Improving Appetite Regulation in Patients With Obesity

NCT ID: NCT05200520

Last Updated: 2023-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-05
• Study Completion Date: 2022-12-20

Brief Summary

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.

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.

Conditions

Weight Loss; Weight Gain Prevention; Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Appetite Self-Regulation Intervention

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rachel Goode, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

UNC-Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

21-2598

Identifier Type: -

Identifier Source: org_study_id