Program for the Comprehensive Neurocognitive Treatment of Excess Weight

NCT05158075 | Completed

• 1 other identifier: RTI2018-098771-B-I00
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The present study aims to determine the effectiveness of a comprehensive neurocognitive program for the treatment of excess weight. The program will include sessions to improve multiple cognitive processes implicated in weight gain and obesity. These cognitive processes include approach-avoidance bias, inhibition control, implementation intentions and episodic future thinking. Participants will be randomly allocated to one of three groups: 1) the experimental group will receive active neurocognitive sessions, 2) an active control group that will receive sham sessions and 3) a usual treatment control group. All three groups will receive a motivational interviewing session, along with personalized diet and physical exercise recommendations. We hypothesized that the neurocognitive program will decrease body mass index in people with overweight and obesity. In addition, the neurocognitive program will improve other anthropometric measures (waist circumference, waist-to-hip and waist-to-height ratios), lifestyle behaviors (eating behavior and physical activity), as well as cognitive processes (approach-avoidance bias, food inhibition, food liking and delay of gratification). Finally, the program will show its efficiency in the economic balance of cost-effectiveness and cost-utility.

Conditions

Obesity; Overweight

Keywords

Excess weight; Obesity; Overweight; Neurocognitive training

Outcome Measures

Primary Outcomes (1)

• Mean change from baseline in Body Mass Index at post-intervention and follow-ups

  Body mass index (BMI) is a measure of body fat based on height and weight. The BMI is defined as the body mass divided by the square of the body height, and is expressed in units of kg/m\^2. Height and weight will be obtained with a pharmacy digital weight.

  Through study completion (8 months)

Secondary Outcomes (15)

• Mean change from baseline in the Approach-avoidance bias on the Tilt Task app at 1 week

  Counterbalanced week 3 or 6 (days 1 and 7)

• Mean change from baseline in food inhibitory control on the Food Training app at 1 week

  Counterbalanced week 4 or 7 (days 1 and 7)

• Mean change from baseline in food choice at post-intervention

  Baseline (week 1), intermediate assessment (week 5) and post-treatment assessment (week 8)

• Mean change from baseline in food liking at post-intervention

  Baseline (week 1), intermediate assessment (week 5) and post-treatment assessment (week 8)

• Mean change from baseline in delay of gratification on Now or Later at 1 week

  Counterbalanced week 6 or 3 (days 1 and 7)

Study Arms (3)

Neurocognitive training

EXPERIMENTAL

The experimental group will: i) receive three pre-treatment group sessions (Motivational Interviewing, nutrition and physical exercise); ii) receive an individualized diet and physical exercise planning for 6 weeks; iii) participate in 4 weekly group neurocognitive intervention sessions, that will last about 60-90 minutes each. Two neurocognitive sessions are intended to train impulsivity, and the other two neurocognitive sessions will focus on reflexive training. Participants will practice the content of each session daily at home.

Behavioral: Approach-Avoidance Bias Modification; Behavioral: Inhibition Training; Behavioral: Implementation of Intentions; Behavioral: Episodic Future Thinking; Behavioral: Motivational Interviewing; Behavioral: Nutritional intervention; Behavioral: Physical exercise intervention

Sham cognitive training

SHAM COMPARATOR

The active control group will: i) receive three pre-treatment group sessions (Motivational Interviewing, nutrition and physical exercise); ii) receive an individualized diet and physical exercise planning for 6 weeks; iii) participate in 4 weekly group sessions of sham intervention that mimic the neurocognitive sessions of the experimental group. Two neurocognitive sessions are intended to train impulsivity, and the other two neurocognitive sessions will focus on reflexive training. Participants will practice the content of each session daily at home.

Behavioral: Sham Approach-Avoidance Bias Modification; Behavioral: Sham Inhibition Treatment; Behavioral: Setting Intentions; Behavioral: Recent Episodic Thinking; Behavioral: Motivational Interviewing; Behavioral: Nutritional intervention; Behavioral: Physical exercise intervention

Control

OTHER

Participants in the control group will receive three pre-treatment group sessions (Motivational Interviewing, nutrition and physical exercise) and will receive an individualized diet and physical exercise planning for 6 weeks.

