Improving the Experience of Exercise Among Individuals With Internalized Weight Bias Using Acceptance-based Strategies
Primary Purpose
Overweight and Obesity
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acceptance and Commitment
Multi-Health Behavior
Sponsored by
About this trial
This is an interventional treatment trial for Overweight and Obesity
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Weight Control and Diabetes Research CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Acceptance-based
Multi Health Behavior
Arm Description
This 90-minute one-on-one intervention will provide psychoeducation and experiential training on the use of acceptance-based strategies for physical activity.
This 90-minute one-on-one intervention will provide psychoeducation on physical activity as one of several interconnected health behaviors.
Outcomes
Primary Outcome Measures
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.
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
Secondary Outcome Measures
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
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.
Full Information
NCT ID
NCT05119504
First Posted
November 1, 2021
Last Updated
November 11, 2021
Sponsor
The Miriam Hospital
Collaborators
The Obesity Society
1. Study Identification
Unique Protocol Identification Number
NCT05119504
Brief Title
Improving the Experience of Exercise Among Individuals With Internalized Weight Bias Using Acceptance-based Strategies
Official Title
Improving the Experience of Exercise Among Individuals With Internalized Weight Bias Using Acceptance-based Strategies
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 14, 2021 (Actual)
Primary Completion Date
July 1, 2022 (Anticipated)
Study Completion Date
September 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Miriam Hospital
Collaborators
The Obesity Society
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Masking Description
Individuals conducting study assessments will remain masked to treatment condition.
Interventions have been matched for time, so that masked assessors are unable to note a discrepancy in treatment condition throughout study procedures. Intervention staff will be responsible for preparing the room with materials and for relocating participant from intervention room back to the assessment room so that the masked assessor is not able to view any materials left behind from the treatment condition. Participants will be reminded by study staff throughout study procedures that they should not disclose their treatment condition or information about their intervention meeting that could inform masked staff of randomization.
Allocation
Randomized
Enrollment
56 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Acceptance-based
Arm Type
Experimental
Arm Description
This 90-minute one-on-one intervention will provide psychoeducation and experiential training on the use of acceptance-based strategies for physical activity.
Arm Title
Multi Health Behavior
Arm Type
Sham Comparator
Arm Description
This 90-minute one-on-one intervention will provide psychoeducation on physical activity as one of several interconnected health behaviors.
Intervention Type
Behavioral
Intervention Name(s)
Acceptance and Commitment
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Multi-Health Behavior
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in perceived exertion
Description
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.
Time Frame
Every five minutes during 30-minute treadmill session
Title
Change in affect
Description
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
Time Frame
Every five minutes during 30-minute treadmill session
Secondary Outcome Measure Information:
Title
Physical Activity Adherence
Description
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
Time Frame
Daily for 14 days
Title
Exercise self-efficacy, intention, motivation
Description
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.
Time Frame
Four times per day for 14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
KayLoni Olson
Phone
401-793-8971
Email
kayloni.olson@lifespan.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
KayLoni Olson
Organizational Affiliation
The Miriam Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weight Control and Diabetes Research Center
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
KayLoni Olson
Phone
401-793-8971
Email
kayloni.olson@lifespan.org
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
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.
Learn more about this trial
Improving the Experience of Exercise Among Individuals With Internalized Weight Bias Using Acceptance-based Strategies
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