitive training (COGNITIVE group).
In order to obtain a similar size in both groups, a randomization in blocks with a 1: 1 allocation ratio was performed.
Cognitive performance measures were performed before and after training. One week before the beginning of the cognitive and dietary intervention, the participants performed a series of cognitive tests. After 12 weeks of both dietary and cognitive intervention, participants were reexamined to measure performance on neurocognitive tests.
- Conditions
- Overweight and Obesity
- Being tested
- Cognitive Training
- Keywords
- obesity, cognitive therapy, executive function
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive TrainingBehavioural
Also called Cognitive Rehabilitation Therapy, Executive Function Training
The intervention was carried out with the PC game Brain Exercise TM (Bandai Namco Games Ltd.). Participants held the training sessions on an HP 250 G3 Notebook PC (Windows 10), with a 15-inch screen, and a resolution of 1366x768x40 Hz. The performance achieved by each participant in each session was recorded to analyze the evolution of the subjects. The participants made a total of 12 practice exercises, which implies approximately 30 minutes of duration per session.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive | Experimental | The participants of the COGNITIVE group performed cognitive training during 12 sessions during the 3 months of hypocaloric treatment. The training was carried out with the PC game Brain Exercise TM (Bandai Namco Games Ltd.). The participants made a total of 12 practice exercises, which implies approximately 30 minutes of duration per session. Receives: Behavioral: Cognitive Training |
| Control | No intervention | As a control group, we used nutrition education sessions of approximately the same duration (30 min) where we simply reinforced the knowledge that was already provided during the sessions with the patient, such as concepts about the balanced diet, nutrient composition and micronutrients, etc. The objective of this control group was to avoid the effect of time with the researcher. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total weight loss percentage
Percentage of weight loss from baseline measurement to the end-of-treatment weight, calculated as (baseline weight - weight at week 12)/baseline weight * 100
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2018
- Study start1 Feb 2016
- Primary completion21 Dec 2016
- Study completion28 Feb 2017
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Jose Hernández Morante, Universidad Católica San Antonio de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03749772
- Sponsor's protocol ID
- PMAFI14/12-2
- Acronym
- COGNI-OB
- Status last verified
- Nov 2018
- First submitted
- 20 Nov 2018
- Last updated
- 21 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Cognitive Training Therapy for Overweight/Obesity Treatment: A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT03749772
- Acronym / sponsor ID
- COGNI-OB / PMAFI14/12-2
- Conditions
- Overweight and Obesity
- Keywords
- obesity, cognitive therapy, executive function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 21 Dec 2016 (actual)
- Study completion
- 28 Feb 2017 (actual)
- First posted
- 21 Nov 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 randomized clinical trial was carried out from January 2017 to December 2017 at the facilities of the Catholic University of Murcia. Written informed consent was required from each patient. The protocols of the present clinical trial follow the CONSORT standards. To measure the impact of cognitive training on weight loss in overweight / obese subjects, a double-blind study (de facto masking) was designed.
Both the participants and the statistical assessors were unaware of the study hypothesis. Participants were unaware of treatments and possible assignments between groups, and only those subjects who were randomly assigned to the cognitive training group were informed that such training was part of dietary therapy.
The principal investigator of the present study (J.J.H.M.) carried out the randomization, with the assistance of the Microsoft Excell program, with the help of a macro designed in Visual Basic® for that purpose.
The randomization divided the subjects into two groups, as they were treated with a hypocaloric diet plus 12 nutrition education sessions (CONTROL group) or a group that were treated with a hypocaloric diet plus 12 sessions of cognitive training (COGNITIVE group).
In order to obtain a similar size in both groups, a randomization in blocks with a 1: 1 allocation ratio was performed.
Cognitive performance measures were performed before and after training. One week before the beginning of the cognitive and dietary intervention, the participants performed a series of cognitive tests. After 12 weeks of both dietary and cognitive intervention, participants were reexamined to measure performance on neurocognitive tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive | Experimental | Behavioral: Cognitive TrainingThe participants of the COGNITIVE group performed cognitive training during 12 sessions during the 3 months of hypocaloric treatment. The training was carried out with the PC game Brain Exercise TM (Bandai Namco Games Ltd.). The participants made a total of 12 practice exercises, which implies approximately 30 minutes of duration per session. |
| Control | No intervention | –As a control group, we used nutrition education sessions of approximately the same duration (30 min) where we simply reinforced the knowledge that was already provided during the sessions with the patient, such as concepts about the balanced diet, nutrient composition and micronutrients, etc. The objective of this control group was to avoid the effect of time with the researcher. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Present a BMI> 27 kg / m2, and want to be part of the study voluntarily
Key exclusion criteria (5 listed)
- subjects with diabetes mellitus type 2
- subjects with a history of a cardiovascular event (acute myocardial infarction, intermittent claudication, etc.)
- subjects with kidney or liver failure or some other significant pathology (cancer)
- subjects under pharmacological treatment that could affect body weight (corticoids, thyroxine, etc.)
- subjects who were on a diet or had been on a diet at least 6 months before their participation in the study were also excluded.
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 |
|---|---|---|
| Cognitive TrainingAlso: Cognitive Rehabilitation Therapy, Executive Function TrainingThe intervention was carried out with the PC game Brain Exercise TM (Bandai Namco Games Ltd.). Participants held the training sessions on an HP 250 G3 Notebook PC (Windows 10), with a 15-inch screen, and a resolution of 1366x768x40 Hz. The performance achieved by each participant in each session was recorded to analyze the evolution of the subjects. The participants made a total of 12 practice exercises, which implies approximately 30 minutes of duration per session. | Behavioural | Cognitive |
Primary outcome
Total weight loss percentage
Time frame: 12 weeks
Percentage of weight loss from baseline measurement to the end-of-treatment weight, calculated as (baseline weight - weight at week 12)/baseline weight * 100
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 21 Nov 2018.
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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 Cognitive Training in people with Overweight and Obesity, run by Universidad Católica San Antonio de Murcia.
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 1 inclusion and 5 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 21 Nov 2018. 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.
What does the primary outcome measure?
Total weight loss percentage (time frame: 12 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 21 Nov 2018.