Overweight and ObesityNCT05119504
Improving the Experience of Exercise Among Individuals With Internalized Weight Bias Using Acceptance-based Strategies
A study testing Acceptance and Commitment and Multi-Health Behavior in people with Overweight and Obesity, run by The Miriam Hospital at 1 site in United States.
Trial summary
The goal of this study is to test whether an acceptance based intervention can modify the relationship between heart rate and perceived exertion/negative during physical activity among individuals who have a high degree of internalized weight bias. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Acceptance and Commitment and Multi-Health Behavior
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2021to 1 Sep 2022
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-60 years old,
- BMI 25-40 kg/m2
- insufficiently active (<60 minutes of moderate intensity activity per week).
- High/low internalized weight bias
- Access to personal smartphone device and willing to download free smartphone app for data collection
Who cannot join
- Comorbid issues that might interfere with ability to engage in physical activity
- Factors that would influence ability to complete study protocol (e.g., cognitive, psychological)
- medication that would affect heart rate (e.g., beta blocker),
- women who are nursing or pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Weight Control and Diabetes Research Center
Providence, Rhode Island, 02903
KayLoni Olson, 401-793-8971, kayloni.olson@lifespan.org
About this study
The goal of this study is to test whether an acceptance based intervention can modify the relationship between heart rate and perceived exertion/negative during physical activity among individuals who have a high degree of internalized weight bias.
Read the detailed description
In this two-phase pilot, we will first test in a controlled setting whether an acceptance-based intervention can modify the relationship between Heart Rate and perceived exertion/negative affect during moderate intensity physical activity among individuals high in internalized weight bias (Phase 1) and then evaluate these mechanisms in real-time during uptake of a two-week physical activity prescription (Phase 2). Using a 2x2 factorial design, we will randomize individuals with Body Mass Index (BMI) ≥25, high and low internalized weight bias, and insufficient activity (<60 min of moderate physical activity/week) to receive a 90-minute acceptance-based intervention workshop versus a multi-health behavior education condition prior to completing a 30-minute session of supervised, moderate intensity treadmill walking. Heart rate, self-reported perceived exertion and affect will be assessed throughout physical activity.
For Phase 2, all participants from Phase 1 will receive a two-week physical activity prescription consistent with National Guidelines (150 minutes moderate intensity aerobic physical activity, recommended in 30-minute bouts) to determine the effect of treatment condition on subsequent adherence to physical activity. Physical activity adherence will be monitored with Actigraphy and Ecological Momentary Assessment (repeated daily surveys via smartphone) will be used to evaluate participant self-efficacy, intention, motivation for physical activity in near real-time.
- Conditions
- Overweight and Obesity
- Being tested
- Acceptance and Commitment, Multi-Health Behavior
- 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 CommitmentBehavioural
During the 90-minute, one-on-one interventionist led session, participants will learn three inter-related acceptance-based techniques tailored for coping with physical discomfort and negative affect during physical activity. (1) cognitive defusion (i.e., disentangling physical sensations and thoughts from behavior), (2) acceptance (i.e., increasing willingness to experience unpleasant physical sensations/negative affect without trying to change or control them), and (3) valued action (i.e., evaluating the role of physical activity as a valued behavior). Participants will be taught these techniques via didactic instruction, metaphors, and experiential activities.
All participants will receive a two-week physical activity prescription based on national guidelines recommending 150 minutes of at least moderate intensity physical activity per week.
Multi-Health BehaviorBehavioural
The multi health behavior condition will include didactic material focused broadly on healthy lifestyle recommendations including physical activity. It will also emphasize that physical activity is one of several interconnected health behaviors including balanced diet, sleep, stress management. All participants will receive a two-week physical activity prescription based on national guidelines recommending 150 minutes of at least moderate intensity physical activity per week.
| Study group | Role | What they receive |
|---|---|---|
| Acceptance-based | Experimental | This 90-minute one-on-one intervention will provide psychoeducation and experiential training on the use of acceptance-based strategies for physical activity. Receives: Behavioral: Acceptance and Commitment |
| Multi Health Behavior | Sham comparator | This 90-minute one-on-one intervention will provide psychoeducation on physical activity as one of several interconnected health behaviors. Receives: Behavioral: Multi-Health Behavior |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in perceived exertion
Assessed using the Borg Ratings of Perceived Exertion-Participants are prompted verbally to rate their exertion on a scale ranging from 6 (no exertion at all) to 20 (maximum exertion) every 5 minutes.
