Weight LossNCT05200520
Improving Appetite Regulation in Patients With Obesity
A study testing Appetite Self-Regulation Intervention in people with Weight Loss and Weight Gain Prevention, run by University of North Carolina, Chapel Hill at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Loss, Weight Gain Prevention, Obesity
- What is being tested?
- Appetite Self-Regulation Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2022to 20 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Appetite Self-Regulation in Patients With Obesity: A Feasibility Study
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.
Read the 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.
- Conditions
- Weight Loss, Weight Gain Prevention, Obesity
- Being tested
- Appetite Self-Regulation Intervention
- Medical subject headings
- Weight Loss, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Appetite Self-Regulation InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Appetite Self-Regulation | Experimental | 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. Receives: Behavioral: Appetite Self-Regulation Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 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.
Measured: 3 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.
Measured: 6 months
Feasibility (Attendance): Percentage of Intervention Sessions Attended
Percentage of intervention sessions attended for the duration of the study by each participant.
Measured: 3 months
Secondary outcomes (2)
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.
Measured: 3 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start5 Mar 2022
- Primary completion20 Dec 2022
- Study completion20 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachel Goode, PhD, MPH, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05200520
- Sponsor's protocol ID
- 21-2598
- Status last verified
- Jun 2023
- First submitted
- 6 Jan 2022
- Last updated
- 9 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Appetite Self-Regulation in Patients With Obesity: A Feasibility Study
- ClinicalTrials.gov ID
- NCT05200520
- Acronym / sponsor ID
- 21-2598
- Conditions
- Weight Loss, Weight Gain Prevention, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- 5 Mar 2022 (actual)
- Primary completion
- 20 Dec 2022 (actual)
- Study completion
- 20 Dec 2022 (actual)
- First posted
- 20 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Appetite Self-Regulation | Experimental | Behavioral: Appetite Self-Regulation InterventionParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Appetite Self-Regulation InterventionThe 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. | Behavioural | Appetite Self-Regulation |
Primary outcome
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.
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.
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.
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.
2 secondary outcomes
Change in weight regain
Time frame: 3 months
Change in weight regain
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel Goode, PhD, MPH principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Appetite Self-Regulation Intervention in people with Weight Loss and Weight Gain Prevention, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (Recruitment): Total Number of Eligible Adults Enrolled in the Study (time frame: 3 Months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2023.