Solutions for Hunger And Regulating Eating

Overweight and Obesity Clinical Trial

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Official title:

Targeting Food Cue Responsiveness for Weight Loss

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05004883
• Other study ID #: 201362
• Secondary ID: R01DK122504
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: August 15, 2026

Study information

• Verified date: July 2023
• Source: University of California, San Diego
• Contact: Kaylen Moline, MPH
• Phone: 1-855-827-3498
• Email: chear[@]ucsd.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this proposed study is to collect efficacy data on ROC+ compared to an active comparator (AC) and to Behavioral Weight Loss (BWL) for participants who are high in Food Responsiveness.

Description:

The investigators have developed a new model for the treatment of obesity, called Regulation of Cues (ROC), which is based on Behavioral Susceptibility Theory. The ROC program targets two theorized mechanisms for overeating; decreased sensitivity to appetitive cues and increased sensitivity to external food cues. Considering that BWL has merit for some people, but fails to facilitate maintenance, this study will compare BWL, ROC with some aspects of BWL (ROC+) and an active comparator (AC). All treatment groups will be 1.5 hours (including weigh-ins) and will be provided in groups of 15-20 participants weekly for 4 months and twice a month for 2 months (total treatment duration = 6 months, 20 meetings). The investigators will recruit adults with overweight or obesity who are high in Food Responsiveness (FR) and will assess them at baseline, post-treatment (month 6), mid-follow-up (month 12) and follow-up (month 18).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: August 15, 2026
• Est. primary completion date: August 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• high Food Responsiveness

• BMI between 25kg/m^2 and 45kg/m^2

• able to read English at a 5th grade reading level

• willing and able to participate in assessment visits and treatment sessions, whether held in-person or via password protected Zoom meetings

• able to provide data through questionnaires

• has a smart phone through which they can complete Ecological Momentary Assessments

Exclusion Criteria:

• major medical conditions such as diabetes or recent history of coronary heart disease; symptoms of angina, stroke, osteoarthritis, osteoporosis, orthopedic problems that would limit activity during the following 18 months; or any other serious medical condition that would make physical activity unsafe

• bulimia or anorexia, significant cognitive impairment, a known psychotic disorder, acute suicidal ideation, moderate or severe alcohol or substance use disorder, or unstable psychiatric illness (e.g., recent psychiatric hospitalization in the past year)

• medical or psychological problems that could make adherence with the study protocol difficult or dangerous

• pregnant, lactating, or planning to become pregnant in the next 18 months

• participating in other weight control programs and/or taking medication for weight loss

• previous bariatric surgery

• moving out of the San Diego area for the duration of their study enrollment (18 months)

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

Intervention

Behavioral:
• Regulation of Cues Enhanced
ROC is based on the Behavioral Susceptibility Theory and designed to incorporate psychoeducation, cue-exposure treatment, appetite awareness training, coping skills, and self-monitoring of satiety and cravings to treat high Food Responsiveness and low Satiety Responsiveness. BWL and ROC will be integrated for this arm, to capitalize on the strengths of both treatments. All participants will be taught to decrease caloric intake and increase physical activity, and to use all of the behavioral skills provided in BWL. However, they will also be taught models of hunger and satiety and about food cue reactivity, and will learn skills to manage these. This arm will include an experiential component, including hunger monitoring during dinner and participating in exposure exercises.
• Behavioral Weight Loss
The BWL program includes dietary, physical activity, and behavioral change recommendations. All participants will be instructed on how to consume a balanced deficit diet of conventional foods; individual goals for energy intake will be based on initial body weight. Participants will be instructed in measuring portion sizes, counting calories, and self-monitoring food intake. The physical activity program will focus on increasing both lifestyle activity and structured exercise programs. Behavior change recommendations include stimulus control, self-monitoring, goal setting, managing high-risk situations, meal planning, slowing eating, problem solving, social support, cognitive restructuring, lapse and relapse prevention skills, and maintaining weight loss.
• Nutrition Education, Stress Management and Social Support
Topics included will be stress management/relaxation, social support, and nutrition education. There will be a strong mindfulness component to this group.

Locations

Country	Name	City	State
United States	UCSD Center for Healthy Eating and Activity Research (CHEAR)	La Jolla	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Diego	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Body Mass Index	Body Mass Index as measured by height and weight	Change from baseline at an average of 6 months, 9 months, 12 months, 15 months, and 18 months
Secondary	Change in Food Responsiveness As Measured by the FR Scale of the AEBQ	The Adult Eating Behavior Questionnaire (AEBQ) assesses appetitive traits, including food responsiveness, hunger, and satiety responsiveness. We will use the food responsiveness (FR) scale to measure participants' food responsiveness at a given time point. The score for the FR scale ranges from 4-20, with higher scores indicating higher food responsiveness, and lower scores indicating lower food responsiveness.	Change from baseline at an average of 6 months, 12 months, and 18 months
Secondary	Change in Satiety Responsiveness As Measured by the SR Scale of the AEBQ	The Adult Eating Behavior Questionnaire (AEBQ) assesses appetitive traits, including food responsiveness, hunger, and satiety responsiveness. We will use the satiety responsiveness (SR) scale to measure participants' satiety responsiveness at a given time point. The score for the SR scale ranges from 4-20, with higher scores indicating higher satiety responsiveness, and lower scores indicating lower satiety responsiveness.	Change from baseline at an average of 6 months, 12 months, and 18 months
Secondary	Change in Inhibition As Measured by the Stop Signal Task	Go stimuli are four pictures of food in landscape or portrait format; participants must respond to the go stimuli by pressing the left and right response keys on the keyboard. On 25% of trials, a visual stop signal will be presented; participants are instructed to withhold responding when this signal is presented. This task measures inhibitory control.	Change from baseline at an average of 6 months, 12 months, and 18 months
Secondary	Change in Restriction As Measured by the TFEQ	The Three-Factor Eating Questionnaire (TFEQ) assesses three cognitive and behavioral domains of eating: cognitive restraint, disinhibition, and hunger. We will use the restraint subscale to measure restriction. Scores on the restraint subscale range from 0-21, with lower scores indicating less restriction and higher scores indicating more restriction.	Change from baseline at an average of 6 months, 12 months, and 18 months
Secondary	Change in Caloric Intake As Measured by the DHQ III	The Diet History Questionnaire III consists of 135 food and beverage line items and 26 dietary supplement questions. Some line items for foods and beverages have additional embedded questions that allow for final assignment to items in the nutrient and food group database leading to 263 foods/beverages listed in the database. For example, a single line item asks frequency of intake and portion size of soda or soft drinks. Embedded underneath are questions regarding whether the soft drinks consumed are regular vs. diet or caffeinated vs. decaffeinated. Answers to these questions lead to assignment of one of four food codes in the database: diet soda with caffeine, diet soda without caffeine, regular soda with caffeine or regular soda without caffeine. We will use this to measure caloric intake.	Change from baseline at an average of 6 months, 12 months, and 18 months
Secondary	Change in Eating Cognitions As Measured by the FCQ-T-reduced	The shortened version of the Food Craving Questionnaire - Trait (FCQ-T-reduced) assesses food cravings and evaluates food craving traits. We will use it to measure eating cognitions. Item scores range from 1-6, and the overall score ranges from 15-90, with higher scores indicating with more food craving cognitions, and lower scores indicating fewer food craving cognitions.	Change from baseline at an average of 6 months, 12 months, and 18 months