Clinical trial NCT04337619: Project Activate: Mindfulness and Acceptance Based Behavioral Treatment for Weight Loss
Official title: Mindfulness and Acceptance Based Behavioral Treatment for Weight Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Weight Loss
Keywords: Obesity
Weight Loss
Behavioral treatment
Acceptance-based behavioral weight loss treatment
Acceptance and Commitment Therapy
Multiphase Optimization Strategy
Lead sponsor: Drexel University
Sponsor class: OTHER
First posted: 2020-04-07
Enrollment: 285
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Weight change
timeFrame: 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 outcomes:
measure: Dietary intake
timeFrame: 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: Physical activity
timeFrame: 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: Change in quality of life
timeFrame: 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).
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Drexel University Center for Weight, Eating and Lifestyle Science
state: Pennsylvania
Study officials:
affiliation: Drexel University Center for Weight, Eating and Lifestyle Science
name: Evan M Forman, PhD
role: PRINCIPAL_INVESTIGATOR
References: