ObesityENACTNCT01858714
Environmental and Acceptance-Based Innovations for Weight Loss Maintenance
A study testing Behavior Therapy for Weight Loss, Behavior Therapy + Environment and Acceptance-based Behavior Therapy + Environment in people with Obesity and Overweight, run by Drexel University at 1 site in United States.
Trial summary
The major goal of this project is to evaluate an innovative approach to obesity involving modification of the home environment. The project also will evaluate if home environment modification is more effective when supplemented with distress tolerance and related skills training. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity, Overweight, Weight Loss
- What is being tested?
- Behavior Therapy for Weight Loss, Behavior Therapy + Environment and Acceptance-based Behavior Therapy + Environment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Have a BMI between 27 and 45 kg/m2
- Have the ability to engage in physical activity (i.e., can walk at least 2 blocks without stopping for rest)
- Successfully complete all steps in the enrollment process, including completion of a 7-day food diary and attendance at all pre-randomization clinic visits
Who cannot join
- Have a medical condition (e.g., cancer) or psychiatric condition (e.g., psychotic disorder, substance dependence, bulimia nervosa) that may limit their ability to comply with the behavioral recommendations of the program or pose a risk to the participant during weight loss
- Are pregnant or plan to become pregnant in next 2 years
- Report recently beginning a course of or changing the dosage of prescription medications that can cause significant weight loss or weight gain
- Are participating in or plan to participate in another weight loss program in the next 2 years
Trial locations and contacts
1 site in 1 country.
About this study
The major goal of this project is to evaluate an innovative approach to obesity involving modification of the home environment. The project also will evaluate if home environment modification is more effective when supplemented with distress tolerance and related skills training.
- Conditions
- Obesity, Overweight, Weight Loss
- Being tested
- Behavior Therapy for Weight Loss, Behavior Therapy + Environment, Acceptance-based Behavior Therapy + Environment
- Keywords
- obesity, overweight, weight loss
- Medical subject headings
- Obesity, Overweight, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavior Therapy for Weight LossBehavioural
Standard behavioral treatment for weight loss and weight loss maintenance.
Behavior Therapy + EnvironmentBehavioural
Standard behavioral therapy with an emphasis on environmental strategies.
Acceptance-based Behavior Therapy + EnvironmentBehavioural
Behavioral therapy with acceptance-based and environmental strategies.
| Study group | Role | What they receive |
|---|---|---|
| Behavior Therapy (BT) | Active comparator | Active Comparator: Behavior Therapy
Behavioral treatment strategies will be utilized to facilitate adherence to the treatment goals in all three treatments. Participants in the BT condition will receive only the BT intervention. Strategies that will be emphasized are listed below:
Self monitoring Stimulus control Changing eating behaviors Goal setting Problem solving Social support Cognitive restructuring Relapse prevention Receives: Behavioral: Behavior Therapy for Weight Loss |
| Behavior Therapy + Environment | Experimental | Participants will receive standard behavioral therapy with an emphasis on environmental strategies. Receives: Behavioral: Behavior Therapy + Environment |
| Acceptance-based BT + Environment | Experimental | Participants will receive acceptance-based behavioral therapy with an emphasis on environmental strategies. Receives: Behavioral: Acceptance-based Behavior Therapy + Environment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Weight
Measured: Baseline, 6 months, 12 months, 18 months, 24 months
Change in Physical Activity
Objectively measured physical activity will be recorded at each time point.
Measured: Baseline, 6 months, 12 months, 18 months, 24 months
Change in Nutritional Intake
Measured by 24-hour food recall
Measured: Baseline, 12 months, 24 months
Change in Psychosocial Status
Measured: Baseline, 6 months, 12 months, 18 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2013 (estimated)
- Study startSep 2011
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drexel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meghan Butryn, Drexel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01858714
- Sponsor's protocol ID
- R01DK092374
- Acronym
- ENACT
- Status last verified
- Aug 2016
- First submitted
- 19 Jun 2012
- Last updated
- 5 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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 40705619Butryn ML, Call CC, Schumacher LM, Kerrigan SG, Forman EM. Time to Peak Weight Loss During Extended Behavioral Treatment. Obesity (Silver Spring). 2018 Apr;26(4):658-664. doi: 10.1002/oby.22127. Epub 2018 Feb 14.
PubMed 29442440Butryn ML, Forman EM, Lowe MR, Gorin AA, Zhang F, Schaumberg K. Efficacy of environmental and acceptance-based enhancements to behavioral weight loss treatment: The ENACT trial. Obesity (Silver Spring). 2017 May;25(5):866-872. doi: 10.1002/oby.21813. Epub 2017 Mar 23.
PubMed 28337847Butryn ML, Arigo D, Raggio GA, Kaufman AI, Kerrigan SG, Forman EM. Measuring the Ability to Tolerate Activity-Related Discomfort: Initial Validation of the Physical Activity Acceptance Questionnaire (PAAQ). J Phys Act Health. 2015 May;12(5):717-6. doi: 10.1123/jpah.2013-0338. Epub 2014 Aug 7.
