Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06600100
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-04
Brief Title:
Inhibitory Control Training for Excess Weight Behavioural Cognitive and Anthropometric Changes
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Inhibitory Control Training for the Treatment of Excess Weight Behavioural Cognitive and Anthropometric Changes InhibeT
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
InhibeT
Brief Summary:
People with excess weight EW are characterized by high impulsivity high levels of craving for high-calorie foods deficits in inhibitory control and maladaptive decision-making The proposed intervention seeks to target these issues Thus the present study aims to determine the effectiveness of combining inhibitory control training with usual treatment diet and physical exercise in treating people with EW to produce cognitive behavioral and anthropometric changes Participants will be randomly allocated to one of two groups 1 the experimental group that would receive active inhibitory control training and 2 the active control group that will receive placebo inhibitory control training Both groups will receive individualized diet and physical exercise guidelines Training requires to inhibit responding to certain foods presented during computerized tasks Using a food GoNo-Go paradigm individuals are asked to press a button when a Go cue is presented next to an image and to refrain from pressing a button when a No-Go cue eg a bold frame is presented In the experimental group pictures of healthy and unhealthy foods are always paired with the Go and the No-Go signal respectively whereas in the control group healthy and unhealthy foods are paired 50 of the time with the Go and 50 with the No-Go signal It is hypothesized that the experimental intervention would be effective improving i Body Mass Index BMI ii food craving iii anthropometric measures waist circumference and waist-to-hip and waist-to-height ratios iv eating and physical exercise behaviors decreased caloric intake and increased frequency and time of physical activity v emotional symptoms and emotional eating depression anxiety emotional regulation emotional eating reward-related eating non-homeostatic eating and vi cognitive abilities motor and cognitive inhibition delay of gratification impulsivity working memory cognitive flexibility and decision making
Detailed Description:
1 HYPOTHESIS Inhibitory control training with the food GoNoGo paradigm will be effective in treating people with EW Thus the active intervention compared to the placebo will achieve i decreased BMI ii decreased craving iii improved anthropometric measures waist circumference and waist-to-hip and waist-to-height ratios iv improved eating and exercise behaviors decreased caloric intake increased frequency and time of physical activity v improved emotional symptoms and emotional eating depression anxiety emotional regulation emotional eating reward-related eating non-homeostatic eating vi improved cognitive abilities motor and cognitive inhibition delay of gratification impulsivity working memory cognitive flexibility and decision making
GENERAL OBJECTIVE To determine the effectiveness of inhibitory control training for the treatment of people with EW improvements in BMI craving anthropometric measures food and physical exercise behaviours emotional symptoms and emotional eating and cognitive measures
2 METHODOLOGY
21 Design Randomized controlled trial of parallel groups The sample size calculation was performed with the GPower 31 tool To do so it will be relied on the only study to date that applied food GoNoGo training 4 sessions in one week on a median effect size for reducing BMI post-treatment Cohens d 057 and at 6-month follow-up Cohens d 048 Thus considering a median effect size for conducting ANOVAs f 025 the minimum recommended N to reach a power of 080 assuming an alpha level of 005 with two groups and three repeated measures was 44 participants 22 per group Nevertheless a conservative approach will be adopted and decided to increase groups to 27 participants
The participants N54 will be randomly allocated to two groups i experimental group active inhibitory control training n27 and ii active control group placebo inhibitory control training n27
23 Interventions
Pre-treatment sessions information dietary plus physical guidelines all groups
First all participants will participate in a group briefing informational session about the procedure and rationale of the study that will last about an hour Also informative videos and brochures will be provided There will be two 90-minute sessions afterwards given by a nutritionist and personal trainer respectively to provide individualized diet and physical exercise instructions to all participants
Cognitive interventions both groups Duration 2 weeks in which participants should train from monday to friday for 10 minutes with the active or the placebo version of the Food Trainer App FoodT with their smart phones
24 Outcome measures change in Body Mass Index BMI will be the main outcome measure Secondary outcomes will be changes in food craving anthropometric measures eating and physical activity behaviours emotional symptoms and emotional eating and cognitive measures Screening and descriptive measured will include a sociodemographic questionnaire depression and anxiety questionnaires motivation and questionnaire on Eating and Weight Patterns-5
3 PROCEDURE The whole study will be delivered online Inclusion and exclusion criteria will be checked through the data collected in a questionnaire of sociodemographic and clinical variables Further psychopathology exclusion criteria will be tested with three questionnaires to measure depression anxiety and stress symptoms as well as binge eating and bulimia BDI DASS-21 and QEWP-5 and a short clinical interview by phone andor information requested by email in those cases where there are doubts about any of the aspects collected through the online instruments
All candidates who meet the criteria will attend an information meeting about the project in which participants will receive written and oral information and will be asked for their informed consent Then participants will be randomly assigned to groups before the pre-treatment assessment sessions Both groups of the study experimental and active control will complete pre and post assessments as well as the 3-month follow-up see below What will differentiate the groups will be therefore the treatment active vs placebo inhibitory control training If at the end of the project the active training has proven to be effective the control group will be offered the possibility to carry out the active training
All sessions will be developed in groups of 4-6 people There will be at least 5 groups of intervention sessions 27 participants and 5 groups for the placebo condition 27 participants The program will comprise 6 weeks including three assessments pre post and 3-month follow-up two FoodT training weeks as well as the information and nutrition and exercise sessions Assessment sessions will last about 2 hours each while the inhibitory control training will last 10 minutes per day
1 Informative session session 1 week 1 For the participants to understand the foundation of the intervention information about the aims basis of the project and the procedure of the research will be given Participants will be provided written informed consent as well At the end of this session participants will be asked for their informed written consent
2 Pre-treatment assessment session 2 week 2 All participants will complete the following instruments to assess the main and secondary outcomes and the exploratory and economic measures WCST Food GoNoGo IGT Stroop Food DD N-Back FCQ-S-r CFA IPAQ DASS-21 BDI-II PEMS RED DEBQ PSRSQ ERQ UPPS-P SF-36 SOCRATES 00 QEWP-5 sociodemographic questionnaire another one about used health resources stigma and previous treatments questions
3 Nutrition and exercise sessions session 3 week 3 Participants will receive information on healthy nutritional PhD Nutritionist and physical exercise PhD Sports Science professional habits In addition participants will receive individualized diet and physical exercise guidelines and participants will be able to consult any doubts to both professionals through WhatsApp groups
4 Training sessions sessions 4 to 14 weeks 4 and 5 A daily reminder will be sent by WhatsApp to the participants phone to train from Monday to Friday during 10 minutes for two weeks The FoodT app will be used to pair high-calorie meals with the no-go cue Images can appear on the left right or center of the screen and should be tapped or not depending on whether the image has a green or red circle around them Participants earn points for correct tapping responses and lose points for incorrect tapping responses and must respond as quickly and accurately as possible The placebo FoodT has images of objects rather than food
5 Post-treatment assessment session 15 week 6 To evaluate the effectiveness of the interventions BMI and the following instruments will be administered to obtain the main and secondary outcomes FCQ-TS-r WCST Food GoNoGo IGT Stroop Food DD N-Back CFA IPAQ DASS-21 BDI-II PEMS RED DEBQ PSRSQ ERQ UPPS-P SF-36 and a questionnaire about used health resources
6 Follow-up session 16 week 18 Follow-up at 3 months after the intervention will include the following measures FCQ-TS-r WCST Food GoNoGo IGT Stroop Food DD N-Back FCQ-S-r CFA IPAQ DASS-21 BDI-II PEMS RED DEBQ PSRSQ ERQ UPPS-P SF-36 and a questionnaire about used health resources Anthropometric measures will be repeated as well Every month after the end of the treatment participants will be contacted by email and mobile message to maintain adherence
GENERAL OBJECTIVE To determine the effectiveness of inhibitory control training for the treatment of people with EW improvements in BMI craving anthropometric measures food and physical exercise behaviours emotional symptoms and emotional eating and cognitive measures
2 METHODOLOGY
21 Design Randomized controlled trial of parallel groups The sample size calculation was performed with the GPower 31 tool To do so it will be relied on the only study to date that applied food GoNoGo training 4 sessions in one week on a median effect size for reducing BMI post-treatment Cohens d 057 and at 6-month follow-up Cohens d 048 Thus considering a median effect size for conducting ANOVAs f 025 the minimum recommended N to reach a power of 080 assuming an alpha level of 005 with two groups and three repeated measures was 44 participants 22 per group Nevertheless a conservative approach will be adopted and decided to increase groups to 27 participants
The participants N54 will be randomly allocated to two groups i experimental group active inhibitory control training n27 and ii active control group placebo inhibitory control training n27
23 Interventions