Behavioral: Motivational Interviewing; Behavioral: Nutritional intervention; Behavioral: Physical exercise intervention

Interventions

Approach-Avoidance Bias Modification BEHAVIORAL

In this task participants must zoom in or zoom out a food image according to its format (vertical or horizontal) using their smartphone device. 90% of healthy food images will appear in the format to be approached (for example, vertical), while only 10% of unhealthy images will appear in that format (to ensure concentration on the task). The format to be approached will be counterbalanced. Participants will practice the task at home at least once a day (about 5 minutes) for one week, and will receive daily reminders to practice via instant messaging on their mobile phones.

Also known as: Tilt Task

Neurocognitive training

Inhibition Training BEHAVIORAL

In this App participants are instructed to touch green circle items as quickly as possible, but to withhold their response and not to press on the red circle items, using their smartphone device. Some images are food, some non-foods. Participants can choose which food categories they would like to train to resist. The food-specific inhibition training condition included pictures of high-calorie foods always paired with the no-go signal. Participants will practice the task at least once a day (about 5 minutes) for one week, and will receive daily reminders to practice via instant messaging on their mobile phones.

Also known as: Food Trainer

Neurocognitive training

Implementation of Intentions BEHAVIORAL

Participants establish one intention related to food and one related to exercise, and write when, where and how they will implement each one, possible inconveniences to do it, and how they will overcome them. Furthermore, motivational cues (why I eat) will be considered (negative emotions -I'm bored; social motives -eat a piece of cake you are offered in a party; politeness/conformity with others' expectations; pleasure). The implementation of intentions related to food will be written in format: "if… then…". This format allows for the consideration of the health goals and medium and long-term objectives for each of the participants. The intention related to food will focus on unhealthy snacking habits whenever possible. Participants will read and visualized their implementation of intentions at least twice a day (about 5 minutes) for one week, and will receive two daily reminders to practice via instant messaging on their mobile phones.

Neurocognitive training

Episodic Future Thinking BEHAVIORAL

Participants will decide health-related goals and anticipate positive future personal events at various time points (next month, 2-3 months and 4-6 months), from which contextual, temporal and emotional cues should be obtained. Goals and future events will be matched to generate episodic future thinking cues that include the necessary keys to facilitate their effectiveness. Participants will read and visualized their three cues at least twice a day (about 5 minutes) for one week, and will receive two daily reminders to practice via instant messaging on their mobile phones.

Neurocognitive training

Sham Approach-Avoidance Bias Modification BEHAVIORAL

Participants must zoom in or zoom out a food image according to the format (vertical or horizontal) using their smartphone device. 50% of healthy food images and 50% of unhealthy food images will appear in the format to be approached (for example, vertical). The format to be approached will be counterbalanced. Participants will practice the task at least once a day (about 5 minutes) for one week, and will receive daily reminders to practice via instant messaging on their mobile phones.

Also known as: Sham Tilt Task

Sham cognitive training

Sham Inhibition Treatment BEHAVIORAL

In this App participants are instructed to touch green circle items as quickly as possible, but to withhold their response and not to press on the red circle items, using their smartphone devices. Some images are food, some non-foods. Participants can choose which food categories they would like to resist. High-calorie and low-calorie foods will be paired with the go signal on 50% of trials and with the no-go signal on 50% of trials. Participants will practice the task at least once a day (about 5 minutes) for one week, and will receive daily reminders to practice via instant messaging on their mobile phones.

Also known as: Sham Food Trainer

Sham cognitive training

Setting Intentions BEHAVIORAL

Participants will choose 10 items of healthy foods to eat whenever they want to eat unhealthy food. They will also order a list of physical activities that they could do to lose weight. Participants will read their lists (food and exercise) at least twice a day (about 5 minutes) for one week, and will receive two daily reminders to practice via instant messaging on their mobile phones.

Sham cognitive training

Recent Episodic Thinking BEHAVIORAL

Participants will match habits and positive recent past events (1 day ago, 2 days ago, 1 week ago), both unrelated to food or physical activity, to establish their cues. Participants will read and visualized their three cues at least twice a day (about 5 minutes) for one week, and will receive two daily reminders to practice via instant messaging on their mobile phones.

