ObesityActivateNCT04337619

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

A study testing Behavioral Treatment, Willingness and Values in people with Obesity and Weight Loss, run by Drexel University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Obesity, Weight Loss
What is being tested?: Behavioral Treatment, Willingness and Values
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 276 participants
Where: 1 siteUnited States
Study dates: 15 Aug 2019to 7 Nov 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

United States1 site

Drexel University Center for Weight, Eating and Lifestyle Science
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: 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.

Conditions: Obesity, Weight Loss
Being tested: Behavioral Treatment, Willingness, Values, Mindful Awareness
Keywords: Obesity, Weight Loss, Behavioral treatment, Acceptance-based behavioral weight loss treatment, Acceptance and Commitment Therapy, Multiphase Optimization Strategy
Medical subject headings: Obesity, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Behavioral TreatmentBehavioural
Standard Behavioral Weight Loss Treatment (remotely delivered)
WillingnessBehavioural
Integration of acceptance and willingness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
ValuesBehavioural
Integration of values clarification and awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
Mindful AwarenessBehavioural
Integration of mindfulness and present-moment awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).

Study groups in NCT04337619
Study group	Role	What they receive
Standard Behavioral Weight Loss Treatment	Experimental	Not described Receives: Behavioral: Behavioral Treatment
Behavioral + Willingness	Experimental	Not described Receives: Behavioral: Behavioral Treatment; Behavioral: Willingness
Behavioral + Values	Experimental	Not described Receives: Behavioral: Behavioral Treatment; Behavioral: Values
Behavioral + Mindful Awareness	Experimental	Not described Receives: Behavioral: Behavioral Treatment; Behavioral: Mindful Awareness
Behavioral + Willingness + Values	Experimental	Not described Receives: Behavioral: Behavioral Treatment; Behavioral: Willingness; Behavioral: Values
Behavioral + Willingness + Awareness	Experimental	Not described Receives: Behavioral: Behavioral Treatment; Behavioral: Willingness; Behavioral: Mindful Awareness
Behavioral + Values + Awareness	Experimental	Not described Receives: Behavioral: Behavioral Treatment; Behavioral: Values; Behavioral: Mindful Awareness
Behavioral + Willingness + Values + Awareness	Experimental	Not described Receives: Behavioral: Behavioral Treatment; Behavioral: Willingness; Behavioral: Values; Behavioral: Mindful Awareness

What is being measured

The primary outcome is the main question the study is designed to answer.

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: 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 (3)

Dietary Intake
Dietary intake was recorded on the popular mobile application MyFitnessPal.
Measured: Measured at baseline, mid-treatment (6 months), post-treatment (12 months) (i.e., at 0, 6, and 12 months).
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.
Measured: 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: 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Aug 20197 Nov 2024

First posted7 Apr 2020
Study start15 Aug 2019
Primary completion7 Nov 2024
Study completion7 Nov 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for ObesityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 276 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04337619
Sponsor's protocol ID: R01DK119658
Acronym: Activate
Status last verified: Mar 2026
First submitted: 25 Feb 2020
Last updated: 14 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 41785111
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.
PubMed 40705619
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.
PubMed 38190202

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Obesity trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Mindfulness and Acceptance Based Behavioral Treatment for Weight Loss
ClinicalTrials.gov ID: NCT04337619
Acronym / sponsor ID: Activate / R01DK119658
Conditions: Obesity, Weight Loss
Keywords: Obesity, Weight Loss, Behavioral treatment, Acceptance-based behavioral weight loss treatment, Acceptance and Commitment Therapy, Multiphase Optimization Strategy
Study type: Interventional
Recruitment status: Completed
Enrolment: 276 participants (actual)
Lead sponsor: Drexel UniversityUniversity, hospital or other
Study start: 15 Aug 2019 (actual)
Primary completion: 7 Nov 2024 (actual)
Study completion: 7 Nov 2024 (actual)
First posted: 7 Apr 2020 (actual)
Results: Posted 11 Mar 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Double blind (participant, outcomes assessor)
Number of arms: 8

Arm	Type	Receives
Standard Behavioral Weight Loss Treatment	Experimental	Behavioral: Behavioral Treatment
Behavioral + Willingness	Experimental	Behavioral: Behavioral Treatment, Behavioral: Willingness
Behavioral + Values	Experimental	Behavioral: Behavioral Treatment, Behavioral: Values
Behavioral + Mindful Awareness	Experimental	Behavioral: Behavioral Treatment, Behavioral: Mindful Awareness
Behavioral + Willingness + Values	Experimental	Behavioral: Behavioral Treatment, Behavioral: Willingness, Behavioral: Values
Behavioral + Willingness + Awareness	Experimental	Behavioral: Behavioral Treatment, Behavioral: Willingness, Behavioral: Mindful Awareness
Behavioral + Values + Awareness	Experimental	Behavioral: Behavioral Treatment, Behavioral: Values, Behavioral: Mindful Awareness
Behavioral + Willingness + Values + Awareness	Experimental	Behavioral: Behavioral Treatment, Behavioral: Willingness, Behavioral: Values, Behavioral: Mindful Awareness

