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Mindfulness and Acceptance based Behavioral Therapies (MABTs) are among the most promising behavioral approaches for obesity, with two recent large trials showing that they achieve better initial weight loss and/or better weight loss maintenance than does gold standard behavioral weight loss treatment (BT). However, results vary, potentially due to inconsistencies in how MABT components are utilized and emphasized. Optimizing MABTs using a typical approach, i.e., successive randomized controlled trials of various MABT packages, is slow and difficult. Multiphase Optimization Strategy (MOST) has been developed as a better method of optimizing treatment. Consistent with Phase I of MOST, we derived three MABT components from the theoretical literature. Evaluation of MABT components through a factorial design (MOST Phase II) will allow us to determine the independent and interacting efficacies of each MABT component, in addition to the identification of subsets of individuals most or least responsive to each component. Whereas mediational analyses have been inconclusive, the use of a factorial design will allow for a critical test of the main and interaction effects of individual MABT treatment components. The current study will use a full factorial design to identify the independent and combined effects of three core MABT components (Awareness, Acceptance, and Values Clarity) as additions to remotely delivered weight loss counseling. Moderators of treatment outcome (disinhibited eating, food cue susceptibility, emotional eating, delay discounting, and inhibitory control), and mediator/process variables implicated in MABTs (mindful eating, acceptance of food cues, mindfulness, body responsiveness, autonomous motivation, values clarity, hunger/satiety perceptions, and motivation and pleasure resulting from social functioning) will be assessed as well.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Behavioral Weight Loss Treatment | Experimental |
| |
| Behavioral + Willingness | Experimental |
| |
| Behavioral + Values | Experimental |
| |
| Behavioral + Mindful Awareness | Experimental |
| |
| Behavioral + Willingness + Values | Experimental |
| |
| Behavioral + Willingness + Awareness | Experimental |
| |
| Behavioral + Values + Awareness |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Treatment | Behavioral | Standard Behavioral Weight Loss Treatment (remotely delivered) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight Change | Measured at home using a standardized weighing procedure. Participants will be weighed in lightweight clothes without shoes using a standardized bluetooth scale accurate to 0.1 kg. | Measured at baseline, mid-treatment (6 months), post-treatment (12 months), and at 6-, 12-, and 24-month follow-up (i.e., at 0, 6, 12, 18, 24 and 36 months). |
| Measure | Description | Time Frame |
|---|---|---|
| Dietary Intake | Dietary intake was recorded on the popular mobile application MyFitnessPal. | Measured at baseline, mid-treatment (6 months), post-treatment (12 months) (i.e., at 0, 6, and 12 months). |
| Physical Activity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Evan M Forman, PhD | Drexel University Center for Weight, Eating and Lifestyle Science | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Drexel University Center for Weight, Eating and Lifestyle Science | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41785111 | Derived | Crochiere RJ, Fitzgerald DT, Butryn ML, Zhang F, Beaulieu K, Maher JP, Huang Z, Cong C, Forman EM. Moderators of the relation between physical activity and subsequent energy intake among behavioral weight loss participants. Health Psychol. 2026 Mar 5:10.1037/hea0001597. doi: 10.1037/hea0001597. Online ahead of print. | |
| 40705619 | Derived | Chabria R, Hagerman CJ, Crane N, Ehmann M, Knudsen FM, Brown KL, Forman E, Butryn ML. Racial disparities in the efficacy of traditional versus acceptance-based behavioral weight loss. Health Psychol. 2026 Feb;45(2):197-205. doi: 10.1037/hea0001537. Epub 2025 Jul 24. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Behavioral Weight Loss Treatment | Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered) |
| FG001 | Behavioral + Willingness | Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered) Willingness: Integration of acceptance and willingness skills into Standard Behavioral Weight Loss Treatment (remotely delivered). |
| FG002 | Behavioral + Values | Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered) Values: Integration of values clarification and awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered). |
| FG003 | Behavioral + Mindful Awareness | Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered) Mindful Awareness: Integration of mindfulness and present-moment awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered). |
| FG004 | Behavioral + Willingness + Values | Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered) Willingness: Integration of acceptance and willingness skills into Standard Behavioral Weight Loss Treatment (remotely delivered). Values: Integration of values clarification and awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered). |
| FG005 | Behavioral + Willingness + Awareness | Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered) Willingness: Integration of acceptance and willingness skills into Standard Behavioral Weight Loss Treatment (remotely delivered). Mindful Awareness: Integration of mindfulness and present-moment awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered). |
| FG006 | Behavioral + Values + Awareness | Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered) Values: Integration of values clarification and awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered). Mindful Awareness: Integration of mindfulness and present-moment awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered). |
| FG007 | Behavioral + Willingness + Values + Awareness | Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered) Willingness: Integration of acceptance and willingness skills into Standard Behavioral Weight Loss Treatment (remotely delivered). Values: Integration of values clarification and awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered). Mindful Awareness: Integration of mindfulness and present-moment awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Behavioral Weight Loss Treatment | Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered) |
