Improving Appetite Regulation in Patients With Obesity

Not Applicable

Completed

• Conditions: Obesity; Weight Loss; Weight Gain Prevention
• Interventions: Behavioral: Appetite Self-Regulation Intervention

• Registration Number: NCT05200520
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Study Timeline

• Study First Submitted: 2022-01-06
• Study First Submitted QC: 2022-01-06
• Study First Posted: 2022-01-20
• Study Start: 2022-03-05
• Primary Completion: 2022-12-20
• Study Completion: 2022-12-20
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-07
• Last Update Posted: 2023-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Appetite Self-Regulation	Appetite Self-Regulation Intervention	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in weight regain	6 months	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.

Trial Locations

Locations (1)

UNC-Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States