Overweight and Obesity Clinical Trial
Official title:
An ACT-Based Physician-Delivered Weight Loss Intervention
Verified date | December 2018 |
Source | McGill University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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McGill University |
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) |
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