Acceptance-Based Treatment for Adolescent Obesity

Overseen By Stephanie Manasse, PhD

Age: < 65

Sex: Female

Trial Phase: Academic

Sponsor: Drexel University

Must not be taking: Appetite suppressants

Disqualifiers: Diabetes, Cancer, Cardiovascular disease, others

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

Compensation: Varies

Number of Visits: 30

Duration: 6 months

148 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new methods to help adolescent girls manage weight and reduce heart disease risk. It compares an acceptance-based healthy lifestyle program (Acceptance-Based Treatment) with standard health education to determine which is more effective for weight loss and overall health improvement. Participants will attend sessions at Drexel University or online, focusing on healthy habits and lifestyle changes. The trial seeks girls aged 14-19 who struggle with overweight issues. As an unphased trial, it offers a unique opportunity to contribute to innovative research and potentially improve personal health outcomes.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you have recently started or changed the dosage of any medication that affects appetite or body composition, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that Acceptance-Based Treatment (ABT) for adolescent obesity is generally well-received. Studies have found this method practical and suitable for a wide range of adolescent girls dealing with overweight and obesity. Participants in ABT programs often express high satisfaction and experience improvements in body mass index (BMI) and psychological flexibility, which refers to how well someone can handle changes and stress.

No reports of serious side effects have been linked to ABT, suggesting participants tolerate it well. Since ABT focuses on lifestyle changes and mindset rather than medication, it usually carries fewer risks. The evidence so far supports its safety and effectiveness for managing weight. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Acceptance-Based Treatment (ABT) for adolescent obesity because it offers a fresh approach compared to traditional methods like diet and exercise plans. ABT focuses on helping teens build a healthier relationship with food through mindfulness and acceptance strategies, which can be more sustainable and effective in managing weight long-term. Unlike typical treatments that concentrate purely on physical changes, ABT addresses the psychological aspects of eating behavior, potentially leading to more lasting results. With its emphasis on mental well-being and behavioral change, ABT might provide the tools adolescents need to maintain a healthy weight and lifestyle beyond the initial treatment period.

What evidence suggests that this trial's treatments could be effective for adolescent obesity?

Research shows that acceptance-based treatment (ABT), which participants in this trial may receive, helps adults lose weight and appears promising for teenagers as well. Studies have found that ABT is manageable and worthwhile for teens. Some evidence indicates that ABT can help teens manage their weight and improve their health if they are overweight or obese. Acceptance and Commitment Therapy (ACT), a type of ABT, has proven to be as effective or even better than standard weight loss treatments. These findings suggest that ABT could improve weight and health in teenagers. ^{1 2 3 6 7}

Who Is on the Research Team?

Stephanie Manasse, PhD

Principal Investigator

Drexel University

Are You a Good Fit for This Trial?

This trial is for adolescent girls aged 14-19 who are experiencing obesity, with a BMI percentile at or above the 85th percentile for their sex and age. It's designed to help them lose weight and improve cardiovascular health.

Inclusion Criteria

My BMI is in the top 15% for my age and sex.

I am between 14 and 19 years old.

I identify as a girl.

Exclusion Criteria

Plans to move out of the area within the next year

Unwillingness to report possible or confirmed pregnancies promptly during the course of the trial

Recent or ongoing problem with drug abuse, alcohol abuse, or addiction

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 6-month intervention, including acceptance-based therapy or health education, with a mix of in-person and remote group sessions

6 months

18 sessions (in-person and remote for ABT), 9 sessions (in-person and remote for HE)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 6-month and 12-month intervals

12 months

Assessments at month 12 and month 18

What Are the Treatments Tested in This Trial?

Interventions

• Acceptance-Based Treatment

Trial Overview The study compares two methods: an acceptance-based healthy lifestyle intervention (ABT) versus standard health education (HE). Over six months, participants will attend both in-person and remote sessions to see which method leads to more weight loss and better health outcomes.

How Is the Trial Designed?

Group I: Acceptance-based Treatment (ABT) Experimental Treatment 1 Intervention

ABT will consist of 18, 90-minute group sessions over 6 months.

Group II: Health Education (HE) Comparison Placebo Group 1 Intervention

HE will include nine, 75-minute group health education sessions handouts over 6 months.

Who Is Running the Clinical Trial?

Drexel University

Lead Sponsor

Trials

160

Recruited

48,600+

Published Research Related to This Trial

Acceptance-based behavioral treatment (ABT) led to significantly greater weight loss compared to standard behavioral treatment (SBT) when administered by experts, with participants losing an average of 13.17% versus 7.54% at post-treatment.

