ObesityNCT03564392
Post-Bariatric Weight Regain Behavioral Intervention
A study testing Acceptance Based Behavioral Intervention in people with Obesity, run by Rush University Medical Center at 1 site in United States.
Trial summary
This project aims to evaluate a newly developed Internet-delivered (via e-learning modules) acceptance-based behavioral intervention (ABTi) for individuals who are experiencing weight regain after bariatric surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity
- What is being tested?
- Acceptance Based Behavioral Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2017to 31 Jan 2019
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has undergone any type of weight loss surgery at least 1.5 years ago
- Demonstrate ≥ 10% weight regain of maximum weight loss or 5% of their minimum weight post-surgery, with weight regain lasting for at least 3 months prior to enrollment.
- Ability to give consent and speak, write, and understand English.
Who cannot join
- Currently enrolled in structured weight loss program
- Currently pregnant/plan to become pregnant within 6 months of enrollment
- Have a serious medical condition that has the potential of affecting weight or that would prevent engagement in dietary changes and/or an exercise regimen
- Exhibit psychiatric symptoms that would interfere with the ability to benefit from the intervention, or report acute suicidality
- Non-ambulatory (i.e., unable to walk at least one city block without a cane or walker at the time of screening
- Use of medications known to affect body weight, such as chronic systemic steroids or psychiatric medications including lithium, tricyclic antidepressants, and antipsychotic agents
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: The Investigation of a Remotely Delivered Behavioral Intervention for Postoperative Weight Regain
This project aims to evaluate a newly developed Internet-delivered (via e-learning modules) acceptance-based behavioral intervention (ABTi) for individuals who are experiencing weight regain after bariatric surgery. Specifically, the investigators aim to assess ABTi's efficacy on stopping and/or reversing weight by comparing it to a wait-list control (WLC) condition. The investigators also aim to evaluate its effect on targeted weight control behaviors and acceptance-based skills. Finally, the investigators will examine the relationship between weight outcomes and changes in process variables through exploratory analyses. Treatment outcomes (i.e., weight, maladaptive behaviors, physical activity, acceptance-based skills) will be measured at assessments pre-, mid-, and post-treatment, as well as at 3 months after treatment has ended.
Primary Aims.
Read more
- To test the hypothesis that participants randomly assigned to ABTi will display greater weight loss from pre- to post-treatment than those assigned to WLC.
- To test the hypothesis those receiving ABTi, compared to WLC, will display decreased maladaptive eating behaviors (i.e., loss of control episodes, grazing, emotional eating, disinhibition), increased physical activity, and greater improvements in acceptance-based skills (i.e., mindfulness, defusion, food-related acceptance).
Exploratory Aim.
(1) To assess if changes in acceptance-based skills, maladaptive eating behaviors, and physical activity are associated with pre- to post-treatment weight outcomes.
- Conditions
- Obesity
- Being tested
- Acceptance Based Behavioral Intervention
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance Based Behavioral InterventionBehavioural
This intervention focuses on acceptance-based strategies with an emphasis on willingness to experience less pleasurable internal experiences (e.g., pleasure from eating calorically-dense foods) and aversive internal experiences (e.g., hunger, food cravings). Strategies to increase this willingness will be taught, including defusion (i.e., getting psychological distance from internal experiences to allow oneself to act independently of them). Mindful decision-making, as it relates to eating and exercise, will also be emphasized. Clarification and commitment to core values is another key component, as living life in accordance with one's values (e.g., health) makes willingness to make difficult choices worthwhile. Standard behavioral techniques for weight loss (i.e., self-monitoring, stimulus control, psychoeducation) will also be included.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Ten weekly modules will be delivered through an e-learning platform (i.e., Coursesites). Each module includes a video presentation of material synchronized with a slideshow illustrating session material with interactive features, and directed assignments to be completed throughout the week. At the end of every two weeks, a brief (i.e., 20 min) telephone call with a member of the study team will be scheduled to discuss and clarify the content of the session, discuss how the participant utilized skills demonstrated in the session, problem-solve difficulties in utilizing the skills, and review homework. Participants will be required to weigh themselves weekly (data will be transferred wirelessly to the laboratory) and feedback regarding weight losses will be provided during the phone call. The interventionist will provide individualized feedback on food records via email. Receives: Behavioral: Acceptance Based Behavioral Intervention |
| Wait List Control | No intervention | The Wait-List Control (WLC) condition does not receive any intervention during the study period. They receive the intervention after completing the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Measured: 10 weeks
Secondary outcomes (8)
Loss of Control Eating Scale (LOCES)
LOCES measures loss of control eating.
Measured: 10 weeks
Repetitive Eating Assessment-Questionnaire (Rep(eat))
Rep(eat) measures grazing behaviors.
Measured: 10 weeks
Emotional Eating Scale (EES)
EES will be used to measure emotional eating
Measured: 10 weeks
The Eating Inventory
The Eating Inventory will be used to measure disinhibition.
