Skip to content

Improving the Experience of Exercise Among Individuals With Internalized Weight Bias Using Acceptance-based Strategies

Improving the Experience of Exercise Among Individuals With Internalized Weight Bias Using Acceptance-based Strategies

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05119504
Enrollment
56
Registered
2021-11-15
Start date
2021-10-14
Completion date
2022-09-01
Last updated
2021-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight and Obesity

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.

Interventions

BEHAVIORALAcceptance and Commitment

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.

BEHAVIORALMulti-Health Behavior

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.

Sponsors

The Obesity Society
CollaboratorOTHER
The Miriam Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in perceived exertionEvery five minutes during 30-minute treadmill sessionAssessed 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 affectEvery five minutes during 30-minute treadmill sessionAssessed 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

MeasureTime frameDescription
Physical Activity AdherenceDaily for 14 daysFor 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, motivationFour times per day for 14 daysUsing 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.

Countries

United States

Contacts

Primary ContactKayLoni Olson
kayloni.olson@lifespan.org401-793-8971

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026