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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a psychological approach can help individuals maintain regular exercise and prevent weight gain after bariatric surgery. The study compares two methods: one uses Acceptance and Commitment Therapy-Based Physical Activity Intervention to improve motivation and manage the discomfort of physical activity, while the other offers educational support on exercise and behavior strategies. Individuals who have undergone Roux-en-Y gastric bypass or sleeve gastrectomy at Hartford Hospital or a related center and have maintained most of their weight loss may be suitable candidates. Participants will engage in online workshops, complete short homework tasks, have calls with a counselor, and track their activity and weight over 18 months. As an unphased trial, this study provides a unique opportunity to explore new strategies for maintaining weight loss and enhancing well-being after surgery.

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 prior data suggests that this psychological intervention is safe for increasing physical activity?

Research has shown that Acceptance and Commitment Therapy (ACT) is generally safe for people. In a previous study, a short ACT workshop proved both feasible and well-received by participants, indicating that attendees managed it well and found it helpful. Another study demonstrated that ACT, combined with mindfulness techniques, improved participants' quality of life related to their weight.

Additionally, ACT has effectively encouraged healthy habits, such as boosting motivation to exercise. This suggests that people are more likely to exercise regularly without feeling pressured. In one study, an ACT program increased the ability to exercise longer by 15% in women who were not very active before.

Overall, these findings suggest that ACT is well-tolerated and can positively impact motivation and physical activity, making it a promising option for those looking to maintain their weight after surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Acceptance and Commitment Therapy-Based Physical Activity Intervention because it offers a fresh approach to tackling obesity by focusing on psychological factors. Unlike traditional treatments that often emphasize strict exercise regimens or diet plans, this intervention uses values-clarification and acceptance strategies to boost motivation for physical activity. This method encourages participants to align their activities with personal values, potentially leading to more sustainable lifestyle changes. Additionally, the intervention is delivered through group workshops, email feedback, and support calls, providing a supportive community environment that can enhance engagement and success.

What evidence suggests that this psychological intervention is effective for increasing physical activity and preventing weight regain after bariatric surgery?

Research has shown that Acceptance and Commitment Therapy (ACT) can aid in weight management. In this trial, participants may receive the ACT-Based Physical Activity Intervention, which studies have found to be as effective as, or sometimes better than, standard weight loss treatments. This intervention can also enhance how weight impacts quality of life. ACT boosts motivation for exercise and improves mental well-being. Although evidence is mixed, many studies suggest that ACT shows promise in encouraging physical activity and managing weight. Another group in this trial will receive the Physical Activity Education Intervention, which offers didactic instruction on physical activity and behavioral strategies for achieving prescribed physical activity goals. ^{2 6 7 8 9}

Who Is on the Research Team?

Dale S Bond, PhD

Principal Investigator

Hartford Hospital

Are You a Good Fit for This Trial?

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.

Able to provide consent

Willing to engage in and complete the study protocol

Exclusion Criteria

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

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

Are pregnant, lactating, <6-months postpartum or plan to become pregnant during the course of the study

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9918584/

Effectiveness of acceptance and commitment therapy on ...

The effectiveness of ACT in this application was found to be of limited effectiveness in changing weight-related outcomes and eating behaviours.

2.

link.springer.com

link.springer.com/article/10.1007/s13679-025-00634-y

Acceptance and Commitment Therapy for Obesity

Current data indicate that ACT-based interventions produce comparable, or, in some cases, superior weight loss compared to standard behavioral interventions.

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S2212144724001078

An acceptance and commitment therapy and mindfulness ...

This study suggests that an ACT and mindfulness-based group intervention could produce improvements in the impact of weight on quality of life.

4.

semanticscholar.org

semanticscholar.org/paper/Effectiveness-of-Acceptance-and-Commitment-Therapy-Pears-Sutton/e56e6f5f3811292eae514512fb15ac7a35daf3b6

Effectiveness of Acceptance and Commitment Therapy ...

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

5.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/full/10.1002/cpp.2695

The effectiveness of acceptance and commitment therapy ...

This work provides support for ACT to enhance psychological well-being in people with overweight or obesity, and the results are promising for ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9917958/

Preliminary Evaluation of a 1-Day Acceptance and ...

This single-arm trial aimed to test the feasibility, acceptability, and preliminary efficacy of a 4-h acceptance and commitment therapy (ACT)-based workshop ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06484621?spons=NIDDK&aggFilters=status:rec&viewType=Table&rank=9

Motivating Increases in Physical Activity for Prevention of ...

Acceptance and Commitment Therapy (ACT)-based interventions are effective at promoting health behavior changes via improved autonomous (or internal) motivation.

8.

bmjopen.bmj.com

bmjopen.bmj.com/content/9/1/e025115

Values-based and acceptance-based intervention to ...

This study integrates two robust theories relevant to health behaviour change (self-determination theory, and acceptance and commitment therapy) to develop a ...

9.

withpower.com

withpower.com/trial/phase-obesity-7-2024-960ed

Physical Activity Intervention for Obesity

The acceptance and commitment therapy (ACT) intervention significantly increased exercise tolerance time by 15% in low-active women, while the control group ...