Physical Activity Intervention for Obesity

Recruiting at 1 trial location

Overseen By Anna S Schwartz, MPH

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Hartford Hospital

Must not be taking: Weight loss medications

Disqualifiers: Pregnancy, Weight regain, Psychiatric problems, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 12 months

164 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are taking newly prescribed medications related to weight loss or gain, you may not be eligible to participate.

What data supports the effectiveness of the treatment Acceptance and Commitment Therapy-Based Physical Activity Intervention for obesity?

Research shows that Acceptance and Commitment Therapy (ACT) interventions can help increase physical activity, which is important for weight loss. A review found that ACT interventions had small-to-moderate positive effects on physical activity, suggesting they may be effective in promoting healthier behaviors in people with obesity. ^{1 2 3 4 5}

Is the Acceptance and Commitment Therapy-Based Physical Activity Intervention safe for humans?

The research does not specifically mention any safety concerns related to the Acceptance and Commitment Therapy-Based Physical Activity Intervention, suggesting it is generally considered safe for humans. ^{1 2 3 4 6}

How is the Acceptance and Commitment Therapy-Based Physical Activity Intervention different from other treatments for obesity?

This treatment is unique because it uses Acceptance and Commitment Therapy (ACT) to increase motivation for physical activity by focusing on personal values and acceptance, rather than just prescribing exercise routines. It aims to help people with obesity adopt and maintain regular physical activity by addressing psychological factors, which is different from traditional methods that often focus solely on physical activity goals. ^{1 2 3 4 7}

What is the purpose of this trial?

The goal of this clinical trial is to learn if a psychological intervention can increase regular physical activity to help prevent weight regain after metabolic bariatric surgery in adults. The main questions it aims to answer are: 1. Does the psychological intervention increase physical activity? 2. Does the psychological intervention prevent weight regain? 3. Does the psychological intervention increase internal motivation for physical activity and acceptance of the discomfort that can come with physical activity? Researchers will compare the psychological intervention to an educational intervention to see if the psychological intervention works to increase physical activity and prevent weight regain after metabolic bariatric surgery. Participants will: * Complete 12 months of either the psychological or educational intervention. This includes attending online workshops with a small group of participants, completing brief homework assignments, and having individual telephone calls with a counselor. * Wear a device to measure physical activity, use an electronic scale to measure body weight, and complete questionnaires at home on five separate occasions over an 18-month period

Research Team

Dale S Bond, PhD

Principal Investigator

Hartford Hospital

Eligibility Criteria

This trial is for adults who have had metabolic bariatric surgery and are looking to prevent weight regain. Participants should be willing to attend workshops, complete homework, engage in counseling calls, wear a physical activity tracker, use an electronic scale regularly, and fill out questionnaires over an 18-month period.

Inclusion Criteria

I have regained less than 10% of my maximum weight loss.

My surgery was done at Hartford Hospital or within its healthcare system.

My surgeon says I can safely do physical activities.

Exclusion Criteria

Have experienced >=10% weight regain from maximum weight loss

Do not speak/read English at a 6th grade level

I need help to walk.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 12 months of either a psychological or educational intervention, including online workshops, homework, and individual calls

12 months

Online workshops, individual telephone calls

Follow-up

Participants are monitored for changes in physical activity and weight regain

6 months

Assessments at 3, 6, 12, and 18 months post-randomization

Treatment Details

Interventions

• Acceptance and Commitment Therapy-Based Physical Activity Intervention

Trial Overview The study tests if a psychological intervention based on Acceptance and Commitment Therapy can boost regular physical activity and stop weight gain after bariatric surgery. It will be compared with a control group receiving only educational information about physical activity.

Participant Groups

Group I: Acceptance and Commitment Therapy-Based Physical Activity Intervention Experimental Treatment 1 Intervention

Provides experiential training in values-clarification and acceptance strategies to increase autonomous motivation for achieving self-determined physical activity goal via group-based workshops, email feedback, and brief support calls.

Group II: Physical Activity Education Intervention Active Control 1 Intervention

Provides didactic instruction on physical activity and behavioral strategies for achieving prescribed physical activity goals via group-based workshops, email feedback, and brief support calls.

Who Is Running the Clinical Trial?

Hartford Hospital

Lead Sponsor

Trials

140

Recruited

19,700+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Findings from Research

A 4-hour acceptance and commitment therapy (ACT) workshop for 41 adults with overweight/obesity was found to be feasible and highly acceptable, with participants rating the intervention components positively.

