Overweight and ObesityNCT03611829
An ACT-Based Physician-Delivered Weight Loss Intervention
A study testing ACT Intervention in people with Overweight and Obesity and Eating Behavior, run by McGill University.
Trial summary
The purpose of the present study was to conduct a pilot RCT to test the feasibility of a physician-delivered ACT-based intervention for emotional eaters with overweight/obesity against standard care at a network of weight loss clinics. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity, Eating Behavior
- What is being tested?
- ACT Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- No sites listed yet
- Study dates
- 7 May 2016to 7 Mar 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Only participants considered to be emotional eaters, as assessed by a score of 3.25 or higher on the Dutch Eating Behavior Questionnaire (DEBQ), were recruited for the study (van Strien, Herman, Anschutz, Engels, \& de Weerth, 2012).
Who cannot join
- Not being an emotional eater.
- Participants who did not speak, write, and read in English fluently were excluded from the study, as well as those who were pregnant.
About this study
The purpose of the present study was to conduct a pilot RCT to test the feasibility of a physician-delivered ACT-based intervention for emotional eaters with overweight/obesity against standard care at a network of weight loss clinics. Participants were randomized to receive either standard care at the clinics or the ACT intervention.
Read the detailed description
The purpose of the present study was to conduct a pilot RCT to test the feasibility of a physician-delivered ACT-based intervention for emotional eaters with overweight/obesity against standard care at a network of weight loss clinics. Psychology clinical PhD students trained physicians in the delivery of the brief manualized intervention and were available for regular consults. The intervention consisted of eight, 5-10 minute sessions that could be easily incorporated into the physician's current practice. Over the duration of the ACT intervention, physicians met individually with patients to teach them various techniques to address and improve mindfulness, acceptance, and values clarification and commitment, all of which emotional eaters have been found to struggle with (Forman \& Butryn, 2014). The proven habit formation technique of if-then planning (Gollwitzer, 1993) was used throughout these sessions in order to train emotional eaters to habitually use ACT techniques and to change the maladaptive habit of eating in response to negative emotions.
- Conditions
- Overweight and Obesity, Eating Behavior
- Being tested
- ACT Intervention, Standard Care
- Keywords
- emotional eating
- Medical subject headings
- Overweight, Obesity, Feeding Behavior, Emotional Eating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT InterventionBehavioural
Standard CareBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | Active comparator | Participants in the standard care condition were provided with diet and exercise counselling and psychoeducation from their physicians over the course of 8 sessions, as was routinely done at the clinic. Standard care did not involve any targeted intervention to reduce emotional eating. Receives: Behavioral: Standard Care |
| ACT Intervention | Experimental | In addition to receiving standard care, participants in the ACT condition were taught techniques to reduce their emotional eating. Three overarching skills were taught over the course of the ACT intervention: (1) values clarification and commitment, (2) metacognitive awareness, and (3) distress tolerance. Throughout the sessions, physicians formed if-then plans with the patients to specify how to habitually use the ACT techniques to reduce emotional eating in their everyday lives. At the end of each session, participants were given a one-page homework sheet that asked them to monitor their behavior and their use of the ACT techniques during the week. Receives: Behavioral: ACT Intervention; Behavioral: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Change
Weight change in kilograms
Measured: Baseline to Post-Intervention (on average, 16 weeks)
Emotional Eating Change
Assessed by the Dutch Eating Behavior Questionnaire (DEBQ) emotional eating subscale. Scores range from 1 (never) to 5 (very often). Lower scores reflect lower emotional eating. This subscale score is calculated by taking the mean of all items on the subscale. Negative change scores reflect decreases in emotional eating.
Measured: Baseline to Post-Intervention (on average, 16 weeks)
Secondary outcomes (6)
Body Fat Percentage Change
Change in body fat percentage
Measured: Baseline to Post-Intervention (on average, 16 weeks)
External Eating Change
Assessed by the Dutch Eating Behavior Questionnaire (DEBQ) external eating subscale. Scores range from 1 (never) to 5 (very often). Lower scores reflect lower external eating. This subscale score is calculated by taking the mean of all items on the subscale. Negative change scores reflect decreases in external eating.
