What side effects are associated with this type of intervention?

Common treatments for obesity that incorporate mindfulness techniques and motivational interviewing, such as Mindfulness-based Motivational Interviewing (MM-based-MI), generally have minimal side effects. These behavioral interventions primarily focus on promoting healthier behaviors and reducing stress. Potential side effects may include temporary increases in anxiety or emotional discomfort as individuals confront and modify their eating habits and lifestyle choices. However, these effects are usually mild and transient. Overall, these treatments are considered safe and beneficial for improving mental well-being and promoting sustainable weight management.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of obesity, including orlistat, phentermine-topiramate, naltrexone-bupropion, liraglutide, and semaglutide. These medications work through various mechanisms such as appetite suppression, increased satiety, and reduced fat absorption. While these pharmacological treatments are effective, combining them with behavioral therapies like Cognitive Behavioral Therapy (CBT) and mindfulness-based interventions can enhance outcomes. Mindfulness-based Motivational Interviewing (MM-based-MI) is a novel approach that integrates mindfulness techniques with motivational interviewing to promote healthier behaviors and reduce stress, potentially offering a complementary strategy to existing pharmacotherapies for obesity.

What other types of research exist?

Promising, novel alternatives to Mindfulness-based Motivational Interviewing for obesity patients include: 1) Cognitive-Behavioral Therapy (CBT) tailored for weight loss, which focuses on changing dysfunctional thoughts and behaviors related to eating and physical activity. 2) Digital self-help interventions, such as internet-based guided self-help programs and smartphone applications, which provide structured support and monitoring. 3) Integrative therapies like Mindfulness-Oriented Recovery Enhancement (MORE), which combines mindfulness with cognitive-behavioral techniques to enhance self-regulation and reduce stress. 4) Comprehensive lifestyle interventions that incorporate dietary counseling, physical activity, and behavioral strategies to promote sustainable weight loss and improve overall health.

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Mindfulness-Based Intervention for Obesity (MHFproject Trial)

N/A

Waitlist Available

Led By Tsui-Sui A Kao, PhD

Research Sponsored by Michigan State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline parent's mindful eating scores at 4 -6 months after baseline assessment.

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a program that teaches mindfulness and motivational techniques to overweight or obese parents in rural/suburban Michigan. The goal is to help these parents make healthier lifestyle choices for themselves and their families through online sessions and motivational messages.

Who is the study for?

This trial is for families in rural or suburban Michigan with one overweight/obese parent (BMI between 25 and 45) and a child aged 3-6. Both must enroll together. It's not open to those who are mentally/physically disabled or pregnant women.

What is being tested?

The study tests a mindfulness-based Motivational Interviewing intervention via online sessions every other week, comparing it to receiving educational materials by mail. Measurements like BMI, body fat percentage, waist circumference, blood pressure, and stress levels will be tracked.

What are the potential side effects?

Since the interventions involve behavioral therapy (mindfulness and motivation techniques) and education rather than medication, significant physical side effects are not expected; however, participants may experience emotional discomfort.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ changes from baseline to post intervention about 4-6 months after baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~changes from baseline to post intervention about 4-6 months after baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and changes from baseline to post intervention about 4-6 months after baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Parents' Healthy Eating Index (HEI) converted from ASA24

Secondary study objectives

Centre for Epidemiological Studies Depression Scale (CES-D10)

Child's Physical Activity

Collective family efficacy (parents)

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: MM-based MI groupExperimental Treatment1 Intervention

Intervention group parents will receive 9 intervention sessions every other week by trained staff via 9 online sessions via Zoom or phone calls. Each intervention session will last 30-40 minutes. Intervention group parents will receive 3 text messages per week. No in-person contacts will be conducted without MSU department permission. All assessments will be delivered remotely with guided phone calls or zoom conference. The assessment of dyads' BMI, %BF, and WC will be obtained remotely from the parents using the scale and measuring tape delivered to their home.

Group II: Control groupExperimental Treatment1 Intervention

Control group parents will receive a total of 9 emailed packets of educational materials (without information related to the mindfulness-based motivational interviewing \[MM-based-MI\]). The pre and post assessments will be collected the same way as the participants at intervention group.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The combination of mindfulness techniques and motivational interviewing in obesity treatment works by enhancing awareness and acceptance of thoughts and feelings related to eating and body image, while also resolving ambivalence and building intrinsic motivation for behavior change. This dual approach helps patients develop healthier eating habits, manage stress, and sustain long-term weight management. This is important for obesity patients as it addresses both psychological and behavioral aspects, promoting a holistic and sustainable approach to weight loss.

Impact on mindfulness, emotion regulation, and emotional overeating of a DBT skills training group: a pilot study.Mindfulness-Oriented Recovery Enhancement versus CBT for co-occurring substance dependence, traumatic stress, and psychiatric disorders: Proximal outcomes from a pragmatic randomized trial.