Clinical trial NCT03611829: An ACT-Based Physician-Delivered Weight Loss Intervention
Official title: An ACT-Based Physician-Delivered Weight Loss Intervention
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Overweight and Obesity
Eating Behavior
Keywords: emotional eating
Lead sponsor: McGill University
Sponsor class: OTHER
First posted: 2018-08-02
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The present study was a two-arm pilot randomized controlled trial.
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Weight Change
timeFrame: Baseline to Post-Intervention (on average, 16 weeks)
measure: Emotional Eating Change
timeFrame: Baseline to Post-Intervention (on average, 16 weeks)
Secondary outcomes:
measure: Body Fat Percentage Change
timeFrame: Baseline to Post-Intervention (on average, 16 weeks)
measure: External Eating Change
timeFrame: Baseline to Post-Intervention (on average, 16 weeks)
measure: Restraint Eating Change
timeFrame: Baseline to Post-Intervention (on average, 16 weeks)
measure: Distress Tolerance Change
timeFrame: Baseline to Post-Intervention (on average, 16 weeks)
measure: Mindfulness Awareness Change
timeFrame: Baseline to Post-Intervention (on average, 16 weeks)
measure: Values Clarification/ACT Application Change
timeFrame: Baseline to Post-Intervention (on average, 16 weeks)
Other outcomes:
measure: Patient Treatment Satisfaction
timeFrame: Administered Post-Intervention (at on average, 16 weeks)
measure: Physician Treatment Satisfaction
timeFrame: Each physician was asked to complete this questionnaire once during their administration of the ACT intervention (from July 2016 to February 2017)
measure: Recruitment Rates
timeFrame: Prescreen questionnaire to Baseline
measure: Number of Participants That Dropped Out From Study
timeFrame: Baseline to Post-Intervention (on average, 16 weeks)
measure: Questionnaire Completion
timeFrame: Baseline to Post-Intervention (on average, 16 weeks)
measure: Intervention Completion Time
timeFrame: Baseline to Post-Intervention (on average, 16 weeks)
Locations:
Study officials:
affiliation: McGill University
name: Mallory Frayn, PhD (c)
role: PRINCIPAL_INVESTIGATOR
affiliation: McGill University
name: Kimberly Carrière, PhD Student
role: STUDY_DIRECTOR
affiliation: McGill University
name: Bärbel Knäuper, PhD
role: PRINCIPAL_INVESTIGATOR
References: