Improving Appetite Regulation in Patients With Obesity

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05200520
• Other study ID #: 21-2598
• Status: Completed
• Phase: N/A
• Start date: March 5, 2022
• Est. completion date: December 20, 2022

Study information

• Verified date: June 2023
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: December 20, 2022
• Est. primary completion date: December 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Obesity
• Weight Gain
• Weight Gain Prevention
• Weight Loss

Intervention

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.

Locations

Country	Name	City	State
United States	UNC-Chapel Hill	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Feasibility (Attendance): Percentage of Intervention Sessions Attended	Percentage of intervention sessions attended for the duration of the study by each participant.	3 months
Secondary	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
Secondary	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