ObesityNCT02156752
Using Novel Behavioral Approaches to Improve Long-Term Weight Loss Outcomes
A study testing ACT, SR and WLO in people with Obesity, run by The Miriam Hospital at 1 site in United States.
Trial summary
This project is a randomized controlled trial to compare the efficacy of two interventions- one based on Acceptance and Commitment Therapy (ACT) and one based on Self-Regulation (SR)- and a control group (called weight loss only (WLO)) on 24-month weight loss outcomes. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- ACT, SR and WLO
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to 29 Aug 2019
- 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI 27.5-40
- Age 30-65
Who cannot join
- currently participating in a weight loss program
- pregnant or planning to become pregnant
- medical condition that would preclude physical activity
- terminal illness
- plans to relocate
- history of substance abuse or psychological problems that are judged by the investigators to be likely to interfere with study participation
Trial locations and contacts
1 site in 1 country.
United States1 site
Weight Control and Diabetes Research Center
Providence, Rhode Island, 02903
About this study
This project is a randomized controlled trial to compare the efficacy of two interventions- one based on Acceptance and Commitment Therapy (ACT) and one based on Self-Regulation (SR)- and a control group (called weight loss only (WLO)) on 24-month weight loss outcomes. All participants will first participate in an initial 4-month standard behavioral weight loss program. Participants will be randomized into 1 of 3 groups and receive a 3-part workshop; the ACT workshop will teach ACT skills including acceptance and mindfulness techniques designed to promote behavior change and health behavior persistence consistent with one's core values. The SR program will focus on self-regulation, regular weighing, and modeling behavior on successful maintainers. The WLO group will receive a control workshop focused on cooking demonstrations and general nutrition topics.The primary outcome is weight loss at 24 months. The secondary outcome is change in psychological flexibility, a critical component of ACT interventions and a potential innovative mediating mechanism. Primary Hypothesis: At 24 months, the ACT group will show significantly greater weight loss as compared to the SR and WLO groups.
- Conditions
- Obesity
- Being tested
- ACT, SR, WLO
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACTBehavioural
Treatment is based on Acceptance and Commitment Therapy
SRBehavioural
Treatment is based on Self-Regulation theory.
WLOBehavioural
Treatment is based on cooking tips and demonstrations.
| Study group | Role | What they receive |
|---|---|---|
| ACT | Experimental | Behavioral weight loss plus techniques from Acceptance and Commitment Therapy Receives: Behavioral: ACT |
| SR | Active comparator | Behavioral weight loss plus self-regulation techniques Receives: Behavioral: SR |
| WLO | Active comparator | Behavioral weight loss plus cooking tips and demonstrations Receives: Behavioral: WLO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2014 (estimated)
- Study startJan 2015
- Primary completion1 Jul 2018
- Study completion29 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- None (open label)
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jason Lillis, Ph.D., Principal investigator, Lifespan/ The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02156752
- Sponsor's protocol ID
- 5K23KDK097143
- Status last verified
- Aug 2019
- First submitted
- 22 May 2014
- Last updated
- 18 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Lillis J, Dunsiger S, Thomas JG, Ross KM, Wing RR. Novel behavioral interventions to improve long-term weight loss: A randomized trial of acceptance and commitment therapy or self-regulation for weight loss maintenance. J Behav Med. 2021 Aug;44(4):527-540. doi: 10.1007/s10865-021-00215-z. Epub 2021 Mar 27.
PubMed 33772702Lillis J, Thomas JG, Levin ME, Wing RR. Self-stigma and weight loss: The impact of fear of being stigmatized. J Health Psychol. 2020 Jun;25(7):922-930. doi: 10.1177/1359105317739101. Epub 2017 Nov 6.
PubMed 29105491
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Novel Behavioral Approaches to Improve Long-Term Weight Loss Outcomes
- ClinicalTrials.gov ID
- NCT02156752
- Acronym / sponsor ID
- 5K23KDK097143
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jan 2015
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 29 Aug 2019 (actual)
- First posted
- 5 Jun 2014 (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.
This project is a randomized controlled trial to compare the efficacy of two interventions- one based on Acceptance and Commitment Therapy (ACT) and one based on Self-Regulation (SR)- and a control group (called weight loss only (WLO)) on 24-month weight loss outcomes. All participants will first participate in an initial 4-month standard behavioral weight loss program. Participants will be randomized into 1 of 3 groups and receive a 3-part workshop; the ACT workshop will teach ACT skills including acceptance and mindfulness techniques designed to promote behavior change and health behavior persistence consistent with one's core values. The SR program will focus on self-regulation, regular weighing, and modeling behavior on successful maintainers. The WLO group will receive a control workshop focused on cooking demonstrations and general nutrition topics.The primary outcome is weight loss at 24 months. The secondary outcome is change in psychological flexibility, a critical component of ACT interventions and a potential innovative mediating mechanism. Primary Hypothesis: At 24 months, the ACT group will show significantly greater weight loss as compared to the SR and WLO groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ACT | Experimental | Behavioral: ACTBehavioral weight loss plus techniques from Acceptance and Commitment Therapy |
| SR | Active comparator | Behavioral: SRBehavioral weight loss plus self-regulation techniques |
| WLO | Active comparator | Behavioral: WLOBehavioral weight loss plus cooking tips and demonstrations |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI 27.5-40
- Age 30-65
Key exclusion criteria (6 listed)
- currently participating in a weight loss program
- pregnant or planning to become pregnant
- medical condition that would preclude physical activity
- terminal illness
- plans to relocate
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 |
|---|---|---|
| ACTTreatment is based on Acceptance and Commitment Therapy | Behavioural | ACT |
| SRTreatment is based on Self-Regulation theory. | Behavioural | SR |
| WLOTreatment is based on cooking tips and demonstrations. | Behavioural | WLO |
Primary outcome
Weight
Time frame: 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 18 Sep 2019.
- Derived from this study: PubMed 33772702Lillis J, Dunsiger S, Thomas JG, Ross KM, Wing RR. Novel behavioral interventions to improve long-term weight loss: A randomized trial of acceptance and commitment therapy or self-regulation for weight loss maintenance. J Behav Med. 2021 Aug;44(4):527-540. doi: 10.1007/s10865-021-00215-z. Epub 2021 Mar 27.
- Derived from this study: PubMed 29105491Lillis J, Thomas JG, Levin ME, Wing RR. Self-stigma and weight loss: The impact of fear of being stigmatized. J Health Psychol. 2020 Jun;25(7):922-930. doi: 10.1177/1359105317739101. Epub 2017 Nov 6.
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Obesity
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.
Jason Lillis, Ph.D. principal investigator
Lifespan/ The Miriam Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACT, SR and WLO in people with Obesity, run by The Miriam Hospital 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 2 inclusion and 6 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 18 Sep 2019. 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?
Weight (time frame: 24 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 NCT02156752, which also lists 2 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 18 Sep 2019.