Program for the Comprehensive Neurocognitive Treatment of Excess Weight

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

Interventions

BEHAVIORAL

Approach-Avoidance Bias Modification

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.

BEHAVIORAL

Inhibition Training

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.

BEHAVIORAL

Implementation of Intentions

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.

BEHAVIORAL

Episodic Future Thinking

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.

BEHAVIORAL

Sham Approach-Avoidance Bias Modification

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.

BEHAVIORAL

Sham Inhibition Treatment

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.

BEHAVIORAL

Setting Intentions

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.

BEHAVIORAL

Recent Episodic Thinking

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.

BEHAVIORAL

Motivational Interviewing

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.

BEHAVIORAL

Nutritional intervention

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.

BEHAVIORAL

Physical exercise intervention

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.

Sponsors & Collaborators

• Ministerio de Ciencia, Innovación y Universidades, Spain

  collaborator UNKNOWN

• Raquel Vilar López

  lead OTHER

Principal Investigators

• Raquel Vilar-López, Ph.D. · Universidad de Granada

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-03-08

Primary Completion

2022-12-22

Completion

2022-12-31

Countries

• Spain

Study Locations