| BG001 | Behavioral + Willingness | Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered) Mindful Acceptance: Integration of acceptance and willingness skills into Standard Behavioral Weight Loss Treatment (remotely delivered). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Weight Change | Measured at home using a standardized weighing procedure. Participants will be weighed in lightweight clothes without shoes using a standardized bluetooth scale accurate to 0.1 kg. | Posted | Mean | Standard Deviation | percentage of weight change | Measured at baseline, mid-treatment (6 months), post-treatment (12 months), and at 6-, 12-, and 24-month follow-up (i.e., at 0, 6, 12, 18, 24 and 36 months). |
|
up to 36 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Behavioral Weight Loss Treatment | Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ER visit for SVT | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Foot Injury | Injury, poisoning and procedural complications | Systematic Assessment | Participant reported re-injuring right foot after walking (regular physical activity) |
Average daily calorie intake was not analyzed as an outcome or included in the imputation model because this measure is expected to be strongly biased by participants' adherence to food tracking and inaccuracies in calorie estimation (Butryn et al., 2020; Mixon and Davis, 2020).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Fengqing Zhang | Drexel University | 215.553.7172 | fz53@drexel.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 21, 2021 | Feb 17, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Experimental |
|
| Behavioral + Willingness + Values + Awareness | Experimental |
|
| Willingness | Behavioral | Integration of acceptance and willingness skills into Standard Behavioral Weight Loss Treatment (remotely delivered). |
|
| Values | Behavioral | Integration of values clarification and awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered). |
|
| Mindful Awareness | Behavioral | Integration of mindfulness and present-moment awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered). |
|
Measured in minutes per week of moderate-to-vigorous physical activity (MVPA) using one wrist-worn activity tracker including Fitbit Charge 2, 3, 4, and 5.
| Measured at baseline, mid-treatment (6 months), post-treatment (12 months), and at 6-, 12-, and 24-month follow-up (i.e., at 0, 6, 12, 18, 24 and 36 months). |
| Quality of Life Score | Measured using the Quality of Life Inventory (QOLI). The min and max values are 1 and 18. Higher scores mean a better outcome. | Measured at baseline, mid-treatment (6 months), post-treatment (12 months), and at 6-, 12-, and 24-month follow-up (i.e., at 0, 6, 12, 18, 24 and 36 months). |
| 38190202 | Derived | Crochiere RJ, Butryn ML, Zhang F, Beaulieu K, Maher JP, Huang Z, Cong C, Forman EM. Intraday relations between physical activity and energy intake among behavioral weight loss participants. Health Psychol. 2024 May;43(5):376-387. doi: 10.1037/hea0001358. Epub 2024 Jan 8. |
| BG002 | Behavioral + Values | Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered) Values: Integration of values clarification and awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered). |
| BG003 | Behavioral + Mindful Awareness | Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered) Mindful Awareness: Integration of mindfulness and present-moment awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered). |
| BG004 | Behavioral + Willingness + Values | Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered) Mindful Acceptance: Integration of acceptance and willingness skills into Standard Behavioral Weight Loss Treatment (remotely delivered). Values: Integration of values clarification and awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered). |
| BG005 | Behavioral + Willingness + Awareness | Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered) Mindful Acceptance: Integration of acceptance and willingness skills into Standard Behavioral Weight Loss Treatment (remotely delivered). Mindful Awareness: Integration of mindfulness and present-moment awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered). |
| BG006 | Behavioral + Values + Awareness | Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered) Values: Integration of values clarification and awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered). Mindful Awareness: Integration of mindfulness and present-moment awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered). |
| BG007 | Behavioral + Willingness + Values + Awareness | Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered) Mindful Acceptance: Integration of acceptance and willingness skills into Standard Behavioral Weight Loss Treatment (remotely delivered). Values: Integration of values clarification and awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered). Mindful Awareness: Integration of mindfulness and present-moment awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered). |
| BG008 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Behavioral + Values | Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered) Values: Integration of values clarification and awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered). |
| OG003 | Behavioral + Mindful Awareness | Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered) Mindful Awareness: Integration of mindfulness and present-moment awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered). |
| OG004 | Behavioral + Willingness + Values | Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered) Mindful Acceptance: Integration of acceptance and willingness skills into Standard Behavioral Weight Loss Treatment (remotely delivered). Values: Integration of values clarification and awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered). |
| OG005 | Behavioral + Willingness + Awareness | Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered) Mindful Acceptance: Integration of acceptance and willingness skills into Standard Behavioral Weight Loss Treatment (remotely delivered). Mindful Awareness: Integration of mindfulness and present-moment awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered). |
| OG006 | Behavioral + Values + Awareness | Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered) Values: Integration of values clarification and awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered). Mindful Awareness: Integration of mindfulness and present-moment awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered). |
| OG007 | Behavioral + Willingness + Values + Awareness | Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered) Mindful Acceptance: Integration of acceptance and willingness skills into Standard Behavioral Weight Loss Treatment (remotely delivered). Values: Integration of values clarification and awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered). Mindful Awareness: Integration of mindfulness and present-moment awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered). |
|
|
| Secondary | Dietary Intake | Dietary intake was recorded on the popular mobile application MyFitnessPal. | As acknowledged in the limitation section, average daily calorie intake was not included in the imputation model and later analyses as a secondary outcome because this measure expected to be strongly biased by participants' adherence to food tracking. The descriptive statistics (e.g., mean, standard deviation) reported in the table below were computed using available data with missing data points excluded. | Posted | Mean | Standard Deviation | kcal/day | Measured at baseline, mid-treatment (6 months), post-treatment (12 months) (i.e., at 0, 6, and 12 months). |
|
|
|
| Secondary | Physical Activity | Measured in minutes per week of moderate-to-vigorous physical activity (MVPA) using one wrist-worn activity tracker including Fitbit Charge 2, 3, 4, and 5. | Posted | Mean | Standard Deviation | minutes per week | Measured at baseline, mid-treatment (6 months), post-treatment (12 months), and at 6-, 12-, and 24-month follow-up (i.e., at 0, 6, 12, 18, 24 and 36 months). |
|
|
|
| Secondary | Quality of Life Score | Measured using the Quality of Life Inventory (QOLI). The min and max values are 1 and 18. Higher scores mean a better outcome. | Posted | Mean | Standard Deviation | score on a scale | Measured at baseline, mid-treatment (6 months), post-treatment (12 months), and at 6-, 12-, and 24-month follow-up (i.e., at 0, 6, 12, 18, 24 and 36 months). |
|
|
|
| 0 |
| 34 |
| 0 |
| 34 |
| 1 |
| 34 |
| EG001 | Behavioral + Willingness | Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered) Mindful Acceptance: Integration of acceptance and willingness skills into Standard Behavioral Weight Loss Treatment (remotely delivered). | 0 | 35 | 0 | 35 | 1 | 35 |
| EG002 | Behavioral + Values | Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered) Values: Integration of values clarification and awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered). | 0 | 32 | 0 | 32 | 0 | 32 |
| EG003 | Behavioral + Mindful Awareness | Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered) Mindful Awareness: Integration of mindfulness and present-moment awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered). | 0 | 35 | 0 | 35 | 0 | 35 |
| EG004 | Behavioral + Willingness + Values | Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered) Mindful Acceptance: Integration of acceptance and willingness skills into Standard Behavioral Weight Loss Treatment (remotely delivered). Values: Integration of values clarification and awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered). | 0 | 36 | 1 | 36 | 2 | 36 |
| EG005 | Behavioral + Willingness + Awareness | Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered) Mindful Acceptance: Integration of acceptance and willingness skills into Standard Behavioral Weight Loss Treatment (remotely delivered). Mindful Awareness: Integration of mindfulness and present-moment awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered). | 0 | 34 | 1 | 34 | 1 | 34 |
| EG006 | Behavioral + Values + Awareness | Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered) Values: Integration of values clarification and awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered). Mindful Awareness: Integration of mindfulness and present-moment awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered). | 0 | 38 | 0 | 38 | 1 | 38 |
| EG007 | Behavioral + Willingness + Values + Awareness | Behavioral Treatment: Standard Behavioral Weight Loss Treatment (remotely delivered) Mindful Acceptance: Integration of acceptance and willingness skills into Standard Behavioral Weight Loss Treatment (remotely delivered). Values: Integration of values clarification and awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered). Mindful Awareness: Integration of mindfulness and present-moment awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered). | 0 | 32 | 0 | 32 | 1 | 32 |
| Knee replacement with hospitalization | Surgical and medical procedures | Systematic Assessment |
|
|
| shoulder, neck, leg injury | Injury, poisoning and procedural complications | Systematic Assessment | Reported shoulder and neck injury in 7/2020 and fell in 8/2020 and injured leg, which impacted PA. Disclosed in S20 that she'd had a "mild heart attack" midway through treatment that prevented any PA. Did not tell us at the time. |
|
| tearing their rotator cuff | Surgical and medical procedures | Systematic Assessment | Participant reported a rotator cuff tear during supervised strength training at a gym in late January 2022. Diagnosis was confirmed by MRI in late February 2022, followed by rotator cuff surgery. |
|
| surgery and chemotherapy | Surgical and medical procedures | Systematic Assessment | Participant reported having been diagnosed with cancer in June 2023 and since then had surgery and chemotherapy. They were wrapping up radiation at the time of reporting this. |
|
| Knee surgery | Surgical and medical procedures | Systematic Assessment | Reported getting knee surgery |
|
| Foot surgery | Surgical and medical procedures | Systematic Assessment | Reported getting foot surgery |
|
| rectocele surgery | Surgical and medical procedures | Systematic Assessment | Reported getting rectocele surgery |
|
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
|
| 6 months |
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| 12 months |
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| mid-treatment |
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| post-treatment |
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| 6-month follow-up |
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| 12-month follow-up |
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| 24-month follow-up |
|
| mid-treatment |
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| post-treatment |
|
| 6-month follow-up |
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| 12-month follow-up |
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| 24-month follow-up |
|