Measured: Every five minutes during 30-minute treadmill session
Change in affect
Assessed using the Feeling Scale --This single-item measure assesses how participants feel 'at the present moment' on an 11-point scale ranging from -5 (very bad) to +5 (very good)), administered every 5 minutes during PA
Measured: Every five minutes during 30-minute treadmill session
Secondary outcomes (2)
Physical Activity Adherence
For two weeks following the intervention condition, physical activity will be objectively measured using the ActiGraph GT9X Link. This device, worn on the non-dominant wrist, has been previously validated to assess movement and associated energy expenditure. Minute-by-minute data will be analyzed to determine the amount of time spent in bout-related moderate intensity PA (≥ 3 METs, ≥10 min), metrics to increase the likelihood of capturing 'purposeful' PA
Measured: Daily for 14 days
Exercise self-efficacy, intention, motivation
Using the Lifedata platform which includes the RealLife EXP application that can be downloaded onto participants' smartphones, participants will be prompted via vibration and audible tone to complete EMA surveys on self-efficacy, intention, and motivation for PA. Items are adapted from validated measures used in the physical activity literature. Participants will be prompted to complete a survey semi-randomly near four anchor times throughout the day, with 90 minutes to respond.
Measured: Four times per day for 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start14 Oct 2021
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Obesity Society
- Responsible party
- Sponsor
- Investigators
- KayLoni Olson, Principal investigator, The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05119504
- Sponsor's protocol ID
- 1689962
- Status last verified
- Oct 2021
- First submitted
- 1 Nov 2021
- Last updated
- 15 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Consistent with Lifespan IRB policy, any interested individuals seeking access to conduct secondary analysis of study data will be required to submit a formal agreement with the PI, or designee, that 1) the data will be used for research purposes only and will not be used to identify any individual participants, 2) the data will be secured using appropriate computer technology, and 3) that the data will be destroyed or returned to the PI after the analyses are complete. This will be mediated by IRB involvement and the PI retains the right to deny any request for qualitative data access. Generally, we work with the requestor/user to provide the minimum data necessary for their research question to support resource sharing while maintaining patient confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Experience of Exercise Among Individuals With Internalized Weight Bias Using Acceptance-based Strategies
- ClinicalTrials.gov ID
- NCT05119504
- Acronym / sponsor ID
- 1689962
- Conditions
- Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- The Obesity Society
- Study start
- 14 Oct 2021 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 15 Nov 2021 (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.
The goal of this study is to test whether an acceptance based intervention can modify the relationship between heart rate and perceived exertion/negative during physical activity among individuals who have a high degree of internalized weight bias.
Detailed description
In this two-phase pilot, we will first test in a controlled setting whether an acceptance-based intervention can modify the relationship between Heart Rate and perceived exertion/negative affect during moderate intensity physical activity among individuals high in internalized weight bias (Phase 1) and then evaluate these mechanisms in real-time during uptake of a two-week physical activity prescription (Phase 2). Using a 2x2 factorial design, we will randomize individuals with Body Mass Index (BMI) ≥25, high and low internalized weight bias, and insufficient activity (<60 min of moderate physical activity/week) to receive a 90-minute acceptance-based intervention workshop versus a multi-health behavior education condition prior to completing a 30-minute session of supervised, moderate intensity treadmill walking. Heart rate, self-reported perceived exertion and affect will be assessed throughout physical activity.
