Overweight and ObesityNCT04256850
Teaching Novel Values-Based Skills to Improve Long-Term Weight Loss
A study testing Acceptance and Commitment Therapy (ACT) and Self-Regulation (SR) in people with Overweight and Obesity, run by The Miriam Hospital at 1 site in United States.
Trial summary
This NIDDK funded R01 project is a randomized controlled clinical trial to compare the efficacy of an intervention based on Acceptance and Commitment Therapy (ACT) and a Self-Regulation (SR) intervention on weight loss maintenance over a 30-month period. Read more about this study
- Who is it for?
- Ages 25 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Acceptance and Commitment Therapy (ACT) and Self-Regulation (SR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2020to 30 Sep 2024
- 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 25 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- English language fluent and literate at the 6th grade level
- Body mass index (BMI) between 27.5 and 45 kg/m-squared
- Able to walk 2 city blocks without stopping
- Has reliable access to a computer with internet access
Who cannot join
- Currently participating in another weight loss program
- Currently taking weight loss medication
- Has lost ≥5% of body weight in the 6 months prior to enrolling
- Has been pregnant within the 6 months prior to enrolling
- Plans to become pregnant within 18 months of enrolling
- Has a heart condition, chest pain during periods of activity or rest, or loss of consciousness in the 12 months prior to enrolling
- Has any medical condition that would affect the safety of participating in unsupervised physical activity
- Has any condition that would result in inability to follow the study protocol, including terminal illness and untreated major psychiatric illness
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
Official title: Teaching Novel Values-Based Skills to Improve Long-Term Weight Loss: A Randomized Trial Examining the Efficacy of a Weight Loss Maintenance Intervention Based on Acceptance and Commitment Therapy
This NIDDK funded R01 project is a randomized controlled clinical trial to compare the efficacy of an intervention based on Acceptance and Commitment Therapy (ACT) and a Self-Regulation (SR) intervention on weight loss maintenance over a 30-month period. All participants will first complete a well-validated online weight loss intervention (months 1-3 of the study). Participants who lose ≥4 kilograms of initial weight will then be randomly assigned to receive ACT or SR, with both conditions consisting of face-to-face, group-based intervention meetings and weekly email contact for 6 months.
Read the detailed description
Obesity is a major public health problem, and although short-term weight loss is achievable, individuals often regain the majority of weight that was lost. Current approaches have adjusted behavioral prescriptions and lengthened treatment contact in an effort to address this problem, with modest effect. This NIDDK funded R01 project is a randomized controlled clinical trial to compare the efficacy of an intervention based on Acceptance and Commitment Therapy (ACT) and a Self-Regulation (SR) intervention on weight loss maintenance over a 30-month period. All participants will first complete a well-validated online weight loss intervention (months 1-3 of the study). Participants who lose ≥4 kilograms of initial weight will then be randomly assigned to receive ACT or SR, with both conditions consisting of face-to-face, group-based intervention meetings and weekly email contact for 6 months. The ACT intervention will target a novel theoretically derived intervention target, values-consistent behavior, which will help align weight loss goals with personal values and foster internal motivation to continue with weight control efforts. Assessments will be at baseline, post-weight loss/pre-randomization, and then 6, 12, 18, 24, and 30-month follow-up (months from randomization). This project will be conducted at the Weight Control and Diabetes Research Center (WCDRC). The WCDRC is part of the Centers for Behavioral and Preventive Medicine at The Miriam Hospital in Providence, Rhode Island, and the Department of Psychiatry and Human Behavior at the Alpert Medical School of Brown University. This study is significant because it addresses weight loss maintenance - a critical barrier to treating obesity - and results of the study could be used to improve long-term weight loss outcomes and associated health benefits for treatment seeing overweight and obese adults.
