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

NCT05119504 | Unknown

• 1 other identifier: 1689962
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  Every five minutes during 30-minute treadmill session

Secondary Outcomes (2)

• Physical Activity Adherence

  Daily for 14 days

• Exercise self-efficacy, intention, motivation

  Four times per day for 14 days

Study Arms (2)

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.

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.

Behavioral: Multi-Health Behavior

Interventions

Acceptance and Commitment BEHAVIORAL

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.

Acceptance-based

Multi-Health Behavior BEHAVIORAL

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.

Multi Health Behavior

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Miriam Hospital: lead
• The Obesity Society: collaborator

Study Sites (1)

Weight Control and Diabetes Research Center

Providence, Rhode Island, 02903, United States

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• KayLoni Olson

  The Miriam Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

KayLoni Olson

CONTACT

401-793-8971; kayloni.olson@lifespan.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2021
• First Posted: November 15, 2021
• Study Start: October 14, 2021
• Primary Completion: July 1, 2022
• Study Completion: September 1, 2022
• Last Updated: November 15, 2021

Record last verified: 2021-10

Locations

US (1)