Obesity, Weight Loss
Conditions
Keywords
Obesity, Weight Loss, Behavioral treatment, Acceptance-based behavioral weight loss treatment, Acceptance and Commitment Therapy, Multiphase Optimization Strategy
Brief summary
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.
Interventions
BEHAVIORALBehavioral Treatment
Standard Behavioral Weight Loss Treatment (remotely delivered)
BEHAVIORALWillingness
Integration of acceptance and willingness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
BEHAVIORALValues
Integration of values clarification and awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
BEHAVIORALMindful Awareness
Integration of mindfulness and present-moment awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
Sponsors
Drexel University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Individuals must be of overweight or obese BMI (27-50 kg/m2) * Individuals must be adults (aged 18-70) * Completion of a 3-day food diary * Completion of baseline assessment tasks * Willingness to lose weight, be physically active, and participate in-group sessions. * Participants must also provide consent for the research team to contact their personal physician if necessary to provide clearance or to consult about rapid weight gain.
Exclusion criteria
* Inability to engage in physical activity (defined as walking a city block without stopping) * Medical or psychiatric condition that may pose a risk to the participant during intervention, cause a change in weight, or limit ability to comply with the program * Recently began or changed the dose of a medication that can cause significant change in weight * History of bariatric surgery; weight loss of \> 5% in the previous 3 months * Currently pregnant or breastfeeding or planning to become pregnant * Planning to, or participating in, another weight loss treatment in the next 3 years. * Engaging in compensatory vomiting, other severe compensatory behaviors, or more than 12 of any compensatory behavior in the previous 3 months * Experiencing significant loss of control eating (9 or more binge episodes in the previous 3 months)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dietary Intake | Measured at baseline, mid-treatment (6 months), post-treatment (12 months) (i.e., at 0, 6, and 12 months). | Dietary intake was recorded on the popular mobile application MyFitnessPal. |
| Physical Activity | 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). | 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. |
| Quality of Life Score | 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). | Measured using the Quality of Life Inventory (QOLI). The min and max values are 1 and 18. Higher scores mean a better outcome. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATOREvan M Forman, PhD
Drexel University Center for Weight, Eating and Lifestyle Science
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 28 Participants |
| Age, Categorical Between 18 and 65 years | 248 Participants |
| Age, Continuous | 51.8 years STANDARD_DEVIATION 10.92 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 204 Participants |
| Region of Enrollment United States | 32 participants |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 35 | 0 / 32 | 0 / 35 | 0 / 36 | 0 / 34 | 0 / 38 | 0 / 32 |
| other Total, other adverse events | 1 / 34 | 1 / 35 | 0 / 32 | 0 / 35 | 2 / 36 | 1 / 34 | 1 / 38 | 1 / 32 |
| serious Total, serious adverse events | 0 / 34 | 0 / 35 | 0 / 32 | 0 / 35 | 1 / 36 | 1 / 34 | 0 / 38 | 0 / 32 |
Outcome results
None listed