Clinical trial NCT05119504: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Overweight and Obesity
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: The Obesity Society
First posted: 2021-11-15
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in perceived exertion
timeFrame: Every five minutes during 30-minute treadmill session
measure: Change in affect
timeFrame: Every five minutes during 30-minute treadmill session
Secondary outcomes:
measure: Physical Activity Adherence
timeFrame: Daily for 14 days
measure: Exercise self-efficacy, intention, motivation
timeFrame: Four times per day for 14 days
Other outcomes:
Locations:
city: Providence
country: United States
facility: Weight Control and Diabetes Research Center
state: Rhode Island
Study officials:
affiliation: The Miriam Hospital
name: KayLoni Olson
role: PRINCIPAL_INVESTIGATOR
References: