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Acceptance-based Group Intervention for Binge Eating

Acceptance-based Group Intervention for Binge Eating

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01757847
Enrollment
90
Registered
2012-12-31
Start date
2013-01-31
Completion date
2015-12-31
Last updated
2016-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Binge-Eating Disorder

Keywords

Binge-Eating Disorder, Obesity, emotional eating

Brief summary

This study proposes to compare a brief Acceptance and Commitment Therapy (ACT) group intervention to an active control group in a sample of 154 overweight or obese binge eating Veterans who have completed the VA's national behavioral weight management program (MOVE!). This study anticipates that the ACT intervention will reduce binge eating and distress while improving functioning and maintenance of weight loss.

Detailed description

Approximately two-thirds of all adults and close to 75% of Veterans are overweight or obese, making obesity a national epidemic with significant impairments in physical and psychological functioning, increasing healthcare costs, and high mortality rates. A significant proportion of overweight and obese individuals binge eat in response to stress or negative emotions, further contributing to obesity. Obesity and binge eating are independently related to a number of physical and mental health co-morbidities such as diabetes, coronary heart disease, osteoarthritis, respiratory symptoms, depression, and anxiety. Although behavioral weight loss interventions have been partially effective, few show long-term maintenance of weight loss, especially for patients with binge eating behavior. Thus, a stepped-care approach that provides more intensive treatment to specifically address the emotional and behavioral factors associated with problematic eating and obesity may be necessary. Acceptance and Commitment Therapy (ACT), an empirically-supported intervention that is being rolled out nationally by the VA, has been effective in reducing distress, increasing quality of life, and improving other indices of health in a wide range of conditions from depression to diabetes. The investigator's preliminary findings suggest that a brief ACT-based group intervention for patients with overweight or obesity can substantially reduce binge eating and distress, and improve functioning. This study proposes to test the efficacy of an ACT intervention for binge eating in conjunction with a standard behavioral weight loss intervention, Managing Overweight and/or Obesity for Veterans Everywhere (MOVE!), at the VA San Diego Healthcare System (VASDHS). Patients (N = 154) who are overweight or obese (body mass index \> 25 kg/m2) and meet the clinical criteria for binge eating will be randomized to receive either four 2-hour weekly ACT intervention groups or brief MOVE-II active control groups after their participation in MOVE!. This study hypothesizes that: 1) patients in the ACT intervention will experience significantly greater reductions in binge eating severity than patients in the brief MOVE-II active control group (primary outcome); 2) patients in the ACT intervention will experience significantly greater improvements in physical and mental health functioning, obesity-related quality of life, physical activity levels, caloric and nutrient intake, emotional distress symptoms, binge frequency, and other forms of emotional eating than patients in the brief MOVE-II active control group; 3) gains associated with the ACT intervention will be maintained longer than gains associated with the brief MOVE-II active control group; 4) at 3-month and 6-month follow-ups, patients in the ACT intervention will have greater decreases in body mass index compared to patients in the brief MOVE-II active control group; and 5) measures of acceptance and action will mediate treatment response in the ACT intervention on outcomes of interest. Given the significant physical and psychological sequelae of binge eating and obesity, a brief intervention that can reduce disordered eating, enhance the maintenance of weight loss, and improve functioning among patients who suffer from binge eating, could be critical in the comprehensive approach to patient care at the VA.

Interventions

BEHAVIORALAcceptance and Commitment Therapy (ACT)

The ACT group protocol consists of four 2-hour weekly sessions focusing on a) thoughts, feelings, and bodily sensations in the context of efforts to lose weight; b) limitations of efforts to control or eliminate negative thoughts or emotions, stress, or food cravings; c) changing expectations and goals from elimination of stress or cravings to living as well as possible with such feelings; d) mindfulness exercises to increase awareness; and e) identification of personal values and goals to achieve improved quality of life.

BEHAVIORALBrief MOVE-II control group intervention

The MOVE-II protocol was designed to reinforce the weight-loss principles that patients learn in MOVE! and to provide support in continued weight loss. The brief MOVE-II active control group protocol will be delivered in four 2-hour weekly group sessions. This protocol includes a psycho-educational component that reinforces the key information from the medical, nutrition, and weight loss strategies modules of the MOVE! program. After review of the psycho-educational components, patients have the opportunity to share their challenges with binge eating and weight loss. Patients will then be able to receive support and feedback from other group members and the therapist. In addition to reinforcing the strategies taught during MOVE! and to provide support in implementing those strategies, the active control group focuses on increasing self-esteem and self-efficacy by exploring patient strengths and maintaining therapeutic alliance and optimism.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Diagnosis of overweight or obesity (i.e., BMI \> 25 kg/m2), as verified by a study physician after a medical evaluation and examination of medical records; * Attendance of at least 60% of weight loss sessions of the MOVE! program (i.e., 5 of 8 sessions). * At least 18 years old