Pre-treatment sessions information dietary plus physical guidelines all groups
First all participants will participate in a group briefing informational session about the procedure and rationale of the study that will last about an hour Also informative videos and brochures will be provided There will be two 90-minute sessions afterwards given by a nutritionist and personal trainer respectively to provide individualized diet and physical exercise instructions to all participants
Cognitive interventions both groups Duration 2 weeks in which participants should train from monday to friday for 10 minutes with the active or the placebo version of the Food Trainer App FoodT with their smart phones
24 Outcome measures change in Body Mass Index BMI will be the main outcome measure Secondary outcomes will be changes in food craving anthropometric measures eating and physical activity behaviours emotional symptoms and emotional eating and cognitive measures Screening and descriptive measured will include a sociodemographic questionnaire depression and anxiety questionnaires motivation and questionnaire on Eating and Weight Patterns-5
3 PROCEDURE The whole study will be delivered online Inclusion and exclusion criteria will be checked through the data collected in a questionnaire of sociodemographic and clinical variables Further psychopathology exclusion criteria will be tested with three questionnaires to measure depression anxiety and stress symptoms as well as binge eating and bulimia BDI DASS-21 and QEWP-5 and a short clinical interview by phone andor information requested by email in those cases where there are doubts about any of the aspects collected through the online instruments
All candidates who meet the criteria will attend an information meeting about the project in which participants will receive written and oral information and will be asked for their informed consent Then participants will be randomly assigned to groups before the pre-treatment assessment sessions Both groups of the study experimental and active control will complete pre and post assessments as well as the 3-month follow-up see below What will differentiate the groups will be therefore the treatment active vs placebo inhibitory control training If at the end of the project the active training has proven to be effective the control group will be offered the possibility to carry out the active training
All sessions will be developed in groups of 4-6 people There will be at least 5 groups of intervention sessions 27 participants and 5 groups for the placebo condition 27 participants The program will comprise 6 weeks including three assessments pre post and 3-month follow-up two FoodT training weeks as well as the information and nutrition and exercise sessions Assessment sessions will last about 2 hours each while the inhibitory control training will last 10 minutes per day
1 Informative session session 1 week 1 For the participants to understand the foundation of the intervention information about the aims basis of the project and the procedure of the research will be given Participants will be provided written informed consent as well At the end of this session participants will be asked for their informed written consent
2 Pre-treatment assessment session 2 week 2 All participants will complete the following instruments to assess the main and secondary outcomes and the exploratory and economic measures WCST Food GoNoGo IGT Stroop Food DD N-Back FCQ-S-r CFA IPAQ DASS-21 BDI-II PEMS RED DEBQ PSRSQ ERQ UPPS-P SF-36 SOCRATES 00 QEWP-5 sociodemographic questionnaire another one about used health resources stigma and previous treatments questions
3 Nutrition and exercise sessions session 3 week 3 Participants will receive information on healthy nutritional PhD Nutritionist and physical exercise PhD Sports Science professional habits In addition participants will receive individualized diet and physical exercise guidelines and participants will be able to consult any doubts to both professionals through WhatsApp groups
4 Training sessions sessions 4 to 14 weeks 4 and 5 A daily reminder will be sent by WhatsApp to the participants phone to train from Monday to Friday during 10 minutes for two weeks The FoodT app will be used to pair high-calorie meals with the no-go cue Images can appear on the left right or center of the screen and should be tapped or not depending on whether the image has a green or red circle around them Participants earn points for correct tapping responses and lose points for incorrect tapping responses and must respond as quickly and accurately as possible The placebo FoodT has images of objects rather than food
5 Post-treatment assessment session 15 week 6 To evaluate the effectiveness of the interventions BMI and the following instruments will be administered to obtain the main and secondary outcomes FCQ-TS-r WCST Food GoNoGo IGT Stroop Food DD N-Back CFA IPAQ DASS-21 BDI-II PEMS RED DEBQ PSRSQ ERQ UPPS-P SF-36 and a questionnaire about used health resources
6 Follow-up session 16 week 18 Follow-up at 3 months after the intervention will include the following measures FCQ-TS-r WCST Food GoNoGo IGT Stroop Food DD N-Back FCQ-S-r CFA IPAQ DASS-21 BDI-II PEMS RED DEBQ PSRSQ ERQ UPPS-P SF-36 and a questionnaire about used health resources Anthropometric measures will be repeated as well Every month after the end of the treatment participants will be contacted by email and mobile message to maintain adherence
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None