Participants showed significant increases in moderate-to-vigorous physical activity (MVPA) at 3 months, which were maintained at 6 months, along with improvements in physical activity acceptance and motivation, suggesting the potential effectiveness of this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary Evaluation of a 1-Day Acceptance and Commitment Therapy Workshop for Increasing Moderate-to-Vigorous Physical Activity in Adults with Overweight or Obesity. Lillis, J., Schumacher, LM., Bond, DS.[2023]

Acceptance-based treatment (ABT) for weight loss significantly increased participants' intentions to engage in physical activity compared to standard behavioral treatment (SBT), with notable improvements observed at mid-treatment and the end of treatment.

The study found that higher intentions for physical activity partially mediated the weight loss effects of ABT, as participants who intended to be more active also increased their actual moderate-to-vigorous physical activity over the treatment period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Activity Intentions and Behavior Mediate Treatment Response in an Acceptance-Based Weight Loss Intervention. Godfrey, KM., Schumacher, LM., Butryn, ML., et al.[2020]

Acceptance and Commitment Therapy (ACT) interventions have been found to be effective in promoting physical activity, showing small-to-moderate effects based on a meta-analysis of six randomized controlled trials involving various participants.

Despite the positive outcomes, the specific behavior change techniques (BCTs) used in ACT interventions were not well-defined, suggesting a need for clearer identification and description of these techniques in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Acceptance and Commitment Therapy (ACT) interventions for promoting physical activity: a systematic review and meta-analysis. Pears, S., Sutton, S.[2021]

In a pilot study involving young adult females, those who participated in Acceptance and Commitment Therapy (ACT) showed a significant increase in physical activity compared to those who received an Education intervention.

The ACT intervention, which included mindfulness and values clarification techniques, suggests that this therapeutic approach can effectively promote short-term behavior change related to physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of acceptance and commitment therapy for promotion of physical activity. Butryn, ML., Forman, E., Hoffman, K., et al.[2022]

A 4-week intervention using either acceptance and commitment therapy (ACT) or behavioral weight loss (BWL) led to significant improvements in exercise capacity, as measured by the 6-minute walk test, among 61 veterans over a 6-month follow-up period.

Improvements in exercise capacity were associated with factors such as younger age, female gender, and increased dietary restraint, indicating that better eating habits may enhance overall physical performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement in 6-min Walk Test Distance Following Treatment for Behavioral Weight Loss and Disinhibited Eating: an Exploratory Secondary Analysis. Wooldridge, JS., Herbert, MS., Hernandez, J., et al.[2021]

The acceptance and commitment therapy (ACT) intervention significantly increased exercise tolerance time by 15% in low-active women, while the control group experienced an 8% decrease, indicating that ACT can enhance performance during high-intensity cycling.

Participants in the ACT group reported lower perceived effort during exercise and higher enjoyment post-exercise compared to the control group, suggesting that ACT not only improves physical performance but also enhances the overall exercise experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptance and commitment therapy improves exercise tolerance in sedentary women. Ivanova, E., Jensen, D., Cassoff, J., et al.[2022]

This study aims to test a brief workshop intervention based on acceptance and commitment therapy (ACT) to help 48 inactive adults with overweight or obesity increase their moderate-to-vigorous physical activity (MVPA) over 3 months.

The intervention focuses on enhancing values-based autonomous motivation through values clarification and acceptance skills, with assessments conducted at baseline, 3 months, and 6 months to evaluate feasibility, acceptability, and preliminary efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Values-based and acceptance-based intervention to promote adoption and maintenance of habitual physical activity among inactive adults with overweight/obesity: a study protocol for an open trial. Lillis, J., Bond, DS.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

Preliminary Evaluation of a 1-Day Acceptance and Commitment Therapy Workshop for Increasing Moderate-to-Vigorous Physical Activity in Adults with Overweight or Obesity. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Physical Activity Intentions and Behavior Mediate Treatment Response in an Acceptance-Based Weight Loss Intervention. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Effectiveness of Acceptance and Commitment Therapy (ACT) interventions for promoting physical activity: a systematic review and meta-analysis. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

A pilot study of acceptance and commitment therapy for promotion of physical activity. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Improvement in 6-min Walk Test Distance Following Treatment for Behavioral Weight Loss and Disinhibited Eating: an Exploratory Secondary Analysis. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Acceptance and commitment therapy improves exercise tolerance in sedentary women. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Values-based and acceptance-based intervention to promote adoption and maintenance of habitual physical activity among inactive adults with overweight/obesity: a study protocol for an open trial. [2020]