Exclusion criteria

* Serious or unstable medical or psychiatric illness (i.e., current unmanaged psychosis, manic episode, anorexia nervosa, bulimia nervosa, or substance abuse within the past year) or psychosocial instability (e.g., homelessness) that could compromise study participation; * Conditions in which exercise or weight loss will be detrimental to one's health (e.g., pregnancy); * Active suicidal ideation or history of suicide attempt within 5 years; * Pharmacotherapy for obesity (e.g., Orlistat or Meridia) or bariatric surgery within the past 6 months or planning to start such treatments in the next 6 months; * Current participation in group or individual psychotherapy for weight management or binge eating; * Previous treatment with ACT; * Unwillingness to agree not to change professionally delivered mood treatments and psychotherapy (e.g., begin new therapy or group; discontinue a treatment; increase the dose of medication) for the duration of 4-week study treatment period unless medically necessary.

Design outcomes

Primary

MeasureTime frameDescription
Change From Baseline in Binge Eating Scale (BES) at 4 Weeks, 3 Months and 6 Monthspost treatment (4 weeks), 3 months, 6 monthsThis measure contains 16 questions that describe both behavioral and emotional manifestations of a binge episode. This scale was specifically developed to assess binge eating severity and associated emotional distress in overweight and obese individuals. The total score for the measure ranges from 0-46 points with higher scores indicating greater problems with binge eating and lower scores indicating better outcome.

Secondary

MeasureTime frameDescription
Change From Baseline in The Obesity-related Well Being Scale (ORWELL-97) at 4 Weeks, 3 Months, and 6 Monthspost treatment (4 weeks), 3 months, 6 monthsThe ORWELL-97 is a self-report measure of obesity-related quality of life. It has been validated on obese patients. The total score ranges from 0-162 with higher scores indicating lower quality of life and decreasing scores indicating improvement in the outcome.

Countries

United States

Participant flow

Participants by arm

ArmCount
Brief MOVE-II Active Control Group Intervention
The MOVE-II protocol was designed to reinforce the weight-loss principles that patients learn in MOVE! and to provide support in continued weight loss. The brief MOVE-II active control group protocol was delivered in four 2-hour weekly group sessions. This protocol includes a psycho-educational component that reinforces the key information from the medical, nutrition, and weight loss strategies modules of the MOVE! program. After review of the psycho-educational components, patients have the opportunity to share their challenges with binge eating and weight loss. Patients will then be able to receive support and feedback from other group members and the therapist. In addition, the active control group focuses on increasing self-esteem and self-efficacy
44
Acceptance and Commitment Therapy (ACT)
The ACT group protocol consists of four 2-hour weekly sessions focusing on a) thoughts, feelings, and bodily sensations in the context of efforts to lose weight; b) limitations of efforts to control or eliminate negative thoughts or emotions, stress, or food cravings; c) changing expectations and goals from elimination of stress or cravings to living as well as possible with such feelings; d) mindfulness exercises to increase awareness; and e) identification of personal values and goals to achieve improved quality of life.
46
Total90

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyWithdrawal by Subject34

Baseline characteristics

CharacteristicBrief MOVE-II Active Control Group InterventionAcceptance and Commitment Therapy (ACT)Total
Age, Continuous57.52 years
STANDARD_DEVIATION 9.33
56.23 years
STANDARD_DEVIATION 10.34
56.87 years
STANDARD_DEVIATION 9.83
Binge Eating Scale17.48 units on a scale
STANDARD_DEVIATION 8.25
15.53 units on a scale
STANDARD_DEVIATION 9.28
16.47 units on a scale
STANDARD_DEVIATION 8.8
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants6 Participants8 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
42 Participants40 Participants82 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants2 Participants3 Participants
Race (NIH/OMB)
Asian
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Black or African American
10 Participants7 Participants17 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants0 Participants1 Participants
Race (NIH/OMB)
White
32 Participants36 Participants68 Participants
Region of Enrollment
United States
44 participants46 participants90 participants
Sex: Female, Male
Female
7 Participants13 Participants20 Participants
Sex: Female, Male
Male
37 Participants33 Participants70 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 440 / 46
serious
Total, serious adverse events
0 / 440 / 46

Outcome results

Primary

Change From Baseline in Binge Eating Scale (BES) at 4 Weeks, 3 Months and 6 Months

This measure contains 16 questions that describe both behavioral and emotional manifestations of a binge episode. This scale was specifically developed to assess binge eating severity and associated emotional distress in overweight and obese individuals. The total score for the measure ranges from 0-46 points with higher scores indicating greater problems with binge eating and lower scores indicating better outcome.