Measured: Baseline to Post-Intervention (on average, 16 weeks)
Restraint Eating Change
Assessed by the Dutch Eating Behavior Questionnaire (DEBQ) restraint eating subscale. Scores range from 1 (never) to 5 (very often). Lower scores reflect lower restraint eating. This subscale score is calculated by taking the mean of all items on the subscale. Positive change scores reflect increase in restraint eating.
Measured: Baseline to Post-Intervention (on average, 16 weeks)
Distress Tolerance Change
Assessed by the Distress Tolerance Scale (DTS). All items were rated on a 5-point Likert scale from 1 (strongly agree) to 5 (strongly disagree). The score is calculated as the mean of all items. Higher scores reflect higher levels of distress tolerance. Positive change scores reflect increases in distress tolerance.
Measured: Baseline to Post-Intervention (on average, 16 weeks)
Mindfulness Awareness Change
Assessed by the Philadelphia Mindfulness Scale (PHLMS). All items were rated on a 5-point Likert scale from 1 (never) to 5 (very often). The subscale score is calculated as the sum of all items on the subscale, with the minimum possible score being 10 and the maximum possible score being 50. Higher scores reflect higher levels of awareness. Negative change scores reflect decreases in mindfulness and positive change scores reflect increases in mindfulness.
Measured: Baseline to Post-Intervention (on average, 16 weeks)
Values Clarification/ACT Application Change
This questionnaire was developed for the present study to evaluate participants' real world application of the intervention. Participants were asked to indicate their level of agreement on a 5-point scale (1 = strongly agree and 5 = strongly disagree) to prompts such as "My values motivate me to lose weight" and "I am able to accept negative emotions and don't have to eat when I'm feeling bad". Total score was calculated as the mean of all items. Lower scores indicate higher values clarification. Negative change scores reflect increases in ACT application and values clarification.
Measured: Baseline to Post-Intervention (on average, 16 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start7 May 2016
- Primary completion7 Mar 2018
- Study completion7 Mar 2018
Why it stopped: The trial was ended prematurely due to low recruitment/enrolment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Overweight and 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
- Model description
- The present study was a two-arm pilot randomized controlled trial.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mallory Frayn, PhD (c), Principal investigator, McGill UniversityKimberly Carrière, PhD Student, Study director, McGill UniversityBärbel Knäuper, PhD, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03611829
- Sponsor's protocol ID
- 405-0316
- Other IDs
- CIHR PJT-153383
- Status last verified
- Dec 2018
- First submitted
- 18 Jun 2018
- Last updated
- 14 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study data, including the intervention manual, study protocol, statistical analysis plan, and outcomes will be shared with other researchers upon request.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An ACT-Based Physician-Delivered Weight Loss Intervention
- ClinicalTrials.gov ID
- NCT03611829
- Acronym / sponsor ID
- 405-0316
- Conditions
- Overweight and Obesity, Eating Behavior
- Keywords
- emotional eating
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The trial was ended prematurely due to low recruitment/enrolment.
- Enrolment
- 87 participants (actual)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Study start
- 7 May 2016 (actual)
- Primary completion
- 7 Mar 2018 (actual)
- Study completion
- 7 Mar 2018 (actual)
- First posted
- 2 Aug 2018 (actual)
- Results
- Posted 14 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the present study was to conduct a pilot RCT to test the feasibility of a physician-delivered ACT-based intervention for emotional eaters with overweight/obesity against standard care at a network of weight loss clinics. Participants were randomized to receive either standard care at the clinics or the ACT intervention.