Sham cognitive training

Motivational Interviewing BEHAVIORAL

Participants will assist a 90-minute group Motivational Interviewing session to maximize motivation and adherence to the program. The session will be guided through open questions and empathic reflections and affirmations to promote change talk. Participants will share their personal aims to reduce weight, improve their diet and increase their level of physical activity. Further, participants will talk about obstacles they have had on previous occasions, their expectations, and their motivations in regards to weight loss. When needed, information will be provided with the elicit-provide-elicit format. Sessions will end with an individual empathic summary for each participant's interventions.

Control; Neurocognitive training; Sham cognitive training

Nutritional intervention BEHAVIORAL

Participants will maintain a 60-minute group session with a nutritionist and will watch a 20-minute video to match and complete relevant information on nutrition. The nutritionist will design a 6-week individualized diet that participants will receive after the initial assessment. When the 6-week diet ends, participants will assist another 60-minute group session with the nutritionist and will watch another video intended to teach them how to design their own healthy diet and maintain long-term healthy eating habits.

Control; Neurocognitive training; Sham cognitive training

Physical exercise intervention BEHAVIORAL

Participants will maintain a 60-minute group session with a physical exercise professional and will watch a 20-minute video to match and complete relevant information on exercise. The physical exercise professional will design a 6-week physical exercise planning that participants will receive after the initial assessment. After those 6-weeks, participants will assist another 60-minute group session with the physical exercise professional and will watch another video intended to teach them how to design their own physical activity planning and maintain long-term healthy exercise habits.

Control; Neurocognitive training; Sham cognitive training

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI between 25 and 39.9
• Age between 18 and 55 years
• Good command of the Spanish language
• Have at least two electronic devices available, one of them a smartphone with a gyroscope

You may not qualify if:

• Traumatic, digestive, metabolic or systemic disorders that affect the central nervous system, autonomic or endocrine
• Cardiovascular or any other disorders that prevent physical exercise
• Psychopathological disorders or presence of severe symptoms in the Depression Anxiety and Stress Scale-21 (DASS-21)
• Eating disorders or presence of criteria in the Questionnaire on Eating and Weight Patterns-5 (QEWP-5)
• Pharmacological or any other kind of treatment for losing weight at present
• Candidates for bariatric surgery
• Food conditions that could interfere with the stimulus of the program (allergies, spru, vegetarianism, veganism)
• Current pregnancy or breastfeeding (or expected pregnancy in the following six months)
• Weight loss \>5% on the 3 months previous to the program
• Use of medication that affects weight
• Frequent use of alcohol or other drugs that affects food intake.

Sponsors & Collaborators

• Raquel Vilar López: lead
• Ministerio de Ciencia, Innovación y Universidades, Spain: collaborator

Study Sites (1)

Mind, Brain and Behavior Research Center at University of Granada (CIMCYC-UGR)

Granada, 18071, Spain

Location

Related Publications (1)

• Gonzalez-Gonzalez R, Solier-Lopez L, Vilar-Lopez R, Verdejo-Garcia A, Navarro-Perez CF, Caracuel A. Online Mental Contrasting with Implementation Intentions for changing snacking behavior and reducing body mass index in people with excess weight: a randomized controlled trial. Appetite. 2025 Oct 1;214:108209. doi: 10.1016/j.appet.2025.108209. Epub 2025 Jun 26.

  PMID: 40581182 DERIVED

Related Links

• Web of the project

MeSH Terms

Conditions

Obesity; Overweight

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Raquel Vilar-López, Ph.D.

  Universidad de Granada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The psychologists that conduct the assessments (screening, assessment sessions and follow-ups) will be blinded to the group allocation during the whole project. Moreover, since all assessments will be computerized and online, they are not subject to the biases of the evaluator. Further, all participants will be blind to their condition. Also, the people who perform the statistical analyses will be blind to the condition of the groups, through the coding of the interventions. Only the therapist performing the interventions will not be blind to the allocation of the participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Parallel group randomized controlled trial

Study Record Dates

• First Submitted: November 17, 2021
• First Posted: December 15, 2021
• Study Start: March 8, 2021
• Primary Completion: December 22, 2022
• Study Completion: December 31, 2022
• Last Updated: October 26, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available beginning 3 months and ending 5 years following article publication.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee and who provide a methodologically sound proposal. Proposals should be directed to rvilar@ugr.es

Locations

ES (1)