For Phase 2, all participants from Phase 1 will receive a two-week physical activity prescription consistent with National Guidelines (150 minutes moderate intensity aerobic physical activity, recommended in 30-minute bouts) to determine the effect of treatment condition on subsequent adherence to physical activity. Physical activity adherence will be monitored with Actigraphy and Ecological Momentary Assessment (repeated daily surveys via smartphone) will be used to evaluate participant self-efficacy, intention, motivation for physical activity in near real-time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acceptance-based | Experimental | Behavioral: Acceptance and CommitmentThis 90-minute one-on-one intervention will provide psychoeducation and experiential training on the use of acceptance-based strategies for physical activity. |
| Multi Health Behavior | Sham comparator | Behavioral: Multi-Health BehaviorThis 90-minute one-on-one intervention will provide psychoeducation on physical activity as one of several interconnected health behaviors. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 18-60 years old,
- BMI 25-40 kg/m2
- insufficiently active (<60 minutes of moderate intensity activity per week).
- High/low internalized weight bias
- Access to personal smartphone device and willing to download free smartphone app for data collection
Key exclusion criteria (4 listed)
- Comorbid issues that might interfere with ability to engage in physical activity
- Factors that would influence ability to complete study protocol (e.g., cognitive, psychological)
- medication that would affect heart rate (e.g., beta blocker),
- women who are nursing or 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 |
|---|---|---|
| Acceptance and CommitmentDuring the 90-minute, one-on-one interventionist led session, participants will learn three inter-related acceptance-based techniques tailored for coping with physical discomfort and negative affect during physical activity. (1) cognitive defusion (i.e., disentangling physical sensations and thoughts from behavior), (2) acceptance (i.e., increasing willingness to experience unpleasant physical sensations/negative affect without trying to change or control them), and (3) valued action (i.e., evaluating the role of physical activity as a valued behavior). Participants will be taught these techniques via didactic instruction, metaphors, and experiential activities. All participants will receive a two-week physical activity prescription based on national guidelines recommending 150 minutes of at least moderate intensity physical activity per week. | Behavioural | Acceptance-based |
| Multi-Health BehaviorThe multi health behavior condition will include didactic material focused broadly on healthy lifestyle recommendations including physical activity. It will also emphasize that physical activity is one of several interconnected health behaviors including balanced diet, sleep, stress management. All participants will receive a two-week physical activity prescription based on national guidelines recommending 150 minutes of at least moderate intensity physical activity per week. | Behavioural | Multi Health Behavior |
Primary outcome
Change in perceived exertion
Time frame: Every five minutes during 30-minute treadmill session
Assessed using the Borg Ratings of Perceived Exertion-Participants are prompted verbally to rate their exertion on a scale ranging from 6 (no exertion at all) to 20 (maximum exertion) every 5 minutes.
Change in affect
Time frame: Every five minutes during 30-minute treadmill session
Assessed using the Feeling Scale --This single-item measure assesses how participants feel 'at the present moment' on an 11-point scale ranging from -5 (very bad) to +5 (very good)), administered every 5 minutes during PA
2 secondary outcomes
Physical Activity Adherence
Time frame: Daily for 14 days
Exercise self-efficacy, intention, motivation
Time frame: Four times per day for 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2021.
- Individual participant dataSharing planned: Undecided. Consistent with Lifespan IRB policy, any interested individuals seeking access to conduct secondary analysis of study data will be required to submit a formal agreement with the PI, or designee, that 1) the data will be used for research purposes only and will not be used to identify any individual participants, 2) the data will be secured using appropriate computer technology, and 3) that the data will be destroyed or returned to the PI after the analyses are complete. This will be mediated by IRB involvement and the PI retains the right to deny any request for qualitative data access. Generally, we work with the requestor/user to provide the minimum data necessary for their research question to support resource sharing while maintaining patient confidentiality.
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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.
KayLoni Olson 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 and Multi-Health Behavior 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 5 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: status not confirmed, as of the sponsor's last update on 15 Nov 2021. 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. Some participants in this study may receive a placebo. 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?
Contact KayLoni Olson (401-793-8971, kayloni.olson@lifespan.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in perceived exertion (time frame: Every five minutes during 30-minute treadmill session). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Nov 2021.