Improving Appetite Regulation in Patients With Obesity

Improving Appetite Self-Regulation in Patients With Obesity: A Feasibility Study

Over 70% of U.S. adults have overweight or obesity. Currently, the most efficacious behavioral intervention for obesity is standard behavioral treatment (SBT), often composed of group sessions, calorie goals, and physical activity goals. With this approach, participants often lose 8-10% of the person's baseline weight, and also decrease risk for cardiovascular disease. Long-term weight loss, however, is limited; many participants return to baseline weight within five years following treatment. One reason SBT may not create long-term weight loss may be due to treatment components that teach participants to rely on external methods for changing eating decisions (e.g., counting calories, restricting certain foods), rather than internal cues of hunger and satiety. Because individuals with obesity report significant challenges with adhering to these cues, augmenting behavioral interventions with appetite self-regulation training may be a solution. Thus, the investigator propose to examine the feasibility and acceptability of a 6-month remotely-delivered appetite regulation + lifestyle modification intervention to treat obesity.

Study Overview

• Status: Completed
• Conditions: Obesity; Weight Loss; Weight Gain Prevention
• Intervention / Treatment: Behavioral: Appetite Self-Regulation Intervention

Detailed Description

Aim 1. Using a single-arm design, the investigator will examine the feasibility and acceptability of a 6-month, remotely-delivered, appetite self-regulation intervention for weight loss maintenance.

Aim 2. Examine the preliminary efficacy of the intervention on weight maintenance at 4 and 6 months.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • UNC-Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• over 18 years of age,
• BMI ≥ 25-45 kg/m^2,
• have and regularly use a smartphone,
• weight loss of 5% or more within the last 2 years
• complete the screening questionnaire

Exclusion Criteria:

• have no internet access,
• report a medical condition that could jeopardize the person's safety in a weight control program with diet and exercise guidelines
• are currently pregnant
• are in substance use treatment
• are involved in another weight reduction program
• have received prior or planned bariatric surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Appetite Self-Regulation; Participants will attend 12-weekly classes, delivered through virtual small group sessions (via zoom), self-monitor the participant's episodes of hunger and satiety with digital eating behavior website, weigh daily with a wireless Wi-Fi enabled scale, and use a FitBit to track physical activity. Participants will also receive weekly tailored feedback on eating, physical activity, and weight trends. Assessments will be conducted at 0, 3, and 6 months.

Behavioral: Appetite Self-Regulation Intervention; The intervention will consist of content from Appetite Awareness Training (AAT), a cognitive-behavioral intervention to promote intuitive eating and the Diabetes Prevention Program (DPP)20, a behavioral lifestyle intervention. The goal of AAT is to enable participants to relearn their stomach's hunger signals and begin to obey and monitor functions of satiety. AAT has been successful in helping participants to reduce binge and overeating. Participants are taught to respond to external cues to eat (e.g., social gatherings), self-monitor the participant's adherence to biological signals of hunger and satiety, and to develop appropriate coping skills to manage urges to eat when not physically hungry.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility (Recruitment): Total Number of Eligible Adults Enrolled in the Study	Recruitment is defined as the number of potential eligible adults screened for the study versus the number of persons who enrolled in the study.	3 Months
Feasibility (Retention): Percentage of Participants Retained in the Study	Percentage of eligible participants who were enrolled and retained in the study through the 6 months.	3 months
Feasibility (Retention): Percentage of Participants Retained in the Study	Percentage of eligible participants who were enrolled and retained in the study through the 6 months.	6 months
Feasibility (Attendance): Percentage of Intervention Sessions Attended	Percentage of intervention sessions attended for the duration of the study by each participant.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in weight regain	Participant body weight will be measured by trained research staff using calibrated digital scales, with participants in light indoor clothing, with pockets emptied and belts and shoes removed.	3 months
Change in weight regain	Participant body weight will be measured by trained research staff using calibrated scales with participants in light indoor clothing, with pockets emptied and belts and shoes removed.	6 months

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Investigators: Principal Investigator: Rachel Goode, PhD, MPH, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2022
• Primary Completion (Actual): December 20, 2022
• Study Completion (Actual): December 20, 2022

Study Registration Dates

• First Submitted: January 6, 2022
• First Submitted That Met QC Criteria: January 6, 2022
• First Posted (Actual): January 20, 2022

Study Record Updates

• Last Update Posted (Actual): June 9, 2023
• Last Update Submitted That Met QC Criteria: June 7, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight Changes; Obesity; Weight Loss; Body Weight; Weight Gain
• Other Study ID Numbers: 21-2598

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No