PubMed 25106049
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Environmental and Acceptance-Based Innovations for Weight Loss Maintenance
- ClinicalTrials.gov ID
- NCT01858714
- Acronym / sponsor ID
- ENACT / R01DK092374
- Conditions
- Obesity, Overweight, Weight Loss
- Keywords
- obesity, overweight, weight loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- Drexel UniversityUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 21 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The major goal of this project is to evaluate an innovative approach to obesity involving modification of the home environment. The project also will evaluate if home environment modification is more effective when supplemented with distress tolerance and related skills training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Behavior Therapy (BT) | Active comparator | Behavioral: Behavior Therapy for Weight LossActive Comparator: Behavior Therapy Behavioral treatment strategies will be utilized to facilitate adherence to the treatment goals in all three treatments. Participants in the BT condition will receive only the BT intervention. Strategies that will be emphasized are listed below: Self monitoring Stimulus control Changing eating behaviors Goal setting Problem solving Social support Cognitive restructuring Relapse prevention |
| Behavior Therapy + Environment | Experimental | Behavioral: Behavior Therapy + EnvironmentParticipants will receive standard behavioral therapy with an emphasis on environmental strategies. |
| Acceptance-based BT + Environment | Experimental | Behavioral: Acceptance-based Behavior Therapy + EnvironmentParticipants will receive acceptance-based behavioral therapy with an emphasis on environmental strategies. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Have a BMI between 27 and 45 kg/m2
- Have the ability to engage in physical activity (i.e., can walk at least 2 blocks without stopping for rest)
- Successfully complete all steps in the enrollment process, including completion of a 7-day food diary and attendance at all pre-randomization clinic visits
Key exclusion criteria (4 listed)
- Have a medical condition (e.g., cancer) or psychiatric condition (e.g., psychotic disorder, substance dependence, bulimia nervosa) that may limit their ability to comply with the behavioral recommendations of the program or pose a risk to the participant during weight loss
- Are pregnant or plan to become pregnant in next 2 years
- Report recently beginning a course of or changing the dosage of prescription medications that can cause significant weight loss or weight gain
- Are participating in or plan to participate in another weight loss program in the next 2 years
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 |
|---|---|---|
| Behavior Therapy for Weight LossStandard behavioral treatment for weight loss and weight loss maintenance. | Behavioural | Behavior Therapy (BT) |
| Behavior Therapy + EnvironmentStandard behavioral therapy with an emphasis on environmental strategies. | Behavioural | Behavior Therapy + Environment |
| Acceptance-based Behavior Therapy + EnvironmentBehavioral therapy with acceptance-based and environmental strategies. | Behavioural | Acceptance-based BT + Environment |
Primary outcome
Change in Body Weight
Time frame: Baseline, 6 months, 12 months, 18 months, 24 months
Change in Physical Activity
Time frame: Baseline, 6 months, 12 months, 18 months, 24 months
Objectively measured physical activity will be recorded at each time point.
Change in Nutritional Intake
Time frame: Baseline, 12 months, 24 months
Measured by 24-hour food recall
Change in Psychosocial Status
Time frame: Baseline, 6 months, 12 months, 18 months, 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2016.
- 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 29442440Butryn ML, Call CC, Schumacher LM, Kerrigan SG, Forman EM. Time to Peak Weight Loss During Extended Behavioral Treatment. Obesity (Silver Spring). 2018 Apr;26(4):658-664. doi: 10.1002/oby.22127. Epub 2018 Feb 14.
- Derived from this study: PubMed 28337847Butryn ML, Forman EM, Lowe MR, Gorin AA, Zhang F, Schaumberg K. Efficacy of environmental and acceptance-based enhancements to behavioral weight loss treatment: The ENACT trial. Obesity (Silver Spring). 2017 May;25(5):866-872. doi: 10.1002/oby.21813. Epub 2017 Mar 23.
- Derived from this study: PubMed 25106049Butryn ML, Arigo D, Raggio GA, Kaufman AI, Kerrigan SG, Forman EM. Measuring the Ability to Tolerate Activity-Related Discomfort: Initial Validation of the Physical Activity Acceptance Questionnaire (PAAQ). J Phys Act Health. 2015 May;12(5):717-6. doi: 10.1123/jpah.2013-0338. Epub 2014 Aug 7.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavior Therapy for Weight Loss, Behavior Therapy + Environment and Acceptance-based Behavior Therapy + Environment in people with Obesity and Overweight, 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 3 inclusion and 4 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 5 Aug 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Body Weight (time frame: Baseline, 6 months, 12 months, 18 months, 24 months). The study lists 4 primary outcomes in all. 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 NCT01858714, which also lists 4 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 5 Aug 2016.