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Improving Appetite Regulation in Patients With Obesity

Primary Purpose

Weight Loss, Weight Gain Prevention, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Appetite Self-Regulation Intervention
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Weight Loss

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UNC-Chapel Hill

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Appetite Self-Regulation

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
Feasibility (Attendance): Percentage of Intervention Sessions Attended
Percentage of intervention sessions attended for the duration of the study by each participant.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
January 6, 2022
Last Updated
June 7, 2023
Sponsor
University of North Carolina, Chapel Hill
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1. Study Identification

Unique Protocol Identification Number
NCT05200520
Brief Title
Improving Appetite Regulation in Patients With Obesity
Official Title
Improving Appetite Self-Regulation in Patients With Obesity: A Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
March 5, 2022 (Actual)
Primary Completion Date
December 20, 2022 (Actual)
Study Completion Date
December 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss, Weight Gain Prevention, Obesity

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Appetite Self-Regulation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Appetite Self-Regulation Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility (Recruitment): Total Number of Eligible Adults Enrolled in the Study
Description
Recruitment is defined as the number of potential eligible adults screened for the study versus the number of persons who enrolled in the study.
Time Frame
3 Months
Title
Feasibility (Retention): Percentage of Participants Retained in the Study
Description
Percentage of eligible participants who were enrolled and retained in the study through the 6 months.
Time Frame
3 months
Title
Feasibility (Retention): Percentage of Participants Retained in the Study
Description
Percentage of eligible participants who were enrolled and retained in the study through the 6 months.
Time Frame
6 months
Title
Feasibility (Attendance): Percentage of Intervention Sessions Attended
Description
Percentage of intervention sessions attended for the duration of the study by each participant.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change in weight regain
Description
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.
Time Frame
3 months
Title
Change in weight regain
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel Goode, PhD, MPH
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
UNC-Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Improving Appetite Regulation in Patients With Obesity

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