Trial Outcomes & Findings for An ACT-Based Physician-Delivered Weight Loss Intervention (NCT NCT03611829)

NCT ID: NCT03611829

Last Updated: 2019-08-14

Results Overview

Weight change in kilograms

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 87 participants
• Primary outcome timeframe: Baseline to Post-Intervention (on average, 16 weeks)
• Results posted on: 2019-08-14

Participant Flow

Participant milestones

Measure	Standard Care 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. Standard Care	ACT Intervention 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. ACT Intervention Standard Care
Overall Study STARTED	43	44
Overall Study COMPLETED	21	19
Overall Study NOT COMPLETED	22	25

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

An ACT-Based Physician-Delivered Weight Loss Intervention

Baseline characteristics by cohort

Measure	Standard Care n=43 Participants 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. Standard Care	ACT Intervention n=44 Participants 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. ACT Intervention Standard Care	Total n=87 Participants Total of all reporting groups
Age, Continuous	46.87 years STANDARD_DEVIATION 15.18 • n=5 Participants	46.94 years STANDARD_DEVIATION 14.21 • n=7 Participants	46.91 years STANDARD_DEVIATION 14.56 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	31 Participants n=7 Participants	61 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	15 Participants n=5 Participants	24 Participants n=7 Participants	39 Participants n=5 Participants
Region of Enrollment Canada	43 participants n=5 Participants	44 participants n=7 Participants	87 participants n=5 Participants
DEBQ Emotional Eating	4.09 units on a scale STANDARD_DEVIATION 0.53 • n=5 Participants	3.96 units on a scale STANDARD_DEVIATION 0.49 • n=7 Participants	4.02 units on a scale STANDARD_DEVIATION 0.51 • n=5 Participants
DEBQ External Eating	3.57 units on a scale STANDARD_DEVIATION 0.65 • n=5 Participants	3.56 units on a scale STANDARD_DEVIATION 0.56 • n=7 Participants	3.56 units on a scale STANDARD_DEVIATION 0.60 • n=5 Participants
DEBQ Restraint Eating	3.18 units on a scale STANDARD_DEVIATION 0.64 • n=5 Participants	3.17 units on a scale STANDARD_DEVIATION 0.69 • n=7 Participants	3.17 units on a scale STANDARD_DEVIATION 0.66 • n=5 Participants
DTS Total Score	2.48 units on a scale STANDARD_DEVIATION 0.94 • n=5 Participants	2.69 units on a scale STANDARD_DEVIATION 0.84 • n=7 Participants	2.59 units on a scale STANDARD_DEVIATION 0.89 • n=5 Participants
PHLMS awareness	36.03 units on a scale STANDARD_DEVIATION 6.02 • n=5 Participants	36.06 units on a scale STANDARD_DEVIATION 6.78 • n=7 Participants	36.04 units on a scale STANDARD_DEVIATION 6.38 • n=5 Participants
PHLMS acceptance	24.94 units on a scale STANDARD_DEVIATION 7.79 • n=5 Participants	26.00 units on a scale STANDARD_DEVIATION 7.00 • n=7 Participants	25.50 units on a scale STANDARD_DEVIATION 7.34 • n=5 Participants
ACT assessment	2.92 units on a scale STANDARD_DEVIATION 0.73 • n=5 Participants	2.90 units on a scale STANDARD_DEVIATION 0.70 • n=7 Participants	2.91 units on a scale STANDARD_DEVIATION 0.71 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline to Post-Intervention (on average, 16 weeks)

Population: Of those who initiated the intervention, 40 individuals completed all 8 sessions and had weight data at session 8.

Weight change in kilograms

Outcome measures

Measure	Standard Care n=21 Participants 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. Standard Care	ACT Intervention n=19 Participants 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. ACT Intervention Standard Care
Weight Change	1.56 kilograms Interval -7.49 to 10.62	0.71 kilograms Interval -2.32 to 3.76

PRIMARY outcome

Timeframe: Baseline to Post-Intervention (on average, 16 weeks)

Population: Of those who initiated the intervention, only 26 participants completed the DEBQ at baseline and post-intervention (session 8) to be included in the analyses.

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.

Outcome measures

Measure	Standard Care n=13 Participants 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. Standard Care	ACT Intervention n=13 Participants 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. ACT Intervention Standard Care
Emotional Eating Change	-0.92 units on a scale Interval -1.35 to -0.49	-0.91 units on a scale Interval -1.47 to -0.35

SECONDARY outcome

Timeframe: Baseline to Post-Intervention (on average, 16 weeks)

Population: Of those who initiated the intervention, 40 individuals completed all 8 sessions and had body fat data at session 8.

Change in body fat percentage

Outcome measures

Measure	Standard Care n=21 Participants 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. Standard Care	ACT Intervention n=19 Participants 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. ACT Intervention Standard Care
Body Fat Percentage Change	-0.72 percentage of body fat Interval -1.53 to 0.09	0.16 percentage of body fat Interval -0.92 to 1.23

SECONDARY outcome

Timeframe: Baseline to Post-Intervention (on average, 16 weeks)

Population: Of those who initiated the intervention, only 26 participants completed the DEBQ at baseline and post-intervention (session 8) to be included in the analyses.

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.