ABT was particularly effective for individuals more susceptible to eating cues, such as those with higher depression symptoms, showing a weight loss of 11.18% compared to 4.63% in SBT, highlighting the potential of ABT in enhancing weight loss outcomes for vulnerable populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The mind your health project: a randomized controlled trial of an innovative behavioral treatment for obesity. Forman, EM., Butryn, ML., Juarascio, AS., et al.[2022]

In a pilot study involving 40 adolescent girls, the acceptance-based therapy (ABT) intervention led to a significant decrease in weight-related outcomes (%BMIp95) compared to enhanced care, suggesting its potential effectiveness for weight loss in this population.

While the ABT group showed improvements in psychological flexibility, the overall intervention effects were not significantly different from enhanced care, indicating that further research is needed to optimize ABT for adolescents, especially in virtual settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wellness Achieved Through Changing Habits: A Randomized Controlled Trial of an Acceptance-Based Intervention for Adolescent Girls With Overweight or Obesity. Newsome, FA., Cardel, MI., Chi, X., et al.[2023]

Participants with overweight and obesity who underwent a revised acceptance-based behavioral treatment (ABT) lost significantly more weight over 12 months (13.3%) compared to those receiving standard behavioral treatment (SBT) (9.8%), indicating that ABT is more effective for long-term weight loss.

ABT not only led to greater weight loss but also helped participants maintain a 10% weight loss better than SBT (64.0% vs. 48.9%), suggesting that the self-regulation skills taught in ABT, such as psychological acceptance and motivation, play a crucial role in successful weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptance-based versus standard behavioral treatment for obesity: Results from the mind your health randomized controlled trial. Forman, EM., Butryn, ML., Manasse, SM., et al.[2022]

In a study of 162 adults with overweight or obesity, the acceptance-based behavioral intervention (ABBI) led to a greater maintenance of weight loss over 24 months compared to standard behavioral treatment (SBT), with participants regaining less weight after the initial treatment period.

ABBI participants were also more successful in achieving a 5% weight loss, with 38% reaching this goal compared to 25% in the SBT group, indicating that ABBI may be particularly effective for individuals with high internal disinhibition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of an acceptance-based behavioral intervention for weight loss in people with high internal disinhibition. Lillis, J., Niemeier, HM., Thomas, JG., et al.[2022]

The acceptance-based therapy (ABT) intervention for adolescent girls with overweight/obesity was feasible and acceptable, achieving a recruitment of 13 participants and an 85% retention rate over 6 months.

Participants showed a mean decrease in BMI Z-score of -0.15, along with improvements in body fat percentage, quality of life, psychological flexibility, and depression, indicating the intervention's potential effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility/acceptability of an acceptance-based therapy intervention for diverse adolescent girls with overweight/obesity. Cardel, MI., Lee, AM., Chi, X., et al.[2022]

In the Mind Your Health Trial involving 190 participants, acceptance-based treatment (ABT) for obesity led to a significantly higher proportion of individuals maintaining a 10% weight loss at 36 months compared to standard behavioral treatment (SBT) (31.6% vs. 17.1%).

ABT also resulted in improved quality of life at 24 and 36 months, suggesting that while initial weight loss benefits may diminish over time, the psychological and motivational aspects of ABT contribute to better long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Follow-up of the Mind Your Health Project: Acceptance-Based versus Standard Behavioral Treatment for Obesity. Forman, EM., Manasse, SM., Butryn, ML., et al.[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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10734897/

A Randomized Controlled Trial of an Acceptance-Based ... Acceptance-based therapy (ABT) is effective for weight loss in adults and feasible and acceptable for weight loss among adolescents. This pilot randomized ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06147973

An Acceptance-Based Healthy Lifestyle Intervention for ... The objective of this proposal is to test the efficacy of a novel ABT weight loss intervention tailored for adolescent girls with OW/OB. This trial is the first ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8170570/

Feasibility/acceptability of an acceptance‐based therapy ... This study assessed the feasibility and acceptability of an ABT healthy lifestyle intervention among diverse adolescent cisgender girls with overweight/obesity ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2212144723001266

The acceptability, feasibility and preliminary efficacy of ... ACT for weight management showed high acceptability among adolescents. Studies demonstrate some evidence that ACT may yield support for weight management.

5. 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.

6. withpower.com withpower.com/trial/phase-overweight-and-obesity-2024-8e54b

Acceptance-Based Treatment for Adolescent Obesity In a study, adolescent girls who participated in an ABT intervention showed a decrease in BMI and improvements in psychological flexibility compared to those ...

7. liebertpub.com liebertpub.com/doi/10.1089/chi.2022.0116

Wellness Achieved Through Changing Habits This study assessed the effectiveness of an ABT intervention for adolescent girls with overweight and obesity. The intervention was developed in collaboration ...