An ACT-Based Physician-Delivered Weight Loss Intervention

Overweight and Obesity Clinical Trial

Official title:

An ACT-Based Physician-Delivered Weight Loss Intervention

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03611829
• Other study ID #: 405-0316
• Secondary ID: CIHR PJT-153383
• Status: Terminated
• Phase: N/A
• Start date: May 7, 2016
• Est. completion date: March 7, 2018

Study information

• Verified date: December 2018
• Source: McGill University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Participants were randomized to receive either standard care at the clinics or the ACT intervention.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 87
• Est. completion date: March 7, 2018
• Est. primary completion date: March 7, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Eating Behavior
• Overweight
• Overweight and Obesity
• Weight Loss

Intervention

Behavioral:
• ACT Intervention

• Standard Care

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
McGill University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient Treatment Satisfaction	Assessed by a self-developed questionnaire with items such as "the program reduced my emotional eating" and "the program was easy to follow". Scores represent mean ratings on a 5-point Likert-type rating scale from 1 (strongly agree) to 5 (strongly disagree). Lower scores reflect higher treatment satisfaction.	Administered Post-Intervention (at on average, 16 weeks)
Other	Physician Treatment Satisfaction	Assessed by a self-developed questionnaire with items such as "ease of difficulty" and "required preparation time". The following questions were assessed on Likert scales from 1 (to little) to 5 (too much) with middle scores (3) reflecting perceived balance (e.g., not too difficult, the right amount of preparation time). Total score was calculated as the mean of all items.	Each physician was asked to complete this questionnaire once during their administration of the ACT intervention (from July 2016 to February 2017)
Other	Recruitment Rates	Percentage of individuals who were eligible to participate in the study (based on the initial prescreen) that actually enrolled.	Prescreen questionnaire to Baseline
Other	Number of Participants That Dropped Out From Study	Dropout rates between conditions from baseline to session 8.	Baseline to Post-Intervention (on average, 16 weeks)
Other	Questionnaire Completion	Percentage of participants who completed questionnaires between conditions	Baseline to Post-Intervention (on average, 16 weeks)
Other	Intervention Completion Time	How long it took participants in each condition to complete the 8-session intervention	Baseline to Post-Intervention (on average, 16 weeks)
Primary	Weight Change	Weight change in kilograms	Baseline to Post-Intervention (on average, 16 weeks)
Primary	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.	Baseline to Post-Intervention (on average, 16 weeks)
Secondary	Body Fat Percentage Change	Change in body fat percentage	Baseline to Post-Intervention (on average, 16 weeks)
Secondary	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.	Baseline to Post-Intervention (on average, 16 weeks)
Secondary	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.	Baseline to Post-Intervention (on average, 16 weeks)
Secondary	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.	Baseline to Post-Intervention (on average, 16 weeks)
Secondary	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.	Baseline to Post-Intervention (on average, 16 weeks)
Secondary	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.	Baseline to Post-Intervention (on average, 16 weeks)