Time frame: post treatment (4 weeks), 3 months, 6 months

Population: participants with measurement at baseline and at least one other time point.

ArmMeasureGroupValue (MEAN)Dispersion
Brief MOVE-II Active Control Group InterventionChange From Baseline in Binge Eating Scale (BES) at 4 Weeks, 3 Months and 6 MonthsPost treatment10.52 units on a scaleStandard Deviation 7.29
Brief MOVE-II Active Control Group InterventionChange From Baseline in Binge Eating Scale (BES) at 4 Weeks, 3 Months and 6 Months6 month follow up10.00 units on a scaleStandard Deviation 7.49
Brief MOVE-II Active Control Group InterventionChange From Baseline in Binge Eating Scale (BES) at 4 Weeks, 3 Months and 6 Months3 month follow up10.47 units on a scaleStandard Deviation 7.4
Brief MOVE-II Active Control Group InterventionChange From Baseline in Binge Eating Scale (BES) at 4 Weeks, 3 Months and 6 MonthsBaseline17.38 units on a scaleStandard Deviation 8.15
Acceptance and Commitment Therapy (ACT)Change From Baseline in Binge Eating Scale (BES) at 4 Weeks, 3 Months and 6 Months3 month follow up11.90 units on a scaleStandard Deviation 8.65
Acceptance and Commitment Therapy (ACT)Change From Baseline in Binge Eating Scale (BES) at 4 Weeks, 3 Months and 6 MonthsPost treatment13.52 units on a scaleStandard Deviation 9.05
Acceptance and Commitment Therapy (ACT)Change From Baseline in Binge Eating Scale (BES) at 4 Weeks, 3 Months and 6 MonthsBaseline15.45 units on a scaleStandard Deviation 9.19
Acceptance and Commitment Therapy (ACT)Change From Baseline in Binge Eating Scale (BES) at 4 Weeks, 3 Months and 6 Months6 month follow up12.20 units on a scaleStandard Deviation 7.32
Secondary

Change From Baseline in The Obesity-related Well Being Scale (ORWELL-97) at 4 Weeks, 3 Months, and 6 Months

The ORWELL-97 is a self-report measure of obesity-related quality of life. It has been validated on obese patients. The total score ranges from 0-162 with higher scores indicating lower quality of life and decreasing scores indicating improvement in the outcome.

Time frame: post treatment (4 weeks), 3 months, 6 months

Population: Participants with measurement at baseline and at least one other time point.

ArmMeasureGroupValue (MEAN)Dispersion
Brief MOVE-II Active Control Group InterventionChange From Baseline in The Obesity-related Well Being Scale (ORWELL-97) at 4 Weeks, 3 Months, and 6 MonthsBaseline50.17 units on a scaleStandard Deviation 28.26
Brief MOVE-II Active Control Group InterventionChange From Baseline in The Obesity-related Well Being Scale (ORWELL-97) at 4 Weeks, 3 Months, and 6 MonthsPost Treatment41.86 units on a scaleStandard Deviation 22.65
Brief MOVE-II Active Control Group InterventionChange From Baseline in The Obesity-related Well Being Scale (ORWELL-97) at 4 Weeks, 3 Months, and 6 Months3 month follow up41.07 units on a scaleStandard Deviation 26.77
Brief MOVE-II Active Control Group InterventionChange From Baseline in The Obesity-related Well Being Scale (ORWELL-97) at 4 Weeks, 3 Months, and 6 Months6 month follow up37.90 units on a scaleStandard Deviation 31.87
Acceptance and Commitment Therapy (ACT)Change From Baseline in The Obesity-related Well Being Scale (ORWELL-97) at 4 Weeks, 3 Months, and 6 Months6 month follow up36.55 units on a scaleStandard Deviation 27.82
Acceptance and Commitment Therapy (ACT)Change From Baseline in The Obesity-related Well Being Scale (ORWELL-97) at 4 Weeks, 3 Months, and 6 MonthsBaseline49.47 units on a scaleStandard Deviation 30.6
Acceptance and Commitment Therapy (ACT)Change From Baseline in The Obesity-related Well Being Scale (ORWELL-97) at 4 Weeks, 3 Months, and 6 Months3 month follow up38.79 units on a scaleStandard Deviation 29.14
Acceptance and Commitment Therapy (ACT)Change From Baseline in The Obesity-related Well Being Scale (ORWELL-97) at 4 Weeks, 3 Months, and 6 MonthsPost Treatment46.02 units on a scaleStandard Deviation 33.57

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026