Recruiting

Acceptance-based Strategies

Sponsor:

The Miriam Hospital

Code:

NCT05119504

Conditions

Overweight and Obesity

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Interventions

Acceptance and Commitment

Multi-Health Behavior

Study Details

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

Study ID

NCT05119504

Start date

Oct 14, 2021

Status verified date

Oct, 2021

Completion date

Sep 1, 2022

Anticipated

Primary completion date

Jul 1, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

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

Study Design

Enrollment

56 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Acceptance-based

This 90-minute one-on-one intervention will provide psychoeducation and experiential training on the use of acceptance-based strategies for physical activity.

sham comparator: Multi Health Behavior

This 90-minute one-on-one intervention will provide psychoeducation on physical activity as one of several interconnected health behaviors.

Interventions

Acceptance 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.

Multi-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.

Primary outcome measure

  • Change in perceived exertion [ Time Frame: Every five minutes during 30-minute treadmill session ]
  • Change in affect [ Time Frame: Every five minutes during 30-minute treadmill session ]

Central Contacts and Locations

Central contacts

Locations

Weight Control and Diabetes Research Center

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

More Information

Sponsor

The Miriam Hospital

Last update posted

Nov 15, 2021

Last verified

Oct, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Miriam Hospital on 2021-11-15.