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Completed

NCT Number: NCT05200520

Improving Appetite Regulation in Patients With Obesity

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.

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Key information

Conditions

Weight Loss Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Gain Prevention

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UNC-Chapel Hill

Chapel Hill, North Carolina, 27599, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Appetite Self-Regulation Intervention

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.

Primary outcomes

  1. Feasibility (Recruitment): Total Number of Eligible Adults Enrolled in the Study

    Time frame: 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.

  2. Feasibility (Retention): Percentage of Participants Retained in the Study

    Time frame: 3 months

    Percentage of eligible participants who were enrolled and retained in the study through the 6 months.

  3. Feasibility (Retention): Percentage of Participants Retained in the Study

    Time frame: 6 months

    Percentage of eligible participants who were enrolled and retained in the study through the 6 months.

  4. Feasibility (Attendance): Percentage of Intervention Sessions Attended

    Time frame: 3 months

    Percentage of intervention sessions attended for the duration of the study by each participant.

Secondary outcomes

  1. Change in weight regain

    Time frame: 3 months

    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.

  2. Change in weight regain

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 20, 2022
Registry last updated
Jun 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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