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Completed

NCT Number: NCT04337619

Project Activate: Mindfulness and Acceptance Based Behavioral Treatment for Weight Loss

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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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Drexel University Center for Weight, Eating and Lifestyle Science

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Behavioral Treatment

Behavioral

Standard Behavioral Weight Loss Treatment (remotely delivered)

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).

Primary outcomes

  1. Weight Change

    Time frame: 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 outcomes

  1. Dietary Intake

    Time frame: 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.

  2. Physical Activity

    Time frame: 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.

  3. Quality of Life Score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Drexel University

Other

Registry information

Official study title

Mindfulness and Acceptance Based Behavioral Treatment for Weight Loss

Acronym: Activate

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Apr 7, 2020
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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