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Behavioral TreatmentStandard Behavioral Weight Loss Treatment (remotely delivered)	Behavioural	Behavioral + Mindful Awareness, Behavioral + Values, Behavioral + Values + Awareness, Behavioral + Willingness, Behavioral + Willingness + Awareness, Behavioral + Willingness + Values, Behavioral + Willingness + Values + Awareness, Standard Behavioral Weight Loss Treatment
WillingnessIntegration of acceptance and willingness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).	Behavioural	Behavioral + Willingness, Behavioral + Willingness + Awareness, Behavioral + Willingness + Values, Behavioral + Willingness + Values + Awareness
ValuesIntegration of values clarification and awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).	Behavioural	Behavioral + Values, Behavioral + Values + Awareness, Behavioral + Willingness + Values, Behavioral + Willingness + Values + Awareness
Mindful AwarenessIntegration of mindfulness and present-moment awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).	Behavioural	Behavioral + Mindful Awareness, Behavioral + Values + Awareness, Behavioral + Willingness + Awareness, Behavioral + Willingness + Values + Awareness

Primary outcome

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.

3 secondary outcomes

Dietary Intake
Time frame: Measured at baseline, mid-treatment (6 months), post-treatment (12 months) (i.e., at 0, 6, and 12 months).
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).
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).

Results and safety

Results posted to the registry on 11 Mar 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard Behavioral Weight Loss Treatment	34	28
Behavioral + Willingness	35	31
Behavioral + Values	32	23
Behavioral + Mindful Awareness	35	29
Behavioral + Willingness + Values	36	29
Behavioral + Willingness + Awareness	34	27
Behavioral + Values + Awareness	38	24
Behavioral + Willingness + Values + Awareness	32	24

Primary outcome: 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).. Mean (Standard Deviation). Unit: percentage of weight change

Measure	Standard Behavioral Weight Loss Treatment n = 34	Behavioral + Willingness n = 35	Behavioral + Values n = 32	Behavioral + Mindful Awareness n = 35	Behavioral + Willingness + Values n = 36	Behavioral + Willingness + Awareness n = 34	Behavioral + Values + Awareness n = 38	Behavioral + Willingness + Values + Awareness n = 32
mid-treatment	7.93 (6.94)	9.17 (7.80)	8.19 (6.54)	9.36 (5.34)	9.11 (6.53)	7.71 (7.22)	7.33 (6.88)	7.66 (6.51)
post-treatment	7.47 (8.05)	9.32 (9.73)	8.66 (10.69)	9.32 (7.88)	9.26 (8.52)	8.21 (9.14)	6.46 (7.87)	6.06 (7.83)
6-month follow-up	4.62 (8.28)	7.65 (8.74)	7.07 (11.14)	7.86 (7.65)	6.83 (8.81)	7.04 (9.20)	4.22 (7.96)	3.76 (7.45)
12-month follow-up	3.28 (8.66)	6.05 (8.78)	5.91 (11.74)	6.85 (7.67)	5.56 (7.95)	5.33 (9.30)	3.47 (7.11)	3.72 (8.19)
24-month follow-up	2.62 (8.43)	6.48 (11.92)	4.47 (10.37)	5.48 (7.58)	5.72 (8.02)	3.78 (9.19)	1.87 (8.52)	1.81 (8.14)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: up to 36 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard Behavioral Weight Loss Treatment	0 of 34 (0%)	1 of 34 (2.9%)	0 of 34
Behavioral + Willingness	0 of 35 (0%)	1 of 35 (2.9%)	0 of 35
Behavioral + Values	0 of 32 (0%)	0 of 32 (0%)	0 of 32
Behavioral + Mindful Awareness	0 of 35 (0%)	0 of 35 (0%)	0 of 35
Behavioral + Willingness + Values	1 of 36 (2.8%)	2 of 36 (5.6%)	0 of 36
Behavioral + Willingness + Awareness	1 of 34 (2.9%)	1 of 34 (2.9%)	0 of 34
Behavioral + Values + Awareness	0 of 38 (0%)	1 of 38 (2.6%)	0 of 38
Behavioral + Willingness + Values + Awareness	0 of 32 (0%)	1 of 32 (3.1%)	0 of 32

Limitations and caveats (from the sponsor): 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).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41785111Crochiere 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.
Derived from this study: PubMed 40705619Chabria 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.
Derived from this study: PubMed 38190202Crochiere 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Evan M Forman, PhD principal investigator

Drexel University Center for Weight, Eating and Lifestyle Science

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Behavioral Treatment, Willingness and Values in people with Obesity and Weight Loss, run by Drexel University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04337619, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.