Clinical trial NCT05200520: Improving Appetite Regulation in Patients With Obesity
Official title: Improving Appetite Self-Regulation in Patients With Obesity: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Weight Gain Prevention
Obesity
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2022-01-20
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: Feasibility (Recruitment): Total Number of Eligible Adults Enrolled in the Study
timeFrame: 3 Months
measure: Feasibility (Retention): Percentage of Participants Retained in the Study
timeFrame: 3 months
measure: Feasibility (Retention): Percentage of Participants Retained in the Study
timeFrame: 6 months
measure: Feasibility (Attendance): Percentage of Intervention Sessions Attended
timeFrame: 3 months
Secondary outcomes:
measure: Change in weight regain
timeFrame: 3 months
measure: Change in weight regain
timeFrame: 6 months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC-Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Rachel Goode, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: