Solutions for Hunger And Regulating Eating - Clinical Trial for Overweight and Obesity | NCT05004883

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Regulation of Cues Enhanced

Behavioral Weight Loss

Nutrition Education, Stress Management and Social Support

About this trial

This is an interventional treatment trial for Overweight and Obesity focused on measuring Food Responsiveness, Satiety Responsiveness, Weight Loss, Overeating

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 3 years)
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)

Sites / Locations

UCSD Center for Healthy Eating and Activity Research (CHEAR)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Regulation of Cues Enhanced Treatment

Behavioral Weight Loss

Nutrition, Stress Management, and Social Support

Arm Description

The ROC program provides psychoeducation, coping skills, self-monitoring and experiential learning, and it will be combined with aspects of BWL to capitalize on the strengths of both treatments.

The BWL program will include dietary recommendations, physical activity recommendations, and behavioral change recommendations.

Nutrition Education, Stress Management and Social Support will be covered. Mindfulness will be practiced in every session.

Outcomes

Primary Outcome Measures

Change in Body Mass Index

Body Mass Index as measured by height and weight

Secondary Outcome Measures

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 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 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 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 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 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.

Full Information

NCT ID

NCT05004883

First Posted

August 6, 2021

Last Updated

July 21, 2023

Sponsor

University of California, San Diego

Collaborators

University of Minnesota, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

1. Study Identification

Unique Protocol Identification Number

NCT05004883

Brief Title

Solutions for Hunger And Regulating Eating

Acronym

SHARE

Official Title

Targeting Food Cue Responsiveness for Weight Loss

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 1, 2021 (Actual)

Primary Completion Date

August 15, 2026 (Anticipated)

Study Completion Date

August 15, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, San Diego

Collaborators

University of Minnesota, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overweight and Obesity

Keywords

Food Responsiveness, Satiety Responsiveness, Weight Loss, Overeating

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Regulation of Cues Enhanced Treatment

Arm Type

Experimental

Arm Description

The ROC program provides psychoeducation, coping skills, self-monitoring and experiential learning, and it will be combined with aspects of BWL to capitalize on the strengths of both treatments.

Arm Title

Behavioral Weight Loss

Arm Type

Active Comparator

Arm Description

The BWL program will include dietary recommendations, physical activity recommendations, and behavioral change recommendations.

Arm Title

Nutrition, Stress Management, and Social Support

Arm Type

Active Comparator

Arm Description

Nutrition Education, Stress Management and Social Support will be covered. Mindfulness will be practiced in every session.

Intervention Type

Behavioral

Intervention Name(s)

Regulation of Cues Enhanced

Other Intervention Name(s)

ROC+

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Behavioral Weight Loss

Other Intervention Name(s)

BWL

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Nutrition Education, Stress Management and Social Support

Intervention Description

Topics included will be stress management/relaxation, social support, and nutrition education. There will be a strong mindfulness component to this group.

Primary Outcome Measure Information:

Title

Change in Body Mass Index

Description

Body Mass Index as measured by height and weight

Time Frame

Change from baseline at an average of 6 months, 9 months, 12 months, 15 months, and 18 months

Secondary Outcome Measure Information:

Title

Change in Food Responsiveness As Measured by the FR Scale of the AEBQ

Description

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.

Time Frame