Measured: 10 weeks
Paffenbarger Physical Activity Recall
Paffenbarger will be used to measure physical activity engagement
Measured: 10 weeks
Philadelphia Mindfulness Scale (PHLMS)
PHLMS will be used to measure mindfulness
Measured: 10 weeks
Drexel Defusion Scale (DDS)
DDS will be used to measure delusion (a psychological construct of cognitive distancing)
Measured: 10 weeks
Food-Related Acceptance and Action Questionnaire (FAAQ)
FAAQ will be used to measure food-related acceptance
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2018
- Study start28 Mar 2017
- Primary completion31 Jan 2019
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lauren Bradley, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03564392
- Sponsor's protocol ID
- 16062305
- Status last verified
- Mar 2019
- First submitted
- 26 Apr 2018
- Last updated
- 28 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Investigation of a Remotely Delivered Behavioral Intervention for Postoperative Weight Regain
- ClinicalTrials.gov ID
- NCT03564392
- Acronym / sponsor ID
- 16062305
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 28 Mar 2017 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 20 Jun 2018 (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.
This project aims to evaluate a newly developed Internet-delivered (via e-learning modules) acceptance-based behavioral intervention (ABTi) for individuals who are experiencing weight regain after bariatric surgery. Specifically, the investigators aim to assess ABTi's efficacy on stopping and/or reversing weight by comparing it to a wait-list control (WLC) condition. The investigators also aim to evaluate its effect on targeted weight control behaviors and acceptance-based skills. Finally, the investigators will examine the relationship between weight outcomes and changes in process variables through exploratory analyses. Treatment outcomes (i.e., weight, maladaptive behaviors, physical activity, acceptance-based skills) will be measured at assessments pre-, mid-, and post-treatment, as well as at 3 months after treatment has ended.
Primary Aims.
- To test the hypothesis that participants randomly assigned to ABTi will display greater weight loss from pre- to post-treatment than those assigned to WLC.
- To test the hypothesis those receiving ABTi, compared to WLC, will display decreased maladaptive eating behaviors (i.e., loss of control episodes, grazing, emotional eating, disinhibition), increased physical activity, and greater improvements in acceptance-based skills (i.e., mindfulness, defusion, food-related acceptance).
Exploratory Aim.
(1) To assess if changes in acceptance-based skills, maladaptive eating behaviors, and physical activity are associated with pre- to post-treatment weight outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: Acceptance Based Behavioral InterventionTen weekly modules will be delivered through an e-learning platform (i.e., Coursesites). Each module includes a video presentation of material synchronized with a slideshow illustrating session material with interactive features, and directed assignments to be completed throughout the week. At the end of every two weeks, a brief (i.e., 20 min) telephone call with a member of the study team will be scheduled to discuss and clarify the content of the session, discuss how the participant utilized skills demonstrated in the session, problem-solve difficulties in utilizing the skills, and review homework. Participants will be required to weigh themselves weekly (data will be transferred wirelessly to the laboratory) and feedback regarding weight losses will be provided during the phone call. The interventionist will provide individualized feedback on food records via email. |
| Wait List Control | No intervention | –The Wait-List Control (WLC) condition does not receive any intervention during the study period. They receive the intervention after completing the study. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Has undergone any type of weight loss surgery at least 1.5 years ago
- Demonstrate ≥ 10% weight regain of maximum weight loss or 5% of their minimum weight post-surgery, with weight regain lasting for at least 3 months prior to enrollment.
- Ability to give consent and speak, write, and understand English.
Key exclusion criteria (6 listed)
- Currently enrolled in structured weight loss program
- Currently pregnant/plan to become pregnant within 6 months of enrollment
- Have a serious medical condition that has the potential of affecting weight or that would prevent engagement in dietary changes and/or an exercise regimen
- Exhibit psychiatric symptoms that would interfere with the ability to benefit from the intervention, or report acute suicidality
- Non-ambulatory (i.e., unable to walk at least one city block without a cane or walker at the time of screening
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 |
|---|---|---|
| Acceptance Based Behavioral InterventionThis intervention focuses on acceptance-based strategies with an emphasis on willingness to experience less pleasurable internal experiences (e.g., pleasure from eating calorically-dense foods) and aversive internal experiences (e.g., hunger, food cravings). Strategies to increase this willingness will be taught, including defusion (i.e., getting psychological distance from internal experiences to allow oneself to act independently of them). Mindful decision-making, as it relates to eating and exercise, will also be emphasized. Clarification and commitment to core values is another key component, as living life in accordance with one's values (e.g., health) makes willingness to make difficult choices worthwhile. Standard behavioral techniques for weight loss (i.e., self-monitoring, stimulus control, psychoeducation) will also be included. | Behavioural | Treatment |
Primary outcome
Weight loss
Time frame: 10 weeks
8 secondary outcomes
Loss of Control Eating Scale (LOCES)
Time frame: 10 weeks
Repetitive Eating Assessment-Questionnaire (Rep(eat))
Time frame: 10 weeks
Emotional Eating Scale (EES)
Time frame: 10 weeks
The Eating Inventory
Time frame: 10 weeks
Paffenbarger Physical Activity Recall
Time frame: 10 weeks
Philadelphia Mindfulness Scale (PHLMS)
Time frame: 10 weeks
Drexel Defusion Scale (DDS)
Time frame: 10 weeks
Food-Related Acceptance and Action Questionnaire (FAAQ)
Time frame: 10 weeks
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 28 Mar 2019.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance Based Behavioral Intervention in people with Obesity, run by Rush University Medical Center 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 3 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 28 Mar 2019. 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?
Weight loss (time frame: 10 weeks). 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 28 Mar 2019.