Detailed description
The purpose of the present study was to conduct a pilot RCT to test the feasibility of a physician-delivered ACT-based intervention for emotional eaters with overweight/obesity against standard care at a network of weight loss clinics. Psychology clinical PhD students trained physicians in the delivery of the brief manualized intervention and were available for regular consults. The intervention consisted of eight, 5-10 minute sessions that could be easily incorporated into the physician's current practice. Over the duration of the ACT intervention, physicians met individually with patients to teach them various techniques to address and improve mindfulness, acceptance, and values clarification and commitment, all of which emotional eaters have been found to struggle with (Forman \& Butryn, 2014). The proven habit formation technique of if-then planning (Gollwitzer, 1993) was used throughout these sessions in order to train emotional eaters to habitually use ACT techniques and to change the maladaptive habit of eating in response to negative emotions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The present study was a two-arm pilot randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Standard Care | Active comparator | Behavioral: Standard CareParticipants in the standard care condition were provided with diet and exercise counselling and psychoeducation from their physicians over the course of 8 sessions, as was routinely done at the clinic. Standard care did not involve any targeted intervention to reduce emotional eating. |
| ACT Intervention | Experimental | Behavioral: ACT Intervention, Behavioral: Standard CareIn addition to receiving standard care, participants in the ACT condition were taught techniques to reduce their emotional eating. Three overarching skills were taught over the course of the ACT intervention: (1) values clarification and commitment, (2) metacognitive awareness, and (3) distress tolerance. Throughout the sessions, physicians formed if-then plans with the patients to specify how to habitually use the ACT techniques to reduce emotional eating in their everyday lives. At the end of each session, participants were given a one-page homework sheet that asked them to monitor their behavior and their use of the ACT techniques during the week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Only participants considered to be emotional eaters, as assessed by a score of 3.25 or higher on the Dutch Eating Behavior Questionnaire (DEBQ), were recruited for the study (van Strien, Herman, Anschutz, Engels, \& de Weerth, 2012).
Key exclusion criteria (2 listed)
- Not being an emotional eater.
- Participants who did not speak, write, and read in English fluently were excluded from the study, as well as those who were pregnant.
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 |
|---|---|---|
| ACT Intervention | Behavioural | ACT Intervention |
| Standard Care | Behavioural | ACT Intervention, Standard Care |
Primary outcome
Weight Change
Time frame: Baseline to Post-Intervention (on average, 16 weeks)
Weight change in kilograms
Emotional Eating Change
Time frame: Baseline to Post-Intervention (on average, 16 weeks)
Assessed by the Dutch Eating Behavior Questionnaire (DEBQ) emotional eating subscale. Scores range from 1 (never) to 5 (very often). Lower scores reflect lower emotional eating. This subscale score is calculated by taking the mean of all items on the subscale. Negative change scores reflect decreases in emotional eating.
6 secondary outcomes
Body Fat Percentage Change
Time frame: Baseline to Post-Intervention (on average, 16 weeks)
External Eating Change
Time frame: Baseline to Post-Intervention (on average, 16 weeks)
Restraint Eating Change
Time frame: Baseline to Post-Intervention (on average, 16 weeks)
Distress Tolerance Change
Time frame: Baseline to Post-Intervention (on average, 16 weeks)
Mindfulness Awareness Change
Time frame: Baseline to Post-Intervention (on average, 16 weeks)
Values Clarification/ACT Application Change
Time frame: Baseline to Post-Intervention (on average, 16 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Study data, including the intervention manual, study protocol, statistical analysis plan, and outcomes will be shared with other researchers upon request.
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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.
Mallory Frayn, PhD (c) principal investigator
McGill University
Kimberly Carrière, PhD Student study director
McGill University
Bärbel Knäuper, PhD principal investigator
McGill University
Questions about this trial
What is this clinical trial studying?
A study testing ACT Intervention in people with Overweight and Obesity and Eating Behavior, run by McGill University.
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 1 inclusion and 2 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: stopped early, as of the sponsor's last update on 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 14 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Change (time frame: Baseline to Post-Intervention (on average, 16 weeks)). The study lists 2 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 14 Aug 2019.