Outcome measures

Measure	Standard Care n=13 Participants 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. Standard Care	ACT Intervention n=13 Participants 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. ACT Intervention Standard Care
External Eating Change	-0.52 units on a scale Interval -0.98 to -0.06	-0.31 units on a scale Interval -0.78 to 0.16

SECONDARY outcome

Timeframe: Baseline to Post-Intervention (on average, 16 weeks)

Population: Of those who initiated the intervention, only 26 participants completed the DEBQ at baseline and post-intervention (session 8) to be included in the analyses.

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.

Outcome measures

Measure	Standard Care n=13 Participants 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. Standard Care	ACT Intervention n=13 Participants 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. ACT Intervention Standard Care
Restraint Eating Change	0.27 units on a scale Interval -0.01 to 0.55	0.26 units on a scale Interval -0.16 to 0.68

SECONDARY outcome

Timeframe: Baseline to Post-Intervention (on average, 16 weeks)

Population: Of those who initiated the intervention, only 26 participants completed the DTS at baseline and post-intervention (session 8) to be included in the analyses.

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.

Outcome measures

Measure	Standard Care n=13 Participants 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. Standard Care	ACT Intervention n=13 Participants 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. ACT Intervention Standard Care
Distress Tolerance Change	0.52 units on a scale Interval 0.18 to 0.86	0.04 units on a scale Interval -0.31 to 0.39

SECONDARY outcome

Timeframe: Baseline to Post-Intervention (on average, 16 weeks)

Population: Of those who initiated the intervention, only 26 participants completed the PHLMS at baseline and post-intervention (session 8) to be included in the analyses.

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.

Outcome measures

Measure	Standard Care n=13 Participants 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. Standard Care	ACT Intervention n=13 Participants 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. ACT Intervention Standard Care
Mindfulness Awareness Change	-1.50 units on a scale Interval -4.51 to 1.51	1.67 units on a scale Interval -1.76 to 5.1

SECONDARY outcome

Timeframe: Baseline to Post-Intervention (on average, 16 weeks)

Population: Of those who initiated the intervention, only 26 participants completed the ACT application at baseline and post-intervention (session 8) to be included in the analyses.

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.

Outcome measures

Measure	Standard Care n=13 Participants 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. Standard Care	ACT Intervention n=13 Participants 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. ACT Intervention Standard Care
Values Clarification/ACT Application Change	-0.60 units on a scale Interval -1.15 to -0.04	-0.43 units on a scale Interval -1.06 to 0.2

OTHER_PRE_SPECIFIED outcome

Timeframe: Administered Post-Intervention (at on average, 16 weeks)

Population: Of those who initiated the intervention, only 28 participants completed the treatment satisfaction questionnaire at post-intervention (session 8) to be included in the analyses.

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.

Outcome measures

Measure	Standard Care n=15 Participants 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. Standard Care	ACT Intervention n=13 Participants 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. ACT Intervention Standard Care
Patient Treatment Satisfaction	1.95 units on a scale Standard Deviation 0.80	2.03 units on a scale Standard Deviation 0.77

OTHER_PRE_SPECIFIED outcome

Timeframe: Each physician was asked to complete this questionnaire once during their administration of the ACT intervention (from July 2016 to February 2017)

Population: Physicians who delivered the ACT intervention were asked to provide their input on the intervention. They only completed this questionnaire in relation to the ACT intervention and not standard care.

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.

Outcome measures

Measure	Standard Care n=7 Participants 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. Standard Care	ACT Intervention 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. ACT Intervention Standard Care
Physician Treatment Satisfaction	3.51 units on a scale Standard Deviation 0.76	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Prescreen questionnaire to Baseline

Population: 123 of those who completed the initial prescreen questionnaire were deemed eligible for the study and randomized to standard care (64) or ACT intervention (59). Of these, 43 and 44 participants, respectively actually began the study.

Percentage of individuals who were eligible to participate in the study (based on the initial prescreen) that actually enrolled.

Outcome measures

Measure	Standard Care n=64 Participants 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. Standard Care	ACT Intervention n=59 Participants 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. ACT Intervention Standard Care
Recruitment Rates	43 Participants	44 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to Post-Intervention (on average, 16 weeks)

Dropout rates between conditions from baseline to session 8.

Outcome measures

Measure	Standard Care n=43 Participants 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. Standard Care	ACT Intervention n=44 Participants 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. ACT Intervention Standard Care
Number of Participants That Dropped Out From Study	22 Participants	25 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to Post-Intervention (on average, 16 weeks)

Percentage of participants who completed questionnaires between conditions

Outcome measures

Measure	Standard Care n=43 Participants 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. Standard Care	ACT Intervention n=44 Participants 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. ACT Intervention Standard Care
Questionnaire Completion	15 Participants	13 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to Post-Intervention (on average, 16 weeks)

How long it took participants in each condition to complete the 8-session intervention

Outcome measures

Measure	Standard Care n=21 Participants 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. Standard Care	ACT Intervention n=19 Participants 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. ACT Intervention Standard Care
Intervention Completion Time	15.41 weeks Standard Deviation 10.97	17.41 weeks Standard Deviation 12.39

Adverse Events

Standard Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

ACT Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mallory Frayn, PhD (c)

McGill University

Phone: 514-398-1399

Email: mallory.frayn@mail.mcgill.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place