- Conditions
- Overweight and Obesity
- Being tested
- Acceptance and Commitment Therapy (ACT), Self-Regulation (SR)
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment Therapy (ACT)Behavioural
Teaches acceptance, mindfulness, and values-based skills
Self-Regulation (SR)Behavioural
Teaches monitoring and reinforcement strategies designed to improve motivation and adherence to positive weight loss behavioral prescriptions.
| Study group | Role | What they receive |
|---|---|---|
| Acceptance and Commitment Therapy (ACT) | Experimental | Focuses on addressing cognitive and emotional barriers to successful weight loss maintenance. Receives: Behavioral: Acceptance and Commitment Therapy (ACT) |
| Self-Regulation (SR) | Experimental | Focuses on using self-monitoring and self-reinforcement techniques to improve weight loss maintenance. Receives: Behavioral: Self-Regulation (SR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Loss Maintenance
weight change from randomization to study end
Measured: 30 months
Secondary outcomes (2)
Waist Circumference
change in waist circumference from randomization to study end
Measured: 30 months
Objectively Measured Physical Activity Minutes Per Week
change in objectively measured physical activity from randomization to study end as measured by 7 days of wearing Actigraph accelerometer device
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start19 Feb 2020
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overweight and 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
- 480 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, The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04256850
- Sponsor's protocol ID
- R01DK120731
- Status last verified
- Oct 2023
- First submitted
- 21 Jan 2020
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data includes objective measurement of weight and height, physical activity, dietary intake, and self-report questionnaire data assessing values-consistent behavior, motivation, and use of weight control strategies. The final dataset will include self-reported demographic data. Research data from participants may be shared with the broader scientific community after publication. Even though the final dataset will be stripped of identifiers prior to release for sharing, we believe that protecting the identities of participants is best achieved by enacting additional safeguards. We will therefore make data and documentation available only under a data-sharing agreement that provides for (1) a commitment to use the data for research purposes only; (2) a commitment to securing the data using appropriate computer technology; (3) a commitment to destroying or returning the data after analyses are completed; and (4) a commitment not to attempt to identify participants individually.
Publications
Emerson JA, Schumacher LM, Bond DS, Thomas JG, Lillis J. Physical activity changes during an automated online weight loss program. J Behav Med. 2023 Aug;46(4):680-688. doi: 10.1007/s10865-022-00383-6. Epub 2023 Jan 5.
PubMed 36602619
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Teaching Novel Values-Based Skills to Improve Long-Term Weight Loss: A Randomized Trial Examining the Efficacy of a Weight Loss Maintenance Intervention Based on Acceptance and Commitment Therapy
- ClinicalTrials.gov ID
- NCT04256850
- Acronym / sponsor ID
- R01DK120731
- Conditions
- Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Study start
- 19 Feb 2020 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 5 Feb 2020 (actual)
- 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 NIDDK funded R01 project is a randomized controlled clinical trial to compare the efficacy of an intervention based on Acceptance and Commitment Therapy (ACT) and a Self-Regulation (SR) intervention on weight loss maintenance over a 30-month period. All participants will first complete a well-validated online weight loss intervention (months 1-3 of the study). Participants who lose ≥4 kilograms of initial weight will then be randomly assigned to receive ACT or SR, with both conditions consisting of face-to-face, group-based intervention meetings and weekly email contact for 6 months.
Detailed description
Obesity is a major public health problem, and although short-term weight loss is achievable, individuals often regain the majority of weight that was lost. Current approaches have adjusted behavioral prescriptions and lengthened treatment contact in an effort to address this problem, with modest effect. This NIDDK funded R01 project is a randomized controlled clinical trial to compare the efficacy of an intervention based on Acceptance and Commitment Therapy (ACT) and a Self-Regulation (SR) intervention on weight loss maintenance over a 30-month period. All participants will first complete a well-validated online weight loss intervention (months 1-3 of the study). Participants who lose ≥4 kilograms of initial weight will then be randomly assigned to receive ACT or SR, with both conditions consisting of face-to-face, group-based intervention meetings and weekly email contact for 6 months. The ACT intervention will target a novel theoretically derived intervention target, values-consistent behavior, which will help align weight loss goals with personal values and foster internal motivation to continue with weight control efforts. Assessments will be at baseline, post-weight loss/pre-randomization, and then 6, 12, 18, 24, and 30-month follow-up (months from randomization). This project will be conducted at the Weight Control and Diabetes Research Center (WCDRC). The WCDRC is part of the Centers for Behavioral and Preventive Medicine at The Miriam Hospital in Providence, Rhode Island, and the Department of Psychiatry and Human Behavior at the Alpert Medical School of Brown University. This study is significant because it addresses weight loss maintenance - a critical barrier to treating obesity - and results of the study could be used to improve long-term weight loss outcomes and associated health benefits for treatment seeing overweight and obese adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acceptance and Commitment Therapy (ACT) | Experimental | Behavioral: Acceptance and Commitment Therapy (ACT)Focuses on addressing cognitive and emotional barriers to successful weight loss maintenance. |
| Self-Regulation (SR) | Experimental | Behavioral: Self-Regulation (SR)Focuses on using self-monitoring and self-reinforcement techniques to improve weight loss maintenance. |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- English language fluent and literate at the 6th grade level
- Body mass index (BMI) between 27.5 and 45 kg/m-squared
- Able to walk 2 city blocks without stopping
- Has reliable access to a computer with internet access
Key exclusion criteria (8 listed)
- Currently participating in another weight loss program
- Currently taking weight loss medication
- Has lost ≥5% of body weight in the 6 months prior to enrolling
- Has been pregnant within the 6 months prior to enrolling
- Plans to become pregnant within 18 months of enrolling
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 |
|---|---|---|
| Acceptance and Commitment Therapy (ACT)Teaches acceptance, mindfulness, and values-based skills | Behavioural | Acceptance and Commitment Therapy (ACT) |
| Self-Regulation (SR)Teaches monitoring and reinforcement strategies designed to improve motivation and adherence to positive weight loss behavioral prescriptions. | Behavioural | Self-Regulation (SR) |
Primary outcome
Weight Loss Maintenance
Time frame: 30 months
weight change from randomization to study end
2 secondary outcomes
Waist Circumference
Time frame: 30 months
Objectively Measured Physical Activity Minutes Per Week
Time frame: 30 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Derived from this study: PubMed 36602619Emerson JA, Schumacher LM, Bond DS, Thomas JG, Lillis J. Physical activity changes during an automated online weight loss program. J Behav Med. 2023 Aug;46(4):680-688. doi: 10.1007/s10865-022-00383-6. Epub 2023 Jan 5.
- Individual participant dataSharing planned: Yes. Data includes objective measurement of weight and height, physical activity, dietary intake, and self-report questionnaire data assessing values-consistent behavior, motivation, and use of weight control strategies. The final dataset will include self-reported demographic data. Research data from participants may be shared with the broader scientific community after publication. Even though the final dataset will be stripped of identifiers prior to release for sharing, we believe that protecting the identities of participants is best achieved by enacting additional safeguards. We will therefore make data and documentation available only under a data-sharing agreement that provides for (1) a commitment to use the data for research purposes only; (2) a commitment to securing the data using appropriate computer technology; (3) a commitment to destroying or returning the data after analyses are completed; and (4) a commitment not to attempt to identify participants individually.
Related trials for Overweight and Obesity
Not yet recruiting
Negative Pressure Wound Therapy Devices in Total Knee Arthroplasty
Wound Surgical, Diabetes
RecruitingObservational study
Asprosin and miRNA Expression in Young Women With Metabolic Syndrome
Metabolic Syndrome, Insulin Resistance
RecruitingObservational study
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
Metabolic Disease, Obesity
Recruiting
Confident Moves Intervention Efficacy Trial: Obesity Care Settings
Obesity, Overweight
Not yet recruiting
Stearic Acid and Endothelial Function
Healthy Middle-aged Subjects, Obesity & Overweight
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
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 Acceptance and Commitment Therapy (ACT) and Self-Regulation (SR) in people with Overweight and 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 4 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: status not confirmed, as of the sponsor's last update on 23 Oct 2023. 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?
Results are not available in the source record.
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 Loss Maintenance (time frame: 30 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 NCT04256850, which also lists 1 linked publication.
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 23 Oct 2023.